Quantitative work demands, emotional demands, and cognitive stress symptoms in surgery nurses.

PubMed

Elfering, Achim; Grebner, Simone; Leitner, Monika; Hirschmüller, Anja; Kubosch, Eva Johanna; Baur, Heiner

2017-06-01

In surgery, cognitive stress symptoms, including problems in concentrating, deciding, memorising, and reflecting are risks to patient safety. Recent evidence points to social stressors as antecedents of cognitive stress symptoms in surgery personnel. The current study tests whether cognitive stress symptoms are positively associated with emotional abuse, emotional- and task-related demands and resources in surgery work. Forty-eight surgery nurses from two hospitals filled out the Copenhagen Psychosocial Questionnaire in its German version. Task-related and emotional demands were positively related to cognitive stress symptoms. In a stepwise, multiple, linear regression of cognitive stress symptoms on task-related and emotional demands, emotional abuse and emotional demands were unique predictors (p < .05). Efforts to increase patient safety should address emotional abuse, emotional demands, and, therefore, communication and cooperation team climate in surgery personnel.

Effects of hospital safety-net burden and hospital volume on failure to rescue after open abdominal aortic surgery.

PubMed

Rosero, Eric B; Joshi, Girish P; Minhajuddin, Abu; Timaran, Carlos H; Modrall, J Gregory

2017-08-01

Failure to rescue (FTR) is defined as the inability to rescue a patient from major perioperative complications, resulting in operative mortality. FTR is a known contributor to operative mortality after open abdominal aortic surgery. Understanding the causes of FTR is essential to designing interventions to improve perioperative outcomes. The objective of this study was to determine the relative contributions of hospital volume and safety-net burden (the proportion of uninsured and Medicaid-insured patients) to FTR. The Nationwide Inpatient Sample (2001-2011) was analyzed to investigate variables associated with FTR after elective open abdominal aortic operations in the United States. FTR was defined as in-hospital death following postoperative complications. Mixed multivariate regression models were used to assess independent predictors of FTR, taking into account the clustered structure of the data (patients nested into hospitals). A total of 47,233 elective open abdominal aortic operations were performed in 1777 hospitals during the study period. The overall incidences of postoperative complications, in-hospital mortality, and FTR in the whole cohort were 32.7%, 3.2%, and 8.6%, respectively. After adjusting for demographics, comorbidities, and hospital characteristics, safety-net burden was significantly associated with increased likelihood of FTR (highest vs lowest quartile of safety-net burden, odds ratio, 1.59; 95% confidence interval, 1.32-1.91; P < .0001). In contrast, after adjusting for safety-net burden, procedure-specific hospital volume was not significantly associated with FTR (P = .897). After adjusting for patient- and hospital-level variables, including hospital volume, safety-net burden was an independent predictor of FTR after open aortic surgery. Future investigations should be aimed at better understanding the relationship between safety-net hospital burden and FTR to design interventions to improve outcomes after open abdominal aortic surgery. Copyright © 2017 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Safety of Laparoscopic Surgery for Colorectal Cancer in Patients with Severe Comorbidities.

PubMed

Sawazaki, Sho; Numata, Masakatsu; Morita, Junya; Maezawa, Yukio; Amano, Shinya; Aoyama, Toru; Tamagawa, Hiroshi; Sato, Tsutomu; Oshima, Takashi; Mushiake, Hiroyuki; Yukawa, Norio; Shiozawa, Manabu; Rino, Yasushi; Masuda, Munetaka

2018-06-01

Previous studies have shown that laparoscopic colorectal cancer surgery is highly safe and effective compared to laparotomy. However, whether laparoscopic colorectal cancer surgery can be safely performed in patients with severe comorbidities remains unclear. The aim of this study was to evaluate the safety of laparoscopic colorectal cancer surgery in patients with severe comorbidities. A total of 82 consecutive patients with colorectal cancer who underwent laparoscopic surgery were retrospectively divided into two groups according to whether they had severe comorbidity (50 patients) or non-severe comorbidity (32 patients). An age-adjusted Charlson comorbidity index of ≥6 was defined as severe comorbidity. Operative time, blood loss, and rate of conversion to laparotomy did not differ between the groups. Postoperative complications and the length of the postoperative hospital stay also did not differ significantly between the groups. Laparoscopic colorectal cancer surgery is feasible and safe, even in patients with severe comorbidities. Copyright© 2018, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.

Safety and efficacy of endovascular therapy and gamma knife surgery for brain arteriovenous malformations in China: Study protocol for an observational clinical trial.

PubMed

Jin, Hengwei; Huo, Xiaochuan; Jiang, Yuhua; Li, Xiaolong; Li, Youxiang

2017-09-01

Brain arteriovenous malformations (BAVMs) are associated with high morbidity and mortality. The treatment of BAVM remains controversial. Microinvasive treatment, including endovascular therapy and gamma knife surgery, has been the first choice in many conditions. However, the overall clinical outcome of microinvasive treatment remains unknown and a prospective trial is needed. This is a prospective, non-randomized, and multicenter observational registry clinical trial to evaluate the safety and efficacy of microinvasive treatment for BAVMs. The study will require up to 400 patients in approximately 12 or more centers in China, followed for 2 years. Main subjects of this study are BAVM patients underwent endovascular therapy and/or gamma knife surgery. The trial will not affect the choice of treatment modality. The primary outcomes are perioperative complications (safety), and postoperative hemorrhage incidence rate and complete occlusion rate (efficacy). Secondary outcomes are elimination of hemorrhage risk factors (coexisting aneurysms and arteriovenous fistula), volume reduction and remission of symptoms. Safety and efficacy of endovascular therapy, gamma knife surgery, and various combination modes of the two modalities will be compared. Operative complications and outcomes at pretreatment, post-treatment, at discharge and at 3 months, 6 months and 2 years follow-up intervals will be analyzed using the modified Rankin Scale (mRS). The most confusion on BAVM treatment is whether to choose interventional therapy or medical therapy, and the choice of interventional therapy modes. This study will provide evidence for evaluating the safety and efficacy of microinvasive treatment in China, to characterize the microinvasive treatment strategy for BAVMs.

Pediatric emergency and essential surgical care in Zambian hospitals: a nationwide study.

PubMed

Bowman, Kendra G; Jovic, Goran; Rangel, Shawn; Berry, William R; Gawande, Atul A

2013-06-01

Pediatric surgical care in developing countries is not well studied. We sought to identify the range of pediatric surgery available, the barriers to provision, and level of safety of surgery performed for the entire pediatric population in Zambia. In cooperation with the Ministry of Health, we validated and adapted a World Health Organization instrument. During onsite visits, the availability of 32 emergency and essential surgical procedures relevant to children was surveyed. The availability of basic World Health Organization surgical safety criteria was determined. A single interviewer visited 103 (95%) of 108 surgical hospitals in Zambia and carried out 495 interviews. An average of 68% of the 32 emergency and essential surgical procedures was available (range 32%-100%). Lack of surgical skill was the primary reason for referral in 72% of procedure types, compared with 24%, 2% and 3% due to lack of equipment, supplies and anesthesia skills, respectively (p<0.001). Minimum pediatric surgical safety criteria were met by 14% of hospitals. The primary limitation to providing pediatric surgical care in Zambia is lack of surgical skills. Minimum safety standards were met by 14% of hospitals. Efforts to improve pediatric surgery should prioritize teaching surgical skills to expand access and providing safety training, equipment and supplies to increase safety. Copyright © 2013 Elsevier Inc. All rights reserved.

Using human factors engineering to improve patient safety in the cardiovascular operating room.

PubMed

Gurses, Ayse P; Martinez, Elizabeth A; Bauer, Laura; Kim, George; Lubomski, Lisa H; Marsteller, Jill A; Pennathur, Priyadarshini R; Goeschel, Chris; Pronovost, Peter J; Thompson, David

2012-01-01

Despite significant medical advances, cardiac surgery remains a high risk procedure. Sub-optimal work system design characteristics can contribute to the risks associated with cardiac surgery. However, hazards due to work system characteristics have not been identified in the cardiovascular operating room (CVOR) in sufficient detail to guide improvement efforts. The purpose of this study was to identify and categorize hazards (anything that has the potential to cause a preventable adverse patient safety event) in the CVOR. An interdisciplinary research team used prospective hazard identification methods including direct observations, contextual inquiry, and photographing to collect data in 5 hospitals for a total 22 cardiac surgeries. We performed thematic analysis of the qualitative data guided by a work system model. 60 categories of hazards such as practice variations, high workload, non-compliance with evidence-based guidelines, not including clinicians' in medical device purchasing decisions were found. Results indicated that hazards are common in cardiac surgery and should be eliminated or mitigated to improve patient safety. To improve patient safety in the CVOR, efforts should focus on creating a culture of safety, increasing compliance with evidence based infection control practices, improving communication and teamwork, and designing better tools and technologies through partnership among all stakeholders.

A strategic approach to quality improvement and patient safety education and resident integration in a general surgery residency.

PubMed

O'Heron, Colette T; Jarman, Benjamin T

2014-01-01

To outline a structured approach for general surgery resident integration into institutional quality improvement and patient safety education and development. A strategic plan to address Accreditation Council for Graduate Medical Education (ACGME) Clinical Learning Environment Review assessments for resident integration into Quality Improvement and Patient Safety initiatives is described. Gundersen Lutheran Medical Foundation is an independent academic medical center graduating three categorical residents per year within an integrated multi-specialty health system serving 19 counties over 3 states. The quality improvement and patient safety education program includes a formal lecture series, online didactic sessions, mandatory quality improvement or patient safety projects, institutional committee membership, an opportunity to serve as a designated American College of Surgeons National Surgical Quality Improvement Project and Quality in Training representative, mandatory morbidity and mortality conference attendance and clinical electives in rural surgery and international settings. Structured education regarding and participation in quality improvement and patient safety programs are able to be accomplished during general surgery residency. The long-term outcomes and benefits of these strategies are unknown at this time and will be difficult to measure with objective data. © 2013 Published by Association of Program Directors in Surgery on behalf of Association of Program Directors in Surgery.

Robotic hepatectomies: advances and perspectives.

PubMed

Dehlawi, Ammar; Memeo, Riccardo; DE Blasi, Vito; Mercoli, Henry A; Mutter, Didier; Marescaux, Jacques; Pessaux, Patrick

2016-12-01

Over recent years, minimally invasive hepatic resections have increasingly been reported in the literature. Even though hepatic surgery is still considered a challenge for surgeons due to its technical difficulties and high morbidity, the development and spread of robotic surgery has highlighted a new interest, which has induced a rapid dissemination of robotic approaches for hepatic pathologies. This article presents a systematic review of the literature regarding robotic hepatectomy in order to assess the safety and feasibility of robotic hepatic surgery. All eligible studies in robotic liver surgery which were published between January 2001 and January 2016 were reviewed systematically. Only series of ten patients and more were chosen in order to consider the experience of high-volume centers. In case of multiple articles on the same centers, the study including the largest number of patients was considered for the study. Overall, 18 studies, involving a total of 572 robotic liver resection (RLR) were finally analyzed. All articles in this review demonstrate that robotic liver surgery must be performed by surgeons trained in open liver surgery and skilled in minimally invasive techniques. RLR and laparoscopic liver resection (LLR) were comparable in terms of safety, feasibility, and outcome for hepatectomies. However, RLR is more expensive than LLR. Further studies are required before any final conclusion can be drawn.

Ketorolac as an analgesic agent for infants and children after cardiac surgery: safety profile and appropriate patient selection.

PubMed

Jalkut, Meredith K

2014-01-01

Ketorolac has been used safely as an analgesic agent for children following cardiac surgery in selected populations. Controversy exists among institutions about the risks involved with this medication in this patient group. This article reviews the current literature regarding the safety of ketorolac for postoperative pain management in children after cardiac surgery. Specifically, concerns about renal dysfunction and increased bleeding risk are addressed. Additionally, the article details pharmacokinetics and potential benefits of ketorolac, such as its opioid-sparing effect. The literature reflects that the use of this medication is not well studied in certain pediatric cardiac patients such as neonates and those with single-ventricle physiology, and the safety of this medication in regards to these special populations is reviewed. In conclusion, ketorolac can be used in specific pediatric patients after cardiac surgery with minimal risk of bleeding or renal dysfunction with appropriate dosing and duration of use.

Professional liability claims in vascular surgery practice.

PubMed

Roche, Enric; Gómez-Durán, Esperanza L; Benet-Travé, Josep; Martin-Fumadó, Carles; Arimany-Manso, Josep

2014-02-01

Patient safety is a major concern worldwide, but particularly high rates of adverse events are reported in the surgery setting. Angiology and vascular surgery is of special interest due to the complexity of the pathologies involved and the esthetic component of some of its procedures. In this study we identified the most frequent factors that apply to vascular surgery claims to determine areas of special risk in vascular surgery, with an aim to improve patient safety. We performed a retrospective and descriptive study of the claims pertaining to vascular surgery from the database of the Service of Professional Liability (SRP) of the Official College of Physicians of Barcelona. The time frame of data collection was from 1986 to 2009. We analyzed both the clinical and legal characteristics of the cases. Of the total of 6952 registered claims during the 23-year period, 91 (1.3%) were related to the practice of vascular surgery. Of these, 53.8% were related to venous pathology and 46.1% to arterial pathology. Neurologic damage was the main motive for claims (15.3%), followed by thromboembolic disease (14.2%), burns as a result of cosmetic treatment (12%), and amputation (10.9%). The neurologic damage in relation to vein pathology registered the greatest proportion of cases with professional liability (30.8%), followed by burns (19.2%), forgotten gauze (11.5%), and amputations (11.5%). Angiology and vascular surgery does not seem to be a specialty with a high risk for claims, but complications, such as thromboembolic disease and neurologic damage after varicose vein intervention, do occur and deserve special attention so improvements can be made to patient safety. Copyright © 2014 Elsevier Inc. All rights reserved.

Surgeon Training in Telerobotic Surgery via a Hardware-in-the-Loop Simulator

PubMed Central

Alemzadeh, Homa; Chen, Daniel; Kalbarczyk, Zbigniew; Iyer, Ravishankar K.; Kesavadas, Thenkurussi

2017-01-01

This work presents a software and hardware framework for a telerobotic surgery safety and motor skill training simulator. The aims are at providing trainees a comprehensive simulator for acquiring essential skills to perform telerobotic surgery. Existing commercial robotic surgery simulators lack features for safety training and optimal motion planning, which are critical factors in ensuring patient safety and efficiency in operation. In this work, we propose a hardware-in-the-loop simulator directly introducing these two features. The proposed simulator is built upon the Raven-II™ open source surgical robot, integrated with a physics engine and a safety hazard injection engine. Also, a Fast Marching Tree-based motion planning algorithm is used to help trainee learn the optimal instrument motion patterns. The main contributions of this work are (1) reproducing safety hazards events, related to da Vinci™ system, reported to the FDA MAUDE database, with a novel haptic feedback strategy to provide feedback to the operator when the underlying dynamics differ from the real robot's states so that the operator will be aware and can mitigate the negative impact of the safety-critical events, and (2) using motion planner to generate semioptimal path in an interactive robotic surgery training environment. PMID:29065635

A Preliminary Report on the CO2 Laser for Lumbar Fusion: Safety, Efficacy and Technical Considerations.

PubMed

Villavicencio, Alan T; Burneikiene, Sigita; Babuska, Jason M; Nelson, Ewell L; Mason, Alexander; Rajpal, Sharad

2015-04-01

The purpose of this study was to evaluate potential technical advantages of the CO2 laser technology in mini-open transforaminal lumbar interbody fusion (TLIF) surgeries and report our preliminary clinical data on the safety and clinical outcomes. There is currently no literature discussing the recently redeveloped CO2 laser technology application for lumbar fusion. Safety and clinical outcomes were compared between two groups: 24 patients that underwent CO2 laser-assisted one-level TLIF surgeries and 30 patients that underwent standard one-level TLIF surgeries without the laser. There were no neural thermal injuries or other intraoperative laser-related complications encountered in this cohort of patients. At a mean follow-up of 17.4 months, significantly reduced lower back pain scores (P=0.013) were reported in the laser-assisted patient group compared to a standard fusion patient group. Lower extremity radicular pain intensity scores were similar in both groups. Laser-assisted TLIF surgeries showed a tendency (P = 0.07) of shorter operative times that was not statistically significant. Based on this preliminary clinical report, the safety of the CO2 laser device for lumbar fusion surgeries was assessed. There were no neural thermal injuries or other intraoperative laser-related complications encountered in this cohort of patients. Further investigation of CO2 laser-assisted lumbar fusion procedures is warranted in order to evaluate its effect on clinical outcomes.

"The Jackson Table Is a Pain in the…": A Qualitative Study of Providers' Perception Toward a Spinal Surgery Table.

PubMed

Asiedu, Gladys B; Lowndes, Bethany R; Huddleston, Paul M; Hallbeck, Susan

2018-03-01

The aim of this study was to define health care providers' perceptions toward prone patient positioning for spine surgery using the Jackson Table, which has not been hitherto explored. We analyzed open-ended questionnaire data and interviews conducted with the spine surgical team regarding the current process of spinal positioning/repositioning using the Jackson Table. Participants were asked to provide an open-ended explanation as to whether they think the current process of spinal positioning/repositioning is safe for the staff or patients. Follow-up qualitative interviews were conducted with 11 of the participants to gain an in-depth understanding of the challenges and safety issues related to prone patient positioning. Data analysis resulted in 6 main categories: general challenges with patient positioning, role-specific challenges, challenges with the Jackson Table and the "sandwich" mechanism, safety concerns for patients, safety concerns for the medical staff, and recommendations for best practices. This study is relevant to everyday practice for spinal surgical team members and advances our understanding of how surgical teams qualitatively view the current process of patient positioning for spinal surgery. Providers recommended best practices for using the Jackson Table, which can be achieved through standardized practice for transfer of patients, educational tools, and checklists for equipment before patient transfer and positioning. This research has identified several important practice opportunities for improving provider and patient safety in spine surgery.

Semuloparin for prevention of venous thromboembolism after major orthopedic surgery: results from three randomized clinical trials, SAVE-HIP1, SAVE-HIP2 and SAVE-KNEE.

PubMed

Lassen, M R; Fisher, W; Mouret, P; Agnelli, G; George, D; Kakkar, A; Mismetti, P; Turpie, A G G

2012-05-01

Semuloparin is a novel ultra-low-molecular-weight heparin under development for venous thromboembolism (VTE) prevention in patients at increased risk, such as surgical and cancer patients. Three Phase III studies compared semuloparin and enoxaparin after major orthopedic surgery: elective knee replacement (SAVE-KNEE), elective hip replacement (SAVE-HIP1) and hip fracture surgery (SAVE-HIP2). All studies were multinational, randomized and double-blind. Semuloparin and enoxaparin were administered for 7-10 days after surgery. Mandatory bilateral venography was to be performed between days 7 and 11. The primary efficacy endpoint was a composite of any deep vein thrombosis, non-fatal pulmonary embolism or all-cause death. Safety outcomes included major bleeding, clinically relevant non-major (CRNM) bleeding, and any clinically relevant bleeding (major bleeding plus CRNM). In total, 1150, 2326 and 1003 patients were randomized in SAVE-KNEE, SAVE-HIP1 and SAVE-HIP2, respectively. In all studies, the incidences of the primary efficacy endpoint were numerically lower in the semuloparin group vs. the enoxaparin group, but the difference was statistically significant only in SAVE-HIP1. In SAVE-HIP1, clinically relevant bleeding and major bleeding were significantly lower in the semuloparin vs. the enoxaparin group. In SAVE-KNEE and SAVE-HIP2, clinically relevant bleeding tended to be higher in the semuloparin group, but rates of major bleeding were similar in the two groups. Other safety parameters were generally similar between treatment groups. Semuloparin was superior to enoxaparin for VTE prevention after hip replacement surgery, but failed to demonstrate superiority after knee replacement surgery and hip fracture surgery. Semuloparin and enoxaparin exhibited generally similar safety profiles. © 2012 International Society on Thrombosis and Haemostasis.

Differences in emergency colorectal surgery in Medicaid and uninsured patients by hospital safety net status.

PubMed

Bradley, Cathy J; Dahman, Bassam; Sabik, Lindsay M

2015-02-01

We examined whether safety net hospitals reduce the likelihood of emergency colorectal cancer (CRC) surgery in uninsured and Medicaid-insured patients. If these patients have better access to care through safety net providers, they should be less likely to undergo emergency resection relative to similar patients at non- safety net hospitals. Using population-based data, we estimated the relationship between safety net hospitals, patient insurance status, and emergency CRC surgery. We extracted inpatient admission data from the Virginia Health Information discharge database and matched them to the Virginia Cancer Registry for patients aged 21 to 64 years who underwent a CRC resection between January 1, 1999, and December 31, 2005 (n = 5488). We differentiated between medically defined emergencies and those that originated in the emergency department (ED). For each definition of emergency surgery, we estimated the linear probability models of the effects of being treated at a safety net hospital on the probability of having an emergency resection. Safety net hospitals reduce emergency surgeries among uninsured and Medicaid CRC patients. When defining an emergency resection as those that involved an ED visit, these patients were 15 to 20 percentage points less likely to have an emergency resection when treated in a safety net hospital. Our results suggest that these hospitals provide a benefit, most likely through the access they afford to timely and appropriate care, to uninsured and Medicaid-insured patients relative to hospitals without a safety net mission.

The second “time-out”: a surgical safety checklist for lengthy robotic surgeries

PubMed Central

2013-01-01

Robotic surgeries of long duration are associated with both increased risks to patients as well as distinct challenges for care providers. We propose a surgical checklist, to be completed during a second “time-out”, aimed at reducing peri-operative complications and addressing obstacles presented by lengthy robotic surgeries. A review of the literature was performed to identify the most common complications of robotic surgeries with extended operative times. A surgical checklist was developed with the goal of addressing these issues and maximizing patient safety. Extended operative times during robotic surgery increase patient risk for position-related complications and other adverse events. These cases also raise concerns for surgical, anesthesia, and nursing staff which are less common in shorter, non-robotic operations. Key elements of the checklist were designed to coordinate operative staff in verifying patient safety while addressing the unique concerns within each specialty. As robotic surgery is increasingly utilized, operations with long surgical times may become more common due to increased case complexity and surgeons overcoming the learning curve. A standardized surgical checklist, conducted three to four hours after the start of surgery, may enhance perioperative patient safety and quality of care. PMID:23731776

Safety of serotonin (5-HT3) receptor antagonists in patients undergoing surgery and chemotherapy: protocol for a systematic review and network meta-analysis.

PubMed

Tricco, Andrea C; Soobiah, Charlene; Antony, Jesmin; Hemmelgarn, Brenda; Moher, David; Hutton, Brian; Straus, Sharon E

2013-06-28

Serotonin (5-HT3) receptor antagonists are a class of antiemetic medications often used to prevent nausea and vomiting among patients undergoing chemotherapy, radiotherapy or surgery. However, recent studies suggest that these agents might be associated with increased cardiac harm. To examine this further, we are proposing to conduct a systematic review and network meta-analysis on the comparative safety of 5-HT3 receptor antagonists among patients undergoing chemotherapy or surgery. Studies reporting one or more safety outcomes of interest for 5-HT3 receptor antagonists compared with each other, placebo, and/or other anti-emetic agents (for example, benzamides, phenothiazines, butyrophenones, antihistamines, and anticholinergics) among children and adult patients undergoing surgery or chemotherapy will be included. Our primary outcome of interest is arrhythmia. Our secondary outcomes include cardiac death, QT prolongation, PR prolongation, all-cause mortality, nausea, and vomiting. We will include experimental studies, quasi-experimental studies (namely controlled before-after and interrupted time series), and observational studies (namely cohort studies). We will not limit inclusion by publication status, time period, duration of follow-up or language of dissemination.Electronic databases (for example, MEDLINE, EMBASE) will be searched from inception onwards. These main searches will be supplemented by searching for difficult to locate and unpublished studies, such as dissertations, and governmental reports. The eligibility criteria will be pilot-tested and subsequently used to screen the literature search results by two reviewers in duplicate. A similar process will be followed for full-text screening, data abstraction, and risk of bias/methodological quality appraisal. The Cochrane Risk of Bias tool will be used to appraise experimental and quasi-experimental studies, and cohort studies will be assessed using the Newcastle Ottawa Scale. If the data allows, random effects meta-analysis and a network (that is, mixed treatment comparisons) meta-analysis will be conducted. All analyses will be conducted separately for different study designs, patient populations (for example, children and adults), and reason for administering 5-HT3 receptor antagonists (for example, post-surgery and chemotherapy). Our results will help inform patients, clinicians, and health policy-makers about the potential safety concerns, as well as the comparative safety, of using these antiemetic agents. PROSPERO registry number:CRD42013003564.

The Role of Smile Train and the Partner Hospital Model in Surgical Safety, Collaboration, and Quality in the Developing World.

PubMed

Purnell, Chad A; McGrath, Jennifer L; Gosain, Arun K

2015-06-01

The partner hospital model identifies hospitals in the developing world to educate and enable local surgeons to deliver effective cleft care. This study aimed to determine the outcomes of this model on safety, education, and quality of surgical care. Twelve partner hospitals, sponsored by Smile Train for 5 or more years and distributed over 4 continents, were selected. Activities at each institution were evaluated using cleft surgical data, and surveys were completed by hospital leadership. A mean of 82% of cleft patients at partner hospitals underwent sponsored surgeries. After partnership, all 12 hospitals implemented preoperative checklists for cleft surgery, and 5 implemented checklists for other surgeries. All hospitals had personnel who received safety training as a result of partnership. There was no change in 30-day reoperations or readmissions. Follow-up rate increased by 18% (P = 0.03). Facilities recruited 1.8 additional cleft surgeons (P < 0.01) and increased the number of cleft surgical trainees by a mean of 13.3 annually (P = 0.012); 2.5 ± 1.7 additional ancillary services were added, resulting in 75% of partner hospitals having a basic multidisciplinary cleft team (surgery, speech, and dental) compared with 25% prior to partnership (P < 0.01). Total cleft surgeries, alveolar bone grafts, and percentage of secondary surgeries increased significantly as length of partnership progressed (P < 0.01). Smile Train's partner hospital model increases both the volume and quality of cleft care delivered at these institutions. Safety initiatives for cleft care demonstrate effects extending to global surgical care delivered at partner hospitals.

[Analgesic efficacy and clinical safety of intraperitoneal instillation combined with rectus sheath block using ropivacaine for pain relief after laparoscopic gynecological surgery].

PubMed

Yakoshi, Chihiro; Hashimoto, Hiroshi; Niwa, Hidetomo; Kitayama, Masatou; Kudo, Tsuyoshi; Kudo, Mihoko; Hirota, Kazuyoshi

2014-03-01

The aim of this study was to evaluate the analgesic efficacy and safety of rectus sheath block combined with intraperitoneal instillation using two doses of ropivacaine in patients undergoing laparoscopic gynecological surgery. Altogether 53 consenting women were randomized to receive intraperitoneal infiltration with 0.25% ropivacaine or 0.5% ropivacaine followed by rectus sheath block with 0.375% ropivacaine. The outcomes of clinical safety were measured using plasma concentration of local anesthetics and occurrence of toxic symptoms. The analgesic efficacy was assessed using numerical rating scales for pain and morphine consumption up to 24 hours after surgery. Patients' baseline characteristics, surgical factors, and analgesic outcomes were comparable between the two groups. Although peak plasma concentration of ropivacaine was significantly higher in patients receiving 0.5% ropivacaine, none of analyzed concentrations was above the toxic ones. Besides, no patients showed any symptoms of local anesthetic toxicity. The present study showed that the combination of rectus sheath block with intraperitoneal instillation of ropivacaine was safe and potent enough to relieve pain after laparoscopic surgery.

[Ambulatory anesthesia in pediatric surgery].

PubMed

Ben Khalifa, S; Hila, S; Hamzaoui, M; el Cadhi, A; Jlidi, S; Nouira, F; Hellal, Y; Houissa, T; Chaouachi, B

2000-04-01

Child is an ideal patient for day care surgery. So more than 60% of paediatric surgery could benefit by ambulatory surgery. Preoperative visit may select patients for ambulatory surgery. Medical exam may lead to choose pre operative screening. The ideal ambulatory anesthesia is locoregional technic or inhalatory one. Tracheal intubation don't contre indicate ambulatory surgery. Recovery of mental abilities following general anesthesia has not the same significance as in adult. Many studies confirm the safety of paediatric outpatients anesthesia.

Can we improve patient safety?

PubMed

Corbally, Martin Thomas

2014-01-01

Despite greater awareness of patient safety issues especially in the operating room and the widespread implementation of surgical time out World Health Organization (WHO), errors, especially wrong site surgery, continue. Most such errors are due to lapses in communication where decision makers fail to consult or confirm operative findings but worryingly where parental concerns over the planned procedure are ignored or not followed through. The WHO Surgical Pause/Time Out aims to capture these errors and prevent them, but the combination of human error and complex hospital environments can overwhelm even robust safety structures and simple common sense. Parents are the ultimate repository of information on their child's condition and planned surgery but are traditionally excluded from the process of Surgical Pause and Time Out, perhaps to avoid additional stress. In addition, surgeons, like pilots, are subject to the phenomenon of "plan-continue-fail" with potentially disastrous outcomes. If we wish to improve patient safety during surgery and avoid wrong site errors then we must include parents in the Surgical Pause/Time Out. A recent pilot study has shown that neither staff nor parents found it added to their stress, but, moreover, 100% of parents considered that it should be a mandatory component of the Surgical Pause nor does it add to the stress of surgery. Surgeons should be required to confirm that the planned procedure is in keeping with the operative findings especially in extirpative surgery and this "step back" should be incorporated into the standard Surgical Pause. It is clear that we must improve patient safety further and these simple measures should add to that potential.

Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational Quality Study.

PubMed

Mantke, Rene; Diener, Markus; Kropf, Siegfried; Otto, Ronny; Manger, Thomas; Vestweber, Boris; Mirow, Lutz; Winde, Günther; Lippert, Hans

2016-09-07

Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist. This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients' perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making. The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period. Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year). This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http://www.webcitation.org/6jK6ZVyUs).

Efficacy and safety of bariatric surgery for craniopharyngioma-related hypothalamic obesity: a matched case-control study with 2 years of follow-up.

PubMed

Wijnen, M; Olsson, D S; van den Heuvel-Eibrink, M M; Wallenius, V; Janssen, J A M J L; Delhanty, P J D; van der Lely, A J; Johannsson, G; Neggers, S J C M M

2017-02-01

Hypothalamic obesity is a devastating consequence of craniopharyngioma. Bariatric surgery could be a promising therapeutic option. However, its efficacy and safety in patients with craniopharyngioma-related hypothalamic obesity remain largely unknown. We investigated the efficacy of bariatric surgery for inducing weight loss in patients with craniopharyngioma-related hypothalamic obesity. In addition, we studied the safety of bariatric surgery regarding its effects on hormone replacement therapy for pituitary insufficiency. In this retrospective matched case-control study, we compared weight loss after bariatric surgery (that is, Roux-en-Y gastric bypass and sleeve gastrectomy) between eight patients with craniopharyngioma-related hypothalamic obesity and 75 controls with 'common' obesity during 2 years of follow-up. We validated our results at 1 year of follow-up in a meta-analysis. In addition, we studied alterations in hormone replacement therapy after bariatric surgery in patients with craniopharyngioma. Mean weight loss after bariatric surgery was 19% vs 25% (difference -6%, 95% confidence of interval (CI) -14.1 to 4.6; P=0.091) at 2 years of follow-up in patients with craniopharyngioma-related hypothalamic obesity compared with control subjects with 'common' obesity. Mean weight loss was 25% vs 29% (difference -4%, 95% CI -11.6 to 8.1; P=0.419) after Roux-en-Y gastric bypass and 10% vs 20% (difference -10%, 95% CI -14.1 to -6.2; P=0.003) after sleeve gastrectomy at 2 years of follow-up in patients with craniopharyngioma-related hypothalamic obesity vs control subjects with 'common' obesity. Our meta-analysis demonstrated significant weight loss 1 year after Roux-en-Y gastric bypass, but not after sleeve gastrectomy. Seven patients with craniopharyngioma suffered from pituitary insufficiency; three of them required minor adjustments in hormone replacement therapy after bariatric surgery. Weight loss after Roux-en-Y gastric bypass, but not sleeve gastrectomy, was comparable between patients with craniopharyngioma-related hypothalamic obesity and control subjects with 'common' obesity at 2 years of follow-up. Bariatric surgery seems safe regarding its effects on hormone replacement therapy.

A clinical study of the LiVac laparoscopic liver retractor system.

PubMed

Gan, Philip; Bingham, Judy

2016-02-01

All retractors for laparoscopic operations on the gallbladder or stomach apply an upward force to the under-surface of the liver or gallbladder, most requiring an additional skin incision. The LiVac laparoscopic liver retractor system (LiVac retractor) comprises a soft silicone ring attached to suction tubing and connected to a regulated source of suction. The suction tubing extends alongside existing ports. When placed between the liver and diaphragm, and suction applied, a vacuum is created within the ring, keeping these in apposition. Following successful proof-of-concept animal testing, a clinical study was conducted to evaluate the performance and safety of the retractor in patients. The study was a dual-centre, single-surgeon, open-label study and recruited ten patients scheduled to undergo routine upper abdominal laparoscopic surgery including cholecystectomy, primary gastric banding surgery or fundoplication. The study was conducted at two sites and was approved by the institutions' ethics committees. The primary objective of the study was to evaluate the performance of the LiVac retractor in patients undergoing upper abdominal single- or multi-port laparoscopic surgery. Performance was measured by the attainment of milestones for the retractor and accessory bevel, where used, and safety outcomes through the recording of adverse events, physical parameters, pain scales, blood tests and a post-operative liver ultrasound. The LiVac retractor achieved both primary and secondary performance and safety objectives in all patients. No serious adverse events and no device-related adverse events or device deficiencies were reported. The LiVac retractor achieved effective liver retraction without clinically significant trauma and has potential application in multi- or single-port laparoscopic upper abdominal surgery. As a separate incision is not required, the use of the LiVac retractor in multi-port surgery therefore reduces the number of incisions.

A safety study of transumbilical single incision versus conventional laparoscopic surgery for colorectal cancer: study protocol for a randomized controlled trial.

PubMed

Wang, Yanan; Liu, Ruoyan; Zhang, Ze; Xue, Qi; Yan, Jun; Yu, Jiang; Liu, Hao; Zhao, Liying; Mou, Tingyu; Deng, Haijun; Li, Guoxin

2015-11-30

Single-incision laparoscopic surgery (SILS) is an emerging minimally invasive surgery to reduce abdominal incisions. However, despite the increasing clinical application of SILS, no evidence from large-scale, randomized controlled trials is available for assessing the feasibility, short-term safety, oncological safety, and potential benefits of SILS compared with conventional laparoscopic surgery (CLS) for colorectal cancer. This is a single-center, open-label, noninferiority, randomized controlled trial. A total of 198 eligible patients will be randomly assigned to transumbilical single incision plus one port laparoscopic surgery (SILS plus one) group or to a CLS group at a 1:1 ratio. Patients ranging in age from 18 to 80 years with rectosigmoid cancer diagnosed as cT1-4aN0-2 M0 and a tumor size no larger than 5 cm are considered eligible. The primary endpoint is early morbidity, as evaluated by an independent investigator. Secondary outcomes include operative outcomes (operative time, estimated blood loss, and incision length), pathologic outcomes (tumor size, length of proximal and distal resection margins, and number of harvested lymph nodes), postoperative inflammatory and immune responses (white blood cells [WBC], neutrophil percentage [NE %], C-reactive protein [CRP], interleukin-6 [IL-6], and tumor necrosis factor-α [TNF-α]), postoperative recovery (time to first ambulation, flatus, liquid diet, soft diet, and duration of hospital stay), pain intensity, body image and cosmetic assessment, 3-year disease free survival (DFS), and 5-year overall survival (OS). Follow-up visits are scheduled for 1 and 3 months after surgery, then every 3 months for the first 2 years and every 6 months for the next 3 years. This trial will provide valuable clinical evidence for the objective assessment of the feasibility, safety, and potential benefits of SILS plus one compared with CLS for the radical resection of rectosigmoid cancer. The hypothesis is that SILS plus one is feasible for the radical resection of rectosigmoid cancer and offers short-term safety and long-term oncological safety comparable to that of CLS, and that SILS plus one offers better cosmetic results and faster convalescence compared to CLS. ClinicalTrials.gov: NCT02117557 (registered on 16 April 2014).

A randomised study of perioperative esmolol infusion for haemodynamic stability during major vascular surgery; rationale and design of DECREASE-XIII.

PubMed

Bakker, E J; Ravensbergen, N J; Voute, M T; Hoeks, S E; Chonchol, M; Klimek, M; Poldermans, D

2011-09-01

This article describes the rationale and design of the DECREASE-XIII trial, which aims to evaluate the potential of esmolol infusion, an ultra-short-acting beta-blocker, during surgery as an add-on to chronic low-dose beta-blocker therapy to maintain perioperative haemodynamic stability during major vascular surgery. A double-blind, placebo-controlled, randomised trial. A total of 260 vascular surgery patients will be randomised to esmolol or placebo as an add-on to standard medical care, including chronic low-dose beta-blockers. Esmolol is titrated to maintain a heart rate within a target window of 60-80 beats per minute for 24 h from the induction of anaesthesia. Heart rate and ischaemia are assessed by continuous 12-lead electrocardiographic monitoring for 72 h, starting 1 day prior to surgery. The primary outcome measure is duration of heart rate outside the target window during infusion of the study drug. Secondary outcome measures will be the efficacy parameters of occurrence of cardiac ischaemia, troponin T release, myocardial infarction and cardiac death within 30 days after surgery and safety parameters such as the occurrence of stroke and hypotension. This study will provide data on the efficacy of esmolol titration in chronic beta-blocker users for tight heart-rate control and reduction of ischaemia in patients undergoing vascular surgery as well as data on safety parameters. Copyright © 2011 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Surgery: a risky business.

PubMed

Vats, Amit; Nagpal, Kamal; Moorthy, Krishna

2009-10-01

The advancement of surgical technology has made surgery an increasingly suitable management option for an increasing number of medical conditions. Yet there is also a growing concern about the number of patients coming to harm as a result of surgery. Studies show that this harm can be prevented by better teamwork and communication in operating theatres. This article discusses the extent of adverse events in surgery and how effective teamwork and communication can improve patient safety. It also highlights the role checklists and briefing in improving teamwork and reducing human error in surgery.

The Impact of System Factors on Quality and Safety in Arterial Surgery: A Systematic Review.

PubMed

Lear, R; Godfrey, A D; Riga, C; Norton, C; Vincent, C; Bicknell, C D

2017-07-01

A systems approach to patient safety proposes that a wide range of factors contribute to surgical outcome, yet the impact of team, work environment, and organisational factors, is not fully understood in arterial surgery. The aim of this systematic review is to summarize and discuss what is already known about the impact of system factors on quality and safety in arterial surgery. A systematic review of original research papers in English using MEDLINE, Embase, PsycINFO, and Cochrane databases, was performed according to PRISMA guidelines. Independent reviewers selected papers according to strict inclusion and exclusion criteria, and using predefined data fields, extracted relevant data on team, work environment, and organisational factors, and measures of quality and/or safety, in arterial procedures. Twelve papers met the selection criteria. Study endpoints were not consistent between papers, and most failed to report their clinical significance. A variety of tools were used to measure team skills in five papers; only one paper measured the relationship between team factors and patient outcomes. Two papers reported that equipment failures were common and had a significant impact on operating room efficiency. The influence of hospital characteristics on failure-to-rescue rates was tested in one large study, although their conclusions were limited to the American Medicare population. Five papers implemented changes in the patient pathway, but most studies failed to account for potential confounding variables. A small number of heterogenous studies have evaluated the relationship between system factors and quality or safety in arterial surgery. There is some evidence of an association between system factors and patient outcomes, but there is more work to be done to fully understand this relationship. Future research would benefit from consistency in definitions, the use of validated assessment tools, measurement of clinically relevant endpoints, and adherence to national reporting guidelines. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER.

ClinicalTrials.gov

2012-04-28

The Primary Study Objective is to Assess the Efficacy and; Safety of Extended 4-week Heparin Prophylaxis Compared to; Prophylaxis Given for 8±2 Days After Planned Laparoscopic; Surgery for Colorectal Cancer.; The Clinical Benefit Will be Evaluated as the Difference in; the Incidence of VTE or VTE-related Death Occurring Within 30 Days; From Surgery in the Two Study Groups.

Statewide Collaborative to Reduce Surgical Site Infections: Results of the Hawaii Surgical Unit-Based Safety Program.

PubMed

Lin, Della M; Carson, Kathryn A; Lubomski, Lisa H; Wick, Elizabeth C; Pham, Julius Cuong

2018-05-18

Surgical site infections (SSIs) after colorectal surgery are common, lead to patient harm, and are costly to the healthcare system. This study's purpose was to evaluate the effectiveness of the AHRQ Safety Program for Surgery in Hawaii. This pre-post cohort study involved 100% of 15 hospitals in Hawaii from January 2013 through June 2015. The intervention was a statewide implementation of the Comprehensive Unit-Based Safety Program and individualized bundles of interventions to reduce SSIs. Primary end point was colorectal SSIs. Secondary end point was safety culture measured by the AHRQ Hospital Survey on Patient Safety Culture. The most common interventions implemented were reliable chlorhexidine wash, wipe before operation, and surgical preparation; appropriate antibiotic choice, dose, and timing; standardized post-surgical debriefing; and differentiating clean-dirty-clean with anastomosis tray and closing tray. From January 2013 (quarter 1) through June 2015 (quarter 2), the collaborative colorectal SSI rate decreased (from 12.08% to 4.63%; p < 0.01). The SSI rate exhibited a linear decrease during the 10-quarter period (p = 0.005). Safety culture increased in 10 of 12 domains: Overall Perception/Patient Safety (from 49% to 53%); Teamwork Across Units (from 49% to 54%); Management-Support Patient Safety (from 53% to 60%); Nonpunitive Response to Error (from 36% to 40%); Communication Openness (from 50% to 55%); Frequency of Events Reported (from 51% to 60%); Feedback/Communication about Error (from 52% to 59%); Organizational Learning/Continuous Improvement (from 59% to 70%); Supervisor/Manager Expectations and Actions Promoting Safety (from 58% to 64%); and Teamwork Within Units (from 68% to 75%) (all p < 0.05). Participation in the national AHRQ Safety Program for Surgery in the state of Hawaii was associated with a 61.7% decrease in colorectal SSI rate and an increase in patient safety culture. Copyright © 2018 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Quality and Safety in Health Care, Part XXVI: The Adult Cardiac Surgery Database.

PubMed

Harolds, Jay A

2017-09-01

The Adult Cardiac Surgery Database of the Society of Thoracic Surgeons has provided highly useful information in quality and safety in general thoracic surgery, including ratings of the surgeons and institutions participating in this type of surgery. The Adult Cardiac Surgery Database information is very helpful for writing guidelines and determining optimal protocols and for many research projects. This article discusses the history and current status of this database.

Prospective randomized controlled study on the validity and safety of an absorbable adhesion barrier (Interceed®) made of oxidized regenerated cellulose for laparoscopic colorectal surgery.

PubMed

Naito, Masanori; Ogura, Naoto; Yamanashi, Takahiro; Sato, Takeo; Nakamura, Takatoshi; Miura, Hirohisa; Tsutsui, Atsuko; Sakamoto, Yasutoshi; Tanaka, Rieko; Kumagai, Yuji; Watanabe, Masahiko

2017-02-01

Clinical use of an adhesion barrier made of oxidized, regenerated cellulose, Interceed®, has been reported in the field of obstetrics and gynecology to help prevent adhesions between the peritoneum and the bowel in various types of operations. In gastrointestinal surgery, sodium hyaluronate/carboxymethylcellulose has been reported as an absorbable membrane to reduce postoperative adhesions. The present study was a prospective randomized controlled study to investigate the safety and usefulness of Interceed in laparoscopic colorectal surgery. We analyzed 99 patients who underwent laparoscopic colorectal surgery from 2013 to 2014. The patients were randomly allocated to the group that used Interceed (Interceed group) or the group that did not (Non-Interceed group). Fifty cases used Interceed, and 49 cases did not. The incidence of adverse events was 12.0% in the Interceed group and 16.3% in the Non-Interceed group (P = 0.58). There were no significant differences, and no adhesive bowel obstructions were observed in the Interceed group. We have shown that using Interceed in laparoscopic colorectal surgery is valid and technically safe. © 2016 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and John Wiley & Sons Australia, Ltd.

Percutaneous coronary intervention with off-site cardiac surgery backup for acute myocardial infarction as a strategy to reduce door-to-balloon time.

PubMed

Peels, Hans O; de Swart, Hans; Ploeg, Tjeerd V D; Hautvast, Raymond W; Cornel, Jan H; Arnold, Alf E; Wharton, Thomas P; Umans, Victor A

2007-11-01

We investigated whether primary percutaneous coronary intervention (PCI) for patients admitted with an acute ST-segment elevation myocardial infarction could be performed more rapidly and with comparable outcomes in a community hospital versus a tertiary center with cardiac surgery. We started the first PCI with an off-site surgery program in The Netherlands in 2002 and report the results of 439 consecutive patients. In the safety phase, 199 patients presenting with ST-segment elevation myocardial infarction were randomly assigned to treatment at our off-site center versus a more distant cardiac surgery center. In the confirmation phase, 240 consecutive patients were treated in the off-site hospital. Safety and efficacy end points were the rate of an angiographically successful PCI procedure (diameter stenosis <50% and Thrombolysis In Myocardial Infarction grade 3 flow) in the absence of major adverse cardiac and cerebrovascular events at 30 days. The randomization phase showed a 37-minute decrease in door-to-balloon time (p <0.001) with comparable procedural and clinical successes (91% Thrombolysis In Myocardial Infarction grade 3 flow in the 2 groups). In the confirmation phase, the 30-day rate without major adverse cardiac and cerebrovascular events was 95%. None of the 439 patients in the study required emergency surgery for failed primary PCI. In conclusion, time to treatment with primary PCI can be significantly shortened when treating patients in a community hospital setting with off-site cardiac surgery backup compared with transport for PCI to a referral center with on-site surgery. PCI at hospitals with off-site cardiac surgery backup can be considered a needed strategy to improve access to primary PCI for a larger segment of the population and can be delivered with a very favorable safety profile.

[Design of a plan for patient safety in pediatric surgery service].

PubMed

Paredes Esteban, R M; Castillo Fernández, A L; Miñarro del Moral, R; Garrido Pérez, J I; Granero Cendón, R; Gómez Beltrán, O; Berenguer Garcia, M J; Tejedor Fernández, M

2014-10-01

Patient safety is a key priority in quality management for healthcare services providers. Every patient is entitled to receive safe and effective healthcare. The aim of this study was to design a patient safety plan for a Paediatric Surgery Department. We carried out a literature review and we established a work group that included healthcare professionals from the Paediatric Surgery Department and the Quality and Medical Records Department. The group identified potential adverse events, failures and causes and established a rating using Failure Mode Effects Analysis. Potential risks were mapped out and a plan was designed establishing actions to reduce risks. We designated leaders to ensure the effective implementation of the plan. A total of 58 adverse events were identified in the Paediatric Surgery Department. We detected 128 failures that were produced by 211 different causes. The group developed a proposal with 424 specific measures to carry out preventive and/or remedial actions that were then narrowed down to 322. The group designed a plan to apply the programme, which is currently being implemented. The methodology used enabled obtaining key information for improvement of patient safety and developing preventive and/or remedial actions. These measures are applicable in practice, as they were designed using proposals and agreements with professionals that take active part in the care of children with surgical conditions.

About Hand Surgery

MedlinePlus

... Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Fireworks Safety Español Artritis ... Lawnmower Safety Snowblower safety Pumpkin Carving Gardening Safety Turkey Carving Removing a Ring Fireworks Safety Español Artritis ...

The natural lifespan of a safety policy: violations and system migration in anaesthesia.

PubMed

de Saint Maurice, Guillaume; Auroy, Yves; Vincent, Charles; Amalberti, René

2010-08-01

Safety rules continue growing rapidly, as if constraining human behaviour was the unique avenue for reaching ultimate safety. Safety rules are essential for a safe system, but their multiplication can have counterproductive effects. To monitor, in an anaesthesia ward, compliance with a process-oriented safety rule, and understand barriers and facilitators which help and hinder physicians from following guidelines. The rule stipulated that the day before surgery anaesthetists had to record in the patient's file the drugs to be used for the anaesthesia (induction, maintenance, airway control). Compliance was assessed before introduction of the rule, immediately after, at 6 months and at 12 months. All medical staff were blinded to the protocol. 717 patient records were included. The results showed an initial compliance with policy, reaching 86% for some items (never 100%). Reduction began within 6 months and returned almost to initial levels within a year. One individual showed poor compliance throughout the study but even initially compliant doctors experienced a reduction. Compliance was higher for complex surgery but lower for unscheduled surgery and when job pressure was greater. Compliance eroded over time. A major trigger of erosion seemed to be lack of continued compliance by a senior member of staff. Rules and procedures constitute fragile safety barriers, and it may be better to forego introducing a new safety rule if it is not considered as a priority by staff and is therefore vulnerable to sacrifice in case of conflict with competitive demands.

Population perception of surgical safety and body image trauma: a plea for scarless surgery?

PubMed

Bucher, Pascal; Pugin, François; Ostermann, Sandrine; Ris, Frederic; Chilcott, Michael; Morel, Philippe

2011-02-01

Laparoendoscopic single-site surgery (LESS) and natural orifice translumenal endoscopic surgery (NOTES) are prospected as the future of minimally invasive surgery. While scarless surgery (NOTES and LESS) is gaining increasing popularity, perception of these approaches should be investigated. An anonymous questionnaire describing laparoscopy, LESS, and NOTES was given to medical staff (n=120), paramedical staff (n=100), surgical patients (n=100), and the general population (n=100). The survey participants (median age, 37 years; range, 18-81 years) were queried about their expectations for surgical treatment and their approach preference. The first concern of the survey responders was the risk of surgical complications (92%). When asked about the respective importance of surgical safety, cure, and cosmetics, cure was placed first by 74%, safety by 33%, and cosmetics by 3%. These results were not influenced by sex, age, prior surgery or endoscopy, or education. When operative risk was similar, 90% of the participants preferred a scarless approach (75% preferred LESS and 15% preferred NOTES) to laparoscopy. The scarless approach preference was significantly higher among the younger participants (age<40 years; p=0.026), whereas sex showed no influence. The LESS preference was significantly higher among patients and the general population (86%) than among medical (67%) and paramedical (70%) staffs (p<0.001). A decreasing trend of preference for LESS and NOTES was observed with increased procedural risks. Although cure and safety remain the main concern, the population has a favorable perception of scarless surgery, even in the case of increased procedural risk, with LESS favored over NOTES. Such a popular adoption of scarless surgery should warrant the promotion of further research, technological innovations, and the establishment of surgeon training to improve its safety.

Efficacy and safety of damage control in experimental animal models of injury: protocol for a systematic review and meta-analysis

PubMed Central

2014-01-01

Background Although abbreviated surgery with planned reoperation (damage control surgery) is now widely used to manage major trauma patients, the procedure and its component interventions have not been evaluated in randomized controlled trials (RCTs). While some have suggested the need for such trials, they are unlikely to be conducted because of patient safety concerns. As animal studies may overcome several of the limitations of existing observational damage control studies, the primary objective of this study is to evaluate the efficacy and safety of damage control versus definitive surgery in experimental animal models of injury. Methods/design We will search electronic databases (Medline, Embase, PubMed, Web of Science, Scopus, and the Cochrane Library), conference abstracts, personal files, and bibliographies of included articles. We will include RCTs and prospective cohort studies that utilized an animal model of injury and compared damage control surgery (or specific damage control interventions or adjuncts) to definitive surgery (or specific definitive surgical interventions). Two investigators will independently evaluate the internal and external/construct validity of individual studies. The primary outcome will be all-cause mortality. Secondary outcomes will include blood loss amounts; blood pressures and heart rates; urinary outputs; core body temperatures; arterial lactate, pH, and base deficit/excess values; prothrombin and partial thromboplastin times; international normalized ratios; and thromboelastography (TEG) results/activated clotting times. We will calculate summary relative risks (RRs) of mortality and mean differences (for continuous outcomes) using DerSimonian and Laird random effects models. Heterogeneity will be explored using subgroup meta-analysis and meta-regression. We will assess for publication bias using funnel plots and Begg’s and Egger’s tests. When evidence of publication bias exists, we will use the Duval and Tweedie trim and fill method to estimate the potential influence of this bias on pooled summary estimates. Discussion This study will evaluate the efficacy and safety of damage control in experimental animal models of injury. Study results will be used to guide future clinical evaluations of damage control surgery, determine which animal study outcomes may potentially be generalizable to the clinical setting, and to provide guidelines to strengthen the conduct and relevance of future pre-clinical studies. PMID:25416175

Improving operating room safety

PubMed Central

2009-01-01

Despite the introduction of the Universal Protocol, patient safety in surgery remains a daily challenge in the operating room. This present study describes one community health system's efforts to improve operating room safety through human factors training and ultimately the development of a surgical checklist. Using a combination of formal training, local studies documenting operating room safety issues and peer to peer mentoring we were able to substantially change the culture of our operating room. Our efforts have prepared us for successfully implementing a standardized checklist to improve operating room safety throughout our entire system. Based on these findings we recommend a multimodal approach to improving operating room safety. PMID:19930577

Current State of Overlapping, Concurrent, and Multiple-Room Surgery in Otolaryngology: A National Survey.

PubMed

Cognetti, David M; Nussenbaum, Brian; Brenner, Michael J; Chi, David H; McCormick, Michael E; Venkatraman, Giri; Zhan, Tingting; McKinlay, Alex J

2017-12-01

Objective Multiple-room surgery has gained attention due to reports in the lay press scrutinizing the activity, with hospitals and the government collecting data on current practice. We studied practices and attitudes toward multiple-room surgery in otolaryngology. Methods A survey was developed by members of the Patient Safety and Quality Improvement Committee of the American Academy of Otolaryngology-Head and Neck Surgery. The survey was distributed to members of the Academy and included questions on demographics, current practices, and opinions regarding multiple-room surgery. The survey was designed to capture the spectrum of multidisciplinary, overlapping, and simultaneous/concurrent surgery practices. Data were collected via SurveyMonkey. Results A total of 907 of 9520 members completed the survey. Of the respondents, 40.4% reported performing some form of multiple-room surgery. Multiple-room surgery is more common amongst subspecialists than general otolaryngologists. Most believed that regulations disallowing multiple-room surgery would result in an increase in late starts (73.5%), an increase in the time to schedule surgery (84.5%), a detriment to residency training (63.1%), and no improvement in patient safety (60%.) Discussion Multiple-room surgery is common among responding otolaryngologists. Most respondents consider the practice to serve a role in facilitating access, efficiency, and training. Implications for Practice Due to recent attention placed on multiple-room surgery, institutions are reviewing policies regarding the practice. This survey suggests that policy changes that restrict multiple-room surgery must consider a potential unintended negative impact on patient care and access.

"The Jackson Table Is a Pain in the…": A Qualitative Study of Providers' Perception Toward a Spinal Surgery Table.

PubMed

Asiedu, Gladys B; Lowndes, Bethany R; Huddleston, Paul M; Hallbeck, Susan

2016-01-07

The aim of this study was to define health care providers' perceptions toward prone patient positioning for spine surgery using the Jackson Table, which has not been hitherto explored. We analyzed open-ended questionnaire data and interviews conducted with the spine surgical team regarding the current process of spinal positioning/repositioning using the Jackson Table. Participants were asked to provide an open-ended explanation as to whether they think the current process of spinal positioning/repositioning is safe for the staff or patients. Follow-up qualitative interviews were conducted with 11 of the participants to gain an in-depth understanding of the challenges and safety issues related to prone patient positioning. Data analysis resulted in 6 main categories: general challenges with patient positioning, role-specific challenges, challenges with the Jackson Table and the "sandwich" mechanism, safety concerns for patients, safety concerns for the medical staff, and recommendations for best practices. This study is relevant to everyday practice for spinal surgical team members and advances our understanding of how surgical teams qualitatively view the current process of patient positioning for spinal surgery. Providers recommended best practices for using the Jackson Table, which can be achieved through standardized practice for transfer of patients, educational tools, and checklists for equipment before patient transfer and positioning. This research has identified several important practice opportunities for improving provider and patient safety in spine surgery.This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivitives 3.0 License, where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially. http://creativecommons.org/licenses/by-nc-nd/3.0.

Emergency general surgery outcomes at safety net hospitals.

PubMed

Shahan, Charles Patrick; Bell, Teresa; Paulus, Elena; Zarzaur, Ben L

2015-06-01

The United States hospital safety net is defined by the Agency for Healthcare Research and Quality as the top decile of hospitals, which see the greatest proportion of uninsured patients. These hospitals provide important access to health care for uninsured patients but are commonly believed to have worse outcomes. The aim of this study was to compare the outcomes of emergency general surgery procedures performed at safety net and nonsafety net hospitals. The Healthcare Cost and Utilization Project Nationwide Inpatient Sample from 2008-2010 was used to create a cohort of inpatients who underwent emergency appendectomy, cholecystectomy, or herniorrhaphy. Outcomes measured included length of stay, charge, cost, death in hospital, complications, and failure to rescue (FTR). Univariate and logistic regression analysis was performed to associate variables with outcomes. A total of 187,913 emergency general surgery cases were identified, 11.5% of which were performed at safety net hospitals. The safety net cohort had increased length of stay but lower mean charge and cost. Age, comorbidity score, black race, male gender, and Medicaid and Medicare insurance were associated with mortality, complication, and FTR. Lower socioeconomic status was associated with mortality and complication. Safety net status was positively associated with complication but not mortality or FTR. Safety net hospitals had higher complication rates but no difference in FTR or mortality. This may mean that the hospitals are able to effectively recognize and treat patient complications and do so without increased cost. Copyright © 2015 Elsevier Inc. All rights reserved.

First series of total robotic hysterectomy (TRH) using new integrated table motion for the da Vinci Xi: feasibility, safety and efficacy.

PubMed

Giannini, Andrea; Russo, Eleonora; Mannella, Paolo; Palla, Giulia; Pisaneschi, Silvia; Cecchi, Elena; Maremmani, Michele; Morelli, Luca; Perutelli, Alessandra; Cela, Vito; Melfi, Franca; Simoncini, Tommaso

2017-08-01

To present the first case series of total robotic hysterectomy (TRH), using integrated table motion (ITM), which is a new feature comprising a unique operating table by Trumpf Medical that communicates wirelessly with the da Vinci Xi surgical system. ITM has been specifically developed to improve multiquadrant robotic surgery such as that conducted in colorectal surgery. Between May and October 2015, a prospective post-market study was conducted on ITM in the EU in 40 cases from different specialties. The gynecological study group comprised 12 patients. Primary endpoints were ITM feasibility, safety and efficacy. Ten patients underwent TRH. Mean number of ITM moves was three during TRH; there were 31 instances of table moves in the ten procedures. Twenty-eight of 31 ITM moves were made to gain internal exposure. The endoscope remained inserted during 29 of the 31 table movements (94%), while the instruments remained inserted during 27 of the 31 moves (87%). No external instrument collisions or other problems related to the operating table were noted. There were no ITM safety-related observations and no adverse events. This preliminary study demonstrated the feasibility, safety and efficacy of ITM for the da Vinci Xi surgical system in TRH. ITM was safe, with no adverse events related to its use. Further studies will be useful to define the real role and potential benefit of ITM in gynecological surgery.

The Impact of Patient Safety Training on Oral and Maxillofacial Surgery Residents' Attitudes and Knowledge: A Mixed Method Case Study

ERIC Educational Resources Information Center

Buhrow, Suzanne

2013-01-01

It is estimated that in the United States, more than 40,000 patients are injured each day because of preventable medical errors. Patient safety experts and graduate medical education accreditation leaders recognize that medical education reform must include the integration of safety training focused on error causation, system engineering, and…

A History of Bariatric Surgery: The Maturation of a Medical Discipline.

PubMed

Celio, Adam C; Pories, Walter J

2016-08-01

This article examines the progression of bariatric surgery since its creation more than 60 years ago with a focus on the effect of surgery on weight loss, comorbidity reduction, and safety. The success has been remarkable. It is possible to cure severe obesity, type 2 diabetes, and hyperlipidemia in addition to the many other manifestations of the metabolic syndrome with remarkable safety. Equally important are the opportunities for research afforded by the surgery and its outcomes. Until better treatments become available, bariatric surgery is the therapy of choice for patients with morbid obesity for weight control and comorbidity improvement. Copyright © 2016 Elsevier Inc. All rights reserved.

A simulation model for determining the optimal size of emergency teams on call in the operating room at night.

PubMed

van Oostrum, Jeroen M; Van Houdenhoven, Mark; Vrielink, Manon M J; Klein, Jan; Hans, Erwin W; Klimek, Markus; Wullink, Gerhard; Steyerberg, Ewout W; Kazemier, Geert

2008-11-01

Hospitals that perform emergency surgery during the night (e.g., from 11:00 pm to 7:30 am) face decisions on optimal operating room (OR) staffing. Emergency patients need to be operated on within a predefined safety window to decrease morbidity and improve their chances of full recovery. We developed a process to determine the optimal OR team composition during the night, such that staffing costs are minimized, while providing adequate resources to start surgery within the safety interval. A discrete event simulation in combination with modeling of safety intervals was applied. Emergency surgery was allowed to be postponed safely. The model was tested using data from the main OR of Erasmus University Medical Center (Erasmus MC). Two outcome measures were calculated: violation of safety intervals and frequency with which OR and anesthesia nurses were called in from home. We used the following input data from Erasmus MC to estimate distributions of all relevant parameters in our model: arrival times of emergency patients, durations of surgical cases, length of stay in the postanesthesia care unit, and transportation times. In addition, surgeons and OR staff of Erasmus MC specified safety intervals. Reducing in-house team members from 9 to 5 increased the fraction of patients treated too late by 2.5% as compared to the baseline scenario. Substantially more OR and anesthesia nurses were called in from home when needed. The use of safety intervals benefits OR management during nights. Modeling of safety intervals substantially influences the number of emergency patients treated on time. Our case study showed that by modeling safety intervals and applying computer simulation, an OR can reduce its staff on call without jeopardizing patient safety.

Air Travel Safety in Postoperative Breast Cancer Patients: A Systematic Review.

PubMed

Co, Michael; Ng, Judy; Kwong, Ava

2018-05-17

Air travel has long been a dilemma in post-breast cancer surgery patients. Anecdotal reports have described adverse outcomes on surgical wound, implants, and lymphedema during air travel. This review aims to evaluate the best evidence from the literature concerning the air travel safety in breast cancer patients. A comprehensive review was performed of the Medline, Embase, CINAHL, and Cochrane databases using a predefined strategy. Retrieved studies were independently screened and rated for relevance. Data were extracted by 2 researchers. We reviewed the best evidence on air travel safety in postoperative breast cancer patients. Evidence was limited in the current literature to suggest adverse effects on postoperative mastectomy wounds and drains by high-altitude travel. Similarly, adverse effects on breast implants were limited to case reports and ex vivo experiments. A systematic review of 12 studies concluded that air travel is not associated with upper limb lymphedema after breast cancer surgery. Deep-vein thrombosis (DVT) is a known complication after air travel; in addition, malignancy itself is a known risk factor for DVT. Evidence of safety to continue tamoxifen during the period of air travel is lacking in the literature. Evidence to support the use of systemic DVT prophylaxis in general postoperative breast cancer patients is also limited. Best evidence from a large retrospective study suggested that mechanical antiembolism devices and early mobilization are the only measures required. Air travel is generally safe in patients after breast cancer surgery. Copyright © 2018. Published by Elsevier Inc.

The S.A.C.S. (Satisfaction-Anatomy-Continence-Safety) score for evaluating pelvic organ prolapse surgery: a proposal for an outcome-based scoring system.

PubMed

Mearini, Luigi; Zucchi, Alessandro; Nunzi, Elisabetta; Di Biase, Manuel; Bini, Vittorio; Costantini, Elisabetta

2015-07-01

To date, there is no overall consensus on the definition of cure after surgery for pelvic organ prolapse (POP). The aim of the study was to design and test the scoring system S.A.C.S. (Satisfaction-Anatomy-Continence-Safety) to assess and compare the outcomes of POP repair. A total of 233 women underwent open sacrocolpopexy. The S.A.C.S. outcome scoring system was scheduled at 24 months of follow-up, and each component was detected according to: Satisfaction by mean of Patient Global Improvement Inventory scale, Anatomy by mean of POP Quantification system and bulge symptom, Continence by mean of pad use, and Safety by mean of the Clavien-Dindo classification of surgical complications. Each component produced a binary nominal categorical variable (1 or 0), with a total score of 4 representing cure. As a comparative tool, patients answered a simple yes/no question: "If you had to undergo surgery all over again, would you still do it?". The degree of concordance was estimated using Cohen's Kappa test. According to the S.A.C.S. scoring system, only 160 patients (68.6 %) reached the maximum score of cure. Sensitivity of the S.A.C.S. score was 74.1 %, specificity was 90 %, total diagnostic capacity was 75.5 %. The S.A.C.S. score internal consistency was good; the k-coefficient was higher for the satisfaction component of the score (k = 0.560). This study proposes an original, simple post-operative scoring system integrating satisfaction, anatomy, continence, and safety reports for patients undergoing surgery for POP, providing a complete, although perfectible, method to accurately report outcomes in all clinical scenarios.

Safety culture among pediatric surgeons: A national survey of attitudes and perceptions of patient safety.

PubMed

Berman, Loren; Rangel, Shawn; Goldin, Adam; Skarda, David; Ottosen, Madelene; Bliss, David; Valusek, Patricia; Fallat, Mary; Tsao, KuoJen

2018-03-01

Improving the culture of safety within health care is an essential component of preventing errors and improving overall health care quality. The purpose of this study was to characterize the attitudes and perceptions of patient safety among pediatric surgeons. We conducted a cross-sectional online survey of American Pediatric Surgery Association members. Survey items assessed surgeons' knowledge, attitudes, and perceptions of patient safety. We performed descriptive statistics and evaluated associations between respondent characteristics and survey responses. Response rate was 38% (353/928). Surgeons in academic practice (96% vs 83% private, P=0.01) and in leadership positions (98% vs 92%, P=0.03) were more likely to feel actively engaged in patient safety initiatives. Surgeons in private practice were less likely to feel safe having their own children undergo surgery at their institution (80% vs 96% academic, P<0.005). Pediatric surgeons have disparate attitudes and perceptions of patient safety within their hospitals. Significant variation exists based on surgeon characteristics. These findings underscore the need to identify barriers to surgeon engagement and develop educational initiatives to empower surgeons as leaders in improving patient safety culture. V. Copyright © 2017 Elsevier Inc. All rights reserved.

Diffusion of robotics into clinical practice in the United States: process, patient safety, learning curves, and the public health.

PubMed

Mirheydar, Hossein S; Parsons, J Kellogg

2013-06-01

Robotic technology disseminated into urological practice without robust comparative effectiveness data. To review the diffusion of robotic surgery into urological practice. We performed a comprehensive literature review focusing on diffusion patterns, patient safety, learning curves, and comparative costs for robotic radical prostatectomy, partial nephrectomy, and radical cystectomy. Robotic urologic surgery diffused in patterns typical of novel technology spreading among practicing surgeons. Robust evidence-based data comparing outcomes of robotic to open surgery were sparse. Although initial Level 3 evidence for robotic prostatectomy observed complication outcomes similar to open prostatectomy, subsequent population-based Level 2 evidence noted an increased prevalence of adverse patient safety events and genitourinary complications among robotic patients during the early years of diffusion. Level 2 evidence indicated comparable to improved patient safety outcomes for robotic compared to open partial nephrectomy and cystectomy. Learning curve recommendations for robotic urologic surgery have drawn exclusively on Level 4 evidence and subjective, non-validated metrics. The minimum number of cases required to achieve competency for robotic prostatectomy has increased to unrealistically high levels. Most comparative cost-analyses have demonstrated that robotic surgery is significantly more expensive than open or laparoscopic surgery. Evidence-based data are limited but suggest an increased prevalence of adverse patient safety events for robotic prostatectomy early in the national diffusion period. Learning curves for robotic urologic surgery are subjective and based on non-validated metrics. The urological community should develop rigorous, evidence-based processes by which future technological innovations may diffuse in an organized and safe manner.

The use of in-situ simulation to improve safety in the plastic surgery office: a feasibility study.

PubMed

Shapiro, Fred E; Pawlowski, John B; Rosenberg, Noah M; Liu, Xiaoxia; Feinstein, David M; Urman, Richard D

2014-01-01

Simulation-based interventions and education can potentially contribute to safer and more effective systems of care. We utilized in-situ simulation to highlight safety issues, regulatory requirements, and assess perceptions of safety processes by the plastic surgery office staff. A high-fidelity human patient simulator was brought to an office-based plastic surgery setting to enact a half-day full-scale, multidisciplinary medical emergency. Facilitated group debriefings were conducted after each scenario with special consideration of the principles of team training, communication, crisis management, and adherence to evidence-based protocols and regulatory standards. Abbreviated AHRQ Medical Office Safety Culture Survey was completed by the participants before and after the session. The in-situ simulations had a high degree of acceptance and face validity according to the participants. Areas highlighted by the simulation sessions included rapid communication, delegation of tasks, location of emergency materials, scope of practice, and logistics of transport. The participant survey indicated greater awareness of patient safety issues following participation in simulation and debriefing exercises in 3 areas (P < 0.05): the need to change processes if there is a recognized patient safety issue (100% vs 75%), openness to ideas about improving office processes (100% vs 88%), and the need to discuss ways to prevent errors from recurring (88% vs 62%). Issues of safety and regulatory compliance can be assessed in an office-based setting through the short-term (half-day) use of in-situ simulation with facilitated debriefing and the review of audiovisual recordings by trained facilities inspectors.

The Use of In-Situ Simulation to Improve Safety in the Plastic Surgery Office: A Feasibility Study

PubMed Central

Shapiro, Fred E.; Pawlowski, John B.; Rosenberg, Noah M.; Liu, Xiaoxia; Feinstein, David M.; Urman, Richard D.

2014-01-01

Objective: Simulation-based interventions and education can potentially contribute to safer and more effective systems of care. We utilized in-situ simulation to highlight safety issues, regulatory requirements, and assess perceptions of safety processes by the plastic surgery office staff. Methods: A high-fidelity human patient simulator was brought to an office-based plastic surgery setting to enact a half-day full-scale, multidisciplinary medical emergency. Facilitated group debriefings were conducted after each scenario with special consideration of the principles of team training, communication, crisis management, and adherence to evidence-based protocols and regulatory standards. Abbreviated AHRQ Medical Office Safety Culture Survey was completed by the participants before and after the session. Results: The in-situ simulations had a high degree of acceptance and face validity according to the participants. Areas highlighted by the simulation sessions included rapid communication, delegation of tasks, location of emergency materials, scope of practice, and logistics of transport. The participant survey indicated greater awareness of patient safety issues following participation in simulation and debriefing exercises in 3 areas (P < 0.05): the need to change processes if there is a recognized patient safety issue (100% vs 75%), openness to ideas about improving office processes (100% vs 88%), and the need to discuss ways to prevent errors from recurring (88% vs 62%). Conclusions: Issues of safety and regulatory compliance can be assessed in an office-based setting through the short-term (half-day) use of in-situ simulation with facilitated debriefing and the review of audiovisual recordings by trained facilities inspectors. PMID:24501616

Efficacy, safety, and economics of bracing after spine surgery: a systematic review of the literature.

PubMed

Zhu, Mary P; Tetreault, Lindsay A; Sorefan-Mangou, Fatimah; Garwood, Philip; Wilson, Jefferson R

2018-01-31

Bracing is often used after spinal surgery to immobilize the spine, improve fusion, and relieve pain. However, controversy exists regarding the efficacy, necessity, and safety of various bracing techniques in the postsurgical setting. In this systematic review, we aimed to compare the effectiveness, safety, and cost-effectiveness of postoperative bracing versus no postoperative bracing after spinal surgery in patients with several common operative spinal pathologies. A systematic review was carried out to compare postoperative bracing and no postoperative bracing. A systematic search was conducted of MEDLINE, Embase, and the Cochrane Collaboration Library from 1970 to May 2017, supplemented by manual searching of the reference list of relevant studies and previously published reviews. Studies were included if they compared disability, quality of life, functional impairment, radiographic outcomes, cost-effectiveness, or complications between patients treated with postoperative bracing and patients not receiving any postoperative bracing. Each article was critically appraised independently by two reviewers, and the overall body of evidence was rated using guidelines outlined by the Grading of Recommendation Assessment, Development and Evaluation (GRADE) Working Group. Of the 858 retrieved citations, 5 studies met the inclusion criteria and were included in this review, consisting of 4 randomized controlled trials and 1 prospective cohort study. Low to moderate evidence suggests that there are no significant differences in most measures of disability, pain, quality of life, functional impairment, radiographic outcomes, and safety between groups. Isolated studies reported statistically significant and inconsistent differences between groups with respect to Neck Disability Index at 6 weeks postoperatively or Short Form-36 Physical Component Score at 1.5, 3, 6, and 12 months postoperatively. Based on limited evidence, postoperative bracing does not result in improved outcomes after spinal surgery. Future high-quality randomized trials will be required to confirm these findings. Copyright © 2018 Elsevier Inc. All rights reserved.

Recent Development of Augmented Reality in Surgery: A Review.

PubMed

Vávra, P; Roman, J; Zonča, P; Ihnát, P; Němec, M; Kumar, J; Habib, N; El-Gendi, A

2017-01-01

The development augmented reality devices allow physicians to incorporate data visualization into diagnostic and treatment procedures to improve work efficiency, safety, and cost and to enhance surgical training. However, the awareness of possibilities of augmented reality is generally low. This review evaluates whether augmented reality can presently improve the results of surgical procedures. We performed a review of available literature dating from 2010 to November 2016 by searching PubMed and Scopus using the terms "augmented reality" and "surgery." Results . The initial search yielded 808 studies. After removing duplicates and including only journal articles, a total of 417 studies were identified. By reading of abstracts, 91 relevant studies were chosen to be included. 11 references were gathered by cross-referencing. A total of 102 studies were included in this review. The present literature suggest an increasing interest of surgeons regarding employing augmented reality into surgery leading to improved safety and efficacy of surgical procedures. Many studies showed that the performance of newly devised augmented reality systems is comparable to traditional techniques. However, several problems need to be addressed before augmented reality is implemented into the routine practice.

Safety, efficacy and cost-effectiveness of consecutive bilateral cataract surgery on two successive days in tribes at base hospital through community outreach program: A prospective study of Aravali Mountain, North West India

PubMed Central

Mohan, Amit; Kaur, Navjot; Bhatanagar, Vishal C

2017-01-01

Purpose: The aim of the study was to evaluate the safety and efficacy of consecutive bilateral cataract surgery (CBCS) on two successive days in a single hospital visit. Methods: Prospective study was conducted on 565 patients of various tribes of hilly area of West Rajasthan who had come to our hospital through community outreach programmed (CORP) between January 2015 and March 2016. Patients with significant bilateral cataract without any other ocular morbidity were advised bilateral manual small incision cataract surgery on two consecutive days. Intraoperative and postoperative complications were evaluated, and follow-up was done at 1 week, 1 month, and 3 months. Results: Out of 565 patients, 519 underwent both eye surgeries. Second eye surgery was deferred for a later date in 46 cases. Because of intraoperative and postoperative complications in the first eye, 31 had delayed surgeries while 15 patients refused to undergo another eye surgery either because of postoperative day 1 poor vision in the operated eye due to retinal pathologies (n = 8) or unwillingness (n = 7). The second eye surgery was performed for 519 patients, out of whom six had intra or postoperative complications. At 1 month follow-up, four patients had unilateral cystoid macular edema and three had prolonged postoperative inflammation. At 3 months, all patients were satisfied and had no complications. None of the patients had sight-threatening complications such as endophthalmitis, corneal decompensation, or vitreoretinal complications. Conclusion: CBCS may be considered safe and cost-effective for patients living in remote locations, dependent on CORP. PMID:29208839

A Clinical Audit of Escorts' Awareness And Patients' Safety Following Intravenous Sedation In Adult Oral Surgery.

PubMed

Licheri, Luca; Erriu, Matteo; Bryant, Vincenzo; Piras, Vincenzo

2016-01-01

To evaluate current level of safety under the care of an escort following intravenous sedation, post-sedation arrangements and to identify potential risk levels. Information and post-sedation arrangements are important to patients'safety following surgery but although there is a general consensus over what is recommended for patients and their escorts, there is little, if any, literature on the escorts' awareness of sedation and accordance to post-sedation arrangement and recommendations. Escorts of 113 consecutive patients treated in oral surgery under sedation (midazolam) completed a questionnaire composed of 27 questions divided into seven sections including demographics, awareness of sedation, source of information and post-operative arrangement. From the data collected, two scores were calculated representative of the escorts' Safety and Reliability. Data were then analysed by ANOVA. Safety scores were statistically correlated with instruction source while Reliability correlated to a wider variety of parameters including gender, age as well as information source. Provision of clear written information to escorts is recommended as likely to improve patients' safety. Assessment of escorts' Safety and Reliability could provide a means for improving quality and safety of sedation service.

Safety and efficacy of bridging with low molecular weight heparins: a systematic review and partial meta-analysis.

PubMed

Eijgenraam, Pieter; ten Cate, Hugo; Ten Cate-Hoek, Arina

2013-01-01

Surgical interventions in patients on long term vitamin K antagonist (VKA) treatment create a dilemma; periprocedural interruption of anticoagulation raises the risk of thrombosis, while continuation raises the risk of bleeding. The anticoagulation- free interval is minimized by "bridging" with parenteral anticoagulants. The efficacy and safety of bridging with low molecular weight heparins (LMWH) has however not been unequivocally established. We performed an EMBASE and MEDLINE search for studies that compared bridging anticoagulation with continuation or cessation of VKA without bridging; with thromboembolism (TE) and bleeding as outcomes. We identified 878 articles and finally selected 17. Results of individual studies were pooled. None of the included studies reported significant differences in incidence of TEs between the bridging group and the comparator group; 4 out of 13 studies reported zero TEs. Heparin was identified as a risk factor for bleeding in multivariable adjusted analyses in 3 studies on pacemaker/implantable cardioverter defibrillator (PM/ICD) surgery. In 5 studies (different types of surgery) with unadjusted analyses, bridging was compared to warfarin cessation: 3 studies reported null results for bleeding; 2 studies identified bridging as a risk factor. We pooled a subset of 6 studies regarding postoperative bleeding after PM/ICD surgery and found a relative risk (RR) of 3.03 (95% confidence interval (CI), 1.86-4.95) for bridging compared to continuation of VKA. While the antithrombotic efficacy of bridging with LMWH has not been demonstrated, increased bleeding risk is observed in different types of surgery. PM/ICD surgery can be safely performed on continued VKA.

Ab interno trabecular bypass surgery with iStent for open angle glaucoma

PubMed Central

Le, Jimmy T; Bicket, Amanda K; Li, Tianjing

2018-01-01

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: The primary objective is to assess the comparative effectiveness and safety of ab interno trabecular bypass surgery with iStent or iStent inject for OAG in comparison to conventional medical, laser, or surgical treatment. A secondary objective is to examine the effectiveness and safety of iStent or iStent Inject surgery in people who have concomitant phacoemulsification. PMID:27526051

The definition of the V zone for the safety space of functional surgery of the tongue.

PubMed

Hou, Tiening; Shao, Jinyan; Fang, Songhua

2012-01-01

To define safety space for functional surgery of the tongue. Prospective nonrandomized study. Computed tomographic angiography of the lingual artery was performed in 107 in-patients with obstructive sleep apnea syndrome and 17 controls. The safety space was ascertained according to the course of lingual artery. The course of the lingual artery, termed the Big Dipper bowl of the tongue, was similar in each group. The tissue above the lingual artery and the vacuity of the hypoglossal/lingual artery neurovascular bundle (HLNVB) formed a three-dimensional structure. The anterior part was named the V prozone. Its anterior border was the tangent plane of the deep lingual artery, its posterior border the circumvallate papilla, its width the interval of bilateral margins at the corresponding parts of the tongue, and its height the level of the middle lingual frenulum. The posterior portion between the bilateral dorsal arteries in the tongue base was named the V postzone. Its width was 31.42±3.82 mm when the tongue was in a resting position, and its height was the distance from the foramen cecum to the bottom of the epiglottic vallecula. The inferior part under the intrinsic lingual muscles was named the hypoglossal floor. It is a relatively restricted surgery zone. The V zone of the tongue without HLNVB travelling provides enough of safety space for functional surgery on the tongue. Copyright © 2011 The American Laryngological, Rhinological, and Otological Society, Inc.

Assessment of the implementation of a national patient safety alert to reduce wrong site surgery.

PubMed

Rhodes, P; Giles, S J; Cook, G A; Grange, A; Hayton, R; Maxwell, M J; Sheldon, T A; Wright, J

2008-12-01

In 2005, guidance on how to prevent wrong site surgery in the form of a national safety alert was issued to all NHS hospital trusts in England and Wales by the National Patient Safety Agency. To investigate the response to the alert among clinicians in England and Wales 12-15 months after it had been issued. A before-after study, using telephone/face-to-face interviews with consultant surgeons and senior nurses in ophthalmology, orthopaedics and urology in 11 NHS hospitals in England & Wales in the year prior to the alert and 12-15 months after. The interviews were coded and analysed thematically. The study revealed marked heterogeneity in organisational processes in response to a national alert. There was a significant change in surgeons' self-reported practice, with only 48% of surgeons routinely marking patients prior to the alert and 85% after (p<0.001). However, inter-specialty differences remained and change in practice was not always matched by change in attitude. Compliance with the detailed recommendations about how marking should be carried out was inconsistent. There were unintended consequences in terms of greater bureaucracy and concerns about diffusion of responsibility and hastily performed marking to enable release of patients from wards. The alert was effective in promoting presurgical marking and encouraging awareness of safety issues in relation to correct site surgery. However, care should be taken to monitor unintended consequences and whether change is sustained. Greater flexibility for local adaptation coupled with better design and early testing of safety alerts prior to national dissemination may facilitate more sustainable changes in practice.

Ambulatory anesthesia for cosmetic surgery in Brazil.

PubMed

May, Diego Marcelo

2016-08-01

Outpatient plastic surgery is growing around the world. This industry faces unique challenges in terms of patient selection and standards of practice to ensure safety and cost-effectiveness. This review will highlight information about anesthesia practice for outpatient cosmetic surgery in Brazil, especially regarding regulation, legislation, and medical tourism. Medical tourism is growing worldwide, with a flow of patients traveling from developed to developing countries where procedures can be done at a fraction of the cost as in the patient's home country. Though generally well tolerated, there are concerns about incomplete data on outcomes of office-based surgeries and lack of safety standards. Brazil is one of the world's leaders in cosmetic surgery. Strong legislation governing outpatient facilities and continued development of accrediting standards for healthcare facilities are indications of a commitment to patient safety and high quality of care. Although the market for medical tourism in this country is high, there are still barriers to overcome before Brazil reaches its full potential in this industry.

Safety Model for the Introduction of Robotic Surgery in Gynecology.

PubMed

Gomes, Mariano Tamura Vieira; Costa Porto, Beatriz Taliberti da; Parise Filho, Jose Pedro; Vasconcelos, Ana Luiz; Bottura, Bruna Fernanda; Marques, Renato Moretti

2018-05-18

 To analyze the perioperative results and safety of performing gynecological surgeries using robot-assisted laparoscopy during implementation of the technique in a community hospital over a 6-year period.  This was a retrospective observational study in which the medical records of 274 patients who underwent robotic surgery from September 2008 to December 2014 were analyzed. We evaluated age, body mass index (BMI), diagnosis, procedures performed, American Society of Anesthesiologists (ASA) classification, the presence of a proctor (experienced surgeon with at least 20 robotic cases), operative time, transfusion rate, perioperative complications, conversion rate, length of stay, referral to the intensive care unit (ICU), and mortality. We compared transfusion rate, perioperative complications and conversion rate between procedures performed by experienced and beginner robotic surgeons assisted by an experienced proctor.  During the observed period, 3 experienced robotic surgeons performed 187 surgeries, while 87 surgeries were performed by 20 less experienced teams, always with the assistance of a proctor. The median patient age was 38 years, and the median BMI was 23.3 kg/m 2 . The most frequent diagnosis was endometriosis (57%) and the great majority of the patients were classified as ASA I or ASA II (99.6%). The median operative time was 225 minutes, and the median length of stay was 2 days. We observed a 5.8% transfusion rate, 0.8% rate of perioperative complications, 1.1% conversion rate to laparoscopy or laparotomy, no patients referred to ICU, and no deaths. There were no differences in transfusion, complications and conversion rates between experienced robotic surgeons and beginner robotic surgeons assisted by an experienced proctor.  In our casuistic, robot-assisted laparoscopy demonstrated to be a safe technique for gynecological surgeries, and the presence of an experienced proctor was considered a highlight in the safety model adopted for the introduction of the robotic gynecological surgery in a high-volume hospital and, mainly, for its extension among several surgical teams, assuring patient safety. Thieme Revinter Publicações Ltda Rio de Janeiro, Brazil.

Laparoscopic and Robotic Total Mesorectal Excision in the Treatment of Rectal Cancer. Brief Review and Personal Remarks

PubMed Central

Bianchi, Paolo Pietro; Petz, Wanda; Luca, Fabrizio; Biffi, Roberto; Spinoglio, Giuseppe; Montorsi, Marco

2014-01-01

The current standard treatment for rectal cancer is based on a multimodality approach with preoperative radiochemotherapy in advanced cases and complete surgical removal through total mesorectal excision (TME). The most frequent surgical approach is traditional open surgery, as laparoscopic TME requires high technical skill, a long learning curve, and is not widespread, still being confined to centers with great experience in minimally invasive techniques. Nevertheless, in several studies, the laparoscopic approach, when compared to open surgery, has shown some better short-term clinical outcomes and at least comparable oncologic results. Robotic surgery for the treatment of rectal cancer is an emerging technique, which could overcome some of the technical difficulties posed by standard laparoscopy, but evidence from the literature regarding its oncologic safety and clinical outcomes is still lacking. This brief review analyses the current status of minimally invasive surgery for rectal cancer therapy, focusing on oncologic safety and the new robotic approach. PMID:24834429

Important Non-Technical Skills in Video-Assisted Thoracoscopic Surgery Lobectomy: Team Perspectives.

PubMed

Gjeraa, Kirsten; Mundt, Anna S; Spanager, Lene; Hansen, Henrik J; Konge, Lars; Petersen, René H; Østergaard, Doris

2017-07-01

Safety in the operating room is dependent on the team's non-technical skills. The importance of non-technical skills appears to be different for minimally invasive surgery as compared with open surgery. The aim of this study was to identify which non-technical skills are perceived by team members to be most important for patient safety, in the setting of video-assisted thoracoscopic surgery (VATS) lobectomy. This was an explorative, semistructured interview-based study with 21 participants from all four thoracic surgery centers in Denmark that perform VATS lobectomy. Data analysis was deductive, and directed content analysis was used to code the text into the Oxford Non-Technical Skills system for evaluating operating teams' non-technical skills. The most important non-technical skills described by the VATS teams were planning and preparation, situation awareness, problem solving, leadership, risk assessment, and teamwork. These non-technical skills enabled the team to achieve shared mental models, which in turn facilitated their efforts to anticipate next steps. This was viewed as important by the participants as they saw VATS lobectomy as a high-risk procedure with complementary and overlapping scopes of practice between surgical and anesthesia subteams. This study identified six non-technical skills that serve as the foundation for shared mental models of the patient, the current situation, and team resources. These findings contribute three important additions to the shared mental model construct: planning and preparation, risk assessment, and leadership. Shared mental models are crucial for patient safety because they enable VATS teams to anticipate problems through adaptive patterns of both implicit and explicit coordination. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

PVA gel as a potential adhesion barrier: a safety study in a large animal model of intestinal surgery.

PubMed

Renz, Bernhard W; Leitner, Kurt; Odermatt, Erich; Worthley, Daniel L; Angele, Martin K; Jauch, Karl-Walter; Lang, Reinhold A

2014-03-01

Intra-abdominal adhesions following surgery are a major source of morbidity and mortality including abdominal pain and small bowel obstruction. This study evaluated the safety of PVA gel (polyvinyl alcohol and carboxymethylated cellulose gel) on intestinal anastomoses and its potential effectiveness in preventing adhesions in a clinically relevant large animal model. Experiments were performed in a pig model with median laparotomy and intestinal anastomosis following small bowel resection. The primary endpoint was the safety of PVA on small intestinal anastomoses. We also measured the incidence of postoperative adhesions in PVA vs. control groups: group A (eight pigs): stapled anastomosis with PVA gel compared to group B (eight pigs), which had no PVA gel; group C (eight pigs): hand-sewn anastomosis with PVA gel compared to group B (eight pigs), which had no anti-adhesive barrier. Animals were sacrificed 14 days after surgery and analyzed. All anastomoses had a patent lumen without any stenosis. No anastomoses leaked at an intraluminal pressure of 40 cmH2O. Thus, anastomoses healed very well in both groups, regardless of whether PVA was administered. PVA-treated animals, however, had significantly fewer adhesions in the area of stapled anastomoses. The hand-sewn PVA group also had weaker adhesions and trended towards fewer adhesions to adjacent organs. These results suggest that PVA gel does not jeopardize the integrity of intestinal anastomoses. However, larger trials are needed to investigate the potential of PVA gel to prevent adhesions in gastrointestinal surgery.

Flexible single-incision surgery: a fusion technique.

PubMed

Noguera, José F; Dolz, Carlos; Cuadrado, Angel; Olea, José; García, Juan

2013-06-01

The development of natural orifice transluminal endoscopic surgery has led to other techniques, such as single-incision surgery. The use of the flexible endoscope for single-incision surgery paves the way for further refinement of both surgical methods. To describe a new, single-incision surgical technique, namely, flexible single-incision surgery. Assessment of the safety and effectiveness of endoscopic cholecystectomy in a series of 30 patients. This technique consists of a single umbilical incision through which a flexible endoscope is introduced and consists of 2 parallel entry ports that provide access to nonarticulated laparoscopic instruments. The technique was applied in all patients for whom it was prescribed. No general or surgical wound complications were noted. Surgical time was no longer than usual for single-port surgery. Flexible single-incision surgery is a new single-site surgical technique offering the same level of patient safety, with additional advantages for the surgeon at minimal cost.

Safety, Efficacy, and Cost-effectiveness of Tranexamic Acid in Orthopedic Surgery.

PubMed

Lin, Zilan X; Woolf, Shane K

2016-01-01

Perioperative bleeding and postsurgical hemorrhage are common in invasive surgical procedures, including orthopedic surgery. Tranexamic acid (TXA) is a pharmacologic agent that acts through an antifibrinolytic mechanism to stabilize formed clots and reduce active bleeding. It has been used successfully in orthopedics to reduce perioperative blood loss, particularly in total hip and knee arthroplasty and spine surgery. Numerous research studies have reported favorable safety and efficacy in orthopedic cases, although there is no universal standard on its administration and its use has not yet become the standard of practice. Reported administration methods often depend on the surgeon's preference, with both topical and intravenous routes showing efficacy. The type and anatomic site of the surgery seem to influence the decision making but also result in conflicting opinions. Reported complication rates with TXA use are low. The incidence of both arterial and venous thromboembolic events, particularly deep venous thrombosis and pulmonary embolism, has not been found to be significantly different with TXA use for healthy patients. The route of administration and dosage do not appear to affect complication rates either. However, data on patients with higher-risk conditions are deficient. In addition, TXA has shown potential to reduce blood loss, transfusion rates and volumes, perioperative hemoglobin change, and hospital-related costs at various degrees among the published studies. Conservation of blood products, reduced laboratory costs, and shorter hospital stays are likely the major factors driving the cost savings associated with TXA use. This article reviews current data supporting the safety, efficacy, and cost-effectiveness of TXA in orthopedic surgery. Copyright 2016, SLACK Incorporated.

Safety of lornoxicam in the treatment of postoperative pain: a post-marketing study of analgesic regimens containing lornoxicam compared with standard analgesic treatment in 3752 day-case surgery patients.

PubMed

Rawal, Narinder; Krøner, Karsten; Simin-Geertsen, Marija; Hejl, Charlotte; Likar, Rudolf

2010-01-01

Post-marketing surveillance studies can provide supplemental data on the safety of medications in the general population. This study aimed to evaluate the safety of analgesic regimens including the NSAID lornoxicam in the short-term treatment of postoperative pain in a clinically relevant population. Randomized, open-label, multicentre, multinational, observational cohort study of 4 days' duration. In-hospital postoperative setting, with discharge to home treatment within 24 hours of surgery. Adults aged > or =18 years expected to be in need of analgesic treatment after day-case surgery. Analgesic regimens containing lornoxicam were compared with a standard analgesic treatment, which was defined as the treatment that the patient would normally receive at the centre. Following day-case surgery, patients were provided with appropriate analgesic medication, and adverse events (AEs; defined as all recorded events with symptoms) were recorded by the investigator during the in-hospital stay and by the patient for the next 3 days using entries recorded morning and evening in a patient diary. Statistical analyses tested for between-treatment differences in AEs, adverse drug reactions (ADRs; defined as events probably, possibly or unlikely to be related to treatment) and gastrointestinal AEs (GI-AEs). A total of 4152 patients were randomized to treatment. Since 400 patients did not take any analgesic, the safety population consisted of 1838 patients for lornoxicam and 1914 patients for standard analgesic treatment. Demographic and disease characteristics were similar between the two treatment groups, as were the type of surgery and the anaesthesia used in surgery. In the safety population, 16.9% of patients received no analgesic in hospital, and when analgesics were provided they were often administered in combination. Similarly, approximately 17% of patients did not take any analgesics at home. AEs were reported in 27.1% and 29.4% of patients in the lornoxicam and standard analgesic treatment groups, respectively, and ADRs constituted the majority of these events. No significant differences were demonstrated with regard to the incidence of AEs between the two groups. Most events were of mild or moderate intensity. Consistent with what may be expected for an NSAID, most AEs with lornoxicam were related to the GI system. GI-AEs were reported in 19.5% and 21.3% of patients in the lornoxicam and standard analgesic treatment groups, respectively, and most of these were considered ADRs. Most patients were satisfied with their pain treatment both in hospital and at home. Lornoxicam-containing regimens are as well tolerated as other analgesic regimens over 4 days in the treatment of postoperative pain.

A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients.

PubMed

Saito, Shuji; Yoshida, Shuntaro; Isayama, Hiroyuki; Matsuzawa, Takeaki; Kuwai, Toshio; Maetani, Iruru; Shimada, Mamoru; Yamada, Tomonori; Tomita, Masafumi; Koizumi, Koichi; Hirata, Nobuto; Kanazawa, Hideki; Enomoto, Toshiyuki; Sekido, Hitoshi; Saida, Yoshihisa

2016-09-01

Endoscopic stenting with a self-expandable metallic stent (SEMS) is a widely accepted procedure for malignant colonic obstruction. The Colonic Stent Safe Procedure Research Group conducted the present prospective feasibility study. Our objectives were to estimate the safety and feasibility of SEMS placement as a bridge to surgery (BTS) for malignant colorectal obstruction. We conducted a prospective, observational, single-arm, multicenter clinical trial from March 2012 to October 2013. Each patient was treated with an uncovered WallFlex enteral colonic stent. Patients were followed up until discharge after surgery. A total of 518 consecutive patients were enrolled in this study. The cohort intended for BTS consisted of 312 patients (61 %), and the stent could be released in 305 patients. Technical and clinical success rates were 98 and 92 %, respectively. Elective surgery was performed in 297 patients, and emergency surgery was performed in eight patients for the treatment of complications. The overall preoperative complication rate was 7.2 %. Major complications, including perforation, occurred in 1.6 %, persistent colonic obstruction occurred in 1.0 %, and stent migration occurred in 1.3 % patients. The median time from SEMS to surgery was 16 days. Silent perforations were observed in 1.3 %. Open and laparoscopic surgery was performed in 121 and 184 patients, respectively. The tumor could be resected in 297 patients. The primary anastomosis rate was 92 %. The rate of anastomotic leakage was 4 %, and the overall stoma creation rate was 10 %. The median duration of hospitalization following surgery was 12 days. Overall postoperative morbidity and mortality rates were 16 and 0.7 %, respectively. This largest, multicenter, prospective study demonstrates the feasibility of SEMS placement as a BTS for malignant colorectal obstruction. SEMS serves as a safe and effective BTS with acceptable stoma creation and complication rates in patients with acute malignant colonic obstruction.

Evidence for robots

PubMed Central

Shenoy, Ravikiran; Nathwani, Dinesh

2017-01-01

Robots have been successfully used in commercial industry and have enabled humans to perform tasks which are repetitive, dangerous and requiring extreme force. Their role has evolved and now includes many aspects of surgery to improve safety and precision. Orthopaedic surgery is largely performed on bones which are rigid immobile structures which can easily be performed by robots with great precision. Robots have been designed for use in orthopaedic surgery including joint arthroplasty and spine surgery. Experimental studies have been published evaluating the role of robots in arthroscopy and trauma surgery. In this article, we will review the incorporation of robots in orthopaedic surgery looking into the evidence in their use. PMID:28534472

Robotic Colorectal Surgery

PubMed Central

2008-01-01

Robotic colorectal surgery has gradually been performed more with the help of the technological advantages of the da Vinci® system. Advanced technological advantages of the da Vinci® system compared with standard laparoscopic colorectal surgery have been reported. These are a stable camera platform, three-dimensional imaging, excellent ergonomics, tremor elimination, ambidextrous capability, motion scaling, and instruments with multiple degrees of freedom. However, despite these technological advantages, most studies did not report the clinical advantages of robotic colorectal surgery compared to standard laparoscopic colorectal surgery. Only one study recently implies the real benefits of robotic rectal cancer surgery. The purpose of this review article is to outline the early concerns of robotic colorectal surgery using the da Vinci® system, to present early clinical outcomes from the most current series, and to discuss not only the safety and the feasibility but also the real benefits of robotic colorectal surgery. Moreover, this article will comment on the possible future clinical advantages and limitations of the da Vinci® system in robotic colorectal surgery. PMID:19108010

Training value of laparoscopic colorectal videos on the World Wide Web: a pilot study on the educational quality of laparoscopic right hemicolectomy videos.

PubMed

Celentano, V; Browning, M; Hitchins, C; Giglio, M C; Coleman, M G

2017-11-01

Instructive laparoscopy videos with appropriate exposition could be ideal for initial training in laparoscopic surgery, but unfortunately there are no guidelines for annotating these videos or agreed methods to measure the educational content and the safety of the procedure presented. Aim of this study is to systematically search the World Wide Web to determine the availability of laparoscopic colorectal surgery videos and to objectively establish their potential training value. A search for laparoscopic right hemicolectomy videos was performed on the three most used English language web search engines Google.com, Bing.com, and Yahoo.com; moreover, a survey among 25 local trainees was performed to identify additional websites for inclusion. All laparoscopic right hemicolectomy videos with an English language title were included. Videos of open surgery, single incision laparoscopic surgery, robotic, and hand-assisted surgery were excluded. The safety of the demonstrated procedure was assessed with a validated competency assessment tool specifically designed for laparoscopic colorectal surgery and data on the educational content of the video were extracted. Thirty-one websites were identified and 182 surgical videos were included. One hundred and seventy-three videos (95%) detailed the year of publication; this demonstrated a significant increase in the number of videos published per year from 2009. Characteristics of the patient were rarely presented, only 10 videos (5.4%) reported operating time and only 6 videos (3.2%) reported 30-day morbidity; 34 videos (18.6%) underwent a peer-review process prior to publication. Formal case presentation, the presence of audio narration, the use of diagrams, and snapshots and a step-by-step approach are all characteristics of peer-reviewed videos but no significant difference was found in the safety of the procedure. Laparoscopic videos can be a useful adjunct to operative training. There is a large and increasing amount of material available for free on the internet, but this is currently unregulated.

Effects of a Brief Team Training Program on Surgical Teams' Nontechnical Skills: An Interrupted Time-Series Study.

PubMed

Gillespie, Brigid M; Harbeck, Emma; Kang, Evelyn; Steel, Catherine; Fairweather, Nicole; Panuwatwanich, Kriengsak; Chaboyer, Wendy

2017-04-27

Up to 60% of adverse events in surgery are the result of poor communication and teamwork. Nontechnical skills in surgery (NOTSS) are critical to the success of surgery and patient safety. The study aim was to evaluate the effect of a brief team training intervention on teams' observed NOTSS. Pretest-posttest interrupted time-series design with statistical process control analysis was used to detect longitudinal changes in teams' NOTSS. We evaluated NOTSS using the revised NOTECHS weekly for 20 to 25 weeks before and after implementation of a team training program. We observed 179 surgical procedures with cardiac, vascular, upper gastrointestinal, and hepatobiliary teams. Mean posttest NOTECHS scores increased across teams, showing special cause variation. There were also significant before and after improvements in NOTECHS scores in respect to professional role and in the use of the Surgical Safety Checklist. Our results suggest associated improvements in teams' NOTSS after implementation of the team training program.

Robotic surgery for benign gynaecological disease.

PubMed

Liu, Hongqian; Lu, DongHao; Wang, Lei; Shi, Gang; Song, Huan; Clarke, Jane

2012-02-15

Robotic surgery is the latest innovation in the field of minimally invasive surgery. In the case of robotic surgery, instead of directly moving the instruments the surgeon uses a robotic system to control the instruments for surgical procedures. Robotic surgical systems have been used in various gynaecological surgeries for benign disease, such as hysterectomy (removal of the uterus), myomectomy (removal of uterine leiomyomas) and tubal reanastomosis (the reuniting of a divided tube). The mounting evidence demonstrates the feasibility and safety of robotic surgery in benign gynaecological disease. Robotic surgery is advertised as having promising advantages including more precise vision and procedures, improved ergonomics and shorter length of hospital stay. However, the main disadvantages of the robotic surgical system should not be overlooked, including the high cost of disposable instruments and retraining for both surgeons and nurses. To assess the effectiveness and safety of robot-assisted surgery in the treatment of benign gynaecological disease. We searched the Cochrane Menstrual Disorders and Subfertility Group's Trial Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 2, 2011), MEDLINE and EMBASE up to November 2011 and citation lists of relevant publications. All randomised controlled trials (RCTs) comparing robotic surgery for benign gynaecological disease to laparoscopic or open surgical procedures. RCTs comparing different types of robotic assistants were also included. We contacted study authors for unpublished information, but failed in obtaining a response. Two review authors independently screened studies for inclusion. The domains assessed for risk of bias were allocation concealment, blinding, incomplete outcome data and selective outcome reporting. Odds ratios (OR) were used for reporting dichotomous data with 95% confidence intervals (CI), whilst mean differences (MD) were determined for continuous data. Statistical heterogeneity was assessed using the I(2) statistic. We contacted the primary authors for missing data but failed in obtaining a response. Two trials involving 158 participants were included. Since one included trial was published in conference proceedings, limited usable data were available for further analysis. The only analysis in this trial showed comparable rates of conversions to open surgery between the robotic group and the laparoscopic group (OR 1.41, 95% CI 0.22 to 9.01; P = 0.72). One RCT showed longer operation time (MD 66.00, 95% CI 40.93 to 91.07; P < 0.00001), higher cost (MD 1936.00, 95% CI 445.69 to 3426.31; P = 0.01) in the robotic group compared with the laparoscopic group. Also, both studies reported that robotic and laparoscopic surgery seemed comparable regarding intraoperative outcome, complications, length of hospital stay and quality of life. Currently, the limited evidence showed that robotic surgery did not benefit women with benign gynaecological disease in effectiveness or in safety. Further well-designed RCTs with complete reported data are required to confirm or refute this conclusion.

Reducing oral and maxillofacial surgery resident risk exposure: lessons from graduate medical education reform.

PubMed

Buhrow, Suzanne Morse; Buhrow, Jack A

2013-12-01

It is estimated that, in the United States, more than 40,000 patients are injured each day because of preventable medical errors. Although numerous studies examine the causes of medical trainee errors and efforts to mitigate patient injuries in this population, little research exists on adverse events experienced by oral and maxillofacial surgery (OMFS) residents or strategies to improve patient safety awareness in OMFS residency programs. The authors conducted a retrospective literature review of contemporary studies on medical trainees' reported risk exposure and the impact of integrating evidence-based patient safety training into residency curricula. A review of the literature suggests that OMFS residents face similar risks as medical trainees in medical, surgical, and anesthesia residency programs and may benefit from integrating competency-based safety training in the OMFS residency curriculum. OMFS trainees face particular challenges when transitioning from dental student to surgical resident, particularly related to their limited clinical exposure to high-reliability organizations, which may place them at higher risk than other medical trainees. OMFS educators should establish resident competence in patient safety principles and system improvement strategies throughout the training period.

The orthopaedic error index: development and application of a novel national indicator for assessing the relative safety of hospital care using a cross-sectional approach.

PubMed

Panesar, Sukhmeet S; Netuveli, Gopalakrishnan; Carson-Stevens, Andrew; Javad, Sundas; Patel, Bhavesh; Parry, Gareth; Donaldson, Liam J; Sheikh, Aziz

2013-11-21

The Orthopaedic Error Index for hospitals aims to provide the first national assessment of the relative safety of provision of orthopaedic surgery. Cross-sectional study (retrospective analysis of records in a database). The National Reporting and Learning System is the largest national repository of patient-safety incidents in the world with over eight million error reports. It offers a unique opportunity to develop novel approaches to enhancing patient safety, including investigating the relative safety of different healthcare providers and specialties. We extracted all orthopaedic error reports from the system over 1 year (2009-2010). The Orthopaedic Error Index was calculated as a sum of the error propensity and severity. All relevant hospitals offering orthopaedic surgery in England were then ranked by this metric to identify possible outliers that warrant further attention. 155 hospitals reported 48 971 orthopaedic-related patient-safety incidents. The mean Orthopaedic Error Index was 7.09/year (SD 2.72); five hospitals were identified as outliers. Three of these units were specialist tertiary hospitals carrying out complex surgery; the remaining two outlier hospitals had unusually high Orthopaedic Error Indexes: mean 14.46 (SD 0.29) and 15.29 (SD 0.51), respectively. The Orthopaedic Error Index has enabled identification of hospitals that may be putting patients at disproportionate risk of orthopaedic-related iatrogenic harm and which therefore warrant further investigation. It provides the prototype of a summary index of harm to enable surveillance of unsafe care over time across institutions. Further validation and scrutiny of the method will be required to assess its potential to be extended to other hospital specialties in the UK and also internationally to other health systems that have comparable national databases of patient-safety incidents.

Truth in Reporting: How Data Capture Methods Obfuscate Actual Surgical Site Infection Rates within a Health Care Network System.

PubMed

Bordeianou, Liliana; Cauley, Christy E; Antonelli, Donna; Bird, Sarah; Rattner, David; Hutter, Matthew; Mahmood, Sadiqa; Schnipper, Deborah; Rubin, Marc; Bleday, Ronald; Kenney, Pardon; Berger, David

2017-01-01

Two systems measure surgical site infection rates following colorectal surgeries: the American College of Surgeons National Surgical Quality Improvement Program and the Centers for Disease Control and Prevention National Healthcare Safety Network. The Centers for Medicare & Medicaid Services pay-for-performance initiatives use National Healthcare Safety Network data for hospital comparisons. This study aimed to compare database concordance. This is a multi-institution cohort study of systemwide Colorectal Surgery Collaborative. The National Surgical Quality Improvement Program requires rigorous, standardized data capture techniques; National Healthcare Safety Network allows 5 data capture techniques. Standardized surgical site infection rates were compared between databases. The Cohen κ-coefficient was calculated. This study was conducted at Boston-area hospitals. National Healthcare Safety Network or National Surgical Quality Improvement Program patients undergoing colorectal surgery were included. Standardized surgical site infection rates were the primary outcomes of interest. Thirty-day surgical site infection rates of 3547 (National Surgical Quality Improvement Program) vs 5179 (National Healthcare Safety Network) colorectal procedures (2012-2014). Discrepancies appeared: National Surgical Quality Improvement Program database of hospital 1 (N = 1480 patients) routinely found surgical site infection rates of approximately 10%, routinely deemed rate "exemplary" or "as expected" (100%). National Healthcare Safety Network data from the same hospital and time period (N = 1881) revealed a similar overall surgical site infection rate (10%), but standardized rates were deemed "worse than national average" 80% of the time. Overall, hospitals using less rigorous capture methods had improved surgical site infection rates for National Healthcare Safety Network compared with standardized National Surgical Quality Improvement Program reports. The correlation coefficient between standardized infection rates was 0.03 (p = 0.88). During 25 site-time period observations, National Surgical Quality Improvement Program and National Healthcare Safety Network data matched for 52% of observations (13/25). κ = 0.10 (95% CI, -0.1366 to 0.3402; p = 0.403), indicating poor agreement. This study investigated hospitals located in the Northeastern United States only. Variation in Centers for Medicare & Medicaid Services-mandated National Healthcare Safety Network infection surveillance methodology leads to unreliable results, which is apparent when these results are compared with standardized data. High-quality data would improve care quality and compare outcomes among institutions.

Practicing Fireworks Safety

MedlinePlus

... Plastic Surgery Center Laser Surgery Education Center Redmond Ethics Center Global Ophthalmology Guide Academy Publications EyeNet Ophthalmology ... Plastic Surgery Center Laser Surgery Education Center Redmond Ethics Center Global Ophthalmology Guide Find an Ophthalmologist Advanced ...

A Phase I study to determine the pharmacokinetic profile, safety and tolerability of sildenafil (Revatio®) in cardiac surgery: the REVAKI‐1 study

PubMed Central

Ring, Arne; Morris, Tom; Wozniak, Marcin; Sullo, Nikol; Dott, William; Verheyden, Veerle; Kumar, Tracy; Brunskill, Nigel; Vaja, Rakesh

2016-01-01

Aims Acute kidney injury (AKI) is a common and severe complication of cardiac surgery. There is no effective prevention or treatment. Sildenafil citrate (Revatio®, Pfizer Inc.), a phosphodiesterase type 5 inhibitor, prevents post cardiac surgery AKI in pre‐clinical studies, however its use is contraindicated in patients with symptomatic cardiovascular disease. The aim of this study is to assess the safety and pharmacokinetics of intravenous sildenafil in cardiac surgery patients. Methods We conducted an open label, dose escalation study with six patients per dose level. The six doses were 2.5 mg, 5 mg or 10 mg as a bolus, either alone or followed by an additional 2 h infusion of 2.5 mg sildenafil. Results Thirty‐six patients entered the trial, of which 33 completed it. The mean age was 69.9 years. One patient died during surgery, two others were removed from the trial before dosing (all at dose level 5 mg + 2.5 mg). The pharmacokinetic profile of sildenafil was similar to previously published studies. For a dose of 10 mg administered as a bolus followed by 2.5 mg administered over 2 h the results were AUC∞ 537 ng h ml−1, C max 189.4 ng ml−1 and t 1/2 10.5 h. The drug was well tolerated with no serious adverse events related to drug administration. Higher sildenafil doses stabilized post‐surgery nitric oxide bioavailability. Conclusions Pharmacokinetics of sildenafil during cardiopulmonary bypass were comparable to those of other patient groups. The drug was well tolerated at therapeutic plasma levels. These results support the further evaluation of sildenafil for the prevention of AKI in cardiac surgery. PMID:27779776

Comparison of Complications Rates in Endoscopic Surgery Performed by a Clinical Assistant vs. An Experienced Endoscopic Surgeon

PubMed Central

Singhi, Aditi

2009-01-01

Study Objectives: (a) To find out the actual incidence of complications during endoscopic surgeries. (b) Comparison of complication rate between an experienced laparoscopic surgeon (> 10 years of experience in endoscopic surgery) and a clinical assistant (> 3 years of experience in endoscopic surgery). (c) How to manage complications in endoscopic surgery. (d) Concrete suggestions to reduce the complication rate. Design: Retrospective study (Canadian Task Force classification ii-2). Setting: Tertiary gynecologic endoscopic unit. Patients: A total of 3204 cases of gynecologic endoscopic surgery out of which 2001 were laparoscopic and 1203 were hysteroscopic surgeries. Interventions: Laparoscopic and hysteroscopic gynecologic surgeries in indicated cases. Measurements and Main Results: The study was carried out between April 2003 and October 2007 at a referral center for endoscopic surgery. A total of 3204 cases of gynecologic endoscopic surgery were studied. There were five significant complications in laparoscopic surgeries and four significant complications in hysteroscopic surgeries seen in four years and six months. All the complications could be managed with no mortality. Conversion to laparotomy was needed in eight cases of laparoscopic surgeries and none in hysteroscopic surgeries. Conclusion: The risk of complication reduces with the experience in endoscopic surgery. However, the proper grooming of a novice in experienced hands, for a sufficient period of time, can minimize the complication rate in the initial learning phase. The complication may be utilized as a stepping-stone to overcome any given situation without panic, but with adequate safety. PMID:22442510

Effectiveness of the surgical safety checklist in correcting errors: a literature review applying Reason's Swiss cheese model.

PubMed

Collins, Susan J; Newhouse, Robin; Porter, Jody; Talsma, AkkeNeel

2014-07-01

Approximately 2,700 patients are harmed by wrong-site surgery each year. The World Health Organization created the surgical safety checklist to reduce the incidence of wrong-site surgery. A project team conducted a narrative review of the literature to determine the effectiveness of the surgical safety checklist in correcting and preventing errors in the OR. Team members used Swiss cheese model of error by Reason to analyze the findings. Analysis of results indicated the effectiveness of the surgical checklist in reducing the incidence of wrong-site surgeries and other medical errors; however, checklists alone will not prevent all errors. Successful implementation requires perioperative stakeholders to understand the nature of errors, recognize the complex dynamic between systems and individuals, and create a just culture that encourages a shared vision of patient safety. Copyright © 2014 AORN, Inc. Published by Elsevier Inc. All rights reserved.

[Use and Safety of Preoperative Oral Rehydration Therapy Using a Jelly Type Oral Rehydration Solution].

PubMed

Yamada, Tomomi; Mukai, Nobuhiro; Tsuchida, Keiichirou; Hayashi, Kazuko

2015-04-01

Traditionally, perioperative nutritional management centered on fluid therapy, but in recent years, with the spread of enhanced recovery after surgery (ERAS) protocols, the utility of oral rehydration therapy (ORT) has been reported. There are few reports, however, on the safety of using jelly type oral rehydration solutions for ORT. We examined the effects of OS-1 jelly on gastric fluid and investigated its safety. A total of 147 patients (age range, 4-91 years), scheduled for elective surgery at our institution for whom ORT was indicated, were enrolled in this study. If the surgery was scheduled for the morning, patients were given two bottles of 200 g OS-1 jelly during the previous evening meal. If surgery was scheduled for the afternoon, two additional 200 g bottles were given to the patient with the morning meal on the day of surgery. Patients were allowed to drink water until two hours before the surgery. Gastric fluid was aspirated with a gastric tube after anesthesia induction, after which, volume and pH were measured. In all cases, gastric content was aspirated as a liquid, not a jelly. The volume and pH were 11.4 ± 14.6 ml and 2.8 ± 2.2, respectively. No major difference was seen in comparison with the data for OS-1 liquid. No postoperative aspiration pneumonia or reflux of gastric contents at the time of anesthesia induction was seen in any of the patients. From the present findings, if the time of water intake is strictly controlled, preoperative rehydration therapy using jelly-type oral rehydration solution is thought to be safe and comparable to liquid solution regarding its effects on gastric fluid.

Diffusing aviation innovations in a hospital in The Netherlands.

PubMed

de Korne, Dirk F; van Wijngaarden, Jeroen D H; Hiddema, U Frans; Bleeker, Fred G; Pronovost, Peter J; Klazinga, Niek S

2010-08-01

Many authors have advocated the diffusion of innovations from other high-risk industries into health care to improve safety. The aviation industry is comparable to health care because of its similarities in (a) the use of technology, (b) the requirement of highly specialized professional teams, and (c) the existence of risk and uncertainties. For almost 20 years, The Rotterdam Eye Hospital (Rotterdam, the Netherlands) has been engaged in diffusing several innovations adapted from aviation. A case-study methodology was used to assess the application of innovations in the hospital, with a focus on the context and the detailed mechanism for each innovation. Data on hospital performance outcomes were abstracted from the hospital information data management system, quality and safety reports, and the incident reporting system. Information on the innovations was obtained from a document search; observations; and semistructured, face-to-face interviews. Aviation industry-based innovations diffused into patient care processes were as follows: patient planning and booking system, taxi service/valet parking, risk analysis (as applied to wrong-site surgery), time-out procedure (also for wrong-site surgery), Crew Resource Management training, and black box. Observations indicated that the innovations had a positive effect on quality and safety in the hospital: Waiting times were reduced, work processes became more standardized, the number of wrong-site surgeries decreased, and awareness of patient safety was heightened. A near-20-year experience with aviation-based innovation suggests that hospitals start with relatively simple innovations and use a systematic approach toward the goal of improving safety.

Safety and Feasibility of a Ketamine Package to Support Emergency and Essential Surgery in Kenya when No Anesthetist is Available: An Analysis of 1216 Consecutive Operative Procedures.

PubMed

Burke, Thomas F; Suarez, Sebastian; Sessler, Daniel I; Senay, Ayla; Yusufali, Taha; Masaki, Charles; Guha, Moytrayee; Rogo, Debora; Jani, Pankaj; Nelson, Brett D; Rogo, Khama

2017-12-01

Lack of access to emergency and essential surgery is widespread in low- and middle-income countries. Scarce anesthesia services contribute to this unmet need. The aim of this study was to evaluate the safety and feasibility of the Every Second Matters for Emergency and Essential Surgery-Ketamine (ESM-Ketamine) package for emergency and essential procedures when no anesthetist was available. From November 2013 to September 2017, the ESM-Ketamine package was used for patients requiring emergency or life-improving surgeries in fifteen selected facilities across Kenya when no anesthetist was available. A mixed-methods approach was used to assess safety and feasibility of the ESM-Ketamine package, including demand, acceptability, and practicality. The primary outcome was ketamine-related adverse events. Key-informant interviews captured perceptions of providers, hospital administrators, and surgeons/proceduralists. Non-anesthetist mid-level providers used ESM-Ketamine for 1216 surgical procedures across the fifteen study facilities. The median ketamine dose was 2.1 mg/kg. Brief (<30 s) oxygen desaturations occurred in 39 patients (3%), and prolonged (>30 s) oxygen desaturations occurred in seven patients (0.6%). There were 157 (13%) reported cases of hallucinations and agitation which were treated with diazepam. All patients recovered uneventfully, and no ketamine-related deaths were reported. Twenty-seven key-informant interviews showed strong support for the program with four main themes: financial considerations, provision of services, staff impact, and scaling considerations. The ESM-Ketamine package appears safe and feasible and is capable of expanding access to emergency and essential surgeries in rural Kenya when no anesthetist is available.

Safety and Efficacy of Microinvasive Glaucoma Surgery

PubMed Central

Chen, David Z.

2017-01-01

Microinvasive glaucoma surgery (MIGS) is emerging as a new therapeutic option for glaucoma patients who wish to reduce their medication burden and avoid the postoperative complications of conventional glaucoma filtration surgery. These devices differ in terms of their efficacy and safety profile. Schlemm's canal devices have the most favorable safety profile at the compromise of modest efficacy, while subconjunctival and suprachoroidal devices are potentially more effective at lowering the intraocular pressure at the expense of a higher rate of complications. This review consolidates the latest evidence on the efficacy and safety of the MIGS devices in clinical use and provides an overview on upcoming devices which would likely also become viable treatment options in the near future. These clinical data would assist a glaucoma surgeon in selecting the most appropriate MIGS device for each patient based on the glaucoma severity and patient expectations. PMID:28512578

Safety of the Combined Use of Praziquantel and Albendazole in the Treatment of Human Hydatid Disease

PubMed Central

Alvela-Suárez, Lucía; Velasco-Tirado, Virginia; Belhassen-Garcia, Moncef; Novo-Veleiro, Ignacio; Pardo-Lledías, Javier; Romero-Alegría, Angela; Pérez del Villar, Luis; Valverde-Merino, María Paz; Cordero-Sánchez, Miguel

2014-01-01

There is still no well-established consensus about the clinical management of hydatidosis. Currently, surgery continues to be the first therapeutic option, although treatment with anti-parasitic drugs is indicated as an adjuvant to surgery to decrease the number of relapses and hydatid cyst size. When surgery is not possible, medical treatment is indicated. Traditionally, albendazole was used in monotherapy as the standard treatment. However, combined therapy with albendazole plus praziquantel appears to improve anti-parasitic effectiveness. To date, no safety studies focusing on such combined therapy have been published for the treatment of hydatidosis. In this work, we analyze the adverse effects seen in 57 patients diagnosed with hydatidosis who were treated with praziquantel plus albendazole combined therapy between 2006 and 2010. PMID:24615131

Robotic surgery for rectal cancer: Current immediate clinical and oncological outcomes

PubMed Central

Araujo, Sergio Eduardo Alonso; Seid, Victor Edmond; Klajner, Sidney

2014-01-01

Laparoscopic rectal surgery continues to be a challenging operation associated to a steep learning curve. Robotic surgical systems have dramatically changed minimally invasive surgery. Three-dimensional, magnified and stable view, articulated instruments, and reduction of physiologic tremors leading to superior dexterity and ergonomics. Therefore, robotic platforms could potentially address limitations of laparoscopic rectal surgery. It was aimed at reviewing current literature on short-term clinical and oncological (pathological) outcomes after robotic rectal cancer surgery in comparison with laparoscopic surgery. A systematic review was performed for the period 2002 to 2014. A total of 1776 patients with rectal cancer underwent minimally invasive robotic treatment in 32 studies. After robotic and laparoscopic approach to oncologic rectal surgery, respectively, mean operating time varied from 192-385 min, and from 158-297 min; mean estimated blood loss was between 33 and 283 mL, and between 127 and 300 mL; mean length of stay varied from 4-10 d; and from 6-15 d. Conversion after robotic rectal surgery varied from 0% to 9.4%, and from 0 to 22% after laparoscopy. There was no difference between robotic (0%-41.3%) and laparoscopic (5.5%-29.3%) surgery regarding morbidity and anastomotic complications (respectively, 0%-13.5%, and 0%-11.1%). Regarding immediate oncologic outcomes, respectively among robotic and laparoscopic cases, positive circumferential margins varied from 0% to 7.5%, and from 0% to 8.8%; the mean number of retrieved lymph nodes was between 10 and 20, and between 11 and 21; and the mean distal resection margin was from 0.8 to 4.7 cm, and from 1.9 to 4.5 cm. Robotic rectal cancer surgery is being undertaken by experienced surgeons. However, the quality of the assembled evidence does not support definite conclusions about most studies variables. Robotic rectal cancer surgery is associated to increased costs and operating time. It also seems to be associated to reduced conversion rates. Other short-term outcomes are comparable to conventional laparoscopy techniques, if not better. Ultimately, pathological data evaluation suggests that oncologic safety may be preserved after robotic total mesorectal excision. However, further studies are required to evaluate oncologic safety and functional results. PMID:25339823

Robotic surgery for rectal cancer: current immediate clinical and oncological outcomes.

PubMed

Araujo, Sergio Eduardo Alonso; Seid, Victor Edmond; Klajner, Sidney

2014-10-21

Laparoscopic rectal surgery continues to be a challenging operation associated to a steep learning curve. Robotic surgical systems have dramatically changed minimally invasive surgery. Three-dimensional, magnified and stable view, articulated instruments, and reduction of physiologic tremors leading to superior dexterity and ergonomics. Therefore, robotic platforms could potentially address limitations of laparoscopic rectal surgery. It was aimed at reviewing current literature on short-term clinical and oncological (pathological) outcomes after robotic rectal cancer surgery in comparison with laparoscopic surgery. A systematic review was performed for the period 2002 to 2014. A total of 1776 patients with rectal cancer underwent minimally invasive robotic treatment in 32 studies. After robotic and laparoscopic approach to oncologic rectal surgery, respectively, mean operating time varied from 192-385 min, and from 158-297 min; mean estimated blood loss was between 33 and 283 mL, and between 127 and 300 mL; mean length of stay varied from 4-10 d; and from 6-15 d. Conversion after robotic rectal surgery varied from 0% to 9.4%, and from 0 to 22% after laparoscopy. There was no difference between robotic (0%-41.3%) and laparoscopic (5.5%-29.3%) surgery regarding morbidity and anastomotic complications (respectively, 0%-13.5%, and 0%-11.1%). Regarding immediate oncologic outcomes, respectively among robotic and laparoscopic cases, positive circumferential margins varied from 0% to 7.5%, and from 0% to 8.8%; the mean number of retrieved lymph nodes was between 10 and 20, and between 11 and 21; and the mean distal resection margin was from 0.8 to 4.7 cm, and from 1.9 to 4.5 cm. Robotic rectal cancer surgery is being undertaken by experienced surgeons. However, the quality of the assembled evidence does not support definite conclusions about most studies variables. Robotic rectal cancer surgery is associated to increased costs and operating time. It also seems to be associated to reduced conversion rates. Other short-term outcomes are comparable to conventional laparoscopy techniques, if not better. Ultimately, pathological data evaluation suggests that oncologic safety may be preserved after robotic total mesorectal excision. However, further studies are required to evaluate oncologic safety and functional results.

Feasibility and safety of augmented reality-assisted urological surgery using smartglass.

PubMed

Borgmann, H; Rodríguez Socarrás, M; Salem, J; Tsaur, I; Gomez Rivas, J; Barret, E; Tortolero, L

2017-06-01

To assess the feasibility, safety and usefulness of augmented reality-assisted urological surgery using smartglass (SG). Seven urological surgeons (3 board urologists and 4 urology residents) performed augmented reality-assisted urological surgery using SG for 10 different types of operations and a total of 31 urological operations. Feasibility was assessed using technical metadata (number of photographs taken/number of videos recorded/video time recorded) and structured interviews with the urologists on their use of SG. Safety was evaluated by recording complications and grading according to the Clavien-Dindo classification. Usefulness of SG for urological surgery was queried in structured interviews and in a survey. The implementation of SG use during urological surgery was feasible with no intrinsic (technical defect) or extrinsic (inability to control the SG function) obstacles being observed. SG use was safe as no grade 3-5 complications occurred for the series of 31 urological surgeries of different complexities. Technical applications of SG included taking photographs/recording videos for teaching and documentation, hands-free teleconsultation, reviewing patients' medical records and images and searching the internet for health information. Overall usefulness of SG for urological surgery was rated as very high by 43 % and high by 29 % of surgeons. Augmented reality-assisted urological surgery using SG is both feasible and safe and also provides several useful functions for urological surgeons. Further developments and investigations are required in the near future to harvest the great potential of this exciting technology for urological surgery.

A cohort study of a general surgery electronic consultation system: safety implications and impact on surgical yield.

PubMed

Ulloa, Jesus G; Russell, Marika D; Chen, Alice Hm; Tuot, Delphine S

2017-06-23

Electronic consultation (eConsult) systems have enhanced access to specialty expertise and enhanced care coordination among primary care and specialty care providers, while maintaining high primary care provider (PCP), specialist and patient satisfaction. Little is known about their impact on the efficiency of specialty care delivery, in particular surgical yield (percent of ambulatory visits resulting in a scheduled surgical case). Retrospective cohort of a random selection of 150 electronic consults from PCPs to a safety-net general surgery clinic for the three most common general surgery procedures (herniorrhaphy, cholecystectomy, anorectal procedures) in 2014. Electronic consultation requests were reviewed for the presence/absence of consult domains: symptom acuity/severity, diagnostic evaluation, concurrent medical conditions, and attempted diagnosis. Logic regression was used to examine the association between completeness of consult requests and scheduling an ambulatory clinic visit. Surgical yield was also calculated, as was the percentage of patients requiring unanticipated healthcare visits. In 2014, 1743 electronic consultations were submitted to general surgery. Among the 150 abstracted, the presence of consult domains ranged from 49% to 99%. Consult completeness was not associated with greater likelihood of scheduling an ambulatory visit. Seventy-six percent of consult requests (114/150) were scheduled for a clinic appointment and surgical yield was 46%; without an eConsult system, surgical yield would have been 35% (p=0.07). Among patients not scheduled for a clinic visit (n=36), 4 had related unanticipated emergency department visits. Econsult systems can be used to safely optimize the surgical yield of a safety-net general surgery service.

Efficacy and Safety of Postoperative Pain Relief by Parecoxib Injection after Laparoscopic Surgeries: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

PubMed

Huang, Jun-Ming; Lv, Zheng-Tao; Zhang, Ya-Nan; Jiang, Wen-Xiu; Li, Han-Ning; Nie, Ming-Bo

2017-10-17

This study aims to evaluate the efficacy and safety of parecoxib injection in pain relief after laparoscopic surgeries. A comprehensive literature search based on 4 online databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science) was applied to retrieve all related randomized controlled trials (RCTs). Two independent reviewers screened each article for eligibility according to the predetermined inclusion criteria. The Cochrane Collaboration's tool was applied to evaluate the methodological quality of included studies. A standardized data collection sheet was designed to extract data from included studies. RevMan version 5.3 (The Cochrane Collaboration, Copenhagen, Denmark) was selected to perform meta-analysis. A total of 1,060 participants who were scheduled for gynecological laparoscopic surgery or laparoscopic cholecystectomy (LC) were enrolled in 12 selected RCTs. The methodological qualities of the studies were evaluated as moderate to high. The combined data showed that perioperative parecoxib injection could significantly reduce the proportion of patients who required adjuvant pain relieve after laparoscopic surgeries. Significantly lower pain scores in the parecoxib groups were observed, which proved that preoperative or intraoperative injection of 40 mg parecoxib was more effective than placebo for immediate pain relief after LC. But preoperative injection of 40 mg parecoxib showed no improvement compared with placebo in the management of immediate pain following gynecological laparoscopic surgery. The occurrence of adverse events showed no differences between perioperative parecoxib administration and placebo control. Perioperative parecoxib administration was effective in reducing the proportion of patients who required adjuvant pain relief after laparoscopic surgeries without significant adverse events compared with placebo. The effect of parecoxib injection on immediate pain relief remains in question. Future RCTs with larger sample sizes are encouraged. © 2017 World Institute of Pain.

Office-based surgery: embracing patient safety strategies.

PubMed

Shapiro, Fred E; Punwani, Nathan; Urman, Richard D

2013-01-01

Office-based surgery continues to grow as more procedures are being performed in the outpatient setting. With this exponential growth, there is an increasing emphasis on safe and effective patient care. Current research shows both gaps in safety and opportunities for improvement. Practice managers, clinicians, and other personnel should be cognizant that office procedures are coming under intense regulatory scrutiny. Effective strategies to maintain quality and patient safety include the use of checklists, obtaining office accreditation, encouraging board-certification and proper credentialing of proceduralists, and appropriate patient and procedure selection. There is increasing regulation of ambulatory surgery on state and national levels that will likely affect the financial and care quality aspects of office-based practice. Socioeconomic and political forces will continue to shape the future of office-based surgery.

Intraoperative Ultrasound in Patients Undergoing Transsphenoidal Surgery for Pituitary Adenoma: Systematic Review [corrected].

PubMed

Marcus, Hani J; Vercauteren, Tom; Ourselin, Sebastien; Dorward, Neil L

2017-10-01

Transsphenoidal surgery is the gold standard for pituitary adenoma resection. However, despite advances in microsurgical and endoscopic techniques, some pituitary adenomas can be challenging to cure. We sought to determine whether, in patients undergoing transsphenoidal surgery for pituitary adenoma, intraoperative ultrasound is a safe and effective technologic adjunct. The PubMed database was searched between January 1996 and January 2016 to identify relevant publications that 1) featured patients undergoing transsphenoidal surgery for pituitary adenoma, 2) used intraoperative ultrasound, and 3) reported on safety or effectiveness. Reference lists were also checked, and expert opinions were sought to identify further publications. Ultimately, 10 studies were included, comprising 1 cohort study, 7 case series, and 2 case reports. One study reported their prototype probe malfunctioned, leading to false-positive results in 2 cases, and another study' prototype probe was too large to safely enter the sphenoid sinus in 2 cases. Otherwise, no safety issues directly related to use of intraoperative ultrasound were reported. In the only comparative study, remission occurred in 89.7% (61/68) of patients with Cushing disease in whom intraoperative ultrasound was used, compared with 83.8% (57/68) in whom it was not. All studies reported that surgeons anecdotally found intraoperative ultrasound helpful. Although there is limited and low-quality evidence available, the use of intraoperative ultrasound appears to be a safe and effective technologic adjunct to transsphenoidal surgery for pituitary adenoma. Advances in ultrasound technology may allow for more widespread use of such devices. Copyright © 2017 Elsevier Inc. All rights reserved.

Failure Modes and Effects Analysis of bilateral same-day cataract surgery

PubMed Central

Shorstein, Neal H.; Lucido, Carol; Carolan, James; Liu, Liyan; Slean, Geraldine; Herrinton, Lisa J.

2017-01-01

PURPOSE To systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety. SETTING Twenty-one Kaiser Permanente surgery centers, Northern California, USA. DESIGN Retrospective cohort study. METHODS Quality experts performed a Failure Modes and Effects Analysis (FMEA) that included an evaluation of sterile processing, pharmaceuticals, perioperative clinic and surgical center visits, and biometry. Potential failures in human factors and communication (modes) were identified. Rates of endophthalmitis, toxic anterior segment syndrome (TASS), and unintended intraocular lens (IOL) implantation were assessed in eyes having bilateral same-day surgery from 2010 through 2014. RESULTS The study comprised 4754 eyes. The analysis identified 15 significant potential failure modes. These included lapses in instrument processing and compounding error of intracameral antibiotic that could lead to endophthalmitis or TASS and ambiguous documentation of IOL selection by surgeons, which could lead to unintended IOL implantation. Of the study sample, 1 eye developed endophthalmitis, 1 eye had unintended IOL implantation (rates, 2 per 10 000; 95% confidence intervals [CI] 0.1–12.0 per 10 000), and no eyes developed TASS (upper 95% CI, 8 per 10 000). Recommendations included improving oversight of cleaning and sterilization practices, separating lots of compounded drugs for each eye, and enhancing IOL verification procedures. CONCLUSIONS Potential failure modes and recommended actions in bilateral same-day cataract surgery were determined using a FMEA. These findings might help improve the reliability and safety of bilateral same-day cataract surgery based on current evidence and standards. PMID:28410711

Recent Development of Augmented Reality in Surgery: A Review

PubMed Central

Vávra, P.; Zonča, P.; Ihnát, P.; El-Gendi, A.

2017-01-01

Introduction The development augmented reality devices allow physicians to incorporate data visualization into diagnostic and treatment procedures to improve work efficiency, safety, and cost and to enhance surgical training. However, the awareness of possibilities of augmented reality is generally low. This review evaluates whether augmented reality can presently improve the results of surgical procedures. Methods We performed a review of available literature dating from 2010 to November 2016 by searching PubMed and Scopus using the terms “augmented reality” and “surgery.” Results. The initial search yielded 808 studies. After removing duplicates and including only journal articles, a total of 417 studies were identified. By reading of abstracts, 91 relevant studies were chosen to be included. 11 references were gathered by cross-referencing. A total of 102 studies were included in this review. Conclusions The present literature suggest an increasing interest of surgeons regarding employing augmented reality into surgery leading to improved safety and efficacy of surgical procedures. Many studies showed that the performance of newly devised augmented reality systems is comparable to traditional techniques. However, several problems need to be addressed before augmented reality is implemented into the routine practice. PMID:29065604

Efficacy and safety profile of antibiotic prophylaxis usage in clean and clean-contaminated plastic and reconstructive surgery: a meta-analysis of randomized controlled trials.

PubMed

Zhang, Yi; Dong, Jiasheng; Qiao, Yufei; He, Jinguang; Wang, Tao; Ma, Sunxiang

2014-01-01

There is no consensus with regard to antibiotic prophylaxis usage in clean and clean-contaminated plastic and reconstructive surgery. This meta-analysis sought to assess the efficacy and safety of antibiotic prophylaxis and to determine appropriate duration of prophylaxis. An English language literature search was conducted using PubMed and the Cochrane Collaboration for randomized controlled trials (RCTs) that evaluate the use of antibiotic prophylaxis to prevent postoperative surgical site infection (SSI) in patients undergoing clean and clean-contaminated plastic and reconstructive surgery. Data from intention-to-treat analyses were used where available. For the dichotomous data, results for each study were odds ratio (OR) with 95% confidence interval (CI) and combined for meta-analysis using the Mantel-Haenszel method or the DerSimonian and Laird method. Study quality was critically appraised by 2 reviewers using established criteria. STATA version 12 was used for meta-analyses. Twelve RCTs involving 2395 patients were included, of which 8 trials were considered to be of high methodological quality. Effect of antibiotic prophylaxis in plastic and reconstructive surgery was found favorable over placebo in SSI prevention (13 studies; 2449 participants; OR, 0.53; 95% CI, 0.4-0.7; P < 0.01) and the other wound complication (OWC) prevention (9 studies; 1843 participants; OR, 0.36; 95% CI, 0.15-0.84; P < 0.02). Subgroup analysis performed according to surgical wound type or the duration of prophylaxis did not modify the results except for the OWC with short-term antibiotic treatment. Compared with short-term antibiotic prophylaxis, long-term administration showed no evidence of a difference in risk of SSI (7 studies; 1012 participants; OR, 0.99; 95% CI, 0.63-1.55; P < 0.95), OWC (5 studies; 824 participants; OR, 0.92; 95% CI, 0.46-1.86; P < 0.82), and adverse event relative to antibiotic administration (3 studies; 653 participants; OR, 0.23; 95% CI, 0.01-4.92; P < 0.35). This meta-analysis of RCTs provides evidence supporting that antibiotic prophylaxis reduced postoperative SSI in clean plastic surgeries with high-risk factors and clean-contaminated plastic surgeries. Besides, a short-course administration regimen seemed to be of adequate efficacy and safety. High-quality prospective trials on larger scale are needed to further confirm these findings.

Evidence for robots.

PubMed

Shenoy, Ravikiran; Nathwani, Dinesh

2017-01-01

Robots have been successfully used in commercial industry and have enabled humans to perform tasks which are repetitive, dangerous and requiring extreme force. Their role has evolved and now includes many aspects of surgery to improve safety and precision. Orthopaedic surgery is largely performed on bones which are rigid immobile structures which can easily be performed by robots with great precision. Robots have been designed for use in orthopaedic surgery including joint arthroplasty and spine surgery. Experimental studies have been published evaluating the role of robots in arthroscopy and trauma surgery. In this article, we will review the incorporation of robots in orthopaedic surgery looking into the evidence in their use. © The Authors, published by EDP Sciences, 2017.

Topical anesthesia for transpupillary silicone oil removal combined with cataract surgery.

PubMed

Jonas, Jost B; Hugger, Philipp; Sauder, Gangolf

2005-09-01

To assess safety of topical anesthesia for transpupillary silicone oil removal in combination with cataract surgery. Department of Ophthalmology Mannheim, University of Heidelberg, Mannheim, Germany. The clinical interventional study included 37 consecutive patients having transpupillary silicone oil removal combined with cataract surgery. Without exception, surgery was carried out in topical anesthesia for all patients. During the study period, there were no patients having transpupillary silicone oil removal in another type of local anesthesia than topical anesthesia. Topical anesthesia was achieved with oxybuprocaine 0.4% eyedrops installed 4 to 5 times prior to surgery. Cataract surgery was performed using the clear cornea technique with implantation of a foldable intraocular posterior chamber lens. Silicone oil was released through a planned posterior capsulotomy during cataract surgery prior to implantation of the intraocular lens (IOL). For all patients, surgery could be carried out in topical anesthesia without switching to peribulbar or any other type of anesthesia. None of the patients complained about severe pain intraoperatively or postoperatively. No severe complications such as expulsive hemorrhage, luxation of the IOL, or iris incarceration were encountered in any of the surgeries. Transpupillary silicone oil through a planned posterior capsulotomy during cataract surgery may be performed in topical surgery.

Robotic thoracic surgery: technical considerations and learning curve for pulmonary resection.

PubMed

Veronesi, Giulia

2014-05-01

Retrospective series indicate that robot-assisted approaches to lung cancer resection offer comparable radicality and safety to video-assisted thoracic surgery or open surgery. More intuitive movements, greater flexibility, and high-definition three-dimensional vision overcome limitations of video-assisted thoracic surgery and may encourage wider adoption of robotic surgery for lung cancer, particularly as more early stage cases are diagnosed by screening. High capital and running costs, limited instrument availability, and long operating times are important disadvantages. Entry of competitor companies should drive down costs. Studies are required to assess quality of life, morbidity, oncologic radicality, and cost effectiveness. Copyright © 2014 Elsevier Inc. All rights reserved.

[Robotic general surgery: where do we stand in 2013?].

PubMed

Buchs, Nicolas C; Pugin, François; Ris, Frédéric; Jung, Minoa; Hagen, Monika E; Volonté, Francesco; Azagury, Dan; Morel, Philippe

2013-06-19

While the number of publications concerning robotic surgery is increasing, the level of evidence remains to be improved. The safety of robotic approach has been largely demonstrated, even for complex procedures. Yet, the objective advantages of this technology are still lacking in several fields, notably in comparison to laparoscopy. On the other hand, the development of robotic surgery is on its way, as the enthusiasm of the public and the surgical community can testify. Still, clear clinical indications remain to be determined in the field of general surgery. The study aim is to review the current literature on robotic general surgery and to give the reader an overview in 2013.

Effectiveness and Safety of an Overnight Patch Containing Allium cepa Extract and Allantoin for Post-Dermatologic Surgery Scars.

PubMed

Prager, Welf; Gauglitz, Gerd G

2018-06-14

An occlusive overnight intensive patch medical device (OIP) containing onion extract and allantoin has been developed for preventing and treating dermatologic scars and keloids. Here, we examined the efficacy and safety of the OIP for post-dermatologic surgery scars. This was an intra-individual randomized, observer-blind, controlled study in adults with post-dermatologic surgery scars. Two scars per subject were randomized to no treatment or overnight treatment with the OIP for 12-24 weeks. Scar quality was assessed using the Patient and Observer Scar Assessment Scale (POSAS) and a Global Aesthetic Improvement Scale. A total of 125 subjects were included. The decrease in observer-assessed POSAS from baseline was significantly greater for treated than untreated scars at week 6 (p < 0.001) and 24 (p = 0.001). The decrease in patient-assessed POSAS was significantly greater for the treated scar than the untreated scar at week 12 (p = 0.017) and 24 (p = 0.014). Subject- and investigator-evaluated Global Aesthetic Improvement Scale scores were higher for the treated than the untreated scar at all visits. All subjects considered the global comfort of the OIP to be good or very good, and no safety concerns were identified. This study confirmed that the OIP safely promotes scar healing after minor dermatologic surgery. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Resident Cosmetic Clinic: Practice Patterns, Safety, and Outcomes at an Academic Plastic Surgery Institution.

PubMed

Qureshi, Ali A; Parikh, Rajiv P; Myckatyn, Terence M; Tenenbaum, Marissa M

2016-10-01

Comprehensive aesthetic surgery education is an integral part of plastic surgery residency training. Recently, the ACGME increased minimum requirements for aesthetic procedures in residency. To expand aesthetic education and prepare residents for independent practice, our institution has supported a resident cosmetic clinic for over 25 years. To evaluate the safety of procedures performed through a resident clinic by comparing outcomes to benchmarked national aesthetic surgery outcomes and to provide a model for resident clinics in academic plastic surgery institutions. We identified a consecutive cohort of patients who underwent procedures through our resident cosmetic clinic between 2010 and 2015. Major complications, as defined by CosmetAssure database, were recorded and compared to published aesthetic surgery complication rates from the CosmetAssure database for outcomes benchmarking. Fisher's exact test was used to compare sample proportions. Two hundred and seventy-one new patients were evaluated and 112 patients (41.3%) booked surgery for 175 different aesthetic procedures. There were 55 breast, 19 head and neck, and 101 trunk or extremity aesthetic procedures performed. The median number of preoperative and postoperative visits was 2 and 4 respectively with a mean follow-up time of 35 weeks. There were 3 major complications (2 hematomas and 1 infection requiring IV antibiotics) with an overall complication rate of 1.7% compared to 2.0% for patients in the CosmetAssure database (P = .45). Surgical outcomes for procedures performed through a resident cosmetic clinic are comparable to national outcomes for aesthetic surgery procedures, suggesting this experience can enhance comprehensive aesthetic surgery education without compromising patient safety or quality of care. 4 Risk. © 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

Operating force information on-line acquisition of a novel slave manipulator for vascular interventional surgery.

PubMed

Zhao, Yan; Guo, Shuxiang; Xiao, Nan; Wang, Yuxin; Li, Youxiang; Jiang, Yuhua

2018-04-02

Vascular interventional surgery has its advantages compared to traditional operation. Master-slave robotic technology can further improve the operation accuracy, efficiency and safety of this complicated and high risk surgery. However, on-line acquisition of operating force information of catheter and guidewire remains to be a significant obstacle on the path to enhancing robotic surgery safety. Thus, a novel slave manipulator is proposed in this paper to realize on-line sensing of guidewire torsional operating torque and axial operation force during robotic assisted operations. A strain sensor is specially designed to detect the small scale torsional operation torque with low rotational frequency. Additionally, the axial operating force is detected via a load cell, which is incorporated into a sliding mechanism to eliminate the influence of friction. For validation, calibration and performance evaluation experiments are conducted. The results indicate that the proposed operation torque and force detection device is effective. Thus, it can provide the foundation for enabling accurate haptic feedback to the surgeon to improve surgical safety.

Surgical Evacuation of Spontaneous Supratentorial Lobar Intracerebral Hemorrhage: Comparison of Safety and Efficacy of Stereotactic Aspiration, Endoscopic Surgery, and Craniotomy.

PubMed

Li, Yuqian; Yang, Ruixin; Li, Zhihong; Yang, Yanping; Tian, Bo; Zhang, Xingye; Wang, Bao; Lu, Dan; Guo, Shaochun; Man, Minghao; Yang, Yang; Luo, Tao; Gao, Guodong; Li, Lihong

2017-09-01

The safety and efficacy of craniotomy, endoscopic surgery, and stereotactic aspiration for surgical evacuation of spontaneous supratentorial lobar intracerebral hemorrhage (ICH) is yet uncertain. The present study analyzed the clinical and radiographic data from 99 patients with spontaneous supratentorial lobar ICH, retrospectively, to address this issue. Patients who underwent craniotomy, endoscopy surgery, or stereotactic aspiration were assigned to the craniotomy group (n = 31), endoscopy surgery group (n = 32), or stereotactic aspiration group (n = 36), respectively. The characteristics of all the enrolled patients at the time of admission were assimilated. Also, the therapeutic effects of the three surgical procedures were evaluated based on short-term outcomes within 30 days and long-term outcomes at 6 months after the ictus. The results showed that stereotactic aspiration and endoscopic surgery were associated with a superior clinical therapeutic effect in both short-term and long-term outcomes than craniotomy for the treatment of spontaneous supratentorial lobar ICH. Notably, severely affected patients with hematoma volume > 60 mL or Glasgow Coma Scale score 4-8 may benefit more from endoscopic surgery than the two other surgical procedures. The current findings demonstrate that both stereotactic aspiration and endoscopic surgery possess an apparent advantage over craniotomy for the evacuation of spontaneous supratentorial lobar ICH. The endoscopic surgery might be more safe and effective with higher evacuation rate, better functional neurological outcomes, and lower complication and mortality rates. Copyright © 2017 Elsevier Inc. All rights reserved.

Black box warning: is ketorolac safe for use after cardiac surgery?

PubMed

Oliveri, Lisa; Jerzewski, Katie; Kulik, Alexander

2014-04-01

In 2005, after the identification of cardiovascular safety concerns with the use of nonsteroidal anti-inflammatory drugs (NSAIDs), the FDA issued a black box warning recommending against the use of NSAIDs following cardiac surgery. The goal of this study was to assess the postoperative safety of ketorolac, an intravenously administered NSAID, after cardiac surgery. Retrospective observational study. Single center, regional hospital. A total of 1,309 cardiac surgical patients (78.1% coronary bypass, 28.0% valve) treated between 2006 and 2012. A total of 488 of these patients received ketorolac for postoperative analgesia within 72 hours of surgery. Ketorolac-treated patients were younger, had better preoperative renal function, and underwent less complex operations compared with non-ketorolac patients. Ketorolac was administered, on average, 8.7 hours after surgery (mean doses: 3.1). Postoperative outcomes for ketorolac-treated patients were similar to those expected using Society of Thoracic Surgery database risk-adjusted outcomes. In unadjusted analysis, patients who received ketorolac had similar or better postoperative outcomes compared with patients who did not receive ketorolac, including gastrointestinal bleeding (1.2% v 1.3%; p = 1.0), renal failure requiring dialysis (0.4% v 3.0%; p = 0.001), perioperative myocardial infarction (1.0% v 0.6%; p = 0.51), stroke or transient ischemic attack (1.0% v 1.7%; p = 0.47), and death (0.4% v 5.8%; p<0.0001). With adjustment in a multivariate model, treatment with ketorolac was not a predictor for adverse outcome in this cohort (odds ratio: 0.72; p = 0.23). Ketorolac appears to be well-tolerated for use when administered selectively after cardiac surgery. Although a black box warning exists, the data highlights the need for further research regarding its perioperative administration. Copyright © 2014 Elsevier Inc. All rights reserved.

Utility and safety of the flexible-fiber CO2 laser in endoscopic endonasal transsphenoidal surgery.

PubMed

Jayarao, Mayur; Devaiah, Anand K; Chin, Lawrence S

2011-01-01

This study sought to report on the utility and safety of the flexible-fiber CO2 laser in endoscopic endonasal transsphenoidal surgery. A retrospective chart review identified 16 patients who underwent laser-assisted transsphenoidal surgery. All tumor pathology types were considered. Results were assessed based on hormone status, tumor size, pathology, complications, and resection rates. Sixteen pituitary lesions (pituitary adenomas, 12; Rathke cleft cyst, 2; pituitary cyst and craniopharyngioma, 1 each) with an average size of 22.7 mm were identified by radiographic and pathologic criteria. All patients underwent flexible-fiber CO2 laser-assisted endoscopic endonasal transsphenoidal surgery. Of the adenomas, 8 were nonsecreting and 4 were secreting (3 prolactinomas and 1 ACTH secreting). Gross total resection was achieved in 7 of 16 patients (43.75%) with hormone remission in all patients (100%) after a mean follow-up of 19.3 months. Postoperative complications occurred in 3 patients (18.75%): 2 patients developed transient diabetes insipidus (DI) and 1 developed a CSF leak requiring surgical repair. Five patients (31.25%) underwent postoperative radiation to the residual lesions. We found that CO2-laser-assisted endoscopic endonasal transsphenoidal surgery for sellar tumors is a minimally invasive approach using a tool that is quick and effective at cutting and coagulation. The surgery has a low rate of complication, and no laser-related complications were encountered. The laser fiber allows the surgeon to safely cut and coagulate without the line-of-sight problems encountered with conventional CO2 lasers. Further studies are recommended to further define its role in endoscopic endonasal sellar surgery. Copyright © 2011 Elsevier Inc. All rights reserved.

Laser-assisted cataract surgery versus standard ultrasound phacoemulsification cataract surgery.

PubMed

Day, Alexander C; Gore, Daniel M; Bunce, Catey; Evans, Jennifer R

2016-07-08

Cataract is the leading cause of blindness in the world, and cataract surgery is one of the most commonly performed operations in the Western world. Preferred surgical techniques have changed dramatically over the past half century with associated improvements in outcomes and safety. Femtosecond laser platforms that can accurately and reproducibly perform key steps in cataract surgery, including corneal incisions, capsulotomy and lens fragmentation, are now available. The potential advantages of laser-assisted surgery are broad, and include greater safety and better visual outcomes through greater precision and reproducibility. To compare the effectiveness of laser-assisted cataract surgery with standard ultrasound phacoemulsification cataract surgery by gathering evidence on safety from randomised controlled trials (RCTs). We searched CENTRAL (which contains the Cochrane Eyes and Vision Trials Register) (2016, Issue 4), Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, Ovid OLDMEDLINE (January 1946 to May 2016), EMBASE (January 1980 to May 2016), Latin American and Caribbean Health Sciences Literature Database (LILACS) (January 1982 to May 2016), the ISRCTN registry (www.isrctn.com/editAdvancedSearch), ClinicalTrials.gov (www.clinicaltrials.gov), the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (www.who.int/ictrp/search/en) and the U.S. Food and Drugs Administration (FDA) website (www.fda.gov). We did not use any date or language restrictions in the electronic searches for trials. We last searched the electronic databases on 10 May 2016. We included randomised controlled trials where laser-assisted cataract surgery was compared to standard ultrasound phacoemulsification cataract surgery. We graded the certainty of the evidence using GRADE. Two review authors independently screened the search results, assessed risk of bias and extracted data using the standard methodological procedures expected by Cochrane. The primary outcome for this review was intraoperative complications in the operated eye, namely anterior capsule and posterior capsule tears. The secondary outcomes were visual acuity (corrected distance visual acuity (CDVA) and uncorrected distance visual acuity (UDVA)), refractive outcomes, quality of vision (as measured by any validated visual function score), postoperative complications and cost-effectiveness. We included 16 RCTs conducted in Germary, Hungary, Italy, India, China and Brazil that enrolled a total of 1638 eyes of 1245 adult participants. Overall, the studies were at unclear or high risk of bias. In 11 of the studies the authors reported financial links with the manufacturer of the laser platform evaluated in their studies. Five of the studies were within-person (paired-eye) studies with one eye allocated to one procedure and the other eye allocated to the other procedure. These studies were reported ignoring the paired nature of the data.The number of anterior capsule and posterior capsule tears reported in the included studies for both laser cataract surgery and manual phacoemulsification cataract surgery were low. There were four anterior capsule tears and one posterior capsule tear in 1076 eyes reported in 10 studies (2 anterior capsule tears in laser arms, 2 anterior capsule tears and 1 posterior capsule tear in standard phacoemulsification arms). We are very uncertain as to the effect of laser-assisted surgery compared to standard phacoemulsification surgery with respect to these two outcomes. For postoperative cystoid macular oedema and elevated postoperative intraocular pressures, again the evidence was inconclusive (odds ratio (OR) 0.58, 95% confidence interval (CI) 0.20 to 1.68; 957 eyes, 9 studies, low certainty evidence; and OR 0.57, 95% CI 0.11 to 2.86; 903 eyes, 8 studies, low certainty evidence).We found little evidence of any important difference in postoperative visual acuity between laser-assisted and standard phacoemulsification arms. There was a small advantage for laser-assisted cataract surgery at six months in CDVA. However, the mean difference (MD) was -0.03 logMAR (95% CI -0.05 to -0.00; 224 eyes, 3 studies, low certainty evidence) which is equivalent to 1.5 logMAR letters and is therefore, clinically insignificant. No studies reported patient-reported outcome measures such as visual function.There were no data reported on costs or resource use but three studies reported the time taken to do the surgery. There was little evidence of any major difference between the two procedures in this respect (MD 0.1 minutes, 95% CI -0.02 to 0.21; 274 eyes, low certainty evidence). The evidence from the 16 randomised controlled trials RCTs included in this review could not determine the equivalence or superiority of laser-assisted cataract surgery compared to standard manual phacoemulsification for our chosen outcomes due to the low to very low certainty of the evidence available from these studies. As complications occur rarely, large, adequately powered, well designed, independent RCTs comparing the safety and efficacy of laser-assisted cataract surgery with standard phacoemulsification cataract surgery are needed. Standardised reporting of complications and visual and refractive outcomes for cataract surgery would facilitate future synthesis. Data on patient-reported outcomes and cost-effectiveness are needed. Paired-eye studies should be analysed and reported appropriately.

Nepafenac 0.3% after Cataract Surgery in Patients with Diabetic Retinopathy: Results of 2 Randomized Phase 3 Studies.

PubMed

Singh, Rishi P; Lehmann, Robert; Martel, Joseph; Jong, Kevin; Pollack, Ayala; Tsorbatzoglou, Alexis; Staurenghi, Giovanni; Cervantes-Coste Cervantes, Guadalupe; Alpern, Louis; Modi, Satish; Svoboda, Liza; Adewale, Adeniyi; Jaffe, Glenn J

2017-06-01

To demonstrate the efficacy and safety of once-daily nepafenac 0.3% ophthalmic suspension versus vehicle, based on clinical outcomes, after cataract surgery in patients with diabetes. Two prospective, randomized, multicenter, double-masked, vehicle-controlled phase 3 studies. Total, 615 patients in study 1 and 605 patients in study 2. Patients were randomized (1:1) to topical nepafenac 0.3% or vehicle once-daily starting the day before surgery and continuing for 90 days thereafter. Key efficacy variables were: patients (%) in whom macular edema (ME) developed (≥30% increase from preoperative baseline central subfield macular thickness) within 90 days after cataract surgery and the patients (%) with a best-corrected visual acuity (BCVA) improvement of ≥15 letters from preoperative baseline through day 14 maintained through day 90. Secondary end points included: patients (%) with a BCVA improvement of ≥15 letters from preoperative baseline through days 90 and 60 and safety over 3 months. A significantly lower percentage of patients demonstrated ME within 90 days after surgery with nepafenac 0.3% versus vehicle (study 1: 2.3% vs. 17.3%; P < 0.001; study 2: 5.9% vs. 14.3%; P = 0.001; pooled: 4.1% vs. 15.9%; P < 0.001). The percentage of patients achieving a ≥15-letter improvement from baseline through day 14 maintained through day 90 with nepafenac 0.3% versus vehicle was 61.7% versus 43.0% (P < 0.001) in study 1, 48.8% versus 50.5% (P = 0.671) in study 2, and 55.4% versus 46.7% (P = 0.003) in the pooled analysis. A greater percentage of patients treated with nepafenac 0.3% versus vehicle in study 1 and similar percentage in study 2 had a BCVA improvement of ≥15 letters from preoperative baseline through day 90 (77.2% vs. 67.7% [P = 0.009] and 65.4% vs. 65.9% [P = 0.888]) and through day 60 (76.2% vs. 64.7% [P = 0.002] and 68.9% vs. 62.1% [P = 0.092]). No unanticipated adverse events were observed. These studies demonstrated the clinical benefits of nepafenac 0.3% over vehicle in reducing the risk of postoperative ME, with the integrated analysis showing improved BCVA after cataract surgery in patients with diabetic retinopathy, with no unanticipated safety events. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

The impact of organisational and individual factors on team communication in surgery: a qualitative study.

PubMed

Gillespie, Brigid M; Chaboyer, Wendy; Longbottom, Paula; Wallis, Marianne

2010-06-01

Effective teamwork and communication is a crucial determinant of patient safety in the operating room. Communication failures are often underpinned by the inherent differences in professional practices across disciplines, and the ways in which they collaborate. Despite the overwhelming international support to improve team communication, progress has been slow. The aim of this paper is to extend understanding of the organisational and individual factors that influence teamwork in surgery. This qualitative study used a grounded theory approach to generate a theoretical model to explain the relations between organisational and individual factors that influence interdisciplinary communication in surgery. A purposive sample of 16 participants including surgeons, anaesthetists, and nurses who worked in an operating room of a large metropolitan hospital in south east Queensland, Australia, were selected. Participants were interviewed during 2008 using semi-structured individual and group interviews. All interviews were recorded and transcribed. Using a combination of inductive and deductive approaches, thematic analyses uncovered individual experiences in association with teamwork in surgery. Analysis generated three themes that identified and described causal patterns of interdisciplinary teamwork practices; interdisciplinary diversity in teams contributes to complex interpersonal relations, the pervasive influence of the organisation on team cohesion, and, education is the panacea to improving team communications. The development of shared mental models has the potential to improve teamwork in surgery, and thus enhance patient safety. This insight presents a critical first step towards the development teambuilding interventions in the operating room that would specifically address communication practices in surgery. (c) 2009 Elsevier Ltd. All rights reserved.

Exploring the safety range via the transoral approach to the craniovertebral junction.

PubMed

Wang, Ying; Yang, Ming; Zhang, Hongliang; Zheng, Yuhao; Tian, Yong; Li, Youqiong

2014-07-01

Surgeries via the transoral approach are widely used to deal with lesions near the craniovertebral junction. For this approach, the pharyngeal tubercle is an important landmark to identify the midline. The foramen lacerum, another important anatomic area where some crucial structures pass, is close to the pharyngeal tubercle. In the current study, we measured relevant distances and angles on 120 adults without brain diseases to estimate the safety range of the transoral approach. Distances between the pharyngeal tubercle and the foramen lacerum were expressed as mean (SD) and 95% confidence interval. Angles between the straight lines, which pass through the pharyngeal tubercle and the foramen lacerum, and the sagittal plane, as well as the horizontal plane, were also presented as mean (SD) and 95% confidence interval. As regards the 95% confidence intervals of the angles and the distances, which were used to define the safety range, no differences were observed between the right side and the left side. During such surgeries, if the midline is defined as a datum line, it is less likely for surgeons to destroy adjacent structures when moving within 36.30 degrees on the sagittal plane and 45.00 degrees on the horizontal plane once they find the pharyngeal tubercle. It is also safe to move within 16.20 mm from the pharyngeal tubercle. With these data, we have successfully defined the safety range of the surgery, which may help operators choose proper instruments in surgery and avoid injuries to important structures. Moreover, operators may use these data to position the pharyngeal tubercle so as not to deviate from the midline.

Angiogenesis in Glaucoma Filtration Surgery and Neovascular Glaucoma-A Review

PubMed Central

Kim, Megan; Lee, Chelsea; Payne, Rachael; Yue, Beatrice Y.J.T.; Chang, Jin-Hong; Ying, Hongyu

2015-01-01

Angiogenesis may pose a clinical challenge in glaucoma, for example during the wound healing phase after glaucoma filtration surgery and in a severe form of secondary glaucoma called neovascular glaucoma (NVG). Up regulation of vascular endothelial growth factor (VEGF), a key mediator of angiogenesis, occurs in eyes that have undergone glaucoma filtration surgery, as well as those with NVG. This has led to studies investigating the ability of anti-VEGF therapy to improve outcomes, and we examine their findings with respect to the safety and efficacy of anti-VEGF agents, mainly bevacizumab and ranibizumab, in eyes that have undergone glaucoma filtration surgery or have NVG. Combining conventional therapies—such as anti-metabolites after filtration surgery and panretinal photocoagulation in NVG—and anti-VEGF drugs may achieve a synergetic effect, although further studies are required to evaluate the long-term efficacy of combination treatments. PMID:25980779

Feasibility Study of Utilization of Action Camera, GoPro Hero 4, Google Glass, and Panasonic HX-A100 in Spine Surgery.

PubMed

Lee, Chang Kyu; Kim, Youngjun; Lee, Nam; Kim, Byeongwoo; Kim, Doyoung; Yi, Seong

2017-02-15

Study for feasibility of commercially available action cameras in recording video of spine. Recent innovation of the wearable action camera with high-definition video recording enables surgeons to use camera in the operation at ease without high costs. The purpose of this study is to compare the feasibility, safety, and efficacy of commercially available action cameras in recording video of spine surgery. There are early reports of medical professionals using Google Glass throughout the hospital, Panasonic HX-A100 action camera, and GoPro. This study is the first report for spine surgery. Three commercially available cameras were tested: GoPro Hero 4 Silver, Google Glass, and Panasonic HX-A100 action camera. Typical spine surgery was selected for video recording; posterior lumbar laminectomy and fusion. Three cameras were used by one surgeon and video was recorded throughout the operation. The comparison was made on the perspective of human factor, specification, and video quality. The most convenient and lightweight device for wearing and holding throughout the long operation time was Google Glass. The image quality; all devices except Google Glass supported HD format and GoPro has unique 2.7K or 4K resolution. Quality of video resolution was best in GoPro. Field of view, GoPro can adjust point of interest, field of view according to the surgery. Narrow FOV option was the best for recording in GoPro to share the video clip. Google Glass has potentials by using application programs. Connectivity such as Wi-Fi and Bluetooth enables video streaming for audience, but only Google Glass has two-way communication feature in device. Action cameras have the potential to improve patient safety, operator comfort, and procedure efficiency in the field of spinal surgery and broadcasting a surgery with development of the device and applied program in the future. N/A.

Cost Analysis of Adult Male Circumcision with the PrePex Device versus Surgery in Rwanda.

PubMed

Mutabazi, Vincent; Bitega, Jean Paul; Muyenzi Ngeruka, Leon; Nyemazi, Jean Pierre; Dain, Mary; Kaplan, Steven A; Karema, Corine; Binagwaho, Agnes

2014-01-01

In this study from Rwanda, voluntary adult male circumcision costs 33% less with trained nurses using the PrePex device compared with physician-nurse teams performing dorsal-slit surgery. These cost savings and the documented safety, speed, and efficacy of the PrePex procedure, serve Rwanda's HIV prevention program.

Consensus Bundle on Prevention of Surgical Site Infections After Major Gynecologic Surgery.

PubMed

Pellegrini, Joseph E; Toledo, Paloma; Soper, David E; Bradford, William C; Cruz, Deborah A; Levy, Barbara S; Lemieux, Lauren A

2017-01-01

Surgical site infections are the most common complication of surgery in the United States. Of surgeries in women of reproductive age, hysterectomy is one of the most frequently performed, second only to cesarean birth. Therefore, prevention of surgical site infections in women undergoing gynecologic surgery is an ideal topic for a patient safety bundle. The primary purpose of this safety bundle is to provide recommendations that can be implemented into any surgical environment in an effort to reduce the incidence of surgical site infection. This bundle was developed by a multidisciplinary team convened by the Council on Patient Safety in Women's Health Care. The bundle is organized into four domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning. In addition to recommendations for practice, each of the domains stresses communication and teamwork between all members of the surgical team. Although the bundle components are designed to be adaptable to work in a variety of clinical settings, standardization within institutions is encouraged.

Early audit of renal complications in a new cardiac surgery service in Australia.

PubMed

Bolsin, Stephen N; Stow, Peter; Bucknell, Sarah

2004-09-01

To assess the incidence of renal failure in a cardiac surgery service commencing in Australia. Prospective data collection and retrospective database analysis. A tertiary referral, university teaching hospital in the state of Victoria, Australia. The first 502 patients undergoing cardiac surgery in this institution from commencement of the service. The overall rate of renal failure was low in comparison to other studies at 0.2% (95% CI 0.04-1.3%). The rate of postoperative renal dysfunction was also low at 4.2% (95% CI 2.7-6.5%). The safety of the new service with respect to this complication of cardiac surgery was good when compared with published data. However the lack of uniform definitions of renal failure following cardiac surgery make comparisons between studies difficult. Uniform reporting of this complication would facilitate comparisons between units and quality assurance activities in this field.

Best practices for minimally invasive procedures.

PubMed

Ulmer, Brenda C

2010-05-01

Techniques and instrumentation for minimally invasive surgical procedures originated in gynecologic surgery, but the benefits of surgery with small incisions or no incisions at all have prompted the expansion of these techniques into numerous specialties. Technologies such as robotic assistance, single-incision laparoscopic surgery, natural orifice transluminal endoscopic surgery, and video-assisted thoracoscopic surgery have led to the continued expansion of minimally invasive surgery into new specialties. With this expansion, perioperative nurses and other members of the surgical team are required to continue to learn about new technology and instrumentation, as well as the techniques and challenges involved in using new technology, to help ensure the safety of their patients. This article explores the development of minimally invasive procedures and offers suggestions for increasing patient safety. Copyright 2010 AORN, Inc. Published by Elsevier Inc. All rights reserved.

Efficacy and Safety of Injectable Robenacoxib for the Treatment of Pain Associated With Soft Tissue Surgery in Dogs.

PubMed

Friton, G; Thompson, C; Karadzovska, D; King, S; King, J N

2017-05-01

Nonsteroidal anti-inflammatory drugs (NSAIDs) are used routinely to control pain and inflammation after surgery in dogs. Robenacoxib is a cyclooxygenase-2 selective NSAID. Assess the clinical efficacy and safety of an injectable formulation of robenacoxib in dogs undergoing surgery. Three hundred and seventeen client-owned dogs (N = 159 robenacoxib or N = 158 placebo). In this prospective, multicenter, randomized, masked, placebo-controlled, parallel-group study, dogs received a SC injection of either robenacoxib, at a target dose of 2.0 mg/kg, or placebo once prior to surgery and for 2 additional days postoperatively. Pain assessments were performed using the short form of the Glasgow Composite Measure Pain Scale (CMPS-SF). The primary efficacy variable was treatment success/failure, with failure defined as the need for rescue therapy to control pain or withdrawal of the dog from the study due to an adverse event. Significantly (P = .006) more dogs administered robenacoxib were considered treatment successes (108 of 151, 73.7%) compared to dogs given placebo (85 of 152, 58.1%). Total pain scores (P < .01), pain at the surgery sites (response to touch, P < .01), and posture/activity (P < .05) were significantly improved at 3, 5, and 8 hours postextubation in dogs receiving robenacoxib versus placebo. Robenacoxib administered by SC injection prior to surgery and for 2 additional days postoperatively was effective and well tolerated in the control of postoperative pain and inflammation associated with soft tissue surgery in dogs. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

A Safety and Efficacy Study of Tolvaptan Following Open Heart Surgery in 109 Cases.

PubMed

Kono, Takanori; Tayama, Eiki; Hori, Hidetsugu; Ueda, Tomohiro; Yamaki, Yuta; Tanaka, Hiroyuki

2016-07-27

This study was conducted to evaluate the safety and efficacy of tolvaptan following open heart surgery.We retrospectively reviewed 109 patients who were administered tolvaptan following open heart surgery between August 2011 and July 2014. We divided the patients according to their urine output index (amount of urine output/body surface area) into tertiles as follows: T1 (low responders; n = 36), T2 (intermediate responders; n = 36), and T3 (high responders; n = 37). No fatal adverse events were observed following tolvaptan administration. The factors that showed a significant difference among the 3 groups were body surface area (BSA) and preoperative body weight. Body weight rapidly decreased and a greater increase in the serum sodium level was observed on day 1 in the T3 group than in the other 2 groups. No decrease in blood pressure and no significant differences in the occurrence of atrial fibrillation were observed among the 3 groups during tolvaptan administration.Tolvaptan can be safely and effectively administered to increase the urine output without adversely affecting the cardiovascular system or renal function following open heart surgery. However, careful attention is required regarding the possibility of a rapid increase in the serum sodium level so it is important to monitor changes in serum Na levels.

Botulinum Toxin Use in Pediatric Plastic Surgery.

PubMed

Fu, Katherine J; Teichgraeber, John F; Greives, Matthew R

2016-11-01

Botulinum toxin has increasingly become a prevalent treatment option for a wide range of conditions, many of which have their roots in plastic surgery and have been well studied. In adults, chronic headache, hyperhidrosis, and facial muscular hypertrophy have been effectively treated with botulinum toxin, and emerging studies have begun looking at its efficacy in children, as well. Successful treatment of spasticity and muscular contraction has allowed for the creation of safety profiles and dosage guidelines for botulinum toxin usage in children. The expanded indications for its use have since flourished in all arenas of pediatric care, including plastic surgery. Recent studies have described the use of botulinum toxin as an adjunct to the treatment of congenital torticollis and cleft lip. This review discusses the various applications of botulinum toxin for pediatric patients in the field of plastic surgery.

Minimally invasive colorectal surgery: status and technical specifications.

PubMed

Keller, D S; Ibarra, S; Haas, E M

2015-10-01

Laparoscopy was the most significant technologic advance in colorectal surgery in the last quarter century. The safety, feasibility and oncologic equivalence have been proven, and undisputed clinical benefits have also been demonstrated over open approaches. Despite proven benefits, laparoscopic has not dominated the market, especially for colon and rectal cancer cases. Adaptations in laparoscopic technique were developed to increase use of minimally invasive surgery. Concurrently, there has been a paradigm shift toward less invasive technologies to further optimize patient outcomes. From these needs, hand assisted laparoscopic surgery (HALS), single incision laparoscopic surgery (SILS), and robotic assisted laparoscopic surgery (RALS) were applied to colorectal surgery. Each platform has unique costs and benefits, and similar outcomes when likened to each other in comparative studies. However, conventional laparoscopy, HALS, SILS, and RALS actually serve a complementary role as tools to increase the use of minimally invasive colorectal surgery. The goal of this paper is to review the history, current status, technical specifications, and evolution of the major minimally invasive platforms for colorectal surgery.

Ramosetron compared with granisetron for the prevention of vomiting following strabismus surgery in children

PubMed Central

Fujii, Y.; Tanaka, H.; Ito, M.

2001-01-01

BACKGROUND/AIMS—Postoperative vomiting occurs frequently after strabismus surgery in children. Granisetron, a selective 5-hydroxytryptamine type 3 receptor antagonist, is effective for the prevention of vomiting following paediatric strabismus surgery. Ramosetron, another new antagonist of 5-hydroxytryptamine type 3 receptor, has more potent and longer acting properties than granisetron against cisplatin induced emesis. This study was undertaken to compare the efficacy and safety of granisetron and ramosetron for the prevention of vomiting following strabismus surgery in children.
METHODS—In a randomised, double blinded manner 80 children, aged 4-10 years, received intravenously granisetron 40 µg/kg or ramosetron 6 µg/kg (n=40 each) at the end of surgery. A standard general anaesthetic technique and postoperative analgesia were used. Emetic episodes and safety assessment were performed during the first 24 hours and the next 24 hours after anaesthesia.
RESULTS—The percentage of patients who were emesis free during 0-24 hours after anaesthesia was 85% with granisetron and 90% with ramosetron, respectively (p = 0.369); the corresponding rate during 24-48 hours after anaesthesia was 70% and 95% (p = 0.003). No clinically serious adverse events caused by the study drug were observed in any of the groups.
CONCLUSION—Prophylactic antiemetic therapy with ramosetron is comparable with granisetron for the prevention of vomiting during 0-24 hours after anaesthesia in children undergoing strabismus surgery. During 24-48 hours after anaesthesia, ramosetron is more effective than granisetron for prophylaxis against postoperative vomiting.

 PMID:11371485

Safety and efficacy of noncardiac surgical procedures in the management of patients with trisomy 13: A single institution-based detailed clinical observation.

PubMed

Shibuya, Soichi; Miyake, Yuichiro; Takamizawa, Shigeru; Nishi, Eriko; Yoshizawa, Katsumi; Hatata, Tomoko; Yoshizawa, Kazuki; Fujita, Kenya; Noguchi, Masahiko; Ohata, Jun; Hiroma, Takehiko; Nakamura, Tomohiko; Kosho, Tomoki

2018-05-01

Intensive treatment including surgery for patients with trisomy 13 (T13) remains controversial. This study aimed to evaluate the safety and efficacy of noncardiac surgical intervention for T13 patients. Medical records of patients with karyotypically confirmed T13 treated in the neonatal intensive care unit in Nagano Children's Hospital from January 2000 to October 2016 were retrospectively reviewed, and data from patients who underwent noncardiac surgery were analyzed. Of the 20 patients with T13, 15 (75%) underwent a total of 31 surgical procedures comprising 15 types, including tracheostomy in 10 patients and gastrostomy in 4. Operative time, anesthesia time, and amount of bleeding are described for the first time in a group of children with T13. All the procedures were completed safely with no anesthetic complications or surgery-related death. The overall rate of postoperative complications was 19.3%. Patients receiving tracheostomy had stable or improved respiratory condition. Six of them were discharged home and were alive at the time of this study. These results suggest at least short-term safety and efficacy of major noncardiac surgical procedures, and long-term efficacy of tracheostomy on survival or respiratory stabilization for home medical care of children with T13. Noncardiac surgical intervention is a reasonable choice for patients with T13. © 2018 Wiley Periodicals, Inc.

Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC.

PubMed

Sekulic, Aleksandar; Migden, Michael R; Lewis, Karl; Hainsworth, John D; Solomon, James A; Yoo, Simon; Arron, Sarah T; Friedlander, Philip A; Marmur, Ellen; Rudin, Charles M; Chang, Anne Lynn S; Dirix, Luc; Hou, Jeannie; Yue, Huibin; Hauschild, Axel

2015-06-01

Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. An efficacy and safety analysis was conducted 12 months after primary analysis. This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC. Copyright © 2015 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Identifying positive deviants in healthcare quality and safety: a mixed methods study.

PubMed

O'Hara, Jane K; Grasic, Katja; Gutacker, Nils; Street, Andrew; Foy, Robbie; Thompson, Carl; Wright, John; Lawton, Rebecca

2018-01-01

Objective Solutions to quality and safety problems exist within healthcare organisations, but to maximise the learning from these positive deviants, we first need to identify them. This study explores using routinely collected, publicly available data in England to identify positively deviant services in one region of the country. Design A mixed methods study undertaken July 2014 to February 2015, employing expert discussion, consensus and statistical modelling to identify indicators of quality and safety, establish a set of criteria to inform decisions about which indicators were robust and useful measures, and whether these could be used to identify positive deviants. Setting Yorkshire and Humber, England. Participants None - analysis based on routinely collected, administrative English hospital data. Main outcome measures We identified 49 indicators of quality and safety from acute care settings across eight data sources. Twenty-six indicators did not allow comparison of quality at the sub-hospital level. Of the 23 remaining indicators, 12 met all criteria and were possible candidates for identifying positive deviants. Results Four indicators (readmission and patient reported outcomes for hip and knee surgery) offered indicators of the same service. These were selected by an expert group as the basis for statistical modelling, which supported identification of one service in Yorkshire and Humber showing a 50% positive deviation from the national average. Conclusion Relatively few indicators of quality and safety relate to a service level, making meaningful comparisons and local improvement based on the measures difficult. It was possible, however, to identify a set of indicators that provided robust measurement of the quality and safety of services providing hip and knee surgery.

Simulation-Based Testing of Pager Interruptions During Laparoscopic Cholecystectomy.

PubMed

Sujka, Joseph A; Safcsak, Karen; Bhullar, Indermeet S; Havron, William S

2018-01-30

To determine if pager interruptions affect operative time, safety, or complications and management of pager issues during a simulated laparoscopic cholecystectomy. Twelve surgery resident volunteers were tested on a Simbionix Lap Mentor II simulator. Each resident performed 6 randomized simulated laparoscopic cholecystectomies; 3 with pager interruptions (INT) and 3 without pager interruptions (NO-INT). The pager interruptions were sent in the form of standardized patient vignettes and timed to distract the resident during dissection of the critical view of safety and clipping of the cystic duct. The residents were graded on a pass/fail scale for eliciting appropriate patient history and management of the pager issue. Data was extracted from the simulator for the following endpoints: operative time, safety metrics, and incidence of operative complications. The Mann-Whitney U test and contingency table analysis were used to compare the 2 groups (INT vs. NO-INT). Level I trauma center; Simulation laboratory. Twelve general surgery residents. There was no significant difference between the 2 groups in any of the operative endpoints as measured by the simulator. However, in the INT group, only 25% of the time did the surgery residents both adequately address the issue and provide effective patient management in response to the pager interruption. Pager interruptions did not affect operative time, safety, or complications during the simulated procedure. However, there were significant failures in the appropriate evaluations and management of pager issues. Consideration for diversion of patient care issues to fellow residents not operating to improve quality and safety of patient care outside the operating room requires further study. Copyright © 2018. Published by Elsevier Inc.

Evaluation of the SEDline to improve the safety and efficiency of conscious sedation

PubMed Central

Caputo, Thomas D.; Rossmann, Jeffrey A.; Beach, M. Miles; Griffiths, Garth R.; Meyrat, Benjamin; Barnes, James B.; Kerns, David G.; Crump, Brad; Bookatz, Barnett; Ezzo, Paul

2011-01-01

Brain function monitors have improved safety and efficiency in general anesthesia; however, they have not been adequately tested for guiding conscious sedation for periodontal surgical procedures. This study evaluated the patient state index (PSI) obtained from the SEDline monitor (Sedline Inc., San Diego, CA) to determine its capacity to improve the safety and efficiency of intravenous conscious sedation during outpatient periodontal surgery. Twenty-one patients at the periodontics clinic of Baylor College of Dentistry were admitted to the study in 2009 and sedated to a moderate level using midazolam and fentanyl during periodontal surgery. The PSI monitoring was blinded from the clinician, and the following data were collected: vital signs, Ramsay sedation scale (RSS), medications administered, adverse events, PSI, electroencephalography, and the patients' perspective through visual analogue scales. The data were correlated to evaluate the PSI's ability to assess the level of sedation. Results showed that the RSS and PSI did not correlate (r = −0.25) unless high values associated with electromyographical (EMG) activity were corrected (r = −0.47). Oxygen desaturation did not correlate with the PSI (r = −0.08). Satisfaction (r = −0.57) and amnesia (r = −0.55) both increased as the average PSI decreased. In conclusion, within the limits of this study, PSI appears to correlate with amnesia, allowing a practitioner to titrate medications to that effect. It did not provide advance warning of adverse events and had inherent inaccuracies due to EMG activity during oral surgery. The PSI has the potential to increase safety and efficiency in conscious sedation but requires further development to eliminate EMG activity from confounding the score. PMID:21738291

[Present situation and prospect of enhanced recovery after surgery in pancreatic surgery].

PubMed

Feng, Mengyu; Zhang, Taiping; Zhao, Yupei

2017-05-25

Enhanced recovery after surgery is a multimodal perioperative strategy according to the evidence-based medicine and multidisciplinary collaboration, aiming to improve the restoration of functional capacity after surgery by reducing surgical stress, optimal control of pain, early oral diet and early mobilization. Compared with other sub-specialty in general surgery, pancreatic surgery is characterized by complex disease, highly difficult procedure and more postoperative complications. Accordingly, pancreatic surgery shares a slow development in enhanced recovery after surgery. In this review, the feasibility, safety, application progress, prospect and controversy of enhanced recovery after surgery in pancreatic surgery are discussed.

[Preliminary investigation on the safety and efficacy of Trabectome].

PubMed

Huang, Ping; Wang, Huaizhou; Wu, Huijuan; Sun, Yanran; Wang, Minshu; Cui, Ying; Qiu, Weiqiang; Yang, Yiquan; Ren, Zeqin; Zhang, Chun; Wang, Ningli

2015-02-01

To evaluate the safety and efficacy of ab interno trabeculectomy (Trabectome) surgery in Chinese open angle glaucoma patients. Prospective non-comparative case series study. A total of 41 cases (34 primary open angle glaucoma patients, 3 developmental glaucoma patients and 4 pigmentary glaucoma patients) were included in the study. All the cases underwent Trabectome, including 9 cases combined with phacoemulsification cataract extraction. Major outcomes include intraocular pressure (IOP), number of glaucoma medications, secondary glaucoma surgery and postoperative complications. Criteria for successful operation were defined as IOP ≤ 21 mmHg (1 mmHg = 0.133 kPa), at least 20% IOP reduction in any two consecutive visits after 3 months with or without IOP-lowering drugs and no additional glaucoma surgery. IOP and number of glaucoma medications were compared to baseline using Wilcoxon signed-rank test with Bonferroni correction. Kaplan-Meier analysis was performed to analyze the success rate of surgery. In the all 41 patients, 21 cases (51.2%) were followed up for up to 12 months. IOP was reduced from (22.5 ± 8.1) mmHg to (17.6 ± 6.4) mmHg (P = 0.02), meanwhile number of glaucoma medications was reduced from 2.0 ± 0.9 to 1.2 ± 0.9 (P = 0.02) at 12 months. The success rate at one year was 85% and 4 cases required additional glaucoma surgery. Trabectome has many advantages, such as shorter surgery time, simple post-operative care, less intraoperative and postoperative complications and clear IOP-lowering effect. But it slong-term efficacy is still need a large sample, long-term follow-up to verify.

A randomized double-masked study to compare the ocular safety, tolerability, and efficacy of bromfenac 0.075% compared with vehicle in cataract surgery subjects

PubMed Central

Hosseini, Kamran; Walters, Thomas; DaVanzo, Robert; Lindstrom, Richard L

2016-01-01

Purpose The aim of this study was to evaluate the safety, tolerability, and efficacy of a low-dose version of bromfenac 0.075% in DuraSite® (bromfenac 0.075%) compared with DuraSite® vehicle (vehicle) alone for the treatment of postoperative inflammation and ocular pain after cataract surgery. Methods A multicenter, double-masked, vehicle-controlled, parallel-group clinical trial of 240 subjects randomized in a 2:1 ratio to bromfenac 0.075% or vehicle was conducted. Subjects were dosed BID beginning 1 day before the cataract surgery, the day of surgery, and 14 days after surgery. A slit lamp biomicroscopy examination was performed to evaluate the signs of inflammation, including anterior chamber cells (ACC) and anterior chamber flare (ACF). The primary efficacy variable was the proportion of subjects with an ACC grade of 0 at Day 15. Secondary efficacy endpoints included the proportion of subjects who achieved a pain score of 0 at each postsurgical visual analog scale (VAS) assessment and the proportion of subjects with an ACF grade of 0 at Day 15. Results At Day 15, proportionally more subjects in the bromfenac 0.075% group than in the vehicle group had an ACC grade of 0 (57.1% vs 18.8%, respectively; P<0.001). At each of the postsurgical time points (Days 1, 8, 15, and 29), proportionally more bromfenac 0.075%-treated subjects (76.8%, 90.5%, 92.9%, and 85.1%, respectively) had no pain (a VAS score of 0) compared with the vehicle-treated subjects (48.2%, 38.8%, 42.4%, and 47.1%, respectively), and at each time point, these differences in proportions were statistically significant (P<0.001). More subjects in the bromfenac 0.075% group had complete ACF resolution (151/167; 90.4%) compared to those in the vehicle group (54/85; 63.5%). There were no new safety signals reported. Conclusion Bromfenac 0.075% in DuraSite is safe, well tolerated, and effective at reducing inflammation and preventing pain associated with cataract surgery. PMID:27920490

Safety in the operating room during orthopedic trauma surgery-incidence of adverse events related to technical equipment and logistics.

PubMed

van Delft, E A K; Schepers, T; Bonjer, H J; Kerkhoffs, G M M J; Goslings, J C; Schep, N W L

2018-04-01

Safety in the operating room is widely debated. Adverse events during surgery are potentially dangerous for the patient and staff. The incidence of adverse events during orthopedic trauma surgery is unknown. Therefore, we performed a study to quantify the incidence of these adverse events. Primary objective was to determine the incidence of adverse events related to technical equipment and logistics. The secondary objective was to evaluate the consequences of these adverse events. We completed a cross-sectional observational study to assess the incidence, consequences and preventability of adverse events related to technical equipment and logistics during orthopedic trauma surgery. During a 10 week period, all orthopedic trauma operations were evaluated by an observer. Six types of procedures were differentiated: osteosynthesis; arthroscopy; removal of hardware; joint replacement; bone grafting and other. Adverse events were divided in six categories: staff dependent factors; patient dependent factors; anaesthesia; imaging equipment; operation room equipment and instruments and implants. Adverse events were defined as any factor affecting the surgical procedure in a negative way. Hundred-fifty operative procedures were included. In 54% of the procedures, at least one adverse event occurred. In total, 147 adverse events occurred, with a range of 1-5 per procedure. Most adverse events occurred during joint replacement procedures. Thirty-seven percent of the incidents concerned defect, incorrect connected or absent instruments. In 36% of the procedures adverse events resulted in a prolonged operation time with a median prolongation of 10.0 min. In more than half of orthopedic trauma surgical procedures adverse events related to technical equipment and logistics occurred, most of them could easily be prevented. These adverse events could endanger the safety of the patient and staff and should therefore be reduced. 4.

Pyeloplasty techniques using minimally invasive surgery (MIS) in pediatric patients.

PubMed

Turrà, Francesco; Escolino, Maria; Farina, Alessandra; Settimi, Alessandro; Esposito, Ciro; Varlet, François

2016-10-01

Hydronephrosis is the most common presentation of ureteropelvic junction (UPJ) obstruction. We reviewed literature, collecting data from Medline, to evaluate the current status of minimally invasive surgery (MIS) approach to pyeloplasty. Since the first pyeloplasty was described in 1939, several techniques has been applied to correct UPJ obstruction, but Anderson-Hynes dismembered pyeloplasty is established as the gold standard, to date also in MIS technique. According to literature several studies underline the safety and effectiveness of this approach for both trans- and retro-peritoneal routes, with a success rate between 81-100% and an operative time between 90-228 min. These studies have demonstrated the safety and efficacy of this procedure in the management of UPJ obstruction in children. Whether better the transperitoneal, than the retroperitoneal approach is still debated. A long learning curve is needed especially in suturing and knotting.

EAU policy on live surgery events.

PubMed

Artibani, Walter; Ficarra, Vincenzo; Challacombe, Ben J; Abbou, Clement-Claude; Bedke, Jens; Boscolo-Berto, Rafael; Brausi, Maurizio; de la Rosette, Jean J M C H; Deger, Serdar; Denis, Louis; Guazzoni, Giorgio; Guillonneau, Bertrand; Heesakkers, John P F A; Jacqmin, Didier; Knoll, Thomas; Martínez-Piñeiro, Luis; Montorsi, Francesco; Mottrie, Alexander; Piechaud, Pierre-Thierry; Rane, Abhay; Rassweiler, Jens; Stenzl, Arnulf; Van Moorselaar, Jeroen; Van Velthoven, Roland F; van Poppel, Hendrik; Wirth, Manfred; Abrahamsson, Per-Anders; Parsons, Keith F

2014-07-01

Live surgery is an important part of surgical education, with an increase in the number of live surgery events (LSEs) at meetings despite controversy about their real educational value, risks to patient safety, and conflicts of interest. To provide a European Association of Urology (EAU) policy on LSEs to regulate their organisation during urologic meetings. The project was carried out in phases: a systematic literature review generating key questions, surveys sent to Live Surgery Panel members, and Internet- and panel-based consensus finding using the Delphi process to agree on and formulate a policy. The EAU will endorse LSEs, provided that the EAU Code of Conduct for live surgery and all organisational requirements are followed. Outcome data must be submitted to an EAU Web-based registry and complications reported using the revised Martin criteria. Regular audits will take place to evaluate compliance as well as the educational role of live surgery. This policy represents the consensus view of an expert panel established to advise the EAU. The EAU recognises the educational role of live surgery and endorses live case demonstration at urologic meetings that are conducted within a clearly defined regulatory framework. The overriding principle is that patient safety must take priority over all other considerations in the conduct of live surgery. Controversy exists regarding the true educational value of live surgical demonstrations on patients at surgical meetings. An EAU committee of experts developed a policy on how best to conduct live surgery at urologic meetings. The key principle is to ensure safety for every patient, including a code of conduct and checklist for live surgery, specific rules for how the surgery is organised and performed, and how each patient's results are reported to the EAU. For detailed information, please visit www.uroweb.org. Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Designing safety into the minimally invasive surgical revolution: a commentary based on the Jacques Perissat Lecture of the International Congress of the European Association for Endoscopic Surgery.

PubMed

Clarke, John R

2009-01-01

Surgical errors with minimally invasive surgery differ from those in open surgery. Perforations are typically the result of trocar introduction or electrosurgery. Infections include bioburdens, notably enteric viruses, on complex instruments. Retained foreign objects are primarily unretrieved device fragments and lost gallstones or other specimens. Fires and burns come from illuminated ends of fiber-optic cables and from electrosurgery. Pressure ischemia is more likely with longer endoscopic surgical procedures. Gas emboli can occur. Minimally invasive surgery is more dependent on complex equipment, with high likelihood of failures. Standardization, checklists, and problem reporting are solutions for minimizing failures. The necessity of electrosurgery makes education about best electrosurgical practices important. The recording of minimally invasive surgical procedures is an opportunity to debrief in a way that improves the reliability of future procedures. Safety depends on reliability, designing systems to withstand inevitable human errors. Safe systems are characterized by a commitment to safety, formal protocols for communications, teamwork, standardization around best practice, and reporting of problems for improvement of the system. Teamwork requires shared goals, mental models, and situational awareness in order to facilitate mutual monitoring and backup. An effective team has a flat hierarchy; team members are empowered to speak up if they are concerned about problems. Effective teams plan, rehearse, distribute the workload, and debrief. Surgeons doing minimally invasive surgery have a unique opportunity to incorporate the principles of safety into the development of their discipline.

Ambulatory cleft lip surgery: A value analysis.

PubMed

Arneja, Jugpal S; Mitton, Craig

2013-01-01

Socialized health systems face fiscal constraints due to a limited supply of resources and few reliable ways to control patient demand. Some form of prioritization must occur as to what services to offer and which programs to fund. A data-driven approach to decision making that incorporates outcomes, including safety and quality, in the setting of fiscal prudence is required. A value model championed by Michael Porter encompasses these parameters, in which value is defined as outcomes divided by cost. To assess ambulatory cleft lip surgery from a quality and safety perspective, and to assess the costs associated with ambulatory cleft lip surgery in North America. Conclusions will be drawn as to how the overall value of cleft lip surgery may be enhanced. A value analysis of published articles related to ambulatory cleft lip repair over the past 30 years was performed to determine what percentage of patients would be candidates for ambulatory cleft lip repair from a quality and safety perspective. An economic model was constructed based on costs associated with the inpatient stay related to cleft lip repair. On analysis of the published reports in the literature, a minority (28%) of patients are currently discharged in an ambulatory fashion following cleft lip repair. Further analysis suggests that 88.9% of patients would be safe candidates for same-day discharge. From an economic perspective, the mean cost per patient for the overnight admission component of ambulatory cleft surgery to the health care system in the United States was USD$2,390 and $1,800 in Canada. The present analysis reviewed germane publications over a 30-year period, ultimately suggesting that ambulatory cleft lip surgery results in preservation of quality and safety metrics for most patients. The financial model illustrates a potential cost saving through the adoption of such a practice change. For appropriately selected patients, ambulatory cleft surgery enhances overall health care value.

[Recent advances of monitoring and glycaemia control during early postoperative period in patients after pancreas surgery].

PubMed

Lishova, E A; Nikoda, V V; Bondarenko, A V; Ragozin, A K; Skipenko, O G

2013-01-01

Recently new technologies of diagnostics and correction of carbohydrates metabolism disturbances are introduced in the ICU to improve the safety for patients during intensive care. 33 patients after pancreas surgery were included into the study 13 patients (39%) had underlying diabetes mellitus. Glucose level changes in the interstitial liquid of the subcutaneous fat during postoperative period were monitored by system of CGM Medtronic MiniMed Guardian RT, MiniMed Paradigm Real-time. Valid values of glucose were from 4.1 to 10.1 mmol/L. Episodes of glucose level increasing occurred in 94% of patients in postoperative period after pancreas surgery. Average level of glucose was within the limits of valid values. However in 64% of cases patients needed insulin therapy Used systems of continuous glucose monitoring in the ICU allow improving the safety for patients receiving artificial nutrition and intravenous insulin therapy.

[Law and educational components of patient's safety in surgery].

PubMed

Sazhin, V P; Karsanov, A M; Maskin, S S

2018-01-01

To evaluate law and educational components of patient's safety (PS) in surgery. In order to analyze complex causes of adverse outcomes in surgery we performed an interviewing of 110 surgeons, 42 emergency physicians and 25 health care managers. The main keynote consisted in assessing law and educational components of PS. The study revealed significant professional shortcomings in law PS level and low educational and motivational activity of physicians of all specialties. Multi-faceted nature of PS problem requires multidisciplinary training of modern surgeons not only in the knowledge of key risk factors for adverse outcomes, but also in satisfaction of non-medical expectations of patients. Due to numerous objective reasons Russian surgical school should have the opportunity not to blindly copy the experience of our foreign colleagues, but to scientifically substantiate the development of own national security system both for surgical patients and medical workers themselves.

XEN Gel Implant: a new surgical approach in glaucoma.

PubMed

Chaudhary, Ankita; Salinas, Lauriane; Guidotti, Jacopo; Mermoud, André; Mansouri, Kaweh

2018-01-01

Glaucoma is a leading cause of blindness worldwide. Intraocular pressure (IOP) lowering is the only effective treatment strategy. Traditional glaucoma surgeries are generally considered to be unpredictable and associated with a high rate of complications. This has led to the development of a novel XEN Gel Implant, a type of minimally invasive glaucoma surgery (MIGS), lowering the IOP without extensive surgical dissection. Areas covered: A literature search was undertaken on PubMed using the terms XEN glaucoma, gelatin microstent, and MIGS. All the articles and case reports on XEN Gel Implant and selected articles on MIGS were studied and reviewed. We have discussed the results of most studies on XEN Gel Implant related to its efficacy, safety and success. Expert commentary: The XEN Gel Implant effectively lowers IOP and medication use, with a favorable safety profile. Long-term data on its success and cost-effectiveness are lacking. The studies have shown it to be without any serious adverse events and to have good safety profile encouraging future research on this novel implant. There is a need to correctly identify selection criteria for patients, who would benefit the most from the XEN Gel Implant.

One-stage vs. two-stage BAHA implantation in a pediatric population.

PubMed

Saliba, Issam; Froehlich, Patrick; Bouhabel, Sarah

2012-12-01

BAHA implantation surgery in a pediatric population is usually done in two-stage surgeries. This study aims to evaluate the safety and possible superiority of the one-stage over the two-stage BAHA implantation and which one would be the best standard of care for our pediatric patients. A retrospective chart review of 55 patients operated in our tertiary care institutions between 2005 and 2010 was conducted. The actual tendency in our institutions, applied at the time of the study, is to perform a one-stage surgery for all operated patients (pediatric and adult), except for patients undergoing translabyrinthine surgeries for cerebellopontine tumor excision. These patients indeed had a two-stage insertion. 26 patients underwent one-stage surgery (group I) while 29 patients had a two-stage (group II) BAHA insertion. A period of 4 months was allowed for osseointegration before BAHA processor fitting. As for the safety assessment of the one-stage surgery, we compared both groups regarding the incidence and severity (minor, moderate and major) of encountered complications, as well as the operating time and follow-up. The operating time of the two-stage surgery includes the time of the first and of the second stage. The mean age at surgery was 8.5 years old for the group I and 50 years old for the group II patients. There was no difference in the incidence of minor (p=0.12), moderate (p=0.41) nor severe (p=0.68) complications between groups I and II. Two cases of traumatic extrusion were noted in the group I. Furthermore, the one-stage BAHA implantation requests a significantly lower operating time (mean: 54 [32-100] min) than the two-stage surgery (mean: 79 [63-148] min) (p=0.012). All pediatric cases of BAHA insertion were performed in a one day surgery. The mean postoperative follow-up was 114 and 96 weeks for groups I and II respectively (p=0.058). One-stage BAHA insertion surgery in the pediatric population is a reliable, safe and efficient therapeutic option that allows a good result in a significantly lower operating time compared to the two-stage insertion and is achieved in a one day surgery. It could therefore be considered as a standard of care for pediatric patients. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Elective surgical patients' narratives of hospitalization: the co-construction of safety.

PubMed

Doherty, Carole; Saunders, Mark N K

2013-12-01

This research explores how elective surgical patients make sense of their hospitalization experiences. We explore sensemaking using longitudinal narrative interviews (n=72) with 38 patients undergoing elective surgical procedures between June 2010 and February 2011. We consider patients' narratives, the stories they tell of their prior expectations, and subsequent post-surgery experiences of their care in a United Kingdom (UK) hospital. An emergent pre-surgery theme is that of a paradoxical position in which they choose to make themselves vulnerable by agreeing to surgery to enhance their health, this necessitating trust of clinicians (doctors and nurses). To make sense of their situation, patients draw on technical (doctors' expert knowledge and skills), bureaucratic (National Health Service as a revered institution) and ideological (hospitals as places of safety), discourses. Post-operatively, themes of 'chaos' and 'suffering' emerge from the narratives of patients whose pre-surgery expectations (and trust) have been violated. Their stories tell of unmet expectations and of inability to make shared sense of experiences with clinicians who are responsible for their care. We add to knowledge of how patients play a critical part in the co-construction of safety by demonstrating how patient-clinician intersubjectivity contributes to the type of harm that patients describe. Our results suggest that approaches to enhancing patients' safety will be limited if they fail to reflect patients' involvement in the negotiated process of healthcare. We also provide further evidence of the contribution narrative inquiry can make to patient safety. Copyright © 2013 Elsevier Ltd. All rights reserved.

Effect of Previous Abdominal Surgery on Laparoscopic Liver Resection: Analysis of Feasibility and Risk Factors for Conversion.

PubMed

Cipriani, Federica; Ratti, Francesca; Fiorentini, Guido; Catena, Marco; Paganelli, Michele; Aldrighetti, Luca

2018-03-28

Previous abdominal surgery has traditionally been considered an additional element of difficulty to later laparoscopic procedures. The aim of the study is to analyze the effect of previous surgery on the feasibility and safety of laparoscopic liver resection (LLR), and its role as a risk factor for conversion. After matching, 349 LLR in patients known for previous abdominal surgery (PS group) were compared with 349 LLR on patients with a virgin abdomen (NPS group). Subgroup analysis included 161 patients with previous upper abdominal surgery (UPS subgroup). Feasibility and safety were evaluated in terms of conversion rate, reasons for conversion and outcomes, and risk factors for conversion assessed via uni/multivariable analysis. Conversion rate was 9.4%, and higher for PS patients compared with NPS patients (13.7% versus 5.1%, P = .021). Difficult adhesiolysis resulted the commonest reason for conversion in PS group (5.7%). However, operative time (P = .840), blood loss (P = .270), transfusion (P = .650), morbidity rate (P = .578), hospital stay (P = .780), and R1 rate (P = .130) were comparable between PS and NPS group. Subgroup analysis confirmed higher conversion rates for UPS patients (23%) compared with both NPS (P = .015) and PS patients (P = .041). Previous surgery emerged as independent risk factor for conversion (P = .033), alongside the postero-superior location and major hepatectomy. LLR are feasible in case of previous surgery and proved to be safe and maintain the benefits of LLR carried out in standard settings. However, a history of surgery should be considered a risk factor for conversion.

Treatment of Benign Thyroid Nodules: Comparison of Surgery with Radiofrequency Ablation.

PubMed

Che, Y; Jin, S; Shi, C; Wang, L; Zhang, X; Li, Y; Baek, J H

2015-07-01

Nodular goiter is one of the most common benign lesions in thyroid nodule. The main treatment of the disease is still the traditional surgical resection, however there are many problems such as general anesthesia, surgical scar, postoperative thyroid or parathyroid function abnormalities, and high nodules recurrence rate in residual gland. The purpose of this study was to compare the efficacy, safety, and cost-effectiveness of 2 treatment methods, surgery and radiofrequency ablation, for the treatment of benign thyroid nodules. From May 2012 to September 2013, 200 patients with nodular goiters who underwent surgery (group A) and 200 patients treated by radiofrequency ablation (group B) were enrolled in this study. Inclusion criteria were the following: 1) cosmetic problem, 2) nodule-related symptoms, 3) hyperfunctioning nodules related to thyrotoxicosis, and 4) refusal of surgery (for group B). An internally cooled radiofrequency ablation system and an 18-ga internally cooled electrode were used. We compared the 2 groups in terms of efficacy, safety, and cost-effectiveness during a 1-year follow-up. After radiofrequency ablation, the nodule volume decreased significantly from 5.4 to 0.4 mL (P = .002) at the 12-month follow-up. The incidence of complications was significantly higher from surgery than from radiofrequency ablation (6.0% versus 1.0%, P = .002). Hypothyroidism was detected in 71.5% of patients after surgery but in none following radiofrequency ablation. The rate of residual nodules (11.9% versus 2.9%, P = .004) and hospitalization days was significantly greater after surgery (6.6 versus 2.1 days, P < .001), but the cost difference was not significant. Surgical resection and radiofrequency ablation are both effective treatments of nodular goiter. Compared with surgery, the advantages of radiofrequency ablation include fewer complications, preservation of thyroid function, and fewer hospitalization days. Therefore, radiofrequency ablation should be considered a first-line treatment for benign thyroid nodules. © 2015 by American Journal of Neuroradiology.

Effectiveness and Safety of Botulinum Toxin Type A in Children with Musculoskeletal Conditions: What Is the Current State of Evidence?

PubMed Central

Dahan-Oliel, Noémi; Kasaai, Bahar; Montpetit, Kathleen; Hamdy, Reggie

2012-01-01

Children with musculoskeletal conditions experience muscle weakness, difficulty walking and limitations in physical activities. Standard treatment includes physiotherapy, casting, and surgery. The use of botulinum toxins appears as a promising treatment on its own, but usually as an adjunct to other treatment modalities and as an alternative to surgery. The objectives were to establish the evidence on the effectiveness, safety and functional outcome of BTX-A in children with musculoskeletal conditions. A literature search using five electronic databases identified 24 studies that met our inclusion criteria. Two randomized clinical trials were included; most studies were case studies with small sample sizes and no control group. Improvements in gait pattern, function, range of motion, reduction of co-contractions, and avoidance of surgical procedures were found following BTX-A injections. Adverse events were not reported in 10 studies, minor adverse events were reported in 13 children and there were no severe adverse events. Additional doses appear safe. BTX-A is a promising treatment adjunct in improving functional outcomes in children with musculoskeletal conditions. Future studies including larger samples, longer follow-up periods and a comparison group are required to provide evidence on the effectiveness and safety of this drug in children with musculoskeletal conditions. PMID:22548088

Consensus Bundle on Prevention of Surgical Site Infections After Major Gynecologic Surgery.

PubMed

Pellegrini, Joseph E; Toledo, Paloma; Soper, David E; Bradford, William C; Cruz, Deborah A; Levy, Barbara S; Lemieux, Lauren A

Surgical site infections are the most common complications of surgery in the United States. Of surgeries in women of reproductive age, hysterectomy is one of the most frequently performed, second only to cesarean birth. Therefore, prevention of surgical site infections in women undergoing gynecologic surgery is an ideal topic for a patient safety bundle. The primary purpose of this safety bundle is to provide recommendations that can be implemented into any surgical environment in an effort to reduce the incidence of surgical site infection. This bundle was developed by a multidisciplinary team convened by the Council on Patient Safety in Women's Health Care. The bundle is organized into four domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning. In addition to recommendations for practice, each of the domains stresses communication and teamwork between all members of the surgical team. Although the bundle components are designed to be adaptable to work in a variety of clinical settings, standardization within institutions is encouraged. Copyright © 2017 AWHONN, the Association of Women’s Health, Obstetric and Neonatal Nurses. Published by Elsevier Inc. All rights reserved.

Consensus Bundle on Prevention of Surgical Site Infections After Major Gynecologic Surgery.

PubMed

Pellegrini, Joseph E; Toledo, Paloma; Soper, David E; Bradford, William C; Cruz, Deborah A; Levy, Barbara S; Lemieux, Lauren A

2017-02-06

Surgical site infections are the most common complication of surgery in the United states. Of surgeries in women of reproductive age, hysterectomy is one of the most frequently performed, second only to cesarean birth. Therefore, prevention of surgical site infections in women undergoing gynecologic surgery is an ideal topic for a patient safety bundle. The primary purpose of this safety bundle is to provide recommendations that can be implemented into any surgical environment in an effot to reduce the incidence of surgical site infection. This bundle was developed by a multidisciplinary team convened by the Council on Patient Safety in Women's Health Care. The bundle is organized into four domains: Readiness, Recognition and Prevention, Response, and Reporting and Systems Learning. In addition to recommendations for practice, each of the domains stresses communication and teamwork between all members of the surgical team. Although the bundle components are designed to be adaptable to work in a variety of clinical settings, standardization within institutions is encouraged. Copyright ©2016 American College of Obstetricians and Gynecologists.

The safety and efficacy of the administration of recombinant activated factor VII in major surgery and trauma patients.

PubMed

Wilson, Stephen J; Bellamy, Mark C; Giannoudis, Peter V

2005-05-01

Recombinant activated Factor VII (rFVIIa) has been successfully used in the treatment of haemophilia A and B with associated inhibitors for some years. Activated Factor VII binds to activated platelets independently of tissue factor. The resulting stimulation of an exaggerated early thrombin burst at sites of vascular injury makes it an attractive potential treatment for massive, uncontrolled bleeding associated with surgery and trauma. This article describes the evidence relating to surgery and trauma. The lack of large, controlled trials of rFVIIa means that a definitive recommendation regarding its use cannot be made at present. However, in the context of clearly defined protocols and balanced treatment strategies, rFVIIa may have a role in traumatic bleeding. Large scale, randomised controlled trials in trauma are required, as is further work on the safety profile of rFVIIa with an independent international safety monitoring committee.

Topical versus peribulbar anaesthesia for cataract surgery.

PubMed

Sauder, Gangolf; Jonas, Jost B

2003-12-01

To assess and compare the efficacy and safety of topical versus peribulbar anaesthesia in patients undergoing routine cataract surgery. The unicentre, prospective, randomized, clinical interventional trial included 140 consecutive patients undergoing routine cataract surgery performed by one of two surgeons. The patients were randomly distributed to either peribulbar anaesthesia or topical anaesthesia. To assess intraoperative pain, each patient was asked immediately after surgery to quantitate his/her pain using a 10-point pain rating scale. The study groups did not differ significantly in pain score (p=0.54), duration of surgery (p=0.52), anaesthesia-related intraoperative difficulties (p=0.17), postoperative visual acuity (p=0.94), overall intraoperative surgical complication rate, blood pressure rise (p=0.16) or blood oxygen saturation (p=0.74) Patient comfort and surgery-related complications did not differ between topical anaesthesia and peribulbar anaesthesia. As there are no significant differences between the two techniques in terms of subjective pain experienced by patients, intraoperative complications and postoperative visual outcome, and in view of the minimally invasive character of topical anaesthesia compared to peribulbar anaesthesia, the present study suggests the use of topical anaesthesia for routine cataract surgery.

Robotic versus laparoscopic proctectomy for rectal cancer: a meta-analysis.

PubMed

Memon, Sameer; Heriot, Alexander G; Murphy, Declan G; Bressel, Mathias; Lynch, A Craig

2012-07-01

Robot-assisted laparoscopic surgery is being performed more frequently for the minimally invasive management of rectal cancer. The objective of this meta-analysis was to compare the clinical and oncologic safety and efficacy of robot-assisted versus conventional laparoscopic surgery. A search of the Medline and Embase databases was performed for studies that compared clinical or oncologic outcomes of conventional laparoscopic proctectomy with robot-assisted laparoscopic proctectomy for rectal cancer. The methodological quality of the selected studies was critically assessed to identify studies suitable for inclusion. Meta-analysis was performed by a random effects model and analyzed by Review Manager. Clinical outcomes evaluated were conversion rates, operation times, length of hospital stay, and complications. Oncologic outcomes evaluated were circumferential margin status, number of lymph nodes collected, and distal resection margin lengths. Eight comparative studies were assessed for quality, and seven studies were included in the meta-analysis. Two studies were matched case-control studies, and five were unmatched. A total of 353 robot-assisted laparoscopic surgery proctectomy cases and 401 conventional laparoscopic surgery proctectomy cases were analyzed. Robotic surgery was associated with a significantly lower conversion rate (P=0.03; 95% confidence interval 1-12). There was no difference in complications, circumferential margin involvement, distal resection margin, lymph node yield, or hospital stay (P=NS). Robot-assisted surgery decreased the conversion rate compared to conventional laparoscopic surgery. Other clinical outcomes and oncologic outcomes were equivalent. The benefits of robotic rectal cancer surgery may differ between population groups.

A comparison among four tract dilation methods of percutaneous nephrolithotomy: a systematic review and meta-analysis.

PubMed

Dehong, Cao; Liangren, Liu; Huawei, Liu; Qiang, Wei

2013-11-01

The purpose of this study was to evaluate the efficacy and safety of the Amplatz dilation (AD), metal telescopic dilation (MTD), balloon dilation (BD), and one-shot dilation (OSD) methods for tract dilation during percutaneous nephrolithotomy (PCNL). Relevant eligible studies were identified using three electronic databases (Medline, EMBASE, and Cochrane CENTRAL). Database acquisition and quality evaluation were independently performed by two reviewers. Efficacy (stone-free rate, surgical duration, and tract dilatation fluoroscopy time) and safety (transfusion rate and hemoglobin decrease) were evaluated using Review Manager 5.2. Four randomized controlled trials and eight clinical controlled trials involving 6,820 patients met the inclusion criteria. The pooled result from a meta-analysis showed statistically significant differences in tract dilatation fluoroscopy time and hemoglobin decrease between the OSD and MTD groups, which showed comparable stone-free and transfusion rates. Significant differences in transfusion rate were found between the BD and MTD groups. Among patients without previous open renal surgery, those who underwent BD exhibited a lower blood transfusion rate and a shorter surgical duration compared with those who underwent AD. The OSD technique is safer and more efficient than the MTD technique for tract dilation during PCNL, particularly in patients with previous open renal surgery, resulting in a shorter tract dilatation fluoroscopy time and a lesser decrease in hemoglobin. The efficacy and safety of BD are better than AD in patients without previous open renal surgery. The OSD technique should be considered for most patients who undergo PCNL therapy.

Robot-assisted versus other types of radical prostatectomy: Population-based safety and cost comparison in Japan, 2012–2013

PubMed Central

Sugihara, Toru; Yasunaga, Hideo; Horiguchi, Hiromasa; Matsui, Hiroki; Fujimura, Tetsuya; Nishimatsu, Hiroaki; Fukuhara, Hiroshi; Kume, Haruki; Changhong, Yu; Kattan, Michael W; Fushimi, Kiyohide; Homma, Yukio

2014-01-01

In 2012, Japanese national insurance started covering robot-assisted surgery. We carried out a population-based comparison between robot-assisted and three other types of radical prostatectomy to evaluate the safety of robot-assisted prostatectomy during its initial year. We abstracted data for 7202 open, 2483 laparoscopic, 1181 minimal incision endoscopic, and 2126 robot-assisted radical prostatectomies for oncological stage T3 or less from the Diagnosis Procedure Combination database (April 2012–March 2013). Complication rate, transfusion rate, anesthesia time, postoperative length of stay, and cost were evaluated by pairwise one-to-one propensity-score matching and multivariable analyses with covariants of age, comorbidity, oncological stage, hospital volume, and hospital academic status. The proportion of robot-assisted radical prostatectomies dramatically increased from 8.6% to 24.1% during the first year. Compared with open, laparoscopic, and minimal incision endoscopic surgery, robot-assisted surgery was generally associated with a significantly lower complication rate (odds ratios, 0.25, 0.20, 0.33, respectively), autologous transfusion rate (0.04, 0.31, 0.10), homologous transfusion rate (0.16, 0.48, 0.14), lower cost excluding operation (differences, −5.1%, −1.8% [not significant], −10.8%) and shorter postoperative length of stay (–9.1%, +0.9% [not significant], –18.5%, respectively). However, robot-assisted surgery also resulted in a + 42.6% increase in anesthesia time and +52.4% increase in total cost compared with open surgery (all P < 0.05). Introduction of robotic surgery led to a dynamic change in prostate cancer surgery. Even in its initial year, robot-assisted radical prostatectomy was carried out with several favorable safety aspects compared to the conventional surgeries despite its having the longest anesthesia time and the highest cost. PMID:25183452

Advances in Liposuction: Five Key Principles with Emphasis on Patient Safety and Outcomes

PubMed Central

Tabbal, Geo N.; Ahmad, Jamil; Lista, Frank

2013-01-01

Summary: Since Illouz’s presentation of a technique for lipoplasty at the 1982 Annual Meeting of the American Society of Plastic and Reconstructive Surgeons, liposuction has become one of the most commonly performed aesthetic surgery procedures. The evolution of liposuction has seen refinements in technique and improvement of patient safety-related standards of care. Based on long-term experience with body contouring surgery, 5 principles of advanced liposuction are presented: preoperative evaluation and planning, intraoperative monitoring—safety measures, the role of wetting solutions and fluid resuscitation, circumferential contouring and complication prevention, and outcomes measurement. PMID:25289270

Safety culture and the 5 steps to safer surgery: an intervention study.

PubMed

Hill, M R; Roberts, M J; Alderson, M L; Gale, T C E

2015-06-01

Improvements in safety culture have been postulated as one of the mechanisms underlying the association between the introduction of the World Health Organisation (WHO) Surgical Safety Checklist with perioperative briefings and debriefings, and enhanced patient outcomes. The 5 Steps to Safer Surgery (5SSS) incorporates pre-list briefings, the three steps of the WHO Surgical Safety Checklist (SSC) and post-list debriefings in one framework. We aimed to identify any changes in safety culture associated with the introduction of the 5SSS in orthopaedic operating theatres. We assessed the safety culture in the elective orthopaedic theatres of a large UK teaching hospital before and after introduction of the 5SSS using a modified version of the Safety Attitude Questionnaire - Operating Room (SAQ-OR). Primary outcome measures were pre-post intervention changes in the six safety culture domains of the SAQ-OR. We also analysed changes in responses to two items regarding perioperative briefings. The SAQ-OR survey response rate was 80% (60/75) at baseline and 74% (53/72) one yr later. There were significant improvements in both the reported frequency (P<0.001) and perceived importance (P=0.018) of briefings, and in five of the six safety culture domain scores (Working Conditions, Perceptions of Management, Job Satisfaction, Safety Climate and Teamwork Climate) of the SAQ-OR (P<0.001 in all cases). Scores in the sixth domain (Stress Recognition) decreased significantly (P=0.028). Implementation of the 5SSS was associated with a significant improvement in the safety culture of elective orthopaedic operating theatres. © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Safety and Efficacy of Rocuronium With Sugammadex Reversal Versus Succinylcholine in Outpatient Surgery-A Multicenter, Randomized, Safety Assessor-Blinded Trial.

PubMed

Soto, Roy; Jahr, Jonathan S; Pavlin, Janet; Sabo, Daniel; Philip, Beverly K; Egan, Talmage D; Rowe, Everton; de Bie, Joris; Woo, Tiffany

Complex surgical procedures are increasingly performed in an outpatient setting, with emphasis on rapid recovery and case turnover. In this study, the combination of rocuronium for neuromuscular blockade (NMB) reversed by single-dose sugammadex was compared with succinylcholine followed by spontaneous recovery in outpatient surgery. This multicenter, randomized, safety assessor-blinded study enrolled adults undergoing a short elective outpatient surgical procedure requiring NMB and tracheal intubation. Patients were randomized to NMB with either rocuronium 0.6 mg/kg for tracheal intubation with incremental doses of rocuronium 0.15 mg/kg and subsequent reversal with sugammadex 4.0 mg/kg at 1-2 posttetanic counts or succinylcholine 1.0 mg/kg for intubation with spontaneous recovery. The primary efficacy end point was the time from sugammadex administration to recovery of the train-of-four ratio to 0.9; for succinylcholine, time from administration to recovery of the first twitch (T1) to 90% was assessed. From 167 patients enrolled, 150 received treatment. The all-subjects-treated population comprised 70 patients in the rocuronium-sugammadex group and 80 in the succinylcholine group. Geometric mean (95% confidence interval) time from the start of sugammadex administration to recovery of the train-of-four ratio to 0.9 was 1.8 (1.6-2.0) minutes. Geometric mean (95% confidence interval) time from succinylcholine administration to recovery of T1 to 90% was 10.8 (10.1-11.5) minutes. Health outcome variables were similar between the groups. Adverse events were reported in 87.1% and 93.8% of patients for rocuronium-sugammadex and succinylcholine, respectively. In conclusion, rocuronium for intubation followed by sugammadex for reversal of NMB offers a viable treatment option in outpatient surgery without prolonging recovery duration or jeopardizing safety.

[The rational application of Da Vinci surgical system in thyroidectomy].

PubMed

He, Q Q

2017-08-01

Da Vinci surgical system is the most advanced minimally invasive surgical platform in the world, and this system has been widely used in cardiac surgery, urology surgery, gynecologic surgery and general surgery. Although the application of this system was relatively late in thyroid surgery, the number of thyroidectomy with Da Vinci surgical system is increasing quickly. Having reviewed recent studies and summarized clinical experience, compared with traditional open operation, the robotic thyroidectomy has the same surgical safety and effectiveness in selective patients with thyroid cancer. In this paper, several aspects on this novel operation were demonstrated, including surgical indications and contraindications, the approaches, surgical procedures and postoperative complications, in order to promote the rational application of Da Vinci surgical system in thyroidectomy.

Oral Anticoagulant Use After Bariatric Surgery: A Literature Review and Clinical Guidance.

PubMed

Martin, Karlyn A; Lee, Craig R; Farrell, Timothy M; Moll, Stephan

2017-05-01

Bariatric surgery may alter the absorption, distribution, metabolism, or elimination (disposition) of orally administered drugs via changes to the gastrointestinal tract anatomy, body weight, and adipose tissue composition. As some patients who have undergone bariatric surgery will need therapeutic anticoagulation for various indications, appropriate knowledge is needed regarding anticoagulant drug disposition and resulting efficacy and safety in this population. We review general considerations about oral drug disposition in patients after bariatric surgery, as well as existing literature on oral anticoagulation after bariatric surgery. Overall, available evidence on therapeutic anticoagulation is very limited, and individual drug studies are necessary to learn how to safely and effectively use the direct oral anticoagulants. Given the sparsity of currently available data, it appears most prudent to use warfarin with international normalized ratio monitoring, and not direct oral anticoagulants, when full-dose anticoagulation is needed after bariatric surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

Ergonomic problems encountered by the surgical team during video endoscopic surgery.

PubMed

Kaya, Oskay I; Moran, Munevver; Ozkardes, Alper B; Taskin, Emre Y; Seker, Gaye E; Ozmen, Mahir M

2008-02-01

The aim of this study is to analyze the problems related to the ergonomic conditions faced by video endoscopic surgical teams during video endoscopic surgery by means of a questionnaire. A questionnaire was distributed to 100 medical personnel, from 8 different disciplines, who performed video endoscopic surgeries. Participants were asked to answer 13 questions related to physical, perceptive, and cognitive problems. Eighty-two questionnaires were returned. Although there were differences among the disciplines, participants assessment of various problems ranged from 32% to 72% owing to poor ergonomic conditions. As the problems encountered by the staff during video endoscopic surgery and the poor ergonomic conditions of the operating room affect the productivity of the surgical team and the safety and efficiency of the surgery, redesigning of the instruments and the operating room is required.

Driving Safety after Spinal Surgery: A Systematic Review

PubMed Central

Alkhalili, Kenan; Hannallah, Jack; Ibeche, Bashar; Bajammal, Sohail; Baco, Abdul Moeen

2017-01-01

This study aimed to assess driving reaction times (DRTs) after spinal surgery to establish a timeframe for safe resumption of driving by the patient postoperatively. The MEDLINE and Google Scholar databases were analyzed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) Statement for clinical studies that investigated changes in DRTs following cervical and lumbar spinal surgery. Changes in DRTs and patients' clinical presentation, pathology, anatomical level affected, number of spinal levels involved, type of intervention, pain level, and driving skills were assessed. The literature search identified 12 studies that investigated postoperative DRTs. Six studies met the inclusion criteria; five studies assessed changes in DRT after lumbar spine surgery and two studies after cervical spina surgery. The spinal procedures were selective nerve root block, anterior cervical discectomy and fusion, and lumbar fusion and/ordecompression. DRTs exhibited variable responses to spinal surgery and depended on the patients' clinical presentation, spinal level involved, and type of procedure performed. The evidence regarding the patients' ability to resume safe driving after spinal surgery is scarce. Normalization of DRT or a return of DRT to pre-spinal intervention level is a widely accepted indicator for safe driving, with variable levels of statistical significance owing to multiple confounding factors. Considerations of the type of spinal intervention, pain level, opioid consumption, and cognitive function should be factored in the assessment of a patient's ability to safely resume driving. PMID:28443178

Driving Safety after Spinal Surgery: A Systematic Review.

PubMed

Alhammoud, Abduljabbar; Alkhalili, Kenan; Hannallah, Jack; Ibeche, Bashar; Bajammal, Sohail; Baco, Abdul Moeen

2017-04-01

This study aimed to assess driving reaction times (DRTs) after spinal surgery to establish a timeframe for safe resumption of driving by the patient postoperatively. The MEDLINE and Google Scholar databases were analyzed according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) Statement for clinical studies that investigated changes in DRTs following cervical and lumbar spinal surgery. Changes in DRTs and patients' clinical presentation, pathology, anatomical level affected, number of spinal levels involved, type of intervention, pain level, and driving skills were assessed. The literature search identified 12 studies that investigated postoperative DRTs. Six studies met the inclusion criteria; five studies assessed changes in DRT after lumbar spine surgery and two studies after cervical spina surgery. The spinal procedures were selective nerve root block, anterior cervical discectomy and fusion, and lumbar fusion and/ordecompression. DRTs exhibited variable responses to spinal surgery and depended on the patients' clinical presentation, spinal level involved, and type of procedure performed. The evidence regarding the patients' ability to resume safe driving after spinal surgery is scarce. Normalization of DRT or a return of DRT to pre-spinal intervention level is a widely accepted indicator for safe driving, with variable levels of statistical significance owing to multiple confounding factors. Considerations of the type of spinal intervention, pain level, opioid consumption, and cognitive function should be factored in the assessment of a patient's ability to safely resume driving.

Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study.

PubMed

Stoppe, C; Fahlenkamp, A V; Rex, S; Veeck, N C; Gozdowsky, S C; Schälte, G; Autschbach, R; Rossaint, R; Coburn, M

2013-09-01

To date, only limited data exist about the use of xenon as an anaesthetic agent in patients undergoing cardiac surgery. The favourable cardio- and neuroprotective properties of xenon might attenuate postoperative complications, improve outcome, and reduce the incidence of delirium. Thus, the aims of this study were to investigate the feasibility and safety of balanced xenon anaesthesia in patients undergoing cardiac surgery and to gather pilot data for a future randomized multicentre study. Thirty patients undergoing elective coronary artery bypass grafting were enrolled in this randomized, single-blind controlled trial. They were randomized to receive balanced general anaesthesia with either xenon (45-50 vol%) or sevoflurane (1-1.4 vol%). The primary outcome was the occurrence of adverse events (AEs). Secondary outcome parameters were feasibility criteria (bispectral index, perioperative haemodynamic, and respiratory profile) and safety parameters (dosage of study treatments, renal function, intraoperative blood loss, need for inotropic support, regional cerebral tissue oxygenation). Furthermore, at predefined time points, systemic and pulmonary haemodynamics were assessed by the use of a pulmonary artery catheter. There were no patient characteristic differences between the groups. Patients undergoing xenon anaesthesia did not differ with respect to the incidence of AE (6 vs 8, P=0.464) compared with the sevoflurane group. No differences were detected regarding secondary feasibility and safety criteria. The haemodynamic and respiratory profile was comparable between the treatment groups. Balanced xenon anaesthesia is feasible and safe compared with sevoflurane anaesthesia in patients undergoing coronary artery bypass surgery. Acronym CARDIAX: A pre- and post-coronary artery bypass graft implantation disposed application of xenon. Clinical trial registration ClinicalTrials.gov: NCT01285271; EudraCT-number: 2010-023942-63. Approved by the ethics committee 'Ethik-Kommission an der Medizinischen Fakultät der Rheinisch-Westfälischen Technischen Hochschule Aachen (RWTH Aachen)': EK-218/10.

Intravenous and oral levetiracetam in patients with a suspected primary brain tumor and symptomatic seizures undergoing neurosurgery: the HELLO trial.

PubMed

Bähr, Oliver; Hermisson, Mirjam; Rona, Sabine; Rieger, Johannes; Nussbaum, Susanne; Körtvelyessy, Peter; Franz, Kea; Tatagiba, Marcos; Seifert, Volker; Weller, Michael; Steinbach, Joachim P

2012-02-01

Levetiracetam (LEV) is a newer anticonvulsant with a favorable safety profile. There seem to be no relevant drug interactions, and an intravenous formulation is available. Therefore, LEV might be a suitable drug for the perioperative anticonvulsive therapy of patients with suspected brain tumors undergoing neurosurgery. In this prospective study (NCT00571155) patients with suspected primary brain tumors and tumor-related seizures were perioperatively treated with oral and intravenous LEV up to 4 weeks before and until 4 weeks after a planned neurosurgical procedure. Thirty patients with brain tumor-related seizures and intended neurosurgery were included. Three patients did not undergo the scheduled surgery after enrollment, and two patients were lost to follow-up. Therefore, 25 patients were fully evaluable. After initiation of therapy with LEV, 100% of the patients were seizure-free in the pre-surgery phase (3 days up to 4 weeks before surgery), 88% in the 48 h post-surgery phase and 84% in the early follow-up phase (48 h to 4 weeks post surgery). Treatment failure even after dose escalation to 3,000 mg/day occurred in three patients. No serious adverse events related to the treatment with LEV occurred. Our data show the feasibility and safety of oral and intravenous LEV in the perioperative treatment of tumor-related seizures. Although this was a single arm study, the efficacy of LEV appears promising. Considering the side effects and interactions of other anticonvulsants, LEV seems to be a favorable option in the perioperative treatment of brain tumor-related seizures.

[Analysis of clinical effectiveness and risk factors for complication of percutaneous nephrolototripsia in patients with a solitary kidney].

PubMed

Arustamov, L D; Katibov, M I; Merinov, D S; Gurbanov, Sh Sh; Artemov, A V; Epishov, V A

2017-12-01

Management of patients with large and staghorn stones of a solitary kidney is widely debated among urologists and has not been sufficiently investigated, which determined the relevance of this study. The study comprised 80 patients with large (>20 mm) and staghorn stones of an anatomically or functionally solitary kidney. Of them, 58 patients underwent percutaneous nephrolithotripsy (PNL), and 22 had open surgery. The criterion of the treatment effectiveness was the complete stone clearance or small residual fragments sized less than 3 mm. The safety criterion was the absence of intra- and postoperative complications, according to Clavien-Dindo grading system. The study analyzed the following factors influencing the effectiveness and safety of PNL: the number of accesses; nephroscope diameter; use of a nephroscope sheath; type of lithotripter; size, density, type and composition of the stone. Percutaneous nephrolithotripsy demonstrated statistically significantly better safety results compared with open surgery with comparable effectiveness. Long-term stone recurrence rate after PNL and open surgery was 10.4 and 18.2%, respectively. PNL resulted in a statistically significant improvement in the kidney function while it worsened after open surgery. The effectiveness of PNL depends on the stone type and size and the kind of lithotripter. It was 7.5 times greater for a large stone than for staghorn calculi and 4.6 times higher for stones sized less or equal 45 mm than for those sized > 45 mm. Ultrasonic lithotripter was 2.2 times more effective than another type of lithotripter. The safety of PNL depends on the nephroscope diameter, of a sheath, the number of accesses, the type of lithotripter and the type of stone. Using a 24-Ch nephroscope was 3.6 times safer than that with a diameter greater than 24-Ch; not using a sheath was 3.2 times safer than using it; one access was 3 times safer than at multiple ones; using an ultrasound lithotripter was 2.7 times safer than with another type of lithotripter; treating a large stone was 2.1 times safer than a staghorn stone. The study findings can be used to optimize the treatment of patients with large and staghorn stones of a solitary kidney.

Transumbilical Thoracoscopy Versus Conventional Thoracoscopy for Lung Wedge Resection: Safety and Efficacy in a Live Canine Model.

PubMed

Chen, Tzu-Ping; Yen-Chu; Wu, Yi-Cheng; Yeh, Chi-Ju; Liu, Chien-Ying; Hsieh, Ming-Ju; Yuan, Hsu-Chia; Ko, Po-Jen; Liu, Yun-Hen

2015-12-01

Transumbilical single-port surgery has been associated with less postoperative pain and offers better cosmetic outcomes than conventional 3-port laparoscopic surgery. This study compares the safety and efficacy of transumbilical thoracoscopy and conventional thoracoscopy for lung wedge resection. The animals (n = 16) were randomly assigned to the transumbilical thoracoscopic approach group (n = 8) or conventional thoracoscopic approach group (n = 8). Transumbilical lung resection was performed via an umbilical incision and a diaphragmatic incision. In the conventional thoracoscopic group, lung resection was completed through a thoracic incision. For both procedures, we compared the surgical outcomes, for example, operating time and operative complications; physiologic parameters, for example, respiratory rate and body temperature; inflammatory parameters, for example, white blood cell count; and pulmonary parameters, for example, arterial blood gas levels. The animals were euthanized 2 weeks after the surgery for gross and histologic evaluations. The lung wedge resection was successfully performed in all animals. There was no significant difference in the mean operating times or complications between the transumbilical and the conventional thoracoscopic approach groups. With regard to the physiologic impact of the surgeries, the transumbilical approach was associated with significant elevations in body temperature on postoperative day 1, when compared with the standard thoracoscopic approach. This study suggests that both approaches for performing lung wedge resection were comparable in efficacy and postoperative complications. © The Author(s) 2014.

No-go decision: A newly identified adverse event in orthopaedic surgery - causes and medico-legal implications.

PubMed

Coudane, H; Benfrech, E; Lecoq, C; Zabee, L; Tracol, P; Danan, J L; Bruno, P Y; Lighezzolo Alnot, J

2018-06-01

No-go designates a decision not to perform surgery when it becomes apparent that safety and/or feasibility requirements are not met. No-go decisions can occur at any time between patient admission to a hospital department and immediately before the first incision. The primary objective of this study was to assess the causes of no-go decisions reported as healthcare-associated adverse events (HAAEs). Most no-go decisions in orthopaedic surgery are related to problems with medical devices. A preliminary retrospective study assessed HAAEs reported over the 1-year period from 1st October 2014 to 30th September 2015, using the risk-management tool ALARM. A prospective survey was then performed by emailing a 15-item questionnaire to the 1828 members of Orthorisq (the French orthopaedic surgeon accreditation agency). Responses were either yes/no or open. Statistical comparisons were performed, using the paired Wilcoxon signed-rank test to estimate p values. Among reported HAAEs, 5.6% were no-go decisions. Of the 101 reported no-go decisions, 43.5% and 45.2% were due to problems with managing implantable medical devices in the retrospective and prospective assessments, respectively. In over 85% of cases, surgery was cancelled or postponed. Over half the no-go decisions were associated with unnecessary anaesthesia. Checklist completion was performed in only half the cases and was not associated with no-go decisions (p>0.8). This study provides descriptive data on no-go decisions in orthopaedic surgery. Healthcare professionals use many methods to enhance patient safety by preventing adverse events or diminishing their impact. Errors in managing implantable medical devices are the leading cause of no-go decisions. The current checklist is not appropriate for managing implantable medical devices in orthopaedic surgery, in part because it does not include checking devices upon receipt. Before surgery, patients should be informed of the risk of a no-go decision, since unnecessary anaesthesia occurs in over half the cases. IV, prospective study. Copyright © 2018. Published by Elsevier Masson SAS.

Effectiveness and Safety of Immunomodulators with Anti-TNF Therapy in Crohn's Disease

PubMed Central

Osterman, Mark T.; Haynes, Kevin; Delzell, Elizabeth; Zhang, Jie; Bewtra, Meenakshi; Brensinger, Colleen M.; Chen, Lang; Xie, Fenglong; Curtis, Jeffrey R.; Lewis, James D.

2015-01-01

Background & Aims The benefit of continuing immunomodulators when “stepping up” to anti-tumor necrosis factor (anti-TNF) therapy for Crohn's disease (CD) is uncertain. This study assessed the effectiveness and safety of immunomodulators with anti-TNF therapy in CD. Methods We conducted a retrospective cohort study of new users of anti-TNF therapy for CD in Medicare. Users of anti-TNF combination therapy with immunomodulators were matched to up to 3 users of anti-TNF monotherapy via propensity score and compared using 3 metrics of effectiveness – surgery, hospitalization, and discontinuation of anti-TNF therapy or surgery – and 2 metrics of safety – serious infection and non-Candida opportunistic infection. Cox regression was used for all analyses. Results Among new users of infliximab, we matched 381 users of combination therapy to 912 users of monotherapy; among new users of adalimumab, we matched 196 users of combination therapy to 505 users of monotherapy. Combination therapy occurred predominantly as “step up” after thiopurine therapy. The rates of surgery (hazard ratio [HR] 1.20, 95% CI 0.73-1.96), hospitalization (HR 0.82 [0.57-1.19]), discontinuation of anti-TNF therapy or surgery (HR 1.09, [0.88-1.34]), and serious infection (HR 0.93 [0.88-1.34]) did not differ between users of anti-TNF combination therapy and monotherapy. However, the risk of opportunistic infection (HR 2.64 [1.21-5.73]) and herpes zoster (HR 3.16 [1.25-7.97]) were increased with combination therapy. Conclusions We found that continuation of immunomodulators after “stepping up” to anti-TNF therapy did not improve outcomes but was associated with an increased risk of opportunistic infection. PMID:25724699

Effectiveness and Safety of Immunomodulators With Anti-Tumor Necrosis Factor Therapy in Crohn's Disease.

PubMed

Osterman, Mark T; Haynes, Kevin; Delzell, Elizabeth; Zhang, Jie; Bewtra, Meenakshi; Brensinger, Colleen M; Chen, Lang; Xie, Fenglong; Curtis, Jeffrey R; Lewis, James D

2015-07-01

The benefit of continuing immunomodulators when "stepping up" to anti-tumor necrosis factor (anti-TNF) therapy for Crohn's disease (CD) is uncertain. This study assessed the effectiveness and safety of immunomodulators with anti-TNF therapy in CD. We conducted a retrospective cohort study of new users of anti-TNF therapy for CD in Medicare. Users of anti-TNF combination therapy with immunomodulators were matched to up to 3 users of anti-TNF monotherapy via propensity score and compared by using 3 metrics of effectiveness-surgery, hospitalization, and discontinuation of anti-TNF therapy or surgery-and 2 metrics of safety-serious infection and non-Candida opportunistic infection. Cox regression was used for all analyses. Among new users of infliximab, we matched 381 users of combination therapy to 912 users of monotherapy; among new users of adalimumab, we matched 196 users of combination therapy to 505 users of monotherapy. Combination therapy occurred predominantly as "step up" after thiopurine therapy. The rates of surgery (hazard ratio [HR], 1.20; 95% confidence interval, 0.73-1.96), hospitalization (HR, 0.82; 0.57-1.19), discontinuation of anti-TNF therapy or surgery (HR, 1.09; 0.88-1.34), and serious infection (HR, 0.93; 0.88-1.34) did not differ between users of anti-TNF combination therapy and monotherapy. However, the risks of opportunistic infection (HR, 2.64; 1.21-5.73) and herpes zoster (HR, 3.16; 1.25-7.97) were increased with combination therapy. We found that continuation of immunomodulators after "stepping up" to anti-TNF therapy did not improve outcomes but was associated with an increased risk of opportunistic infection. Copyright © 2015 AGA Institute. Published by Elsevier Inc. All rights reserved.

Analysis of Incident and Accident Reports and Risk Management in Spine Surgery.

PubMed

Kobayashi, Kazuyoshi; Imagama, Shiro; Ando, Kei; Hida, Tetsuro; Ito, Kenyu; Tsushima, Mikito; Ishikawa, Yoshimoto; Matsumoto, Akiyuki; Morozumi, Masayoshi; Nishida, Yoshihiro; Nagao, Yoshimasa; Ishiguro, Naoki

2017-08-01

A review of accident and incident reports. To analyze prevalence, characteristics, and details of perioperative incidents and accidents in patients receiving spine surgery. In our institution, a clinical error that potentially results in an adverse event is usually submitted as an incident or accident report through a web database, to ensure anonymous and blame-free reporting. All reports are analyzed by a medical safety management group. These reports contain valuable data for management of medical safety, but there have been no studies evaluating such data for spine surgery. A total of 320 incidents and accidents that occurred perioperatively in 172 of 415 spine surgeries were included in the study. Incidents were defined as events that were "problematic, but with no damage to the patient," and accidents as events "with damage to the patient." The details of these events were analyzed. There were 278 incidents in 137 surgeries and 42 accidents in 35 surgeries, giving prevalence of 33% (137/415) and 8% (35/415), respectively. The proportion of accidents among all events was significantly higher for doctors than non-doctors [68.0% (17/25) vs. 8.5% (25/295), P < 0.01] and in the operating room compared with outside the operating room [40.5% (15/37) vs. 9.5% (27/283), P < 0.01]. There was no significant difference in years of experience among personnel involved in all events. The major types of events were medication-related, line and tube problems, and falls and slips. Accidents also occurred because of a long-term prone position, with complications such as laryngeal edema, ulnar nerve palsy, and tooth damage. Surgery and procedures in the operating room always have a risk of complications. Therefore, a particular effort is needed to establish safe management of this environment and to provide advice on risk to the doctor and medical care team. 4.

Sugammadex given for rocuronium-induced neuromuscular blockade in infants: a retrospectıve study.

PubMed

Ozmete, Ozlem; Bali, Cagla; Cok, Oya Yalcin; Turk, Hatice Evren Eker; Ozyilkan, Nesrın Bozdogan; Civi, Soner; Aribogan, Anıs

2016-12-01

To evaluate the efficacy and safety of sugammadex in reversing profound neuromuscular block induced by rocuronium in infant patients. Retrospective observational study. University teaching hospital. Twenty-six infants (2-12 months of age; 3-11 kg) with an American Society of Anesthesiologists classification I, II, or III who were scheduled to undergo neurosurgical procedures were included in the study. Anesthesia was induced with 5 mg/kg thiopental, 1 μg/kg fentanyl and 0.6 mg/kg rocuronium. Sevoflurane was administered to all patients after intubation. The neuromuscular block was monitored with acceleromyography using train-of-four (TOF) stimuli. Patients received additional doses of rocuronium to maintain a deep block during surgery. If profound neuromuscular block (TOF, 0) persisted at the end of the surgery, 3mg/kg sugammadex was administered. The demographic data, surgeries, and anesthetic agents were recorded. The time from sugammadex administration to recovery of neuromuscular function (TOF ratio, >0.9) and complications during and after extubation were also recorded. Twenty-six infants who had a deep neuromuscular block (TOF, 0) at the end of surgery received 3 mg/kg sugammadex. The mean recovery time of the T4/T1 ratio of 0.9 was 112 seconds. No clinical evidence of recurarization or residual curarization was observed. The efficacy and safety of sugammadex were confirmed in infant surgical patients for reversal of deep neuromuscular block induced by rocuronium. Copyright © 2016 Elsevier Inc. All rights reserved.

Increasing Safety of a Robotic System for Inner Ear Surgery Using Probabilistic Error Modeling Near Vital Anatomy

PubMed Central

Dillon, Neal P.; Siebold, Michael A.; Mitchell, Jason E.; Blachon, Gregoire S.; Balachandran, Ramya; Fitzpatrick, J. Michael; Webster, Robert J.

2017-01-01

Safe and effective planning for robotic surgery that involves cutting or ablation of tissue must consider all potential sources of error when determining how close the tool may come to vital anatomy. A pre-operative plan that does not adequately consider potential deviations from ideal system behavior may lead to patient injury. Conversely, a plan that is overly conservative may result in ineffective or incomplete performance of the task. Thus, enforcing simple, uniform-thickness safety margins around vital anatomy is insufficient in the presence of spatially varying, anisotropic error. Prior work has used registration error to determine a variable-thickness safety margin around vital structures that must be approached during mastoidectomy but ultimately preserved. In this paper, these methods are extended to incorporate image distortion and physical robot errors, including kinematic errors and deflections of the robot. These additional sources of error are discussed and stochastic models for a bone-attached robot for otologic surgery are developed. An algorithm for generating appropriate safety margins based on a desired probability of preserving the underlying anatomical structure is presented. Simulations are performed on a CT scan of a cadaver head and safety margins are calculated around several critical structures for planning of a robotic mastoidectomy. PMID:29200595

Increasing safety of a robotic system for inner ear surgery using probabilistic error modeling near vital anatomy

NASA Astrophysics Data System (ADS)

Dillon, Neal P.; Siebold, Michael A.; Mitchell, Jason E.; Blachon, Gregoire S.; Balachandran, Ramya; Fitzpatrick, J. Michael; Webster, Robert J.

2016-03-01

Safe and effective planning for robotic surgery that involves cutting or ablation of tissue must consider all potential sources of error when determining how close the tool may come to vital anatomy. A pre-operative plan that does not adequately consider potential deviations from ideal system behavior may lead to patient injury. Conversely, a plan that is overly conservative may result in ineffective or incomplete performance of the task. Thus, enforcing simple, uniform-thickness safety margins around vital anatomy is insufficient in the presence of spatially varying, anisotropic error. Prior work has used registration error to determine a variable-thickness safety margin around vital structures that must be approached during mastoidectomy but ultimately preserved. In this paper, these methods are extended to incorporate image distortion and physical robot errors, including kinematic errors and deflections of the robot. These additional sources of error are discussed and stochastic models for a bone-attached robot for otologic surgery are developed. An algorithm for generating appropriate safety margins based on a desired probability of preserving the underlying anatomical structure is presented. Simulations are performed on a CT scan of a cadaver head and safety margins are calculated around several critical structures for planning of a robotic mastoidectomy.

Crude versus case-mix-adjusted control charts for safety monitoring in thyroid surgery.

PubMed

Duclos, Antoine; Voirin, Nicolas; Touzet, Sandrine; Soardo, Pietro; Schott, Anne-Marie; Colin, Cyrille; Peix, Jean-Louis; Lifante, Jean-Christophe

2010-12-01

Patient-safety monitoring based on health-outcome indicators can lead to misinterpretation of changes in case mix. This study aimed to compare the detection of indicator variations between crude and case-mix-adjusted control charts using data from thyroid surgeries. The study population included each patient who underwent thyroid surgery in a teaching hospital from January 2006 to May 2008. Patient safety was monitored according to two indicators, which are immediately recognisable postoperative complications: recurrent laryngeal nerve palsy and hypocalcaemia. Each indicator was plotted monthly on a p-control chart using exact limits. The weighted κ statistic was calculated to measure the agreement between crude and case-mix-adjusted control charts. We evaluated the outcomes of 1405 thyroidectomies. The overall proportions of immediate recurrent laryngeal nerve palsy and hypocalcaemia were 7.4% and 20.5%, respectively. The proportion of agreement in the detection of indicator variations between the crude and case-mix-adjusted p-charts was 95% (95% CI 85% to 99%). The strength of the agreement was κ = 0.76 (95% CI 0.54 to 0.98). The single special cause of variation that occurred was only detected by the case-mix-adjusted p-chart. There was good agreement in the detection of indicator variations between crude and case-mix-adjusted p-charts. The joint use of crude and adjusted charts seems to be a reasonable approach to increase the accuracy of interpretation of variations in outcome indicators.

Efficacy and safety of tranexamic acid versus ϵ-aminocaproic acid in cardiovascular surgery.

PubMed

Falana, Olabisi; Patel, Gourang

2014-12-01

Blood conservation is a major concern in the management of surgical patients because of transfusion-related complications, limited supply, and health care costs. Tranexamic acid (TXA) and ϵ-aminocaproic acid (ϵACA) are lysine analogue antifibrinolytics used to reduce surgical bleeding and transfusions. To evaluate the efficacy and safety of TXA compared with ϵACA in the management of cardiovascular surgical bleeding at an academic medical center. This single-center, retrospective, observational cohort study included 120 patients undergoing cardiovascular surgery with or without cardiopulmonary bypass, who received at least 1 dose of perioperative TXA or ϵACA. The efficacy outcome-massive perioperative bleeding-was a composite end point of chest tube drainage >1500 mL in any 8-hour period after surgery, perioperative transfusion of 10 or more units of packed red blood cells, reoperation for bleeding, or death from hemorrhage within 30 days. The safety outcomes were incidence of thromboembolic events, postoperative renal dysfunction, seizure, and 30-day all-cause mortality. The primary end point-massive perioperative bleeding-occurred in 10 patients (16.7%) in the TXA group compared with 5 patients (8.3%) in the ϵACA group (P = 0.17). There were no significant differences in the secondary end points of 30-day all-cause mortality, thromboembolic events, renal dysfunction, and seizure. There were no differences in the efficacy and safety outcomes between TXA and ϵACA in the management of cardiovascular surgical bleeding at our institution. Considering the substantial cost difference and comparable efficacy and safety, ϵACA may have better value over TXA for reducing cardiovascular surgical bleeding. © The Author(s) 2014.

Transition to Office-based Obstetric and Gynecologic Procedures: Safety, Technical, and Financial Considerations.

PubMed

Peacock, Lisa M; Thomassee, May E; Williams, Valerie L; Young, Amy E

2015-06-01

Office-based surgery is increasingly desired by patients and providers due to ease of access, overall efficiency, reimbursement, and satisfaction. The adoption of office-based surgery requires careful consideration of safety, efficacy, cost, and feasibility within a providers practice. This article reviews the currently available data regarding patient and provider satisfaction as well as practical considerations of staffing, equipment, and supplies. To aid the practitioner, issues of office-based anesthesia and safety with references to currently available national guidelines and protocols are provided. Included is a brief review of billing, coding, and reimbursement. Technical procedural aspects with information and recommendations are summarized.

Safety of implanting sustained-release 5-fluorouracil into hepatic cross-section and omentum majus after primary liver cancer resection.

PubMed

Chen, Jiangtao; Zhang, Junjie; Wang, Chenyu; Yao, Kunhou; Hua, Long; Zhang, Liping; Ren, Xuequn

2016-09-01

This study was designed to evaluate the short-term safety of implanting sustained-release 5-fluorouracil (5-FU) into hepatic cross-section and omentum majus after primary liver cancer resection and its impact on related indexes of liver. Forty patients were selected and divided into an implantation group (n = 20) and a control group (n = 20). On the first day after admission, first week after surgery, and first month after surgery, fasting venous blood was extracted from patients for measuring hematological indexes. The reduction rate of alpha fetoprotein (AFP) on the first week and first month after surgery was calculated, and moreover, drainage volume of the abdominal cavity drainage tube, length of stay after surgery, and wound healing condition were recorded. We found that levels of alanine aminotransferase, aspartate amino transferase, blood urea nitrogen, creatinine, total bilirubin, albumin, and white blood cells measured on the first week and first month after surgery, length of stay, and wound healing of patients in the two groups had no significant difference (P >0.05). Drainage volume and reduction rate of AFP of two groups were significantly different on the first week and first month after surgery (P <0.05). Implanting sustained-release 5-FU into hepatic cross-section and omentum majus after primary liver cancer resection is proved to be safe as it has little impact on related indexes. © The Author(s) 2016.

Safety of robotic general surgery in elderly patients.

PubMed

Buchs, Nicolas C; Addeo, Pietro; Bianco, Francesco M; Ayloo, Subhashini; Elli, Enrique F; Giulianotti, Pier C

2010-08-01

As the life expectancy of people in Western countries continues to rise, so too does the number of elderly patients. In parallel, robotic surgery continues to gain increasing acceptance, allowing for more complex operations to be performed by minimally invasive approach and extending indications for surgery to this population. The aim of this study is to assess the safety of robotic general surgery in patients 70 years and older. From April 2007 to December 2009, patients 70 years and older, who underwent various robotic procedures at our institution, were stratified into three categories of surgical complexity (low, intermediate, and high). There were 73 patients, including 39 women (53.4%) and 34 men (46.6%). The median age was 75 years (range 70-88 years). There were 7, 24, and 42 patients included, respectively, in the low, intermediate, and high surgical complexity categories. Approximately 50% of patients underwent hepatic and pancreatic resections. There was no statistically significant difference between the three groups in terms of morbidity, mortality, readmission or transfusion. Mean overall operative time was 254 ± 133 min (range 15-560 min). Perioperative mortality and morbidity was 1.4% and 15.1%, respectively. Transfusion rate was 9.6%, and median length of stay was 6 days (range 0-30 days). Robotic surgery can be performed safely in the elderly population with low mortality, acceptable morbidity, and short hospital stay. Age should not be considered as a contraindication to robotic surgery even for advanced procedures.

Weight Loss Surgery (Bariatric Surgery) (For Parents)

MedlinePlus

... Development Infections Diseases & Conditions Pregnancy & Baby Nutrition & Fitness Emotions & Behavior School & Family Life First Aid & Safety Doctors & ... it takes to make it a success: the motivation to make lifelong changes and the support of ...

[Safety Culture in Orthopaedic Surgery and Trauma Surgery - Where Are We Today?

PubMed

Münzberg, Matthias; Rüsseler, Miriam; Egerth, Martin; Doepfer, Anna Katharina; Mutschler, Manuel; Stange, Richard; Bouillon, Bertil; Kladny, Bernd; Hoffmann, Reinhard

2018-06-05

The development of a new safety culture in orthopaedics and trauma surgery needs to be based on the knowledge of the status quo. The objective of this research was therefore to perform a survey of orthopaedic and trauma surgeons to achieve a subjective assessment of the frequency and causes of "insecurities" or errors in daily practice. Based on current literature, an online questionnaire was created by a team of experts (26 questions total) and was sent via e-mail to all active members of a medical society (DGOU) in April 2015. This was followed by two reminder e-mails. The survey was completed in May 2015. The results were transmitted electronically, anonymously and voluntarily into a database and evaluated by univariate analyses. 799 active members took part in the survey. 65% of the interviewed people stated that they noticed mistakes in their own clinical work environment at least once a week. The main reasons for these mistakes were "time pressure", "lack of communication", "lack of staff" and "stress". Technical mistakes or lack of knowledge were not of primary importance. The survey indicated that errors in orthopaedics and trauma surgery are observed regularly. "Human factors" were regarded as a major cause. In order to develop a new safety culture in orthopaedics and trauma surgery, new approaches must focus on the human factor. Georg Thieme Verlag KG Stuttgart · New York.

Safety syringes and anti-needlestick devices in orthopaedic surgery.

PubMed

Sibbitt, Wilmer L; Band, Philip A; Kettwich, Lawrence G; Sibbitt, Cristina R; Sibbitt, Lori J; Bankhurst, Arthur D

2011-09-07

The American Academy of Orthopaedic Surgery (AAOS), The Joint Commission, the Occupational Safety and Health Administration (OSHA), and the Needlestick Safety and Prevention Act encourage the integration of safety-engineered devices to prevent needlestick injuries to health-care workers and patients. We hypothesized that safety syringes and needles could be used in outpatient orthopaedic injection and aspiration procedures. The study investigated the orthopaedic uses and procedural idiosyncrasies of safety-engineered devices, including (1) four safety needles (Eclipse, SafetyGlide, SurGuard, and Magellan), (2) a mechanical safety syringe (RPD), (3) two automatic retractable syringes (Integra, VanishPoint), (4) three manual retractable syringes (Procedur-SF, Baksnap, Invirosnap), and (5) three shielded syringes (Safety-Lok, Monoject, and Digitally Activated Shielded [DAS] Syringe). The devices were first tested ex vivo, and then 1300 devices were used for 425 subjects undergoing outpatient arthrocentesis, intra-articular injections, local anesthesia, aspiration biopsy, and ultrasound-guided procedures. During the clinical observation, there were no accidental needlesticks (0 needlesticks per 1300 devices). Safety needles could be successfully used on a Luer syringe but were limited to ≤1.5 in (≤3.81 cm) in length and the shield could interfere with sonography. The mechanical safety syringes functioned well in all orthopaedic procedures. Automatic retractable syringes were too small for arthrocentesis of the knee, and the plunger blew out and prematurely collapsed with high-pressure injections. The manual retractable syringes and shielded syringes could be used with conventional needles for most orthopaedic procedures. The most effective and reliable safety devices for orthopaedic syringe procedures are shielded safety needles, mechanical syringes, manual retractable syringes, and shielded syringes, but not automatic retractable syringes. Even when adopting safety-engineered devices for an orthopaedic clinic, conventional syringes larger than 20 mL and conventional needles longer than 1.5 in (3.8 cm) are necessary.

Application of an engineering problem-solving methodology to address persistent problems in patient safety: a case study on retained surgical sponges after surgery.

PubMed

Anderson, Devon E; Watts, Bradley V

2013-09-01

Despite innumerable attempts to eliminate the postoperative retention of surgical sponges, the medical error persists in operating rooms worldwide and places significant burden on patient safety, quality of care, financial resources, and hospital/physician reputation. The failure of countless solutions, from new sponge counting methods to radio labeled sponges, to truly eliminate the event in the operating room requires that the emerging field of health-care delivery science find innovative ways to approach the problem. Accordingly, the VA National Center for Patient Safety formed a unique collaboration with a team at the Thayer School of Engineering at Dartmouth College to evaluate the retention of surgical sponges after surgery and find a solution. The team used an engineering problem solving methodology to develop the best solution. To make the operating room a safe environment for patients, the team identified a need to make the sponge itself safe for use as opposed to resolving the relatively innocuous counting methods. In evaluation of this case study, the need for systematic engineering evaluation to resolve problems in health-care delivery becomes clear.

First report on the safety and efficacy of an extended half-life glycoPEGylated recombinant FVIII for major surgery in severe haemophilia A.

PubMed

Hampton, K; Chowdary, P; Dunkley, S; Ehrenforth, S; Jacobsen, L; Neff, A; Santagostino, E; Sathar, J; Takedani, H; Takemoto, C M; Négrier, C

2017-09-01

N8-GP (turoctocog alfa pegol) is an extended half-life glycoPEGylated recombinant factor VIII (FVIII) product developed for the prevention and treatment of bleeds in haemophilia A patients. This is a planned interim analysis of pathfinder™3, an international, open-label, Phase 3 trial evaluating the efficacy and safety (including immunogenicity) of N8-GP administered before, during and after major surgery in severe haemophilia A patients aged ≥12 years. Sixteen patients who underwent 18 major surgical procedures (including synovectomy, joint replacement and ankle arthrodesis) were included here. Postoperative assessments were conducted daily for days 1-6, and once for days 7-14. Primary endpoint was N8-GP haemostatic efficacy, assessed after completion of surgery using a four-point scale ('excellent', 'good', 'moderate', 'none'). Haemostasis was successful (rated 'excellent' or 'good') on completion of surgery in 17 (94.4%) procedures and rated as 'moderate' (5.6%) for one surgery in a patient with multiple comorbidities who needed an intraoperative N8-GP dose (20.7 IU kg -1 ). In the postoperative period, three bleeds occurred (one during days 1-6; two during days 7-14); all were successfully treated with N8-GP. Mean N8-GP consumption on day of surgery was 80.0 IU kg -1 ; patients received a mean of 1.7 doses (median: 2, range: 1-3). No safety concerns were identified. The data showed that N8-GP was effective and well tolerated for the prevention and treatment of bleeds during major surgery; such FVIII products with extended half-lives may modify current treatment schedules, enabling fewer infusions and earlier patient discharge. © 2017 John Wiley & Sons Ltd.

An Employee Questionnaire for Assessing Patient Safety in Outpatient Surgery

DTIC Science & Technology

2005-01-01

461 An Employee Questionnaire for Assessing Patient Safety in Outpatient Surgery Pascale Carayon, Carla J. Alvarado, Ann Schoofs Hundt, Scott...Springman, Amanda Borgsdorf, Peter L.T. Hoonakker Abstract This paper provides information on the reliability and validity of an employee ...intervention on both employees and patients. In this paper, we describe the SEIPS employee questionnaire, which surveys various elements of the work system

[Operating Room Nurses' Experiences of Securing for Patient Safety].

PubMed

Park, Kwang Ok; Kim, Jong Kyung; Kim, Myoung Sook

2015-10-01

This study was done to evaluate the experience of securing patient safety in hospital operating rooms. Experiential data were collected from 15 operating room nurses through in-depth interviews. The main question was "Could you describe your experience with patient safety in the operating room?". Qualitative data from the field and transcribed notes were analyzed using Strauss and Corbin's grounded theory methodology. The core category of experience with patient safety in the operating room was 'trying to maintain principles of patient safety during high-risk surgical procedures'. The participants used two interactional strategies: 'attempt continuous improvement', 'immersion in operation with sharing issues of patient safety'. The results indicate that the important factors for ensuring the safety of patients in the operating room are manpower, education, and a system for patient safety. Successful and safe surgery requires communication, teamwork and recognition of the importance of patient safety by the surgical team.

Endoscopy Assisted Oncoplastic Breast Surgery (EAOBS)

PubMed Central

Soybir, Gürsel; Fukuma, Eisuke

2015-01-01

Endoscopic oncoplastic breast surgery represents a minimal invasive approach with the aim of both removing cancer safely and also restoring the breast image. It has less noticeable scar, excellent cosmetic outcomes, high patient satisfaction rate and recently reported relatively long term safety. Operative techniques for both endoscopic breast conserving surgery and endoscopic nipple/areola/skin sparing mastectomy have been described in detail. Two different working planes in which one of them is subcutaneous and the other one is sub-mammary planes are being used during the surgery. Surgical techniqe needs some instruments such as endoscopic retractor, light guided specific mammary retractor, wound protector and bipolar scissor. Endoscopic breast retractors provide magnified visualization and extensive posterior dissection facility. Tunneling method and hydrodissection simplify the technique in the subcutaneous field. Oncoplastic reconstruction techniques are also applied after the tumor resection by endoscopic method. Complication rates of endoscopic breast surgery are similar to open breast surgery rates. Quite succesful local recurrence, distant metastasis and overall survival rates have been declared. However it looks reasonable to wait for the results with longer follow-up before having a judgement about oncologic efficiency and safety of the endoscopic breast cancer surgery. PMID:28331692

Efficacy and Safety of Autologous Fat Transfer in Facial Reconstructive Surgery: A Systematic Review and Meta-Analysis.

PubMed

Krastev, Todor K; Beugels, Jip; Hommes, Juliette; Piatkowski, Andrzej; Mathijssen, Irene; van der Hulst, Rene

2018-03-29

The use of autologous fat transfer (AFT) or lipofilling for correcting contour deformities is seen as one of the major breakthroughs in reconstructive plastic surgery. Its applications in facial reconstructive surgery have been of particular interest owing to the prospect of achieving autologous reconstruction by a minimally invasive approach. However, its unpredictability and variable degree of resorption have limited its utility and much skepticism still exists regarding its efficacy. Furthermore, more than 2 decades of clinical research have produced a highly fragmented body of evidence that has not been able to provide definite answers. To investigate the safety and efficacy of AFT in facial reconstruction through a systematic review and meta-analysis. A literature search was performed in PubMed, Embase, and the Cochrane Library from inception to October 11, 2017. All published studies investigating the efficacy and safety of AFT in facial reconstructive surgery. Two independent reviewers performed data extraction systematically, adhering to the PRISMA guidelines. Summary measures were pooled in a random-effects model meta-analysis. The patient and surgeon satisfaction, graft survival, number of AFT sessions, and the incidence of AFT-related complications were the main outcomes of interest in this meta-analysis. This systematic review resulted in the inclusion 52 relevant studies consisting of 1568 unique patients. These included 4 randomized clinical trials, 11 cohort studies, and 37 case series. The overall follow-up averaged 1.3 years after AFT. Meta-analysis revealed a very high overall patient satisfaction rate of 91.1% (95% CI, 85.1%-94.8%) and overall surgeon satisfaction rate of 88.6% (95% CI, 83.4%-92.4%). The number of AFT sessions required to achieve the desired result was 1.5 (95% CI, 1.3-1.7) and 50% to 60% of the injected volume was retained at 1 year. Only 4.8% (95% CI, 3.3%-6.9%) of procedures resulted in clinical complications. To our knowledge, this study provides the first overview of the current knowledge about AFT in facial reconstructive surgery. Our results confirm that AFT is an effective technique for treating soft-tissue deformities in the head and neck, with low rate of minor complications. NA.

Procedure-specific Surgical Site Infection Incidence Varies Widely within Certain National Healthcare Safety Network Surgery Groups

PubMed Central

Saeed, Mohammed J; Dubberke, Erik R; Fraser, Victoria J; Olsen, Margaret A

2015-01-01

Background The National Healthcare Safety Network (NHSN) classifies surgical procedures into 40 categories. The objective of this study was to determine surgical site infection (SSI) incidence for clinically defined subgroups within 5 heterogeneous NHSN surgery categories. Methods This is a retrospective cohort study using the longitudinal State Inpatient Database. We identified 5 groups of surgical procedures (amputation; biliary, liver and pancreas [BILI]; breast; colon and hernia) using ICD-9-CM procedure codes in community hospitals in California, Florida and New York from January 2009 through September 2011 in persons aged ≥18 years. Each of these 5 categories was classified to more specific surgical procedures within the group. 90-day SSI rates were calculated using ICD-9-CM diagnosis codes. Results There were 62,901 amputation, 33,358 BILI, 72,058 breast, 125,689 colon and 85,745 hernia surgeries in 349,298 people. 90-day SSI rates varied significantly within each of the 5 subgroups. Within the BILI category, bile duct, pancreas and laparoscopic liver procedures had SSI rates of 7.2%, 17.2%, and 2.2%, respectively (p<0.0001 for each) compared to open liver procedures (11.1% SSI). Conclusion 90-day SSI rates varied widely within certain NHSN categories. Risk adjustment for specific surgery type is needed in order to make valid comparisons between hospitals. PMID:25818024

New Refractive Surgery Procedures and Their Implications for Aviation Safety

DTIC Science & Technology

2006-04-01

airmen with laser refractive surgery, i.e., photorefractive keratectomy ( PRK ) and laser in situ keratomileusis ( LASIK ). A reference guide on refractive...surgery was published in September of 1998 (DOT/FAA/AM-98/25); however, at that time long-term clinical data on PRK and LASIK were not available...fractive surgery procedures (Photorefractive Keratectomy [ PRK ], Laser1 in situ Keratomileusis [ LASIK ]) and to assist Aviation Medical Examiners in

Predicting surgical site infection after spine surgery: a validated model using a prospective surgical registry.

PubMed

Lee, Michael J; Cizik, Amy M; Hamilton, Deven; Chapman, Jens R

2014-09-01

The impact of surgical site infection (SSI) is substantial. Although previous study has determined relative risk and odds ratio (OR) values to quantify risk factors, these values may be difficult to translate to the patient during counseling of surgical options. Ideally, a model that predicts absolute risk of SSI, rather than relative risk or OR values, would greatly enhance the discussion of safety of spine surgery. To date, there is no risk stratification model that specifically predicts the risk of medical complication. The purpose of this study was to create and validate a predictive model for the risk of SSI after spine surgery. This study performs a multivariate analysis of SSI after spine surgery using a large prospective surgical registry. Using the results of this analysis, this study will then create and validate a predictive model for SSI after spine surgery. The patient sample is from a high-quality surgical registry from our two institutions with prospectively collected, detailed demographic, comorbidity, and complication data. An SSI that required return to the operating room for surgical debridement. Using a prospectively collected surgical registry of more than 1,532 patients with extensive demographic, comorbidity, surgical, and complication details recorded for 2 years after the surgery, we identified several risk factors for SSI after multivariate analysis. Using the beta coefficients from those regression analyses, we created a model to predict the occurrence of SSI after spine surgery. We split our data into two subsets for internal and cross-validation of our model. We created a predictive model based on our beta coefficients from our multivariate analysis. The final predictive model for SSI had a receiver-operator curve characteristic of 0.72, considered to be a fair measure. The final model has been uploaded for use on SpineSage.com. We present a validated model for predicting SSI after spine surgery. The value in this model is that it gives the user an absolute percent likelihood of SSI after spine surgery based on the patient's comorbidity profile and invasiveness of surgery. Patients are far more likely to understand an absolute percentage, rather than relative risk and confidence interval values. A model such as this is of paramount importance in counseling patients and enhancing the safety of spine surgery. In addition, a tool such as this can be of great use particularly as health care trends toward pay for performance, quality metrics (such as SSI), and risk adjustment. To facilitate the use of this model, we have created a Web site (SpineSage.com) where users can enter patient data to determine likelihood for SSI. Copyright © 2014 Elsevier Inc. All rights reserved.

Perioperative red blood cell transfusion in orofacial surgery

PubMed Central

2017-01-01

In the field of orofacial surgery, a red blood cell transfusion (RBCT) is occasionally required during double jaw and oral cancer surgery. However, the question remains whether the effect of RBCT during the perioperative period is beneficial or harmful. The answer to this question remains challenging. In the field of orofacial surgery, transfusion is performed for the purpose of oxygen transfer to hypoxic tissues and plasma volume expansion when there is bleeding. However, there are various risks, such as infectious complications (viral and bacterial), transfusion-related acute lung injury, ABO and non-ABO associated hemolytic transfusion reactions, febrile non-hemolytic transfusion reactions, transfusion associated graft-versus-host disease, transfusion associated circulatory overload, and hypersensitivity transfusion reaction including anaphylaxis and transfusion-related immune-modulation. Many studies and guidelines have suggested RBCT is considered when hemoglobin levels recorded are 7 g/dL for general patients and 8-9 g/dL for patients with cardiovascular disease or hemodynamically unstable patients. However, RBCT is occasionally an essential treatment during surgeries and it is often required in emergency cases. We need to comprehensively consider postoperative bleeding, different clinical situations, the level of intra- and postoperative patient monitoring, and various problems that may arise from a transfusion, in the perspective of patient safety. Since orofacial surgery has an especially high risk of bleeding due to the complex structures involved and the extensive vascular distribution, measures to prevent bleeding should be taken and the conditions for a transfusion should be optimized and appropriate in order to promote patient safety. PMID:29090247

From an urologist view: are we safe with endoscopic surgery? Overview of ergonomic problems encountered by the urologist during video endoscopic surgery.

PubMed

Sataa, Sallami; Benzarti, Aida; Ben Jemaa, Abdelmajid

2012-12-01

The importance of minimally invasive surgery in urology has constantly increased in the last 20 years. Endoscopic resection of prostate and bladder tumors is actually a gold standard with many advantages for patients. To analyze the problems related to the ergonomic conditions faced by urologist during video endoscopic surgery by review of the recent literature. All evidence-based experimental ergonomic studies conducted in the fields of urology endoscopic surgery and applied ergonomics for other professions working with a display were identified by PubMed searches. Data from ergonomic studies were evaluated in terms of efficiency as well as comfort and safety aspects. Constraint postures for urologists are described and ergonomic requirements for optimal positions are discussed. The ergonomics of urological endoscopic surgery place urologists at risk for potential injury. The amount of neck flexion or extension, the amount of shoulder girdle adduction or abduction used, and stability of the upper extremities during surgery; which are maintained in a prolonged static posture; are the main risk factors. All these constraints may lead to muscle and joint fatigue, pain, and eventual musculoskeletal injury. Moreover, these issues may impact surgical accuracy. Urologist posture, operating period, training are important ergonomic factor during video surgery to prevent musculoskeletal disorders.

Hand function and quality of life before and after fasciectomy for Dupuytren contracture.

PubMed

Engstrand, Christina; Krevers, Barbro; Nylander, Göran; Kvist, Joanna

2014-07-01

To describe changes in joint motion, sensibility, and scar pliability and to investigate the patients' expectations, self-reported recovery, and satisfaction with hand function, disability, and quality of life after surgery and hand therapy for Dupuytren disease. This prospective cohort study collected measurements before surgery and 3, 6, and 12 months after surgery and hand therapy. Ninety patients with total active extension deficits of 60° or more from Dupuytren contracture were included. Outcomes measures were range of motion; sensibility; scar pliability; self-reported outcomes on expectations, recovery, and satisfaction with hand function; Disabilities of the Arm, Shoulder, and Hand scores; safety and social issues of hand function; physical activity habits; and quality of life with the Euroqol. The extension deficit decreased, and there was a transient decrease in active finger flexion during the first year after surgery. Sensibility remained unaffected. Generally, patients with surgery on multiple fingers had worse scar pliability. The majority of the patients had their expectations met, and at 6 months, 32% considered hand function as fully recovered, and 73% were satisfied with their hand function. Fear of hurting the hand and worry about not trusting the hand function were of greatest concern among safety and social issues. The Disability of the Arm, Shoulder, and Hand score and the Euroqol improved over time. After surgery and hand therapy, disability decreased independent of single or multiple operated fingers. The total active finger extension improved enough for the patients to reach a functional range of motion despite an impairment of active finger flexion still present 12 months after treatment. Therapeutic IV. Copyright © 2014 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Safety in surgery: is selection the missing link?

PubMed

Paice, Alistair G; Aggarwal, Rajesh; Darzi, Ara

2010-09-01

Health care providers comprise an example of a "high risk organization." Safety failings within these organizations have the potential to cause significant public harm. Significant safety improvements in other high risk organizations such as the aviation industry have led to the concept of a high reliability organization (HRO)--a high risk organization that has enjoyed a prolonged safety record. A strong organizational culture is common to all successful HROs, encompassing powerful systems of selection and training. Aircrew selection processes provide a good example of this and are examined in detail in this article using the Royal Air Force process as an example. If the lessons of successful HROs are to be applied to health care organizations, candidate selection to specialties such as surgery must become more objective and robust. Other HROs can provide valuable lessons in how this may be approached.

Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis

PubMed Central

Maule, Milena; Ceccarelli, Manuela; Fea, Antonio Maria

2017-01-01

Background MIGS have been developed as a surgical alternative for glaucomatous patients. Purpose To analyze the change in intraocular pressure (IOP) and glaucoma medications using different MIGS devices (Trabectome, iStent, Excimer Laser Trabeculotomy (ELT), iStent Supra, CyPass, XEN, Hydrus, Fugo Blade, Ab interno canaloplasty, Goniscopy-assisted transluminal trabeculotomy) as a solo procedure or in association with phacoemulsification. Methods Randomized control trials (RCT) and non-RCT (non randomized comparative studies, NRS, and before-after studies) were included. Studies with at least one year of follow-up in patients affected by primary open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma were considered. Risk of Bias assessment was performed using the Cochrane Risk of Bias and the ROBINS-I tools. The main outcome was the effect of MIGS devices compared to medical therapy, cataract surgery, other glaucoma surgeries and other MIGS on both IOP and use of glaucoma medications 12 months after surgery. Outcomes measures were the mean difference in the change of IOP and glaucoma medication compared to baseline at one and two years and all ocular adverse events. The current meta-analysis is registered on PROSPERO (reference n° CRD42016037280). Results Over a total of 3,069 studies, nine RCT and 21 case series with a total of 2.928 eyes were included. Main concerns about risk of bias in RCTs were lack of blinding, allocation concealment and attrition bias while in non-RCTs they were represented by patients’ selection, masking of participants and co-intervention management. Limited evidence was found based on both RCTs and non RCTs that compared MIGS surgery with medical therapy or other MIGS. In before-after series, MIGS surgery seemed effective in lowering both IOP and glaucoma drug use. MIGS showed a good safety profile: IOP spikes were the most frequent complications and no cases of infection or BCVA loss due to glaucoma were reported. Conclusions Although MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted. PMID:28850575

Minimally-invasive glaucoma surgeries (MIGS) for open angle glaucoma: A systematic review and meta-analysis.

PubMed

Lavia, Carlo; Dallorto, Laura; Maule, Milena; Ceccarelli, Manuela; Fea, Antonio Maria

2017-01-01

MIGS have been developed as a surgical alternative for glaucomatous patients. To analyze the change in intraocular pressure (IOP) and glaucoma medications using different MIGS devices (Trabectome, iStent, Excimer Laser Trabeculotomy (ELT), iStent Supra, CyPass, XEN, Hydrus, Fugo Blade, Ab interno canaloplasty, Goniscopy-assisted transluminal trabeculotomy) as a solo procedure or in association with phacoemulsification. Randomized control trials (RCT) and non-RCT (non randomized comparative studies, NRS, and before-after studies) were included. Studies with at least one year of follow-up in patients affected by primary open angle glaucoma, pseudoexfoliative glaucoma or pigmentary glaucoma were considered. Risk of Bias assessment was performed using the Cochrane Risk of Bias and the ROBINS-I tools. The main outcome was the effect of MIGS devices compared to medical therapy, cataract surgery, other glaucoma surgeries and other MIGS on both IOP and use of glaucoma medications 12 months after surgery. Outcomes measures were the mean difference in the change of IOP and glaucoma medication compared to baseline at one and two years and all ocular adverse events. The current meta-analysis is registered on PROSPERO (reference n° CRD42016037280). Over a total of 3,069 studies, nine RCT and 21 case series with a total of 2.928 eyes were included. Main concerns about risk of bias in RCTs were lack of blinding, allocation concealment and attrition bias while in non-RCTs they were represented by patients' selection, masking of participants and co-intervention management. Limited evidence was found based on both RCTs and non RCTs that compared MIGS surgery with medical therapy or other MIGS. In before-after series, MIGS surgery seemed effective in lowering both IOP and glaucoma drug use. MIGS showed a good safety profile: IOP spikes were the most frequent complications and no cases of infection or BCVA loss due to glaucoma were reported. Although MIGS seem efficient in the reduction of the IOP and glaucoma medication and show good safety profile, this evidence is mainly derived from non-comparative studies and further, good quality RCTs are warranted.

Using an International Medical Advisory Board to guide clinical governance in a corporate refractive surgery model.

PubMed

Vukich, John A

2009-07-01

To describe the role played by the International Medical Advisory Board (IMAB) in clinical and corporate governance at Optical Express, a corporate provider of refractive surgery. A review of goals, objectives, and actions of the IMAB. The IMAB has contributed to study design, data analysis, and selection of instruments and procedures. Through interactions with Optical Express corporate and clinical staff, the IMAB has supported management's effort to craft a corporate culture focused on continuous improvement in the safety and visual outcomes of refractive surgery. The IMAB has fashioned significant changes in corporate policies and procedures and has had an impact on corporate culture at Optical Express.

Factors affecting functional recovery after surgery and hand therapy in patients with Dupuytren's disease.

PubMed

Engstrand, Christina; Krevers, Barbro; Kvist, Joanna

2015-01-01

Prospective cohort study. The evidence of the relationship between functional recovery and impairment after surgery and hand therapy are inconsistent. To explore factors that were most related to functional recovery as measured by DASH in patients with Dupuytren's disease. Eighty-one patients undergoing surgery and hand therapy were consecutively recruited. Functional recovery was measured by the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Explanatory variables: range of motion of the finger joints, five questions regarding safety and social issues of hand function, and health-related quality of life (Euroqol). The three variables "need to take special precautions", "avoid using the hand in social context", and health-related quality of life (EQ-5D index) explained 62.1% of the variance in DASH, where the first variable had the greatest relative effect. Safety and social issues of hand function and quality of life had an evident association with functional recovery. IV. Copyright © 2015 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Remotely Programmed Deep Brain Stimulation of the Bilateral Subthalamic Nucleus for the Treatment of Primary Parkinson Disease: A Randomized Controlled Trial Investigating the Safety and Efficacy of a Novel Deep Brain Stimulation System.

PubMed

Li, Dianyou; Zhang, Chencheng; Gault, Judith; Wang, Wei; Liu, Jianmin; Shao, Ming; Zhao, Yanyan; Zeljic, Kristina; Gao, Guodong; Sun, Bomin

2017-01-01

Deep brain stimulation (DBS) is the most commonly performed surgery for the debilitating symptoms of Parkinson disease (PD). However, DBS systems remain largely unaffordable to patients in developing countries, warranting the development of a safe, economically viable, and functionally comparable alternative. To investigate the efficacy and safety of wirelessly programmed DBS of bilateral subthalamic nucleus (STN) in patients with primary PD. Sixty-four patients with primary PD were randomly divided into test and control groups (1:1), where DBS was initiated at either 1 month or 3 months, respectively, after surgery. Safety and efficacy of the treatment were compared between on- and off-medication states 3 months after surgery. Outcome measures included analysis of Unified Parkinson's Disease Rating Scale (UPDRS) scores, duration of "on" periods, and daily equivalent doses of levodopa. All patients were followed up both 6 and 12 months after surgery. Three months after surgery, significant decrease in the UPDRS motor scores were observed for the test group in the off-medication state (25.08 ± 1.00) versus the control group (4.20 ± 1.99). Bilateral wireless programming STN-DBS is safe and effective for patients with primary PD in whom medical management has failed to restore motor function. © 2017 S. Karger AG, Basel.

Surgical Safety Training of World Health Organization Initiatives.

PubMed

Davis, Christopher R; Bates, Anthony S; Toll, Edward C; Cole, Matthew; Smith, Frank C T; Stark, Michael

2014-01-01

Undergraduate training in surgical safety is essential to maximize patient safety. This national review quantified undergraduate surgical safety training. Training of 2 international safety initiatives was quantified: (1) World Health Organization (WHO) "Guidelines for Safe Surgery" and (2) Department of Health (DoH) "Principles of the Productive Operating Theatre." Also, 13 additional safety skills were quantified. Data were analyzed using Mann-Whitney U tests. In all, 23 universities entered the study (71.9% response). Safety skills from WHO and DoH documents were formally taught in 4 UK medical schools (17.4%). Individual components of the documents were taught more frequently (47.6%). Half (50.9%) of the additional safety skills identified were taught. Surgical societies supplemented safety training, although the total amount of training provided was less than that in university curricula (P < .0001). Surgical safety training is inadequate in UK medical schools. To protect patients and maximize safety, a national undergraduate safety curriculum is recommended. © 2013 by the American College of Medical Quality.

A novel hand-assisted laparoscopic versus conventional laparoscopic right hemicolectomy for right colon cancer: study protocol for a randomized controlled trial.

PubMed

Yang, Xuyang; Wu, Qingbin; Jin, Chengwu; He, Wanbin; Wang, Meng; Yang, Tinghan; Wei, Mingtian; Deng, Xiangbing; Meng, Wenjian; Wang, Ziqiang

2017-07-26

Although conventional laparoscopic and hand-assisted laparoscopic surgery for colorectal cancer is widely used today, there remain many technical challenges especially for right colon cancer in obese patients. Herein, we develop a novel hand-assisted laparoscopic surgery (HALS) with complete mesocolic excision (CME), D3 lymphadenectomy, and a total "no-touch" isolation technique (HALS-CME) in right hemicolectomy to overcome these issues. According to previous clinic practice, this novel procedure is not only feasible and safe but has several technical merits. However, the feasibility, short-term minimally invasive virtues, long-term oncological superiority, and potential total "no-touch" isolation technique benefits of HALS-CME should be confirmed by a prospective randomized controlled trial. This is a single-center, open-label, noninferiority, randomized controlled trial. Eligible participants will be randomly assigned to the HALS-CME group or to the laparoscopic surgery with CME, D3 lymphadenectomy, and total "no-touch" isolation technique (LAP-CME) group, or to conventional laparoscopic surgery with CME and D3 lymphadenectomy (cLAP) group at a 1:1:1 ratio using a centralized randomization list. Primary endpoints include safety, efficacy, and being oncologically clear, and 3-year disease-free, progression-free, and overall survival. Second endpoints include operative outcomes (operation time, blood loss, and incision length), pathologic evaluation (grading the plane of surgery, length of proximal and distal resection margins, distance between the tumor and the central arterial high tie, distance between the nearest bowel wall and the same high tie, area of mesentery resected, width of the chain of lymph-adipose tissue, length of the central lymph-adipose chain, number of harvested lymph nodes), and postoperative outcomes (pain intensity, postoperative inflammatory and immune responses, postoperative recovery). This trial will provide valuable clinical evidence for the feasibility, safety, and potential total "no-touch" isolation technique benefits of HALS-CME for right hemicolectomy. The hypothesis is that HALS-CME is feasible for the radical D3 resection of right colon cancer and offers short-term safety and long-term oncological superiority compared with conventional laparoscopic surgery. ClinicalTrials.gov, NCT02625272 . Registered on 8 December 2015.

Outcomes of Surgeries Performed in Physician Offices Compared With Ambulatory Surgery Centers and Hospital Outpatient Departments in Florida

PubMed Central

Ohsfeldt, Robert L; Li, Pengxiang; Schneider, John E; Stojanovic, Ivana; Scheibling, Cara M

2017-01-01

Background: The proportion of outpatient surgeries performed in physician offices has been increasing over time, raising concern about the impact on outcomes. Objective: To use a private insurance claims database to compare 7-day and 30-day hospitalization rates following relatively complex outpatient surgical procedures across physician offices, freestanding ambulatory surgery centers (ASCs), and hospital outpatient departments (HOPDs). Methods: A multivariable logistic regression model was used to compare the risk-adjusted probability of hospitalization among patients after any of the 88 study outpatient procedures at physician offices, ASCs, and HOPDs over 2008-2012 in Florida. Results: Risk-adjusted hospitalization rates were higher following procedures performed in physician offices compared with ASCs for all procedures grouped together, for most procedures grouped by type, and for many individual procedures. Conclusions: Hospitalizations following surgery were more likely for procedures performed in physician offices compared with ASCs, which highlights the need for ongoing research on the safety and efficacy of office-based surgery. PMID:28469457

Task-shifting of orthopaedic surgery to non-physician clinicians in Malawi: effective and safe?

PubMed

Wilhelm, Torsten J; Dzimbiri, Kondwani; Sembereka, Victoria; Gumeni, Martin; Bach, Olaf; Mothes, Henning

2017-10-01

There is a shortage of orthopaedic surgeons in Malawi. Orthopaedic clinical officers (OCOs) treat trauma patients and occasionally perform major orthopaedic surgery. No studies have assessed the efficacy and safety of their work. The aim of this study was to evaluate their contribution to major orthopaedic surgery at Zomba Central Hospital. Data about orthopaedic procedures during 2006-2010 were collected from theatre books. We selected major amputations and open reductions and plating for outcome analysis and collected details from files. We compared patients operated by OCOs alone ('OCOs alone' group) and by surgeons or OCOs assisted by surgeons ('Surgeon present' group). OCOs performed 463/1010 major (45.8%) and 1600/1765 minor operations (90.7%) alone. There was no difference in perioperative outcome between both groups. OCOs carry out a large proportion of orthopaedic procedures with good clinical results. Shifting of clinical tasks including major orthopaedic surgery can be safe. Further prospective studies are recommended.

The image-guided surgery toolkit IGSTK: an open source C++ software toolkit.

PubMed

Enquobahrie, Andinet; Cheng, Patrick; Gary, Kevin; Ibanez, Luis; Gobbi, David; Lindseth, Frank; Yaniv, Ziv; Aylward, Stephen; Jomier, Julien; Cleary, Kevin

2007-11-01

This paper presents an overview of the image-guided surgery toolkit (IGSTK). IGSTK is an open source C++ software library that provides the basic components needed to develop image-guided surgery applications. It is intended for fast prototyping and development of image-guided surgery applications. The toolkit was developed through a collaboration between academic and industry partners. Because IGSTK was designed for safety-critical applications, the development team has adopted lightweight software processes that emphasizes safety and robustness while, at the same time, supporting geographically separated developers. A software process that is philosophically similar to agile software methods was adopted emphasizing iterative, incremental, and test-driven development principles. The guiding principle in the architecture design of IGSTK is patient safety. The IGSTK team implemented a component-based architecture and used state machine software design methodologies to improve the reliability and safety of the components. Every IGSTK component has a well-defined set of features that are governed by state machines. The state machine ensures that the component is always in a valid state and that all state transitions are valid and meaningful. Realizing that the continued success and viability of an open source toolkit depends on a strong user community, the IGSTK team is following several key strategies to build an active user community. These include maintaining a users and developers' mailing list, providing documentation (application programming interface reference document and book), presenting demonstration applications, and delivering tutorial sessions at relevant scientific conferences.

Addressing the High Costs of Pancreaticoduodenectomy at Safety-Net Hospitals.

PubMed

Go, Derek E; Abbott, Daniel E; Wima, Koffi; Hanseman, Dennis J; Ertel, Audrey E; Chang, Alex L; Shah, Shimul A; Hoehn, Richard S

2016-10-01

Safety-net hospitals care for vulnerable patients, providing complex surgery at increased costs. These hospitals are at risk due to changing health care reimbursement policies and demand for better value in surgical care. To model different techniques for reducing the cost of complex surgery performed at safety-net hospitals. Hospitals performing pancreaticoduodenectomy (PD) were queried from the University HealthSystem Consortium database (January 1, 2009, to December 31, 2013) and grouped according to safety-net burden. A decision analytic model was constructed and populated with clinical and cost data. Sensitivity analyses were then conducted to determine how changes in the management or redistribution of patients between hospital groups affected cost. Overall cost per patient after PD. During the 5 years of the study, 15 090 patients underwent PD. Among safety-net hospitals, low-burden hospitals (LBHs), medium-burden hospitals (MBHs), and high-burden hospitals (HBHs) treated 4220 (28.0%), 9505 (63.0%), and 1365 (9.0%) patients, respectively. High-burden hospitals had higher rates of complications or comorbidities and more patients with increased severity of illness. Perioperative mortality was twice as high at HBHs (3.7%) than at LBHs (1.6%) and MBHs (1.7%) (P < .001). In the base case, when all clinical and cost data were considered, PD at HBHs cost $35 303 per patient, 30.1% and 36.2% higher than at MBHs ($27 130) and LBHs ($25 916), respectively. Reducing perioperative complications or comorbidities by 50% resulted in a cost reduction of up to $4607 for HBH patients, while reducing mortality rates had a negligible effect. However, redistribution of HBH patients to LBHs and MBHs resulted in significantly more cost savings of $9155 per HBH patient, or $699 per patient overall. Safety-net hospitals performing PD have inferior outcomes and higher costs, and improving perioperative outcomes may have a nominal effect on reducing these costs. Redirecting patients away from safety-net hospitals for complex surgery may represent the best option for reducing costs, but the implementation of such a policy will undoubtedly meet significant challenges.

3D Endoscope to Boost Safety, Cut Cost of Surgery

NASA Technical Reports Server (NTRS)

2015-01-01

Researchers at the Jet Propulsion Laboratory worked with the brain surgeon who directs the Skull Base Institute in Los Angeles to create the first endoscope fit for brain surgery and capable of producing 3D video images. It is also the first to be able to steer its lens back and forth. These improvements to visibility are expected to improve safety, speeding patient recovery and reducing medical costs.

Robotic Surgery in Gynecology: An Updated Systematic Review

PubMed Central

Weinberg, Lori; Rao, Sanjay; Escobar, Pedro F.

2011-01-01

The introduction of da Vinci Robotic Surgery to the field of Gynecology has resulted in large changes in surgical management. The robotic platform allows less experienced laparoscopic surgeons to perform more complex procedures. In general gynecology and reproductive gynecology, the robot is being increasingly used for procedures such as hysterectomies, myomectomies, adnexal surgery, and tubal anastomosis. Among urogynecology the robot is being utilized for sacrocolopexies. In the field of gynecologic oncology, the robot is being increasingly used for hysterectomies and lymphadenectomies in oncologic diseases. Despite the rapid and widespread adoption of robotic surgery in gynecology, there are no randomized trials comparing its efficacy and safety to other traditional surgical approaches. Our aim is to update previously published reviews with a focus on only comparative observational studies. We determined that, with the right amount of training and skill, along with appropriate patient selection, robotic surgery can be highly advantageous. Patients will likely have less blood loss, less post-operative pain, faster recoveries, and fewer complications compared to open surgery and potentially even laparoscopy. However, until larger, well-designed observational studies or randomized control trials are completed which report long-term outcomes, we cannot definitively state the superiority of robotic surgery over other surgical methods. PMID:22190948

Prophylactic plasma transfusion for patients undergoing non-cardiac surgery

PubMed Central

Huber, Jonathan; Stanworth, Simon J; Doree, Carolyn; Trivella, Marialena; Brunskill, Susan J; Hopewell, Sally; Wilkinson, Kirstin L; Estcourt, Lise J

2017-01-01

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To determine the clinical effectiveness and safety of prophylactic plasma transfusion for people with confirmed or presumed coagulopathy requiring non-cardiac surgery. PMID:29151811

Continuous Postoperative Pericardial Flushing: A Pilot Study on Safety, Feasibility, and Effect on Blood Loss

PubMed Central

Manshanden, Johan S.J.; Gielen, Chantal L.I.; de Borgie, Corianne A.J.M.; Klautz, Robert J.M.; de Mol, Bas A.J.M.; Koolbergen, David R.

2015-01-01

Background Prolonged or excessive blood loss is a common complication after cardiac surgery. Blood remnants and clots, remaining in the pericardial space in spite of chest tube drainage, induce high fibrinolytic activity that may contribute to bleeding complications. Continuous postoperative pericardial flushing (CPPF) with an irrigation solution may reduce blood loss by preventing the accumulation of clots. In this pilot study, the safety and feasibility of CPPF were evaluated and the effect on blood loss and other related complications was investigated. Methods Between November 2011 and April 2012 twenty-one adult patients undergoing surgery for congenital heart disease (CHD) received CPPF from sternal closure up to 12 h postoperative. With an inflow Redivac drain that was inserted through one of the chest tube incision holes, an irrigation solution (NaCl 0.9% at 38 °C) was delivered to the pericardial cavity using a volume controlled flushing system. Safety aspects, feasibility issues and complications were registered. The mean actual blood loss in the CPPF group was compared to the mean of a retrospective group (n = 126). Results CPPF was successfully completed in 20 (95.2%) patients, and no method related complications were observed. Feasibility was good in this experimental setting. Patients receiving CPPF showed a 30% (P = 0.038) decrease in mean actual blood loss 12 h postoperatively. Conclusions CPPF after cardiac surgery was found to be safe and feasible in this experimental setting. The clinically relevant effect on blood loss needs to be confirmed in a randomized clinical trial. PMID:26501121

Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Total Knee Arthroplasty.

PubMed

Soffin, Ellen M; Gibbons, Melinda M; Ko, Clifford Y; Kates, Stephen L; Wick, Elizabeth; Cannesson, Maxime; Scott, Michael J; Wu, Christopher L

2018-06-08

Enhanced recovery after surgery (ERAS) has rapidly gained popularity in a variety of surgical subspecialities. A large body of literature suggests that ERAS leads to superior outcomes, improved patient satisfaction, reduced length of hospital stay, and cost benefits, without affecting rates of readmission after surgery. These patterns have been described for patients undergoing elective total knee arthroplasty (TKA); however, adoption of ERAS to orthopedic surgery has lagged behind other surgical disciplines. The Agency for Healthcare Research and Quality, in partnership with the American College of Surgeons and the Johns Hopkins Medicine Armstrong Institute (AI) for Patient Safety and Quality, has developed the Safety Program for Improving Surgical Care and Recovery. The program comprises a national effort to incorporate best practice in perioperative care and improve patient safety, for over 750 hospitals and multiple procedures over the next 5 years, including orthopedic surgery. We have conducted a full evidence review of anesthetic interventions to derive anesthesiology-related components of an evidence-based ERAS pathway for TKA. A PubMed search was performed for each protocol component, focusing on the highest levels of evidence in the literature. Search findings are summarized in narrative format. Anesthesiology components of care were identified and evaluated across the pre-, intra-, and postoperative phases. A summary of the best available evidence, together with recommendations for inclusion in ERAS protocols for TKA, is provided. There is extensive evidence in the literature, and from society guidelines to support the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery goals for TKA.

Robot-assisted pancreatic surgery: a systematic review of the literature.

PubMed

Strijker, Marin; van Santvoort, Hjalmar C; Besselink, Marc G; van Hillegersberg, Richard; Borel Rinkes, Inne H M; Vriens, Menno R; Molenaar, I Quintus

2013-01-01

To potentially improve outcomes in pancreatic resection, robot-assisted pancreatic surgery has been introduced. This technique has possible advantages over laparoscopic surgery, such as its affordance of three-dimensional vision and increased freedom of movement of instruments. A systematic review was performed to assess the safety and feasibility of robot-assisted pancreatic surgery. The literature published up to 30 September 2011 was systematically reviewed, with no restrictions on publication date. Studies reporting on over five patients were included. Animal studies, studies not reporting morbidity and mortality, review articles and conference abstracts were excluded. Data were extracted and weighted means were calculated. A total of 499 studies were screened, after which eight cohort studies reporting on a total of 251 patients undergoing robot-assisted pancreatic surgery were retained for analysis. Weighted mean operation time was 404 ± 102 min (510 ± 107 min for pancreatoduodenectomy only). The rate of conversion was 11.0% (16.4% for pancreatoduodenectomy only). Overall morbidity was 30.7% (n = 77), most frequently involving pancreatic fistulae (n = 46). Mortality was 1.6%. Negative surgical margins were obtained in 92.9% of patients. The rate of spleen preservation in distal pancreatectomy was 87.1%. Robot-assisted pancreatic surgery seems to be safe and feasible in selected patients and, in left-sided resections, may increase the rate of spleen preservation. Randomized studies should compare the respective outcomes of robot-assisted, laparoscopic and open pancreatic surgery. © 2012 International Hepato-Pancreato-Biliary Association.

Robot-assisted pancreatic surgery: a systematic review of the literature

PubMed Central

Strijker, Marin; van Santvoort, Hjalmar C; Besselink, Marc G; van Hillegersberg, Richard; Borel Rinkes, Inne HM; Vriens, Menno R; Molenaar, I Quintus

2013-01-01

Background To potentially improve outcomes in pancreatic resection, robot-assisted pancreatic surgery has been introduced. This technique has possible advantages over laparoscopic surgery, such as its affordance of three-dimensional vision and increased freedom of movement of instruments. A systematic review was performed to assess the safety and feasibility of robot-assisted pancreatic surgery. Methods The literature published up to 30 September 2011 was systematically reviewed, with no restrictions on publication date. Studies reporting on over five patients were included. Animal studies, studies not reporting morbidity and mortality, review articles and conference abstracts were excluded. Data were extracted and weighted means were calculated. Results A total of 499 studies were screened, after which eight cohort studies reporting on a total of 251 patients undergoing robot-assisted pancreatic surgery were retained for analysis. Weighted mean operation time was 404 ± 102 min (510 ± 107 min for pancreatoduodenectomy only). The rate of conversion was 11.0% (16.4% for pancreatoduodenectomy only). Overall morbidity was 30.7% (n = 77), most frequently involving pancreatic fistulae (n = 46). Mortality was 1.6%. Negative surgical margins were obtained in 92.9% of patients. The rate of spleen preservation in distal pancreatectomy was 87.1%. Conclusions Robot-assisted pancreatic surgery seems to be safe and feasible in selected patients and, in left-sided resections, may increase the rate of spleen preservation. Randomized studies should compare the respective outcomes of robot-assisted, laparoscopic and open pancreatic surgery. PMID:23216773

The feasibility of transvaginal robotic surgery in the repair of pelvic organ prolapse.

PubMed

Yaghnam, Ibrahim; Thomas, Dominique; Rosenblatt, Peter; Chughtai, Bilal

2017-08-01

Pelvic organ prolapse (POP), the descent of one or more pelvic organs, occurs in an estimated 40 to 60% of parous women. Conventional transvaginal surgery for POP has been plagued with high failure rates. The purpose was to determine the safety and feasibility of robotic transvaginal POP surgery. The da Vinci Surgical Robot, SI was used in the POP surgical procedures. There were two cadavers (aged 18 and 78 years of age; BMI 17.2 and 19.2 respectively). POP-Q scores before intervention were stage 1 for both cadavers. The visualization of anatomical landmarks and the placement of sutures at these locations were successful. Robotic transvaginal POP is a feasible option for POP surgery. Further studies are warranted to determine the role of robotic transvaginal POP repair.

Enhanced Time Out: An Improved Communication Process.

PubMed

Nelson, Patricia E

2017-06-01

An enhanced time out is an improved communication process initiated to prevent such surgical errors as wrong-site, wrong-procedure, or wrong-patient surgery. The enhanced time out at my facility mandates participation from all members of the surgical team and requires designated members to respond to specified time out elements on the surgical safety checklist. The enhanced time out incorporated at my facility expands upon the safety measures from the World Health Organization's surgical safety checklist and ensures that all personnel involved in a surgical intervention perform a final check of relevant information. Initiating the enhanced time out at my facility was intended to improve communication and teamwork among surgical team members and provide a highly reliable safety process to prevent wrong-site, wrong-procedure, and wrong-patient surgery. Copyright © 2017 AORN, Inc. Published by Elsevier Inc. All rights reserved.

Pure retroperitoneal natural orifice translumenal endoscopic surgery (NOTES) transvaginal nephrectomy using standard laparoscopic instruments: a safety and feasibility study in a porcine model.

PubMed

Wei, Dechao; Han, Yili; Li, Mingchuan; Wang, Yongxing; Chen, Yatong; Luo, Yong; Jiang, Yongguang

2016-06-11

Among the different organs used for NOTES (natural orifice translumenal endoscopic surgery) technique, the transvaginal approach may be the optimal choice because of a simple and secure closure of colpotomy site. Pure and hybrid NOTES transvaginal operations were routinely performed via transperitoneal access. In this study, we investigate the safety and feasibility of pure retroperitoneal natural orifice translumenal endoscopic surgery (NOTES) transvaginal nephrectomy using conventional laparoscopic techniques in a porcine model. Six female pigs, weighing an average of 30 kg, were used in this study. Under general anesthesia, pure retroperitoneal NOTES transvaginal nephrectomy was conducted using standard laparoscopic instruments. Posterolateral colpotomy was performed, and the incision was enlarged laterally using blunt dissection and pneumatic dilation. A single-port device was inserted to construct the operative channel. The retroperitoneal space was created using sharp and blunt dissection under endoscopic guidance up to the level of the kidney. Dissection and removal of the kidney were performed according to standard surgical procedure, and the colpotomy site was closed using interrupted sutures. The survival and complications were observed 1 week postoperatively. Our results showed that two cases failed because of peritoneal rupture. One case was successful, but required the assistance of an extra 5 mm laparoscopic trocar inserted in the flank. Three cases of pure retroperitoneal NOTES transvaginal nephrectomy were completed, and survived 1 week after the operation. In these three cases, no intra- or postoperative complications were observed. All findings confirmed the safety and feasibility of the retroperitoneal pure retroperitoneal NOTES transvaginal nephrectomy using standard laparoscopic instruments, which suggested the possibility of clinical application in human beings in the future.

A Kalman-Filter-Based Common Algorithm Approach for Object Detection in Surgery Scene to Assist Surgeon's Situation Awareness in Robot-Assisted Laparoscopic Surgery

PubMed Central

2018-01-01

Although the use of the surgical robot is rapidly expanding for various medical treatments, there still exist safety issues and concerns about robot-assisted surgeries due to limited vision through a laparoscope, which may cause compromised situation awareness and surgical errors requiring rapid emergency conversion to open surgery. To assist surgeon's situation awareness and preventive emergency response, this study proposes situation information guidance through a vision-based common algorithm architecture for automatic detection and tracking of intraoperative hemorrhage and surgical instruments. The proposed common architecture comprises the location of the object of interest using feature texture, morphological information, and the tracking of the object based on Kalman filter for robustness with reduced error. The average recall and precision of the instrument detection in four prostate surgery videos were 96% and 86%, and the accuracy of the hemorrhage detection in two prostate surgery videos was 98%. Results demonstrate the robustness of the automatic intraoperative object detection and tracking which can be used to enhance the surgeon's preventive state recognition during robot-assisted surgery. PMID:29854366

Surgical checklists: a systematic review of impacts and implementation

PubMed Central

Treadwell, Jonathan R; Lucas, Scott; Tsou, Amy Y

2014-01-01

Background Surgical complications represent a significant cause of morbidity and mortality with the rate of major complications after inpatient surgery estimated at 3–17% in industrialised countries. The purpose of this review was to summarise experience with surgical checklist use and efficacy for improving patient safety. Methods A search of four databases (MEDLINE, CINAHL, EMBASE and the Cochrane Database of Controlled Trials) was conducted from 1 January 2000 to 26 October 2012. Articles describing actual use of the WHO checklist, the Surgical Patient Safety System (SURPASS) checklist, a wrong-site surgery checklist or an anaesthesia equipment checklist were eligible for inclusion (this manuscript summarises all but the anaesthesia equipment checklists, which are described in the Agency for Healthcare Research and Quality publication). Results We included a total of 33 studies. We report a variety of outcomes including avoidance of adverse events, facilitators and barriers to implementation. Checklists have been adopted in a wide variety of settings and represent a promising strategy for improving the culture of patient safety and perioperative care in a wide variety of settings. Surgical checklists were associated with increased detection of potential safety hazards, decreased surgical complications and improved communication among operating staff. Strategies for successful checklist implementation included enlisting institutional leaders as local champions, incorporating staff feedback for checklist adaptation and avoiding redundancies with existing systems for collecting information. Conclusions Surgical checklists represent a relatively simple and promising strategy for addressing surgical patient safety worldwide. Further studies are needed to evaluate to what degree checklists improve clinical outcomes and whether improvements may be more pronounced in particular settings. PMID:23922403

A pilot study about the oncologic safety of colonic self-expandable metal stents (SEMS) in obstructive colon cancer: is occlusion always better than "silent" perforation?

PubMed

Zanghì, A; Piccolo, G; Cavallaro, A; Pulvirenti, E; Lo Menzo, E; Cardì, F; Di Vita, M; Cappellani, A

2016-12-01

To evaluate the oncologic safety of colonic self-expandable metal stents (SEMS) in obstructive colon cancer. We retrospectively reviewed all the patients who were treated with endoscopic placement of a self-expandable metallic stent (SEMS) at our institution. A total of 26 patients were identified during the study period, of which 24 patients (92.30%) were treated with SEMS as a bridge-to-surgery and 2 (7.69%) as palliation. In 22 cases (80.76%), the stenosis was localized to the left side. Clinical success with resolution of bowel obstructions was achieved in 22 (84.61%) patients within a short period of time. Among patients treated successfully with SEMS insertion as bridge to surgery (n = 22), 20 (90.9%) underwent one-stage surgery with primary anastomosis while 2 patients (9.09%) underwent colostomy due to intraoperative evidence of a covered perforation by cancer tissue in the pelvis. Patients with subclinical perforation developed an early peritoneal carcinomatosis, 10 patients treated with curative intent subsequently developed liver metastasis after 24 months. We reported an overall poor outcome among patients treated with the insertion of SEMS. This led us to think that, in some cases, occlusion may be better than a "silent" perforation.

Low-factor consumption for major surgery in haemophilia B with long-acting recombinant glycoPEGylated factor IX.

PubMed

Escobar, M A; Tehranchi, R; Karim, F A; Caliskan, U; Chowdary, P; Colberg, T; Giangrande, P; Giermasz, A; Mancuso, M E; Serban, M; Tsay, W; Mahlangu, J N

2017-01-01

Surgery in patients with haemophilia B carries a high risk of excessive bleeding and requires adequate haemostatic control until wound healing. Nonacog beta pegol, a long-acting recombinant glycoPEGylated factor IX (FIX), was used in the perioperative management of patients undergoing major surgery. To evaluate the efficacy and safety of nonacog beta pegol in patients with haemophilia B who undergo major surgery. This was an open-label, multicentre, non-controlled surgery trial aimed at assessing peri- and postoperative efficacy and safety of nonacog beta pegol in 13 previously treated patients with haemophilia B. All patients received a preoperative nonacog beta pegol bolus injection of 80 IU kg -1 . Postoperatively, the patients received fixed nonacog beta pegol doses of 40 IU kg -1 , repeated at the investigator's discretion. Safety assessments included monitoring of immunogenicity and adverse events. Intraoperative haemostatic effect was rated 'excellent' or 'good' in all 13 cases. Apart from the preoperative injection, none of the patients needed additional doses of nonacog beta pegol on the day of surgery. The median number of postoperative doses of nonacog beta pegol was 2.0 from days 1 to 6 and 1.5 from days 7 to 13. No unexpected intra- or postoperative complications were observed including deaths or thromboembolic events. No patients developed inhibitors. These results indicated that nonacog beta pegol was safe and effective in the perioperative setting, allowing major surgical interventions in patients with haemophilia B with minimal peri- and postoperative concentrate consumption and infrequent injections as reported with standard FIX products. © 2016 John Wiley & Sons Ltd.

A randomized, controlled trial of Veriset™ hemostatic patch in halting cardiovascular bleeding.

PubMed

Glineur, David; Hendrikx, Marc; Krievins, Dainis; Stradins, Peteris; Voss, Bernhard; Waldow, Thomas; Haenen, Luc; Oberhoffer, Martin; Ritchie, Caroline M

2018-01-01

Obtaining hemostasis during cardiovascular procedures can be a challenge, particularly around areas with a complex geometry or that are difficult to access. While several topical hemostats are currently on the market, most have caveats that limit their use in certain clinical scenarios such as pulsatile arterial bleeding. The aim of this study was to assess the effectiveness and safety of Veriset™ hemostatic patch in treating cardiovascular bleeding. Patients (N=90) scheduled for cardiac or vascular surgery at 12 European institutions were randomized 1:1 to treatment with either Veriset™ hemostatic patch (investigational device) or TachoSil ® (control). After application of the hemostat, according to manufacturer instructions for use, time to hemostasis was monitored. Follow-up occurred up to 90 days post-surgery. Median time to hemostasis was 1.5 min with Veriset™ hemostatic patch, compared to 3.0 min with TachoSil ® ( p <0.0001). Serious adverse events within 30 days post-surgery were experienced by 12/44 (27.3%) patients treated with Veriset™ hemostatic patch and 10/45 (22.2%) in the TachoSil ® group ( p =0.6295). None of these adverse events were device-related, and no reoperations for bleeding were required within 5 days post-surgery in either treatment group. This study reinforces the difference in minimum recommended application time between Veriset™ hemostatic patch and TachoSil ® (30 s versus 3 min respectively). When compared directly at 3 min, Veriset™ displayed no significant difference, showing similar hemostasis and safety profiles on the cardiovascular bleeding sites included in this study.

Impact of Residency Training Level on the Surgical Quality Following General Surgery Procedures.

PubMed

Loiero, Dominik; Slankamenac, Maja; Clavien, Pierre-Alain; Slankamenac, Ksenija

2017-11-01

To investigate the safety of surgical performance by residents of different training level performing common general surgical procedures. Data were consecutively collected from all patients undergoing general surgical procedures such as laparoscopic cholecystectomy, laparoscopic appendectomy, inguinal, femoral and umbilical hernia repair from 2005 to 2011 at the Department of Surgery of the University Hospital of Zurich, Switzerland. The operating surgeons were grouped into junior residents, senior residents and consultants. The comprehensive complication index (CCI) representing the overall number and severity of all postoperative complications served as primary safety endpoint. A multivariable linear regression analysis was used to analyze differences between groups. Additionally, we focused on the impact of senior residents assisting junior residents on postoperative outcome comparing to consultants. During the observed time, 2715 patients underwent a general surgical procedure. In 1114 times, a senior resident operated and in 669 procedures junior residents performed the surgery. The overall postoperative morbidity quantified by the CCI was for consultants 5.0 (SD 10.7), for senior residents 3.5 (8.2) and for junior residents 3.6 (8.3). After adjusting for possible confounders, no difference between groups concerning the postoperative complications was detected. There is also no difference in postoperative complications detectable if junior residents were assisted by consultants then if assisted by senior residents. Patient safety is ensured in general surgery when performed by surgical junior residents. Senior residents are able to adopt the role of the teaching surgeon in charge without compromising patients' safety.

Supervision by a technically qualified surgeon affects the proficiency and safety of laparoscopic colectomy performed by novice surgeons.

PubMed

Ichikawa, Nobuki; Homma, Shigenori; Yoshida, Tadashi; Ohno, Yosuke; Kawamura, Hideki; Kamiizumi, You; Iijima, Hiroaki; Taketomi, Akinobu

2018-01-01

The use of laparoscopic colectomy is becoming widespread and acquisition of its technique is challenging. In this study, we investigated whether supervision by a technically qualified surgeon affects the proficiency and safety of laparoscopic colectomy performed by novice surgeons. The outcomes of 23 right colectomies and 19 high anterior resections for colon cancers performed by five novice surgeons (experience level of <10 cases) between 2014 and 2016 were assessed. A laparoscopic surgeon qualified by the Endoscopic Surgical Skill Qualification System (Japan Society for Endoscopic Surgery) participated in surgeries as the teaching assistant. In the right colectomy group, one patient (4.3%) required conversion to open surgery and postoperative morbidities occurred in two cases (8.6%). The operative time moving average gradually decreased from 216 to 150 min, and the blood loss decreased from 128 to 28 mL. In the CUSUM charts, the values for operative time decreased continuously after the 18th case, as compared to the Japanese standard. The values for blood loss also plateaued after the 18th case. In the high anterior resection group, one patient (5.2%) required conversion to open surgery and no postoperative complication occurred in any patient. The operative time moving average gradually decreased from 258 to 228 min, and the blood loss decreased from 33 to 18 mL. The CUSUM charts showed that the values of operative time plateaued after the 18th case, as compared to the Japanese standard. In the CUSUM chart for blood loss, no distinguishing peak or trend was noted. Supervision by a technically qualified surgeon affects the proficiency and safety of laparoscopic colectomy performed by novice surgeons. The trainee's learning curve in this study represents successful mentoring by the laparoscopic surgeon qualified by the Endoscopic Surgical Skill Qualification System.

Implementation of the Spanish ERAS program in bariatric surgery.

PubMed

Ruiz-Tovar, Jaime; Muñoz, José Luis; Royo, Pablo; Duran, Manuel; Redondo, Elisabeth; Ramirez, Jose Manuel

2018-03-08

The essence of Enhanced Recovery After Surgery (ERAS) programs is the multimodal approach, and many authors have demonstrated safety and feasibility in fast track bariatric surgery. According to this concept, a multidisciplinary ERAS program for bariatric surgery has been developed by the Spanish Fast Track Group (ERAS Spain). The aim of this study was to analyze the initial implementation of this Spanish National ERAS protocol in bariatric surgery, comparing it with a historical cohort receiving standard care. A multi-centric prospective study was performed, including 233 consecutive patients undergoing bariatric surgery during 2015 and following ERAS protocol. It was compared with a historical cohort of 286 patients, who underwent bariatric surgery at the same institutions between 2013 and 2014 and following standard care. Compliance with the protocol, morbidity, mortality, hospital stay and readmission were evaluated. Bariatric techniques performed were Roux-en-Y gastric bypass and sleeve gastrectomy. There were no significant differences in complications, mortality and readmission. Postoperative pain and hospital stay were significantly lower in the ERAS group. The total compliance to protocol was 80%. The Spanish National ERAS protocol is a safe issue, obtaining similar results to standard care in terms of complications, reoperations, mortality and readmissions. It is associated with less postoperative pain and earlier hospital discharge.

Safety and efficacy of combined epidural/general anesthesia during major abdominal surgery in patients with increased intracranial pressure: a cohort study.

PubMed

Zabolotskikh, Igor; Trembach, Nikita

2015-05-15

The increased intracranial pressure can significantly complicate the perioperative period in major abdominal surgery, increasing the risk of complications, the length of recovery from the surgery, worsening the outcome. Epidural anesthesia has become a routine component of abdominal surgery, but its use in patients with increased intracranial pressure remains controversial. The goal of the study was to evaluate the safety and efficacy of epidural anesthesia, according to monitoring of intracranial pressure in patients with increased intracranial pressure. The study includes 65 surgical patients who were routinely undergone the major abdominal surgery under combined epidural/general anesthesia. Depending on the initial ICP all patients were divided into 2 groups: 1 (N group) - patients with the normal intracranial pressure (≤12 mm Hg, n = 35) and 2 (E group) - patients with the elevated intracranial pressure (ICP > 12 mm Hg, n = 30). During the surgery we evaluated ICP, blood pressure, cerebral perfusion pressure (CPP). The parameters of recovery from anesthesia and the effectiveness of postoperative analgesia were also assessed. In N group ICP remained stable. In E group ICP decreased during anesthesia, the overall decline was 40% at the end of the operation (from 15 to 9 mm Hg (P <0.05)). The correction of MAP with vasopressors to maintain normal CPP was required mainly in patients with increased ICP (70% vs. 45%, p <0.05). CPP declined by 19% in N group. In E group the CPP reduction was 23%, and then it remained stable at 60 mm Hg. No significant differences in time of the recovery of consciousness, effectiveness of postoperative analgesia and complications between patients with initially normal levels of ICP and patients with ICH were noted. The combination of general and epidural anesthesia is safe and effective in patients with increased intracranial pressure undergoing elective abdominal surgery under the condition of maintaining the arterial pressure. Its use is not associated with the increase in intracranial pressure during the anesthesia, but it needs an intraoperative monitoring of ICP in order to prevent CPP reduction.

Robotic bariatric surgery: a systematic review.

PubMed

Fourman, Matthew M; Saber, Alan A

2012-01-01

Obesity is a nationwide epidemic, and the only evidence-based, durable treatment of this disease is bariatric surgery. This field has evolved drastically during the past decade. One of the latest advances has been the increased use of robotics within this field. The goal of our study was to perform a systematic review of the recent data to determine the safety and efficacy of robotic bariatric surgery. The setting was the University Hospitals Case Medical Center (Cleveland, OH). A PubMed search was performed for robotic bariatric surgery from 2005 to 2011. The inclusion criteria were English language, original research, human, and bariatric surgical procedures. Perioperative data were then collected from each study and recorded. A total of 18 studies were included in our review. The results of our systematic review showed that bariatric surgery, when performed with the use of robotics, had similar or lower complication rates compared with traditional laparoscopy. Two studies showed shorter operative times using the robot for Roux-en-Y gastric bypass, but 4 studies showed longer operative times in the robotic arm. In addition, the learning curve appears to be shorter when robotic gastric bypass is compared with the traditional laparoscopic approach. Most investigators agreed that robotic laparoscopic surgery provides superior imaging and freedom of movement compared with traditional laparoscopy. The application of robotics appears to be a safe option within the realm of bariatric surgery. Prospective randomized trials comparing robotic and laparoscopic outcomes are needed to further define the role of robotics within the field of bariatric surgery. Longer follow-up times would also help elucidate any long-term outcomes differences with the use of robotics versus traditional laparoscopy. Copyright © 2012 American Society for Metabolic and Bariatric Surgery. All rights reserved.

Clinical and electrophysiologic results after intracameral lidocaine 1% anesthesia: a prospective randomized study.

PubMed

Anders, N; Heuermann, T; Rüther, K; Hartmann, C

1999-10-01

To evaluate the efficacy and safety of intracameral lidocaine in cataract surgery compared to peribulbar anesthesia. A prospective, randomized, controlled study. A total of 200 consecutive cataract patients (200 eyes) participated. Eyes were randomly assigned to two groups: one group received 0.15 ml intracameral 1% unpreserved lidocaine combined with topical anesthesia (oxybuprocaine); the other group received 6 ml prilocaine peribulbar before phacoemulsification with sclerocorneal tunnel incision. Duration of surgery was measured; implicit time and amplitudes of the b-waves of the photopic electroretinogram (ERG) potentials (single-flash ERG and the 30-Hz flicker ERG) were recorded; frequencies of intraoperative problems, complications, intraoperative, and postoperative pain were evaluated. After lidocaine anesthesia combined with topical anesthesia, similar complications were found, longer operation time (P < 0.001), and significantly better visual acuity immediately after surgery (P < 0.001). The ERG amplitudes were not significantly reduced after 0.15-ml intracameral lidocaine half an hour after surgery (P > 0.05). Intracameral lidocaine 1% combined with topical anesthesia can be recommended as an alternative procedure to peribulbar anesthesia in cataract surgery with corneoscleral tunnel incision.

Informed Consent and Cognitive Dysfunction After Noncardiac Surgery in the Elderly.

PubMed

Hogan, Kirk J; Bratzke, Lisa C; Hogan, Kendra L

2018-02-01

Cognitive dysfunction 3 months after noncardiac surgery in the elderly satisfies informed consent thresholds of foreseeability in 10%-15% of patients, and materiality with new deficits observed in memory and executive function in patients with normal test performance beforehand. At present, the only safety step to avoid cognitive dysfunction after surgery is to forego surgery, thereby precluding the benefits of surgery with removal of pain and inflammation, and resumption of normal nutrition, physical activity, and sleep. To assure that consent for surgery is properly informed, risks of both cognitive dysfunction and alternative management strategies must be discussed with patients by the surgery team before a procedure is scheduled.

[Office surgery: organization, legislative, and medico-legal problems. Personal experience].

PubMed

Pepe, N; Actis Dato, G M; Vennarecci, G; Anselmo, A

1993-11-01

The authors approach the subject of office surgery by underlining the advantages of this procedure. In particular, they focus attention on the anesthesiological and legislative problems. Depending on the setting used for surgery and the duration of hospitalisation, ambulatorial surgery can be divided into: day-hospital, office surgery, one-day surgery, short-stay surgery, same-day surgery, The authors report their own experience relating to 103 cases with relative complications. A total of 103 operations of medium-to- major ambulatorial surgery were performed (100 females and 3 males, mean age 36.8). One week prior to surgery all patients attended a medical out-patient examination in order to fill in medical records and be prescribed routine hematochemical tests, chest X-ray and ECG. The preoperative anesthesiological evaluation was made at the time of surgery. All patients received antibiotic prophylactic treatment. Postoperative complications were reported above all following neuroleptoanalgesia and amounted to a total of 5 cases: nausea (4 cases) associated with vomit (1 case), and postural hypotension (1 case). No infective complications were observed. The authors emphasise the importance of a careful preoperative selection of patients; an out-patient structure equipped with the appropriate instrument and machinery for surgery and the constant presence of anesthetists to ensure correct anesthesia (local, neuroleptoanalgesic, peridural general), reanimation and postoperative care. The aims of ambulatorial surgery are, in broad terms, the safety of procedures, convenience for the patient and organisational and economic savings for health structures. Ambulatorial surgery has an extremely high acceptance rate by patients. Lastly, the authors also report the juridical and bureaucratic problems faced by ambulatorial surgery and look forward to its wider diffusion. In the future office surgery might represent an important contribution to surgical therapeutic strategies, allowing, if well organised, an excellent compromise between safety, convenience and reduced costs for the patient.

Analysis of the vitreoretinal surgery learning curve.

PubMed

Martín-Avià, J; Romero-Aroca, P

2017-06-01

To describe intra- and post-operative complications, as well as the evolution of the surgical technique in first 4years of work of a novice retina surgeon, and evaluate minimal learning time required to reduce its complications, deciding which pathologies should still be referred to higher level hospitals, until further experience may be achieved. A study was conducted on patients that had undergone vitreoretinal surgery by a novice surgeon in Tarragona between 23rd October 2007 and 31st December 2011. The primary diagnosis, surgeon learning time, surgical technique, intra-operative and post-operative complications were recorded. A total of 247 surgeries were studied. The percentage of use of 20G and 23G calibres during the time, marks a change towards trans-conjunctival surgery from the ninth trimester (98 surgeries). Surgical complications decreased towards twelfth trimester (130 surgeries) with an increase in the previous months. The shift towards 23G technique around 100 surgeries is interpreted as greater comfort and safety by the surgeon. Increased surgical complications during the following months until its decline around 130 surgeries can be interpreted as an 'overconfidence'. It is arguable that the learning curve is slower than what the surgeon believes. An individual analysis of the complications and surgical outcomes is recommended to ascertain the status of the learning curve. Copyright © 2016 Sociedad Española de Oftalmología. Publicado por Elsevier España, S.L.U. All rights reserved.

Systematic review of 23-hour (outpatient) stay laparoscopic gastric bypass surgery.

PubMed

Thomas, Harun; Agrawal, Sanjay

2011-10-01

The laparoscopic Roux-en-Y gastric bypass (LRYGB) is generally considered the gold-standard bariatric procedure. It has a usual inpatient stay of 3 days. There have been few reports of gastric bypass patients being discharged within 23 hours of surgery, but its safety and feasibility has not been reviewed before. The aim of this study was to review the published literature on 23-hour stay post-LRYGB. Systematic search was performed in Medline, Embase, and Cochrane library using the medical subject heading terms "ambulatory surgical procedures" and "bariatric surgery" with further free text search and cross references. All articles on 23-hour LRYGB that described patient selection criteria, 23-hour discharge, complications, and readmissions were reviewed. Data were extracted by two independent reviewers. There were no randomized controlled trials. Four cohort studies were included in this review. The patients age ranged from 14 to 70 years, mean body mass index ranged from 41.2 to 49.25, and the mean operative time ranged from 112.8 to 169 minutes. 1852/2201(84.14%) patients could be discharged within 23 hours. Forty-eight patients (2.18%) developed complications and 40 patients (1.82%) were readmitted. The commonest 30-day complications were anastomotic strictures (16), gastrointestinal bleeding (9), and internal hernias (9). Five patients developed anastomotic leak and 2 patients developed pulmonary embolism. Two patients died but neither was discharged after their bypass surgery. There is a paucity of data regarding 23-hour discharge after LRYGB. The evidence suggests that it is feasible in selected patients. However, further studies are necessary to assess its safety and acceptability.

Safety of laparoscopic resection for colorectal cancer in patients with liver cirrhosis: A retrospective cohort study.

PubMed

Zhou, Senjun; Zhu, Hepan; Li, Zhenjun; Ying, Xiaojiang; Xu, Miaojun

2018-05-26

Patients with liver cirrhosis represent a high risk group for colorectal surgery. The safety and effectiveness of laparoscopy in colorectal surgery for cirrhotic patients is not clear. The aim of this study was to compare the outcomes of laparoscopic colorectal surgery with those of open procedure for colorectal cancer in patients with liver cirrhosis. A total of 62 patients with cirrhosis who underwent radical resections for colorectal cancer from 2005 to 2014 were identified retrospectively from a prospective database according to the technique adopted (laparoscopic or open). Short- and long-term outcomes were compared between the two groups. Comparison of laparoscopic group and open group revealed no significant differences at baseline. In the laparoscopic group, the laparoscopic surgery was associated with reduced estimated blood loss (136 vs. 266 ml, p = 0.015), faster first flatus (3 vs. 4 days, p = 0.002) and shorter days to first oral intake (4 vs. 5 days, p = 0.033), but similar operative times (p = 0.856), number of retrieved lymph nodes (p = 0.400) or postoperative hospital stays (p = 0.170). Despite the similar incidence of overall complications between the two groups (50.0% vs. 68.8%, p = 0.133), we observed lower morbidities in laparoscopic group in terms of the rate of Grade II complication (20.0% vs. 50.0%, p = 0.014). Long-term of overall and Disease-free survival rates did not differ between the two groups. Laparoscopic colorectal surgery appears to be a safe and less invasive alternative to open surgery in some elective cirrhotic patients in terms of less blood loss or early recovery and does not result in additional harm in terms of the postoperative complications or long-term oncological outcomes. Copyright © 2018. Published by Elsevier Ltd.

Video-assisted thoracoscopic surgery lobectomy via confronting upside-down monitor setting

PubMed Central

Ichinose, Junji; Matsuura, Yosuke; Nakao, Masayuki; Okumura, Sakae

2017-01-01

Video-assisted thoracoscopic surgery (VATS) has been widely accepted as a minimally invasive surgery for treatment of early-stage lung cancer. However, various VATS approaches are available. In patients with lung cancer, VATS should achieve not only minimal invasiveness but also safety and oncological clearance. In this article, we introduce our method of VATS lobectomy. PMID:29078689

Pilot-study on the feasibility of sentinel node navigation surgery in combination with thoracolaparoscopic lymphadenectomy without esophagectomy in early esophageal adenocarcinoma patients.

PubMed

Künzli, H T; van Berge Henegouwen, M I; Gisbertz, S S; van Esser, S; Meijer, S L; Bennink, R J; Wiezer, M J; Seldenrijk, C A; Bergman, J J G H M; Weusten, B L A M

2017-11-01

High-risk submucosal esophageal adenocarcinoma's might be treated curatively by means of radical endoscopic resection, followed by thoracolaparoscopic lymphadenectomy without concomitant esophagectomy. A preclinical study has shown the feasibility and safety of this approach; however, no studies are performed in a clinical setting. In addition, sentinel node navigation surgery could be valuable in tailoring the extent of the lymphadenectomy. This study aimed to evaluate the feasibility and safety of thoracolaparoscopic lymphadenectomy without esophagectomy (phase I) and sentinel node navigation surgery (phase II) in patients with early esophageal adenocarcinoma. Patients with T1N0M0 early esophageal adenocarcinoma scheduled for esophagectomy without neoadjuvant therapy were included. Phase I: Two-field, esophagus preserving, thoracolaparoscopic lymphadenectomy was performed, followed by esophagectomy in the same session. Primary outcome parameters were the number of lymph nodes resected, and number of retained lymph nodes in the esophagectomy specimen. Phase II: A radioactive tracer was injected endoscopically the day before surgery. Static imaging was performed 15 and 120 minutes after injection. The day of surgery, sentinel node navigation surgery followed by esophagectomy was performed. Primary outcome parameters were the percentage of patients with a detectable sentinel node, and the concordance between static imaging and probe-based detection of sentinel node. Phase I: Five patients were included, and a median of 30 (IQR: 25-46) lymph nodes was resected. A median of 6 (IQR: 2-9) retained lymph nodes was found in the esophagectomy specimen. No acute adverse events occurred, but near the end of lymphadenectomy esophageal discoloration was observed, possibly indicating ischemia. Phase II: In all five included patients sentinel nodes could be visualized and resected, at a median of 3 (IQR: 2-5) locations. There was a high concordance between imaging and probe-based detection of sentinel nodes. In conclusion, sentinel node navigation surgery followed by lymphadenectomy without concomitant esophagectomy seems feasible in patients with high-risk submucosal early esophageal adenocarcinoma. More evidence is however needed before applying this technique in clinical practice. © The Authors 2017. Published by Oxford University Press on behalf of International Society for Diseases of the Esophagus. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Twelve-Month Efficacy and Safety Data for the "Stress Incontinence Control, Efficacy and Safety Study": A Phase III, Multicenter, Prospective, Randomized, Controlled Study Treating Female Stress Urinary Incontinence Using the Vesair Intravesical Balloon.

PubMed

Winkler, Harvey; Jacoby, Karny; Kalota, Susan; Snyder, Jeffrey; Cline, Kevin; Robertson, Kaiser; Kahan, Randall; Green, Lonny; McCammon, Kurt; Rovner, Eric; Rardin, Charles

The "Stress Incontinence Control, Efficacy and Safety Study" (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who had failed conservative therapy, and either failed surgery, were not candidates for surgery, or chose not to have surgery. The safety and efficacy of the balloon at 12 months is reported for those participants in the treatment arm who elected to continue with the SUCCESS trial beyond the primary end point at 3 months. The SUCCESS trial is a multicenter, prospective, single-blinded, randomized, sham-controlled study. Participants were randomized on a 2.33:1 basis to either Vesair Balloon placement or placebo. The primary efficacy end point was a composite of both a greater than 50% reduction from baseline on 1-hour provocative pad weight test and an at least 10-point improvement in symptoms on the Incontinence Quality of Life questionnaire assessed at the 3-month study visit. Patients in the treatment arm who opted to continue in the trial were followed up prospectively up to 12 months. A total of 221 participants were randomized, including 157 in the treatment arm and 64 in the control arm. Sixty-seven participants in the treatment arm (42.7% of participants enrolled) were evaluated at 12 months, with 56.3% achieving the composite end point and 78.7% having greater than 50% reduction in pad weight from baseline in a per-protocol analysis. In an intent-to-treat analysis treating all participants who did not continue with the balloon as failures, 24% of the participants achieved the composite end point and 33.6% had a greater than 50% reduction in pad weight from baseline. Treatment-related adverse events in this group included dysuria (40.1%), gross hematuria (36.9%), and urinary tract infection (26.1%). In this phase III trial, symptom relief was maintained for those participants who continued therapy for 12 months. The balloon was found to be safe with no device- or procedure-related serious adverse events reported. Additional studies are warranted to determine which patient populations are more tolerant of the balloon and to assess the efficacy and safety of its longer-term use. Additional screening methods, including screening patients for balloon tolerability, are warranted to reduce participant withdrawals.

A multicentre, randomised, controlled trial to assess the safety, ease of use, and reliability of hyaluronic acid/carboxymethylcellulose powder adhesion barrier versus no barrier in colorectal laparoscopic surgery.

PubMed

Berdah, Stéphane V; Mariette, Christophe; Denet, Christine; Panis, Yves; Laurent, Christophe; Cotte, Eddy; Huten, Nöel; Le Peillet Feuillet, Eliane; Duron, Jean-Jacques

2014-10-27

Intra-peritoneal adhesions are frequent following abdominal surgery and are the most common cause of small bowel obstructions. A hyaluronic acid/carboxymethylcellulose (HA/CMC) film adhesion barrier has been shown to reduce adhesion formation in abdominal surgery. An HA/CMC powder formulation was developed for application during laparoscopic procedures. This was an exploratory, prospective, randomised, single-blind, parallel-group, Phase IIIb, multicentre study conducted at 15 hospitals in France to assess the safety of HA/CMC powder versus no adhesion barrier following laparoscopic colorectal surgery. Subjects ≥18 years of age who were scheduled for colorectal laparoscopy (Mangram contamination class I‒III) within 8 weeks of selection were eligible, regardless of aetiology. Participants were randomised 1:1 to the HA/CMC powder or no adhesion barrier group using a centralised randomisation list. Patients assigned to HA/CMC powder received a single application of 1 to 10 g on adhesion-prone areas. In the no adhesion barrier group, no adhesion barrier or placebo was applied. The primary safety assessments were the incidence of adverse events, serious adverse events, and surgical site infections (SSIs) for 30 days following surgery. Between-group comparisons were made using Fisher's exact test. Of those randomised to the HA/CMC powder (n = 105) or no adhesion barrier (n = 104) groups, one patient in each group discontinued prior to the study end (one death in each group). Adverse events were more frequent in the HA/CMC powder group versus the no adhesion barrier group (63% vs. 39%; P <0.001), as were serious adverse events (28% vs. 11%; P <0.001). There were no statistically significant differences between the HA/CMC powder group and the no adhesion barrier group in SSIs (21% vs. 14%; P = 0.216) and serious SSIs (12% vs. 9%; P = 0.38), or in the most frequent serious SSIs of pelvic abscess (5% and 2%; significance not tested), anastomotic fistula (3% and 4%), and peritonitis (2% and 3%). This exploratory study found significantly higher rates of adverse events and serious adverse events in the HA/CMC powder group compared with the no adhesion barrier group in laparoscopic colorectal resection. ClinicalTrials.gov NCT00813397. Registered 19 December 2008.

iStent trabecular micro-bypass stent for open-angle glaucoma

PubMed Central

Le, Kim; Saheb, Hady

2014-01-01

Trabecular micro-bypass stents, commonly known as iStents, are micro-invasive glaucoma surgery (MIGS) devices used to treat open-angle glaucoma. Like other MIGS procedures that enhance trabecular outflow, the iStent lowers intraocular pressure (IOP) by creating a direct channel between the anterior chamber and Schlemm’s canal. iStents are typically implanted at the time of phacoemulsification for patients with open-angle glaucoma and visually significant cataracts. This review summarizes the published data regarding the efficacy, safety, and cost considerations of trabecular micro-bypass stents. Most studies found statistically significant reductions in mean IOP and ocular medication use after combined phacoemulsification with single or double iStent implantation. The devices were found to be very safe, with a safety profile similar to that of cataract surgery. Complications were infrequent, with the most common complications being temporary stent obstruction or malposition, which resolved with observation or secondary procedures. Future studies are needed to evaluate long-term outcomes, patient satisfaction, cost effectiveness, and expanded indications. PMID:25284980

Safety and efficacy of transdermal buprenorphine versus oral tramadol for the treatment of post-operative pain following surgery for fracture neck of femur: A prospective, randomised clinical study.

PubMed

Desai, Sameer N; Badiger, Santhoshi V; Tokur, Shreesha B; Naik, Prashanth A

2017-03-01

Transdermal buprenorphine, which is used in chronic pain management, has rarely been studied for use in acute pain management. The aim of this study was to compare the safety and efficacy of transdermal buprenorphine patch to oral tramadol for post-operative analgesia, following proximal femur surgeries. Fifty adult patients undergoing surgery for hip fracture under spinal anaesthesia were included in this study. One group (Group TDB) received transdermal buprenorphine 10 mcg/h patch applied a day before the surgery and other group received oral tramadol 50 mg three times a day for analgesia (Group OT). They were allowed to take diclofenac and paracetamol tablets for rescue analgesia. Pain scores at rest, on movement, rescue analgesic requirement and side effects were compared between the groups over 7 days. Chi-square and independent sample t -test were used for categorical and continuous variables, respectively. Resting pain scores and pain on movement were significantly lower in TDB Group on all 7 days starting from 24 h post-operatively. Rescue analgesic requirement was significantly lower in TDB Group compared to OT Group. All the patients needed rescue analgesic in OT Group whereas 68% of the patients needed the same in TDB Group. Incidence of vomiting was less and satisfaction scores were much higher in TDB Group as compared to OT Group (79% vs. 66%, P < 0.001). Transdermal buprenorphine can be safely used for post-operative analgesia and is more efficacious in reducing post-operative pain after 24 hours, with fewer side effects when compared to oral tramadol.

[Protocol for peripheral parenteral nutrition management ready to use in surgical patients].

PubMed

Pinzón Espitia, Olga Lucia; Varón Vega, Martha Liliana

2014-10-03

Patients undergoing elective surgery, require a comprehensive clinical treatment that tends to maintain or prevent deterioration of nutritional status and promote clinical outcomes, and in turn improve the safety of parenteral nutrition therapy through optimization of technology, as a option aimed at minimizing risk and lower operating costs in institutions providing health services. To review the literature in order to study the requirements and recommendations of peripheral parenteral nutritional support and / or complementary ready to use in people undergoing surgery. Data synthesis after reviewing the relevant literature, to allow the protocol design. The search was conducted in the following databases: PubMed, Medline, Embase and ScienceDirect. Peripheral parenteral nutrition is a ready to use alternative nutritional support that improves the contribution Protein-Energy and demonstrate improvements in patient safety, decrease costs and increase patient satisfaction. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery.

PubMed

Lee, Jae Hyup; Kim, Jin-Hyok; Kim, Jin-Hwan; Kim, Hak-Sun; Min, Woo-Kie; Park, Ye-Soo; Lee, Kyu-Yeol; Lee, Jung-Hee

2017-01-01

Control of persistent pain following spinal surgery is an unmet clinical need. This study compared the efficacy and safety of buprenorphine transdermal system (BTDS) to oral tramadol/acetaminophen (TA) in Korean patients with persistent, moderate pain following spinal surgery. Open-label, interventional, randomized multicenter study. Adults with persistent postoperative pain (Numeric Rating Scale [NRS] ≥ 4 at 14-90 days postsurgery) were enrolled. Patients received once-weekly BTDS ( n = 47; 5  μ g/h titrated to 20  μ g/h) or twice-daily TA ( n = 40; tramadol 37.5 mg/acetaminophen 325 mg, one tablet titrated to 4 tablets) for 6 weeks. The study compared pain reduction with BTDS versus TA at week 6. Quality of life (QoL), treatment satisfaction, medication compliance, and adverse events (AEs) were assessed. At week 6, both groups reported significant pain reduction (mean NRS change: BTDS -2.02; TA -2.76, both P < 0.0001) and improved QoL (mean EQ-5D index change: BTDS 0.10; TA 0.19, both P < 0.05). The BTDS group achieved better medication compliance (97.8% versus 91.0%). Incidence of AEs (26.1% versus 20.0%) and adverse drug reactions (20.3% versus 16.9%) were comparable between groups. For patients with persistent pain following spinal surgery, BTDS is an alternative to TA for reducing pain and supports medication compliance. This trial is registered with Clinicaltrials.gov: NCT01983111.

Sustaining Teamwork Behaviors Through Reinforcement of TeamSTEPPS Principles.

PubMed

Lee, Soo-Hoon; Khanuja, Harpal S; Blanding, Renee J; Sedgwick, Jeanne; Pressimone, Kathleen; Ficke, James R; Jones, Lynne C

2017-10-30

Teamwork training improves short-term teamwork behaviors. However, improvements are often not sustained. The purpose of this study was to explore the extent to which teamwork reinforcement activities for orthopedic surgery teams lead to sustained teamwork behaviors. Seven months after 104 staff from an orthopedic surgical unit were trained in Team Strategies and Tools to Enhance Performance and Patient Safety principles, 4 reinforcement activities were implemented regarding leadership and communication: lectures with videos on leadership skills for nursing staff; an online self-paced learning program on communication skills for nursing staff; a 1-page summary on leadership skills e-mailed to surgical staff; and a 1-hour perioperative grand rounds on Team Strategies and Tools to Enhance Performance and Patient Safety principles for anesthesia staff and new staff. Twenty-four orthopedic surgical teams were evaluated on teamwork behaviors during surgery by 2 observers before and after the reinforcement period using the Observational Teamwork Assessment for Surgery tool. After reinforcement, leadership (P = 0.022) and communication (P = 0.044) behaviors improved compared with prereinforcement levels. Specifically, nursing staff improved in leadership (P = 0.016) and communication (P = 0.028) behaviors, surgical staff improved in leadership behaviors (P = 0.009), but anesthesia staff did not improve in any teamwork behaviors. Sustained improvement in teamwork behaviors requires reinforcement. Level III, prospective pre-post cohort study.

Anesthesia for Ambulatory Pediatric Surgery in Sub-Saharan Africa: A Pilot Study in Burkina Faso.

PubMed

Kabré, Yvette B; Traoré, Idriss S S; Kaboré, Flavien A R; Ki, Bertille; Traoré, Alain I; Ouédraogo, Isso; Bandré, Emile; Wandaogo, Albert; Ouédraogo, Nazinigouba

2017-02-01

Long surgical wait times and limited hospital capacity are common obstacles to surgical care in many countries in Sub-Saharan Africa (SSA). Introducing ambulatory surgery might contribute to a solution to these problems. The purpose of this study was to evaluate the safety and feasibility of introducing ambulatory surgery into a pediatric hospital in SSA. This is a cross-sectional descriptive study that took place over 6 months. It includes all patients assigned to undergo ambulatory surgery in the Pediatric University Hospital in Ouagadougou, Burkina Faso. Eligibility criteria for the ambulatory surgery program included >1 year of age, American Society of Anesthesiologists (ASA) 1 status, surgery with a low risk of bleeding, lasting <90 minutes, and with an expectation of mild to moderate postoperative pain. The family had to live within 1 hour of the hospital and be available by telephone. During the study period, a total of 1250 patients underwent surgery, of whom 515 were elective cases; 115 of these met the criteria for ambulatory surgery; 103 patients, with an average age of 59.74 ± 41.57 months, actually underwent surgery. The principal indications for surgery were inguinal (62) and umbilical (47) hernias. All patients had general anesthesia with halothane. Sixty-five percent also received regional or local anesthesia consisting of caudal block in 79.23% or nerve block in 20.77%. The average duration of surgery was 33 ± 17.47 minutes. No intraoperative complications were noted. All the patients received acetaminophen and a nonsteroidal anti-inflammatory drug in the recovery room. Twelve (11.7%) patients had complications in recovery, principally nausea and vomiting. Eight (7.8%) patients were admitted to the hospital. No serious complications were associated with ambulatory surgery. Its introduction could possibly be a solution to improving pediatric surgical access in low-income countries.

Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery.

PubMed

Comstock, Timothy L; Paterno, Michael R; Singh, Angele; Erb, Tara; Davis, Elizabeth

2011-01-01

To compare the safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% (LE ointment), a new topical ointment formulation, with vehicle for the treatment of inflammation and pain following cataract surgery. Two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies were conducted. Patients aged ≥18 years with a combined postoperative anterior chamber cells and flare (ACI) ≥ Grade 3 following uncomplicated cataract surgery participated in seven study visits. Patients self-administered either topical LE ointment or vehicle four times daily for 14 days. Efficacy outcomes included the proportion of patients with complete resolution of ACI and the proportion of patients with no (Grade 0) pain at postoperative day 8. Safety outcomes included the incidence of adverse events, ocular symptoms, changes in intraocular pressure and visual acuity, and biomicroscopy and funduscopy findings. Data from the two studies were combined. The integrated intent-to-treat population consisted of 805 patients (mean [standard deviation] age 69.0 [9.2] years; 58.0% female and 89.7% white). Significantly more LE ointment-treated patients than vehicle-treated patients had complete resolution of ACI (27.7% versus 12.5%) and no pain (75.5% versus 43.1%) at day 8 (P < 0.0001 for both). Fewer LE ointment-treated patients required rescue medication (27.7% versus 63.8%), and fewer had an ocular adverse event (47.2% versus 78.0%, P < 0.0001) while on study treatment. The most common ocular adverse events with LE ointment were anterior chamber inflammation, photophobia, corneal edema, conjunctival hyperemia, eye pain, and iritis. Mean intraocular pressure decreased in both treatment groups. Four patients had increased intraocular pressure ≥10 mmHg (three LE ointment and one vehicle) prior to rescue medication. Visual acuity and dilated funduscopy results were similar between the treatment groups, with the exception of visual acuity at visits 5 and 6, which favored LE ointment. LE ointment was efficacious and well tolerated in the treatment of ocular inflammation and pain following cataract surgery.

Anterior cervical discectomy and fusion in the outpatient ambulatory surgery setting compared with the inpatient hospital setting: analysis of 1000 consecutive cases.

PubMed

Adamson, Tim; Godil, Saniya S; Mehrlich, Melissa; Mendenhall, Stephen; Asher, Anthony L; McGirt, Matthew J

2016-06-01

OBJECTIVE In an era of escalating health care costs and pressure to improve efficiency and cost of care, ambulatory surgery centers (ASCs) have emerged as lower-cost options for many surgical therapies. Anterior cervical discectomy and fusion (ACDF) is one of the most prevalent spine surgeries performed, and the frequency of its performance is rapidly increasing as the aging population grows. Although ASCs offer significant cost advantages over hospital-based surgical centers, concern over the safety of outpatient ACDF has slowed its adoption. The authors intended to 1) determine the safety of the first 1000 consecutive ACDF surgeries performed in their outpatient ASC, and 2) compare the safety of these outpatient ACDFs with that of consecutive ACDFs performed during the same time period in the hospital setting. METHODS A total of 1000 consecutive patients who underwent ACDF in an ACS (outpatient ACDF) and 484 consecutive patients who underwent ACDF at Vanderbilt University Hospital (inpatient ACDF) from 2006 to 2013 were included in this retrospective study of patients' medical records. Data were collected on patient demographics, comorbidities, operative details, and perioperative and 90-day morbidity. Perioperative morbidity and hospital readmission were compared between the outpatient and inpatient ACDF groups. RESULTS Of the first 1000 outpatient ACDF cases performed in the authors' ASC, 629 (62.9%) were 1-level and 365 (36.5%) were 2-level ACDFs. Mean patient age was 49.5 ± 8.6, and 484 (48.4%) were males. All patients were observed postoperatively at the ASC postanesthesia care unit (PACU) for 4 hours before being discharged home. Eight patients (0.8%) were transferred from the surgery center to the hospital postoperatively (for pain control [n = 3], chest pain and electrocardiogram changes [n = 2], intraoperative CSF leak [n = 1], postoperative hematoma [n = 1], and profound postoperative weakness and surgical reexploration [n = 1]). No perioperative deaths occurred. The 30-day hospital readmission rate was 2.2%. All 90-day surgical morbidity was similar between outpatient and inpatient cohorts for both 1-level and 2-level ACDFs. CONCLUSIONS An analysis of 1000 consecutive patients who underwent ACDF in an outpatient setting demonstrates that surgical complications occur at a low rate (1%) and can be appropriately diagnosed and managed in a 4-hour ASC PACU window. Comparison with an inpatient ACDF surgery cohort demonstrated similar results, highlighting that ACDF can be safely performed in the outpatient ambulatory surgery setting without compromising surgical safety. In an effort to decrease costs of care, surgeons can safely perform 1- and 2-level ACDFs in an ASC environment.

How robotic-assisted surgery can decrease the risk of mucosal tear during Heller myotomy procedure?

PubMed

Ballouhey, Quentin; Dib, Nabil; Binet, Aurélien; Carcauzon-Couvrat, Véronique; Clermidi, Pauline; Longis, Bernard; Lardy, Hubert; Languepin, Jane; Cros, Jérôme; Fourcade, Laurent

2017-06-01

We report the first description of robotic-assisted Heller myotomy in children. The purpose of this study was to improve the safety of Heller myotomy by demonstrating, in two adolescent patients, the contribution of the robot to the different steps of this procedure. Due to the robot's freedom of movement and three-dimensional vision, there was an improvement in the accuracy, a gain in the safety regarding different key-points, decreasing the risk of mucosal perforation associated with this procedure.

Feasibility and safety of robot-assisted thoracic surgery for lung lobectomy in patients with non-small cell lung cancer: a systematic review and meta-analysis.

PubMed

Wei, Shiyou; Chen, Minghao; Chen, Nan; Liu, Lunxu

2017-05-08

The aim of this study is to evaluate the feasibility and safety of robot-assisted thoracic surgery (RATS) lobectomy versus video-assisted thoracic surgery (VATS) for lobectomy in patients with non-small cell lung cancer (NSCLC). An electronic search of six electronic databases was performed to identify relevant comparative studies. Meta-analysis was performed by pooling the results of reported incidence of overall morbidity, mortality, prolonged air leak, arrhythmia, and pneumonia between RATS and VATS lobectomy. Subgroup analysis was also conducted based on matched and unmatched cohort studies, if possible. Relative risks (RR) with their 95% confidence intervals (CI) were calculated by means of Revman version 5.3. Twelve retrospective cohort studies were included, with a total of 60,959 patients. RATS lobectomy significantly reduced the mortality rate when compared with VATS lobectomy (RR = 0.54, 95% CI 0.38-0.77; P = 0.0006), but this was not consistent with the pooled result of six matched studies (RR = 0.12, 95% CI 0.01-1.07; P = 0.06). There was no significant difference in morbidity between the two approaches (RR = 0.97, 95% CI 0.85-1.12; P = 0.70). RATS lobectomy is a feasible and safe technique and can achieve an equivalent short-term surgical efficacy when compared with VATS, but its cost effectiveness also should be taken into consideration.

Introducing standardized “readbacks” to improve patient safety in surgery: a prospective survey in 92 providers at a public safety-net hospital

PubMed Central

2012-01-01

Background Communication breakdowns represent the main root cause of preventable complications which lead to harm to surgical patients. Standardized readbacks have been successfully implemented as a main pillar of professional aviation safety for decades, to ensure a safe closed-loop communication between air traffic control and individual pilots. The present study was designed to determine the perception of staff in perioperative services regarding the role of standardized readbacks for improving patient safety in surgery at a single public safety-net hospital and level 1 trauma center. Methods A 12-item questionnaire was sent to 180 providers in perioperative services at Denver Health Medical Center. The survey was designed to determine the individual participants’ perception of (1) appropriateness of current readback processes; (2) willingness to attend a future training module on this topic; (3) specific scenarios in which readbacks may be effective; and (4) perceived major barriers to the implementation of standardized readbacks. Survey results were compared between departments (surgery versus anesthesia) and between specific staff roles (attending or midlevel provider, resident physician, nursing staff), using non-parametric tests. Results The response rate to the survey was 50.1 % (n = 92). Respondents overwhelmingly recognized the role of readbacks in reducing communication errors and improving patient safety. There was a strong agreement among respondents to support participation in a readbacks training program. There was no difference in the responses between the surgery and anesthesia departments. There was a statistically significant difference in the healthcare providers willingness to attend a short training module on readbacks (p < 0.001). Resident physicians were less likely to endorse the importance of readbacks in reducing communication errors (p = 0.01) and less willing to attend a short training module on readbacks (p < 0.001), as compared to staff providers and nursing staff. The main challenge for respondents, which emanated from their responses, appeared to relate to determining the ideal scenarios in which readbacks may be most appropriately used. Overall, respondents strongly felt that readbacks had an important role in patient handoffs, patient orders regarding critical results, counting and verifying surgical instruments, and delegating multiple perioperative tasks. Conclusion The majority of all respondents appear to perceive standardized readbacks as an effective tool for reducing and/or preventing adverse events in the care of surgical patients, derived from a breakdown in communication among perioperative caregivers. Further work needs to be done to define the exact clinical scenarios in which readbacks may be most efficiently implemented, including the definition of a uniform set of scripted quotes and phrases, which should likely be standardized in concert with the aviation safety model. PMID:22713158

Metabolic Syndrome Prevalence and Associations in a Bariatric Surgery Cohort from the Longitudinal Assessment of Bariatric Surgery-2 Study

PubMed Central

Selzer, Faith; Smith, Mark D.; Berk, Paul D.; Courcoulas, Anita P.; Inabnet, William B.; King, Wendy C.; Pender, John; Pomp, Alfons; Raum, William J.; Schrope, Beth; Steffen, Kristine J.; Wolfe, Bruce M.; Patterson, Emma J.

2014-01-01

Abstract Background: Metabolic syndrome is associated with higher risk for cardiovascular disease, sleep apnea, and nonalcoholic steatohepatitis, all common conditions in patients referred for bariatric surgery, and it may predict early postoperative complications. The objective of this study was to determine the prevalence of metabolic syndrome, defined using updated National Cholesterol Education Program criteria, in adults undergoing bariatric surgery and compare the prevalence of baseline co-morbid conditions and select operative and 30-day postoperative outcomes by metabolic syndrome status. Methods: Complete metabolic syndrome data were available for 2275 of 2458 participants enrolled in the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2), an observational cohort study designed to evaluate long-term safety and efficacy of bariatric surgery in obese adults. Results: The prevalence of metabolic syndrome was 79.9%. Compared to those without metabolic syndrome, those with metabolic syndrome were significantly more likely to be men, to have a higher prevalence of diabetes and prior cardiac events, to have enlarged livers and higher median levels of liver enzymes, a history of sleep apnea, and a longer length of stay after surgery following laparoscopic Roux-en-Y gastric bypass (RYGB) and gastric sleeves but not open RYGB or laparoscopic adjustable gastric banding. Metabolic syndrome status was not significantly related to duration of surgery or rates of composite end points of intraoperative events and 30-day major adverse surgical outcomes. Conclusions: Nearly four in five participants undergoing bariatric surgery presented with metabolic syndrome. Establishing a diagnosis of metabolic syndrome in bariatric surgery patients may identify a high-risk patient profile, but does not in itself confer a higher risk for short-term adverse postsurgery outcomes. PMID:24380645

Metabolic syndrome prevalence and associations in a bariatric surgery cohort from the Longitudinal Assessment of Bariatric Surgery-2 study.

PubMed

Purnell, Jonathan Q; Selzer, Faith; Smith, Mark D; Berk, Paul D; Courcoulas, Anita P; Inabnet, William B; King, Wendy C; Pender, John; Pomp, Alfons; Raum, William J; Schrope, Beth; Steffen, Kristine J; Wolfe, Bruce M; Patterson, Emma J

2014-03-01

Metabolic syndrome is associated with higher risk for cardiovascular disease, sleep apnea, and nonalcoholic steatohepatitis, all common conditions in patients referred for bariatric surgery, and it may predict early postoperative complications. The objective of this study was to determine the prevalence of metabolic syndrome, defined using updated National Cholesterol Education Program criteria, in adults undergoing bariatric surgery and compare the prevalence of baseline co-morbid conditions and select operative and 30-day postoperative outcomes by metabolic syndrome status. Complete metabolic syndrome data were available for 2275 of 2458 participants enrolled in the Longitudinal Assessment of Bariatric Surgery-2 (LABS-2), an observational cohort study designed to evaluate long-term safety and efficacy of bariatric surgery in obese adults. The prevalence of metabolic syndrome was 79.9%. Compared to those without metabolic syndrome, those with metabolic syndrome were significantly more likely to be men, to have a higher prevalence of diabetes and prior cardiac events, to have enlarged livers and higher median levels of liver enzymes, a history of sleep apnea, and a longer length of stay after surgery following laparoscopic Roux-en-Y gastric bypass (RYGB) and gastric sleeves but not open RYGB or laparoscopic adjustable gastric banding. Metabolic syndrome status was not significantly related to duration of surgery or rates of composite end points of intraoperative events and 30-day major adverse surgical outcomes. Nearly four in five participants undergoing bariatric surgery presented with metabolic syndrome. Establishing a diagnosis of metabolic syndrome in bariatric surgery patients may identify a high-risk patient profile, but does not in itself confer a higher risk for short-term adverse postsurgery outcomes.

Xenon anaesthesia for patients undergoing off-pump coronary artery bypass graft surgery: a prospective randomized controlled pilot trial.

PubMed

Al Tmimi, L; Van Hemelrijck, J; Van de Velde, M; Sergeant, P; Meyns, B; Missant, C; Jochmans, I; Poesen, K; Coburn, M; Rex, S

2015-10-01

Off-pump coronary artery bypass (OPCAB) surgery carries a high risk for haemodynamic instability and perioperative organ injury. Favourable haemodynamic effects and organ-protective properties could render xenon an attractive anaesthetic for OPCAB surgery. The primary aim of this study was to assess whether xenon anaesthesia for OPCAB surgery is non-inferior to sevoflurane anaesthesia with regard to intraoperative vasopressor requirements. Forty-two patients undergoing elective OPCAB surgery were enrolled in this prospective, single-blind, randomized controlled pilot trial. Patients were randomized to either xenon (50-60 vol%) or sevoflurane (1.1-1.4 vol%) anaesthesia. Primary outcome was intraoperative noradrenaline requirements necessary to achieve predefined haemodynamic goals. Secondary outcomes included safety variables such as the occurrence of adverse events (intraoperatively and during a 6-month follow-up after surgery) and the perioperative cardiorespiratory and inflammatory profile. Baseline and intraoperative data did not differ between groups. Xenon was non-inferior to sevoflurane, as xenon patients required significantly less noradrenaline intraoperatively to achieve the predefined haemodynamic goals {geometric mean 428 [95% confidence interval (CI) 312, 588] vs 1702 [1267, 2285] µg, P<0.0001}. No differences were found for safety. Significantly more sevoflurane patients developed postoperative delirium (POD) (hazard ratio 4.2, P=0.044). The average arterial pressure was lower in the sevoflurane group {median75 [interquartile range (IQR) 6] vs 72 [4] mmHg, P=0.002}. No differences were found for other haemodynamic parameters, the respiratory profile and the perioperative release of inflammatory cytokines, troponin T, serum protein S-100β and erythropoietin. Compared with sevoflurane, xenon anaesthesia allows a significant reduction in vasopressor administration in OPCAB surgery. Moreover, xenon anaesthesia was associated with a lower risk for POD, a finding that has to be confirmed in larger studies. ClinicalTrials.gov (NCT01757106) and EudraCT (2012-002316-12). © The Author 2015. Published by Oxford University Press on behalf of the British Journal of Anaesthesia. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Quality and Safety in Health Care, Part XXIX: The Transcatheter Valve Therapy Registry.

PubMed

Harolds, Jay A

2017-11-01

The American College of Cardiology, the Society of Thoracic Surgeons, and other organizations cooperated to form the Transcatheter Valve Therapy Registry. This registry studies information on the outcome of valve therapy device placement with a transcatheter approach. The companies that manufacture these devices can use the registry to meet the post-product sale surveillance requirements of the US Food and Drug Administration. There will also be linkage to the registry information from the Society of Thoracic Surgeons Adult Cardiac Surgery Database, which has information on open cardiac valve surgery.

Laparoscopic versus open repair for perforated peptic ulcer: A meta analysis of randomized controlled trials.

PubMed

Tan, Shanjun; Wu, Guohao; Zhuang, Qiulin; Xi, Qiulei; Meng, Qingyang; Jiang, Yi; Han, Yusong; Yu, Chao; Yu, Zhen; Li, Ning

2016-09-01

The role of laparoscopic surgery in the repair for peptic ulcer disease is unclear. The present study aimed to compare the safety and efficacy of laparoscopic versus open repair for peptic ulcer disease. Randomized controlled trials (RCTs) comparing laparoscopic versus open repair for peptic ulcer disease were identified from MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, and references of identified articles and relevant reviews. Primary outcomes were postoperative complications, mortality, and reoperation. Secondary outcomes were operative time, postoperative pain, postoperative hospital stay, nasogastric tube duration, and time to resume diet. Statistical analysis was carried out by Review Manage software. Five RCTs investigating a total of 549 patients, of whom, 279 received laparoscopic repair and 270 received open repair, were included in the final analysis. There were no significant differences between these two procedures in some primary outcomes including overal postoperative complication rate, mortality, and reoperation rate. Subcategory analysis of postoperative complications showed that laparoscopic repair had also similar rates of repair site leakage, intra-abdominal abscess, postoperative ileus, pneumonia, and urinary tract infection as open surgery, except of the lower surgical site infection rate (P < 0.05). In addition, there were also no significant differences between these two procedures in some second outcomes including operative time, postoperative hospital stay, and time to resume diet, but laparoscopic repair had shorter nasogastric tube duration (P < 0.05) and less postoperative pain (P < 0.05) than open surgery. Laparoscopic surgery is comparable with open surgery in the setting of repair for perforated peptic ulcer. The obvious advantages of laparoscopic surgery are the lower surgical site infection rate, shorter nasogastric tube duration and less postoperative pain. However, more higher quality studies should be undertaken to further assess the safety and efficacy of laparoscopic repair for peptic ulcer disease. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

New trends in minimally invasive urological surgery: what is beyond the robot?

PubMed

Micali, Salvatore; Pini, Giovannalberto; Teber, Dogu; Sighinolfi, Maria Chiara; De Stefani, Stefano; Bianchi, Giampaolo; Rassweiler, Jens

2013-06-01

To review the minimal-invasive development of surgical technique in urology focusing on nomenclature, history and outcomes of Laparo-Endoscopic Single-site Surgery (LESS), Natural Orifice Translumenal Endoscopic Surgery (NOTES) and Computer-Assisted Surgery (CAS). A comprehensive literature search was conducted in order to find article related to LESS, NOTES and CAS in urology. The most relevant papers over the last 10 years were selected in base to the experience from the panel of experts, journal, authorship and/or content. Seven hundred and fifty manuscripts were found. Papers on LESS describe feasibility/safety in most of the procedures with a clinical experience of more than 300 cases and five compared results to standard laparoscopy without showing significant differences. NOTES accesses have been proved their feasibility/safety in experimental study. In human, the only procedures performed are on kidney and through a hybrid-Transvaginal route. New robots overcome the main drawbacks of the DaVinci® platform. The use of CAS is increasing its popularity in urology. LESS has been applied in clinical practice, but only ongoing technical and instrumental refinement will define its future role and overall benefit. The transition to a clinical application of NOTES seems at present only possible with multiple NOTES access and transvaginal access. Robot and Soft Tissue Navigation appear to be important to improve surgical skills. We are already witness to the advantages offered by the former even if costs need to be redefined based on pending long-term results. The latter will probably upgrade the quality of surgery in a near future.

Piezosurgery to perform hyoid bone osteotomies in thyroglossal duct cyst surgery.

PubMed

Salgarelli, Attilio Carlo; Robiony, Massimo; Consolo, Ugo; Collini, Marco; Bellini, Pierantonio

2011-11-01

Ultrasonic bone-cutting surgery has been introduced as a feasible alternative to the conventional sharp instruments used in craniomaxillofacial surgery because of its precision and safety. The device used is unique in that the cutting action occurs when the tool is used on mineralized tissues and stops on soft tissues. This work describes the use of piezosurgery for hyoid bone resection in thyroglossal duct cyst surgery, briefly reviews the literature on the surgical technique, and reports our experience with 12 cases.

Effect of surgical safety checklists on pediatric surgical complications in Ontario

PubMed Central

O’Leary, James D.; Wijeysundera, Duminda N.; Crawford, Mark W.

2016-01-01

Background: In health care, most preventable adverse events occur in the operating room. Surgical safety checklists have become a standard of care for safe operating room practice, but there is conflicting evidence for the effectiveness of checklists to improve perioperative outcomes in some populations. Our objective was to determine whether surgical safety checklists are associated with a reduction in the proportion of children who had perioperative complications. Methods: We conducted a retrospective cohort study using administrative health care databases housed at the Institute for Clinical Evaluative Sciences to compare the risk of perioperative complications in children undergoing common types of surgery before and after the mandated implementation of surgical safety checklists in 116 acute care hospitals in Ontario. The primary outcome was a composite outcome of 30-day all-cause mortality and perioperative complications. Results: We identified 14 458 and 14 314 surgical procedures in pre- and postchecklist groups, respectively. The proportion of children who had perioperative complications was 4.08% (95% confidence interval [CI] 3.76%–4.40%) before the implementation of the checklist and 4.12% (95% CI 3.80%–4.45%) after implementation. After we adjusted for confounding factors, we found no significant difference in the odds of perioperative complications after the introduction of surgical safety checklists (adjusted odds ratio 1.01, 95% CI 0.90–1.14, p = 0.9). Interpretation: The implementation of surgical safety checklists for pediatric surgery in Ontario was not associated with a reduction in the proportion of children who had perioperative complications. Trial registration: ClinicalTrials.gov, no. NCT02419053 PMID:26976960

Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study.

PubMed

Mao, Jialin; Pfeifer, Samantha; Schlegel, Peter; Sedrakyan, Art

2015-10-13

To compare the safety and efficacy of hysteroscopic sterilization with the "Essure" device with laparoscopic sterilization in a large, all-inclusive, state cohort. Population based cohort study. Outpatient interventional setting in New York State. Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013. Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis. We identified 8048 patients undergoing hysteroscopic sterilization and 44,278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization. Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making. © Mao et al 2015.

How to deal with benign hilar or interlobar lymphadenopathy during video-assisted thoracoscopic surgery lobectomy.

PubMed

Yan, Shi; Lv, Chao; Wang, Xing; Wu, Nan

2016-01-01

Video-assisted thoracoscopic surgery (VATS) surgery has changed the way lobectomy procedure was performed over the past few decades. However, some difficulties impede the accomplishment of VATS lobectomy, which of them, benign lymphadenopathy may pose a threat to safety of surgery. We reported a case with enlarged hilar and interlobar lymph nodes. The video showed the instrumentation and techniques that we had adopted to deal with the complicated dilemma during the operation. Critical experience was also suggested in some hypothetical scenarios. AS techniques were further refined, successful VATS segmentectomy or lobectomy with challenging hilar or interlobar lymphadenopathy could be performed without uncontrolled bleeding or unexpected conversion. A VATS approach is acceptable in the management of benign hilar or interlobar lymphadenopathy. However, facile technique is necessary to deal with intraoperative dilemma. To those who are not sure about the practicability of the VATS procedure, planned conversion is still an effective method to ensure safety of the operation.

Safety and feasibility evaluation of tourniquets for total knee replacement (SAFE-TKR): study protocol.

PubMed

Wall, Peter Dh; Ahmed, Imran; Metcalfe, Andrew; Price, Andrew J; Seers, Kate; Hutchinson, Charles E; Parsons, Helen; Warwick, Jane; Rahman, Bushra; Brown, Jaclyn; Underwood, Martin

2018-04-10

This study is designed to determine whether a full randomised controlled trial (RCT) examining the clinical effectiveness and safety of total knee replacement surgery with or without a tourniquet is warranted and feasible. Single centre, patient-blinded and assessor-blinded RCT. A computer-generated randomisation service will allocate 50 participants into one of two trial treatments, surgery with or without a tourniquet. The primary objective is to estimate recruitment, crossovers and follow-up of patients. All patients will have an MRI scan of their brain preoperatively and day 1 or 2 postoperatively to identify ischaemic cerebral emboli (primary clinical outcome). Oxford Cognitive Screen, Montreal Cognitive Assessment and Mini-Mental State Examination will be evaluated as outcome tools for measuring cognitive impairment at days 1, 2 and 7 postoperatively. Thigh pain, blood transfusion requirements, venous thromboembolism, revision surgery, surgical complications, mortality and Oxford knee and five-level EuroQol-5D scores will be collected over 12 months. Integrated qualitative research study : 30 trial patients and 20 knee surgeons will take part in semistructured interviews. Interviews will capture views regarding the pilot trial and explore barriers and potential solutions to a full trial. Multicentre cohort study : UK National Joint Registry data will be linked to Hospital Episode Statistics to estimate the relationship between tourniquet use and venous thromboembolic event, length of hospital stay, risk of revision surgery and death. The study will conclude with a multidisciplinary workshop to reach a consensus on whether a full trial is warranted and feasible. National Research Ethics Committee (West Midlands-Edgbaston) approved this study on 27 January 2016 (15/WM/0455). The study is sponsored by University of Warwick and University Hospitals Coventry and Warwickshire. The results will be disseminated via high-impact peer-reviewed publication. ISRCTN20873088; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Development and validation of a composite scoring system for robot-assisted surgical training--the Robotic Skills Assessment Score.

PubMed

Chowriappa, Ashirwad J; Shi, Yi; Raza, Syed Johar; Ahmed, Kamran; Stegemann, Andrew; Wilding, Gregory; Kaouk, Jihad; Peabody, James O; Menon, Mani; Hassett, James M; Kesavadas, Thenkurussi; Guru, Khurshid A

2013-12-01

A standardized scoring system does not exist in virtual reality-based assessment metrics to describe safe and crucial surgical skills in robot-assisted surgery. This study aims to develop an assessment score along with its construct validation. All subjects performed key tasks on previously validated Fundamental Skills of Robotic Surgery curriculum, which were recorded, and metrics were stored. After an expert consensus for the purpose of content validation (Delphi), critical safety determining procedural steps were identified from the Fundamental Skills of Robotic Surgery curriculum and a hierarchical task decomposition of multiple parameters using a variety of metrics was used to develop Robotic Skills Assessment Score (RSA-Score). Robotic Skills Assessment mainly focuses on safety in operative field, critical error, economy, bimanual dexterity, and time. Following, the RSA-Score was further evaluated for construct validation and feasibility. Spearman correlation tests performed between tasks using the RSA-Scores indicate no cross correlation. Wilcoxon rank sum tests were performed between the two groups. The proposed RSA-Score was evaluated on non-robotic surgeons (n = 15) and on expert-robotic surgeons (n = 12). The expert group demonstrated significantly better performance on all four tasks in comparison to the novice group. Validation of the RSA-Score in this study was carried out on the Robotic Surgical Simulator. The RSA-Score is a valid scoring system that could be incorporated in any virtual reality-based surgical simulator to achieve standardized assessment of fundamental surgical tents during robot-assisted surgery. Copyright © 2013 Elsevier Inc. All rights reserved.

Laparoscopic Adjustable Gastric Banding Revisions in Singapore: a 10-Year Experience.

PubMed

Ngiam, Kee Yuan; Khoo, Valerie Yu Hui; Kong, Lucy; Cheng, Anton Kui Sing

2016-05-01

Bariatric surgery is increasingly being carried out and revisional procedures have also risen in concert. A review of the complications and revisions might elucidate technical and patient factors that influence the outcomes of bariatric surgeries in Asian patients. The objective of this study is to review the safety and efficacy of revisional bariatric surgery in a single center in Singapore over a 10-year period. The setting of this study is a single public hospital with a multidisciplinary bariatric service including a weight management center, specialized endocrinology services, and bariatric surgical team. Participants were selected for surgery based on body mass index (BMI) and comorbidities. All patients underwent primary laparoscopic adjustable gastric banding (LAGB). Patients were then analyzed according to the types of revisional surgeries. The primary outcome was the type of complications and revisional surgeries. Secondary outcomes include short-term excess weight loss and further complications. A total of 365 patients were analyzed. 9.6% had a secondary procedure. In particular, two groups of complications required revisional surgery: failure of sustained weight loss and complications related to the LAGB insertion and use. Revisional surgeries had equivalent major complication rates (5.7%) compared to primary bariatric surgeries (6.8%). Revisional surgeries such as revisional LAGB (4.9 ± 9.8 kg), laparoscopic sleeve gastrectomy (LSG; 6.9 ± 21.0 kg), Roux-en-Y gastric bypass (RYGB; 4.6 ± 13.0 kg), and bilio-pancreatic diversion (BPD; 3.5 ± 6.3 kg) had modest weight loss compared to primary weight loss (12.7 ± 9.5 kg). Primary LAGB had a greater percentage excess weight loss in the first and second years post-surgery compared to revisional surgeries. There was one mortality post-primary surgery and no post-revisional surgical mortalities. Revisional bariatric surgery for complications related to the primary surgery is safe but had reduced excess weight loss compared to the initial surgery.

Endoscopic Versus Microscopic Transsphenoidal Surgery in the Treatment of Pituitary Adenoma: A Systematic Review and Meta-Analysis.

PubMed

Li, Aijun; Liu, Weisheng; Cao, Peicheng; Zheng, Yuehua; Bu, Zhenfu; Zhou, Tao

2017-05-01

Inconsistent findings have been reported regarding the efficacy and safety of endoscopic and microscopic transsphenoidal surgery for pituitary adenoma. This study aimed to assess the benefits and shortcomings of these surgical methods in patients with pituitary adenoma. The electronic databases PubMed, Embase, and the Cochrane Library were systematically searched, as well as proceedings of major meetings. Eligible studies with a retrospective or prospective design that evaluated endoscopic versus microscopic methods in patients with pituitary adenoma were included. Primary outcomes included gross tumor removal, cerebrospinal fluid leak, diabetes insipidus, and other complications. Overall, 23 studies (4 prospective and 19 retrospective) assessing 2272 patients with pituitary adenoma were included in the final analysis. Endoscopic transsphenoidal surgery was associated with a higher incidence of gross tumor removal (odds ratio, 1.52; 95% confidence interval, 1.11-2.08; P = 0.009) than those with microscopic transsphenoidal surgery. In addition, endoscopic transsphenoidal surgery had no significant effect on the risk of cerebrospinal fluid leak, compared with microscopic transsphenoidal surgery. Furthermore, endoscopic transsphenoidal surgery was associated with a 22% reduction in risk of diabetes insipidus compared with microscopic transsphenoidal surgery, but the difference was not statistically significant. Endoscopic transsphenoidal surgery significantly reduced the risk of septal perforation (odds ratio, 0.29; 95% confidence interval, 0.11-0.78; P = 0.014) and was not associated with the risk of meningitis, epistaxis, hematoma, hypopituitarism, hypothyroidism, hypocortisolism, total mortality, and recurrence. Endoscopic transsphenoidal surgery is associated with higher gross tumor removal and lower incidence of septal perforation in patients with pituitary adenoma. Future large-scale prospective randomized controlled trials are needed to verify these findings. Copyright © 2017 Elsevier Inc. All rights reserved.

Patient Safety Movement: History and Future Directions.

PubMed

Lark, Meghan E; Kirkpatrick, Kay; Chung, Kevin C

2018-02-01

Despite progress within the past 15 years, improving patient safety in health care remains an important public health issue. The history of safety policies, research, and development has revealed that this issue is more complex than initially perceived and is pertinent to all health care settings. Solutions, therefore, must be approached at the systems level and supplemented with a change in safety culture, especially in higher risk fields such as surgery. To do so, health care agents at all levels have started to prioritize the improvement of nontechnical skills such as teamwork, communication, and accountability, as reflected by the development of various checklists and safety campaigns. This progress may be sustained by adopting teamwork training programs that have proven successful in other high-risk industries, such as crew resource management in aviation. These techniques can be readily implemented among surgical teams; however, successful application depends heavily on the strong leadership and vigilance of individual surgeons. Copyright © 2018 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Risk is not our business: safety of thoracic surgery in patients using antiplatelet therapy.

PubMed

Bertolaccini, Luca; Terzi, Alberto; Rizzardi, Giovanna; Gorla, Alberto; Viti, Andrea; Palmisano, Sarah; Coletta, Giuseppe

2012-02-01

American Heart Association recommendations have changed preoperative management of patients with antiplatelet therapy (APT). We assessed safety and outcomes of surgery in patients who were receiving APT. A prospective study of patients operated on while receiving APT was matched with those with no APT (ratio 1:4), using the propensity score method. Logistic regression analysis was used to identify covariates among imbalanced baseline patient variables. Both χ(2) test and Fisher's test were used to calculate the probability value for the comparison of dichotomous variables. Between January 2008 and December 2010, 38 patients who received APT at the time of surgery were matched with 141 patients who had not received APT. APT indications were a history of myocardial infarction, coronary artery by-pass graft and/or valve replacement (19), coronary artery stent (11) and severe peripheral vascular disease (8). None of the patients required re-operation for bleeding. Two patients received blood transfusions. The amount of chest tube drainage was not statistically significantly different. There were no statistically significant differences between the outcomes for the operative time, length of hospital stay, estimated blood loss or morbidity. The results show that thoracic surgical procedures can safely be performed in patients receiving APT at the time of surgery, with no increased risk of bleeding or morbidity and no differences in the operative time and the length of hospital stay.

[The clinical effect and disquisition of anterior cervical approach surgery with posterior longitudinal ligament hook pliers and posterior longitudinal ligament nip pliers].

PubMed

Kuang, Ling-hao; Xu, Dong; Sun, Ya-wei; Cong, Jie; Tian, Ji-wei; Wang, Lei

2010-09-21

To study the clinical effect of anterior cervical approach surgery to removal posterior longitudinal ligament (PLL) with posterior longitudinal ligament hook pliers and posterior longitudinal ligament nip pliers. To retrospectively analyzed anterior cervical approach surgery treatment 73 patients who were cervical spondylosis myelopathy. All patients removal PLL with self-make instrument, According to JOA grade to evaluate effect of operations. Full patients removal PLL were in succeed, in shape of extradural has renew, the JOA grade were increase, (12.8 ± 3.2) vs (8.3 ± 1.9). Removal PLL were increase effect of downright decompress in anterior cervical approach surgery, Operations become safety agile and reduce the complications with self-make instrument.

The case for restraint in spinal surgery: does quality management have a role to play?

PubMed Central

Mirza, Sohail K.

2009-01-01

Most quality improvement efforts in surgery have focused on the technical quality of care provided, rather than whether the care was indicated, or could have been provided with a safer procedure. Because risk is inherent in any procedure, reducing the number of unnecessary operations is an important issue in patient safety. In the case of lumbar spine surgery, several lines of evidence suggest that, in at least some locations, there may be excessively high surgery rates. This evidence comes from international comparisons of surgical rates; study of small area variations within countries; increasing surgical rates in the absence of new indications; comparisons of surgical outcomes between geographic areas with high or low surgical rates; expert opinion; the preferences of well-informed patients; and increasing rates of repeat surgery. From a population perspective, reducing unnecessary surgery may have a greater impact on complication rates than improving the technical quality of surgery that is performed. Evidence suggests this may be true for coronary bypass surgery in the US and hysterectomy rates in Canada. Though similar studies have not been done for spine surgery, wide geographic variations in surgical rates suggest that this could be the case for spine surgery as well. We suggest that monitoring geographic variations in surgery rates may become an important aspect of quality improvement, and that rates of repeat surgery may bear special attention. Patient registries can help in this regard, if they are very complete and rigorously maintained. They can provide data on surgical rates; offer post-marketing surveillance for new surgical devices and techniques; and help to identify patient subgroups that may benefit most from certain procedures. PMID:19266220

The case for restraint in spinal surgery: does quality management have a role to play?

PubMed

Deyo, Richard A; Mirza, Sohail K

2009-08-01

Most quality improvement efforts in surgery have focused on the technical quality of care provided, rather than whether the care was indicated, or could have been provided with a safer procedure. Because risk is inherent in any procedure, reducing the number of unnecessary operations is an important issue in patient safety. In the case of lumbar spine surgery, several lines of evidence suggest that, in at least some locations, there may be excessively high surgery rates. This evidence comes from international comparisons of surgical rates; study of small area variations within countries; increasing surgical rates in the absence of new indications; comparisons of surgical outcomes between geographic areas with high or low surgical rates; expert opinion; the preferences of well-informed patients; and increasing rates of repeat surgery. From a population perspective, reducing unnecessary surgery may have a greater impact on complication rates than improving the technical quality of surgery that is performed. Evidence suggests this may be true for coronary bypass surgery in the US and hysterectomy rates in Canada. Though similar studies have not been done for spine surgery, wide geographic variations in surgical rates suggest that this could be the case for spine surgery as well. We suggest that monitoring geographic variations in surgery rates may become an important aspect of quality improvement, and that rates of repeat surgery may bear special attention. Patient registries can help in this regard, if they are very complete and rigorously maintained. They can provide data on surgical rates; offer post-marketing surveillance for new surgical devices and techniques; and help to identify patient subgroups that may benefit most from certain procedures.

Single administration of intra-articular bupivacaine in arthroscopic knee surgery: a systematic review and meta-analysis.

PubMed

Sun, Qi-Bin; Liu, Shi-Dong; Meng, Qin-Jun; Qu, Hua-Zheng; Zhang, Zheng

2015-02-10

Single administration of intra-articular (IA) bupivacaine for pain relief after arthroscopic knee surgery is effective, but its active duration and dose-response relationship is unclear. We conducted this meta-analysis to summarize all published randomized controlled trials (RCTs), thus providing the most recent information on the safety and efficacy of single-administration IA bupivacaine for pain relief after arthroscopic knee surgery, and to determine whether a dose-response relationship exists. A systematic electronic literature search (through April 2014) was conducted to identify those RCTs that addressed the safety and efficacy of a single administration of IA bupivacaine for pain management after arthroscopic knee surgery. Subgroup analysis was conducted to determine changes in visual analog scale (VAS) scores at seven postoperative time points. Meta-regression and subgroup analyses were carried out to assess the effects of various treatment factors on efficacy and to evaluate the dose-response relationship of bupivacaine. Weighted mean differences or relative risks were calculated and pooled using a random-effects model. Twenty-eight trials involving 1,560 patients who underwent arthroscopic knee surgery met the inclusion criteria. The trials were subject to medium risk of bias. VAS scores at 2, 4, 6, 12, and 24 h postoperatively were significantly lower, the number of patients requiring supplementary analgesia was smaller, and the time to first request for analgesia was longer in the IA bupivacaine group than in the placebo group. The analgesic effect of single-administration IA bupivacaine may be associated with the effect of concomitant administration of epinephrine and concentration of bupivacaine, and no dose-response relationship was identified. No significant difference in side effects was detected between groups. Current evidence shows that the use of single-administration IA bupivacaine is effective for postoperative pain management in patients undergoing arthroscopic knee surgery, with satisfactory short-term safety. Low-dose administration of IA bupivacaine 0.5% combined with epinephrine adjuvant in clinical practice should be performed. Additional high-quality RCTs with longer follow-up periods are required to examine the safety of single-administration IA bupivacaine.

The Development of Enhanced Recovery After Surgery Across Surgical Specialties.

PubMed

Senturk, James C; Kristo, Gentian; Gold, Jason; Bleday, Ronald; Whang, Edward

2017-09-01

Enhanced recovery after surgery (ERAS ® ) principles have gained traction in variety of surgical disciplines. The promise of a reduced length of stay without compromising patient safety or increasing readmission rates has produced a body of literature examining the implementation of ERAS in the care of general, thoracic, urologic, and gynecologic surgery patients. We performed a review of the literature pertaining to studies of ERAS implementation across colorectal surgery, general surgery, thoracic surgery, urology, and gynecology. The extent of ERAS implementation and reported outcomes across key studies as well as systematic reviews and meta-analyses in each field were summarized. The implementation of ERAS protocols has not been uniform across surgical specialties. Despite this, ERAS has produced improvements in patient outcomes. The most commonly described benefit of ERAS application has been reduced length of stay; complication and readmission rates are most consistently decreased in the colorectal literature. Studies have started to measure more nuanced measures of postoperative patient well-being. Efforts are growing to standardize ERAS protocols across diverse fields and call attention to the need for quality control. Challenges remain in the study and execution of ERAS. Controlling for adherence to ERAS components and implementing uniform ERAS protocols across studies are burgeoning topics that have significant implications for study design. The practice of ERAS and its benefits to patients are expected to evolve. Assessing improvements in postdischarge quality of life, timing of return to work and independent living, and adherence to scheduled delivery of adjuvant treatments will strengthen future ERAS investigations.

Less Is Often Best in Treating TMJ Disorders

MedlinePlus

... for TMJ. There have been no long- term studies to test the safety and effectiveness of these procedures. Before considering any surgery on the jaw joint, it’s important to get opinions from other doctors and to fully understand the ...

Efficacy and safety of tranexamic acid in reducing blood loss in scoliosis surgery: a systematic review and meta-analysis.

PubMed

Yuan, Qiu-Ming; Zhao, Zhi-Hu; Xu, Bao-Shan

2017-01-01

The purpose of this systematic review and meta-analysis of randomized controlled trials (RCTs) and non-RCTs was to gather data to evaluate the efficacy and safety of tranexamic acid (TXA) versus placebo after a scoliosis surgery. The electronic databases including Embase, PubMed, CENTRAL (Cochrane Controlled Trials Register), Web of Science, and Google database were searched to identify relevant studies published from the time of the establishment of these databases up to May 2016. This systematic review and meta-analysis was performed according to the PRISMA statement criteria. The primary outcomes were total blood loss, intraoperative blood loss, and hemoglobin after surgery. The second outcome is need for transfusion. Stata 12.0 software was used for the meta-analysis. After testing for publication bias and heterogeneity across studies, data were aggregated for random-effects modeling when necessary. A total of 685 patients (347 patients in the TXA group and 338 in the control group) were finally included for this meta-analysis. The pooled results revealed that administration of TXA can decrease the total blood loss after scoliosis surgery [mean difference (MD) = 682.30, 95% confidence interval (CI) -930.60 to -434.00; P = 0.000] and intraoperative blood loss [(MD) = -535.28; 95% CI -683.74 to -368.82; P = 0.000]. For the hemoglobin (Hb) value after scoliosis surgery, TXA can decrease the Hb value for 0.51 dL [(MD) = 0.51; 95% CI 0.25-0.78; P = 0.000]. There is no statistically significant difference between the TXA versus placebo in terms of the need for transfusion (relative risk = 0.55, 95% CI 0.25-1.20, P = 0.132). Based on the current meta-analysis, TXA can decrease the total blood loss and intraoperative blood loss during scoliosis surgery. It is recommended that it be routinely used in scoliosis surgery. High-dose TXA (>20 mg/kg) is more effective than low-dose TXA (<20 mg/kg) in controlling blood loss. However, for the need for transfusion, more high-quality RCTs need to be identified.

Single-incision Laparoscopic Surgery (SILS) in general surgery: a review of current practice.

PubMed

Froghi, Farid; Sodergren, Mikael Hans; Darzi, Ara; Paraskeva, Paraskevas

2010-08-01

Single-incision laparoscopic surgery (SILS) aims to eliminate multiple port incisions. Although general operative principles of SILS are similar to conventional laparoscopic surgery, operative techniques are not standardized. This review aims to evaluate the current use of SILS published in the literature by examining the types of operations performed, techniques employed, and relevant complications and morbidity. This review considered a total of 94 studies reporting 1889 patients evaluating 17 different general surgical operations. There were 8 different access techniques reported using conventional laparoscopic instruments and specifically designed SILS ports. There is extensive heterogeneity associated with operating methods and in particular ways of overcoming problems with retraction and instrumentation. Published complications, morbidity, and hospital length of stay are comparable to conventional laparoscopy. Although SILS provides excellent cosmetic results and morbidity seems similar to conventional laparoscopy, larger randomized controlled trials are needed to assess the safety and efficacy of this novel technique.

Safety and efficacy of intensive intraoperative glycaemic control in cardiopulmonary bypass surgery: a randomised trial.

PubMed

Rujirojindakul, P; Liabsuetrakul, T; McNeil, E; Chanchayanon, T; Wasinwong, W; Oofuvong, M; Rergkliang, C; Chittithavorn, V

2014-05-01

This study aimed to determine the safety and efficacy of intraoperative intensive glycaemic treatment with modified glucose-insulin-potassium solution by hyperinsulinemic normoglycaemic clamp in cardiopulmonary bypass surgery patients. We hypothesised that the treatment would reduce infection rates in this group of patients. A prospective, randomised, double-blind trial was conducted in cardiopulmonary bypass surgery patients. A total of 199 adult patients (out of a planned 400) were randomly allocated to intensive or conventional treatment with target glucose levels of 4.4-8.3 mmol/l and < 13.8 mmol/l, respectively. The primary outcomes were clinical infection and cytokine levels, including interleukin (IL)-6 and IL-10. The secondary outcomes were morbidity and mortality. The study was terminated early because of safety concerns (hypoglycaemia). The clinical post-operative infection rate was 17% in the intensive group and 13% in the conventional group (P = 0.53). The proportion of patients with hypoglycaemia was significantly higher in the intensive group (23%) compared with the conventional group (3%) (P < 0.001). Morbidity and mortality rates were similar for both groups. Anaesthetic duration > 2 h (vs. ≤ 2 h), pre-operative IL-6 level > 15 pg/ml (vs. ≤ 15 pg/ml) and post-operative IL-6 level 56-110 pg/ml (vs. ≤ 55 pg/ml) were independent predictors for post-operative infection. Intraoperative intensive glycaemic treatment significantly increased the risk of hypoglycaemia, but its effect on post-operative infection by clinical assessment could not be determined. Anaesthetic duration, pre-operative and post-operative IL-6 levels can independently predict post-operative infection. © 2014 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

Graft and mesh use in vaginal surgery.

PubMed

Rizvi, Raheela Mohsin; Chughtai, Novera Ghayoor

2017-12-01

Pelvic organ prolapse and urinary incontinence are among the most common chronic disorders in women. These are common problems whose pathogenesis remains unclear. As life expectancy increases, significantly greater number of women now present with pelvic organ prolapse and urinary incontinence requiring surgical intervention. Currently, the lifetime risk of undergoing prolapse or continence surgery is one in 11, and up to 30% of patients will require repeat reconstructive surgery and repeat surgery for incontinence in 10%. In an attempt to improve surgical outcomes and to preserve vaginal capacity and coital function, a number of synthetic and biological prostheses have been developed. This review aims to look at the role of graft and mesh in vaginal surgery. We conducted a search for English-language articles published during 1997 to 2016, using MEDLINE, PubMed and United States' National Library of Medicine databases. We reviewed around 50 papers but referenced only 30 for this article. The literature review provided us a new insight regarding safety of mesh. Polypropylene mesh is safe for vaginal surgery if used by experienced surgeons. The safety of mesh becomes compromised in the hands of commercial surgical kit providers. All the new mesh tailored kits should undergo evidence-based trials and then can be safely used worldwide.

Prophylactic platelet transfusions prior to surgery for people with a low platelet count

PubMed Central

Estcourt, Lise J; Malouf, Reem; Doree, Carolyn; Trivella, Marialena; Hopewell, Sally; Birchall, Janet

2017-01-01

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To determine the clinical effectiveness and safety of prophylactic platelet transfusions prior to surgery for people with a low platelet count or platelet dysfunction (inherited or acquired). PMID:29151812

A Model for Integrating Ambulatory Surgery Centers Into an Academic Health System Using a Novel Ambulatory Surgery Coordinating Council.

PubMed

Ishii, Lisa; Pronovost, Peter J; Demski, Renee; Wylie, Gill; Zenilman, Michael

2016-06-01

An increasing volume of ambulatory surgeries has led to an increase in the number of ambulatory surgery centers (ASCs). Some academic health systems have aligned with ASCs to create a more integrated care delivery system. Yet, these centers are diverse in many areas, including specialty types, ownership models, management, physician employment, and regulatory oversight. Academic health systems then face challenges in integrating these ASCs into their organizations. Johns Hopkins Medicine created the Ambulatory Surgery Coordinating Council in 2014 to manage, standardize, and promote peer learning among its eight ASCs. The Armstrong Institute for Patient Safety and Quality provided support and a model for this organization through its quality management infrastructure. The physician-led council defined a mission and created goals to identify best practices, uniformly provide the highest-quality patient-centered care, and continuously improve patient outcomes and experience across ASCs. Council members built trust and agreed on a standardized patient safety and quality dashboard to report measures that include regulatory, care process, patient experience, and outcomes data. The council addressed unintentional outcomes and process variation across the system and agreed to standard approaches to optimize quality. Council members also developed a process for identifying future goals, standardizing care practices and electronic medical record documentation, and creating quality and safety policies. The early success of the council supports the continuation of the Armstrong Institute model for physician-led quality management. Other academic health systems can learn from this model as they integrate ASCs into their complex organizations.

A survey of the satisfaction of patients who have undergone implant surgery with and without employing a computer-guided implant surgical template

PubMed Central

Youk, Shin-Young; Lee, Jee-Ho; Heo, Seong-Joo; Roh, Hyun-Ki; Park, Eun-Jin; Shin, Im Hee

2014-01-01

PURPOSE This study aims to investigate the degree of subjective pain and the satisfaction of patients who have undergone an implant treatment using a computer-guided template. MATERIALS AND METHODS A survey was conducted for 135 patients who have undergone implant surgery with and without the use of the computer-guided template during the period of 2012 and 2013 in university hospitals, dental hospitals and dental clinics that practiced implant surgery using the computer-guided template. Likert scale and VAS score were used in the survey questions, and the independent t-test and One-Way ANOVA were performed (α=.05). RESULTS The route that the subjects were introduced to the computer-guided implant surgery using a surgical template was mostly advices by dentists, and the most common reason for which they chose to undergo such surgery was that it was accurate and safe. Most of them gave an answer that they were willing to recommend it to others. The patients who have undergone the computer-guided implant surgery felt less pain during the operation and showed higher satisfaction than those who have undergone conventional implant surgery. Among the patients who have undergone computer-guided implant surgery, those who also had prior experience of surgery without a computer-guided template expressed higher satisfaction with the former (P<.05). CONCLUSION In this study, it could be seen that the patients who have undergone computer-guided implant surgery employing a surgical template felt less pain and had higher satisfaction than those with the conventional one, and the dentist's description could provide the confidence about the safety of surgery. PMID:25352962

Fast-track surgery after gynaecological oncological surgery: study protocol for a prospective randomised controlled trial.

PubMed

Cui, Ling; Shi, Yu; Zhang, G N

2016-12-15

Fast-track surgery (FTS), also known as enhanced recovery after surgery, is a multidisciplinary approach to accelerate recovery, reduce complications, minimise hospital stay without increasing readmission rates, and reduce health care costs, all without compromising patient safety. The advantages of FTS in abdominal surgery most likely extend to gynaecological surgery, but this is an assumption, as FTS in elective gynaecological surgery has not been well studied. No consensus guidelines have been developed for gynaecological oncological surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. To our knowledge, there are no published randomised controlled trials; however, some studies have shown that FTS in gynaecological oncological surgery leads to early hospital discharge with high levels of patient satisfaction. The aim of this study is whether FTS reduces the length of stay in hospital compared to traditional management. The secondary aim is whether FTS is associated with any increase in post-surgical complications compared to traditional management (for both open and laparoscopic surgery). This trial will prospectively compare FTS and traditional management protocols. The primary endpoint is the length of post-operative hospitalisation (days, mean ± standard deviation), defined as the number of days between the date of discharge and the date of surgery. The secondary endpoints are complications in both groups (FTS versus traditional protocol) occurring during the first 3 months post-operatively including infection (wound infection, lung infection, intraperitoneal infection), post-operative nausea and vomiting, ileus, post-operative haemorrhage, post-operative thrombosis, and the Acute Physiology and Chronic Health Enquiry II score. The advantages of FTS most likely extend to gynaecology, although, to our knowledge, there are no randomised controlled trials. The aim of this study is to compare the post-operative length of hospitalisation after major gynaecological or gynaecological oncological surgery and to analyse patients' post-operative complications. This trial may reveal whether FTS leads to early hospital discharge with few complications after gynaecological surgery. NCT02687412 . Approval Number: SCCHEC20160001. Date of registration: registered on 23 February 2016.

High-power diode laser in the circumvestibular incision for Le Fort I osteotomy in orthognathic surgery: a prospective case series study.

PubMed

Jaeger, Filipe; Chiavaioli, Gustavo Marques; de Toledo, Guilherme Lacerda; Freire-Maia, Belini; Amaral, Marcio Bruno Figueiredo; Mesquita, Ricardo Alves

2018-01-01

The incisions during orthognathic surgery are classically performed with conventional scalpel or electrocautery. Considering that the high-power diode laser surgery may provide advantages when compared to conventional incision techniques, the current study aimed to present a prospective case series of patients submitted to circumvestibular incision for Le Fort I osteotomy. Ten patients with dentofacial deformities who underwent to rapid assisted maxillary expansion or bimaxillary orthognathic surgery were enrolled in the study. All incisions were performed by a single surgeon using an 808-nm diode laser, with an optical fiber of 600 μm, at a power of 2.5 W, in a continuous-wave mode. The performance of the incision was evaluated by incision velocity, bleeding, edema, secondary infection, clinical healing, and pain. The velocity of the incision ranged from 0.10 to 0.20 mm/s (mean 0.13 ± 0.03 mm/s). Considering bleeding during the soft tissue incision, all surgeries were classified as absent bleeding. All patients presented a clinical healing of the surgical wound in a period that range from 3 to 5 weeks and experienced swelling during the follow-up period. On average, approximately 50% of the swelling had resolved after the third postoperative week, and 28.8% of swelling remained after 2 months after the surgery. The pain decreased after 2 and 3 days, and 90.0% of the patients reported no pain after 7 postoperative days. High-power diode laser is effective and safety during circumvestibular incisions for Le Fort I osteotomy in orthognathic surgery decreasing bleeding, surgery time, pain, and edema after orthognathic surgery.

Attitudes to teamwork and safety among Italian surgeons and operating room nurses.

PubMed

Prati, Gabriele; Pietrantoni, Luca

2014-01-01

Previous studies have shown that surgical team members' attitudes about safety and teamwork in the operating theatre may play a role in patient safety. The aim of this study was to assess attitudes about teamwork and safety among Italian surgeons and operating room nurses. Fifty-five surgeons and 48 operating room nurses working in operating theatres at one hospital in Italy completed the Operating Room Management Attitudes Questionnaire (ORMAQ). Results showed several discrepancies in attitudes about teamwork and safety between surgeons and operating room nurses. Surgeons had more positive views on the quality of surgical leadership, communication, teamwork, and organizational climate in the theatre than operating room nurses. Operating room nurses reported that safety rules and procedures were more frequently disregarded than the surgeons. The results are only partially aligned with previous ORMAQ surveys of surgical teams in other countries. The differences emphasize the influence of national culture, as well as the particular healthcare system. This study shows discrepancies on many aspects in attitudes to teamwork and safety between surgeons and operating room nurses. The findings support implementation and use of team interventions and human factor training. Finally, attitude surveys provide a method for assessing safety culture in surgery, for evaluating the effectiveness of training initiatives, and for collecting data for a hospital's quality assurance programme.

An unusual surgical indication for cerebral tuberculosis: status dystonicus. Case report.

PubMed

Franzini, Andrea; Franzini, Angelo; Levi, Vincenzo; Cordella, Roberto; Messina, Giuseppe

2018-05-15

Actual indications for surgery in tuberculosis are limited to obtaining a diagnosis, acquiring tissue for culture studies, treating hydrocephalus, aspiring a brain abscess, and reducing intracranial pressure in patients with multiple tuberculomas. Tuberculosis-related movement disorders are usually treated pharmacologically. We report on a child affected by post-tubercular generalized dystonia, who progressed to status dystonicus (SD) and underwent stereotactic bilateral pallidotomy. After surgery, SD resolved, and drugs were rapidly tapered. The successful reversal of SD and the motor improvement observed in our patient demonstrate the safety, feasibility, and clinical efficacy of pallidotomy in post-tuberculous-meningoencephalitis dystonia and SD.

The risks of aorta impingement from pedicle screw may increase due to aorta movement during posterior instrumentation in Lenke 5C curve: a computed tomography study.

PubMed

Chen, Ling; Xu, Leilei; Qiu, Yong; Qiao, Jun; Wang, Fei; Liu, Zhen; Shi, Benglong; Qian, Bang-ping; Zhu, Zezhang

2015-07-01

To investigate the aorta movement following correction surgery for patients with thoracolumbar/lumbar scoliosis and to determine the subsequent risk of the aorta impingement for pedicle screw (PS) misplacement. Thirty-six AIS patients with a main thoracolumbar or lumbar curve were included in this study. According to the direction of the main curve, the patients were divided into Group R and Group L, with Group R comprising 16 patients with a right-sided curve and Group L comprising 20 patients with a left-sided curve. All patients underwent CT scans of the lower thoracic and lumbar spine before and after surgery. To identify the relative positions of the aorta to vertebral body, several parameters were measured from the CT images of the middle transverse planes of vertebrae from T11 to L4, including aorta-vertebra angle (α), vertebral rotation angle (β), left safety distance (LSD) and right safety distance (RSD). The risk of the aorta impingement from T11 to L4 was calculated. An intragroup comparison regarding the position of the aorta relative to the vertebral body before and after correction surgery was performed accordingly. After surgery, the aorta moved toward the vertebral body among all levels in both groups. Compared with that in Group L, the aorta in Group R was significantly closer to the entry point at all levels, especially at T11. Before surgery, the aorta in Group R was at a high risk of impingement from left PS placement regardless of the diameters of the simulated screws. While in Group L, the risk of aorta impingement was mainly caused by the right placement of 45 mm PS. After surgery, both groups had an increased risk of aorta impingement from PS insertion, especially at T11. The risk of aorta impingement from PS placement was significantly higher in Group R than in Group L. The risk of aorta impingement increased as the aorta shifted leftward after correction surgery, especially in right-sided Lenke 5C curve. Thus, preoperative risk evaluation could be insufficient for clinical practice due to aorta movement following correction surgery. Surgeons should be aware of the potential risk of aorta impingement, especially when placing PS in patients with right-sided curves.

Video games and surgical ability: a literature review.

PubMed

Lynch, Jeremy; Aughwane, Paul; Hammond, Toby M

2010-01-01

Surgical training is rapidly evolving because of reduced training hours and the reduction of training opportunities due to patient safety concerns. There is a popular conception that video game usage might be linked to improved operating ability especially those techniques involving endoscopic modalities. If true this might suggest future directions for training. A search was made of the MEDLINE databases for the MeSH term, "Video Games," combined with the terms "Surgical Procedures, Operative," "Endoscopy," "Robotics," "Education," "Learning," "Simulators," "Computer Simulation," "Psychomotor Performance," and "Surgery, Computer-Assisted,"encompassing all journal articles before November 2009. References of articles were searched for further studies. Twelve relevant journal articles were discovered. Video game usage has been studied in relationship to laparoscopic, gastrointestinal endoscopic, endovascular, and robotic surgery. Video game users acquire endoscopic but not robotic techniques quicker, and training on video games appears to improve performance. Copyright (c) 2010 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Surgical Site Infections Following Pediatric Ambulatory Surgery: An Epidemiologic Analysis.

PubMed

Rinke, Michael L; Jan, Dominique; Nassim, Janelle; Choi, Jaeun; Choi, Steven J

2016-08-01

OBJECTIVE To identify surgical site infection (SSI) rates following pediatric ambulatory surgery, SSI outcomes and risk factors, and sensitivity and specificity of SSI administrative billing codes. DESIGN Retrospective chart review of pediatric ambulatory surgeries with International Classification of Disease, Ninth Revision (ICD-9) codes for SSI, and a systematic random sampling of 5% of surgeries without SSI ICD-9 codes, all adjudicated for SSI on the basis of an ambulatory-adapted National Healthcare Safety Network definition. SETTING Urban pediatric tertiary care center April 1, 2009-March 31, 2014. METHODS SSI rates and sensitivity and specificity of ICD-9 codes were estimated using sampling design, and risk factors were analyzed in case-rest of cohort, and case-control, designs. RESULTS In 15,448 pediatric ambulatory surgeries, 34 patients had ICD-9 codes for SSI and 25 met the adapted National Healthcare Safety Network criteria. One additional SSI was identified with systematic random sampling. The SSI rate following pediatric ambulatory surgery was 2.9 per 1,000 surgeries (95% CI, 1.2-6.9). Otolaryngology surgeries demonstrated significantly lower SSI rates compared with endocrine (P=.001), integumentary (P=.001), male genital (P<.0001), and respiratory (P=.01) surgeries. Almost half of patients with an SSI were admitted, 88% received antibiotics, and 15% returned to the operating room. No risk factors were associated with SSI. The sensitivity of ICD-9 codes for SSI following ambulatory surgery was 55.31% (95% CI, 12.69%-91.33%) and specificity was 99.94% (99.89%-99.97%). CONCLUSIONS SSI following pediatric ambulatory surgery occurs at an appreciable rate and conveys morbidity on children. Infect Control Hosp Epidemiol 2016;37:931-938.

Do safety checklists improve teamwork and communication in the operating room? A systematic review.

PubMed

Russ, Stephanie; Rout, Shantanu; Sevdalis, Nick; Moorthy, Krishna; Darzi, Ara; Vincent, Charles

2013-12-01

The aim of this systematic review was to assess the impact of surgical safety checklists on the quality of teamwork and communication in the operating room (OR). Safety checklists have been shown to impact positively on patient morbidity and mortality following surgery, but it is unclear whether this clinical improvement is related to an improvement in OR teamwork and communication. A systematic search strategy of MEDLINE, EMBASE, PsycINFO, Google Scholar, and the Cochrane Database for Systematic Reviews was undertaken to obtain relevant articles. After de-duplication and the addition of limits, 315 articles were screened for inclusion by 2 researchers and all articles meeting a set of prespecified inclusion criteria were retained. Information regarding the type of checklist, study design, assessment tools used, outcomes, and study limitations was extracted. Twenty articles formed the basis of this systematic review. All articles described an empirical study relating to a case-specific safety checklist for surgery as the primary intervention, with some measure of change/improvement in teamwork and/or communication relating to its use. The methods for assessing teamwork and communication varied greatly, including surveys, observations, interviews, and 360° assessments. The evidence suggests that safety checklists improve the perceived quality of OR teamwork and communication and reduce observable errors relating to poor team skills. This is likely to function through establishing an open platform for communication at the start of a procedure: encouraging the sharing of critical case-related information, promoting team coordination and decision making, flagging knowledge gaps, and enhancing team cohesion. However, the evidence would also suggest that when used suboptimally or when individuals have not bought in to the process, checklists may conversely have a negative impact on the function of the team. Safety checklists are beneficial for OR teamwork and communication and this may be one mechanism through which patient outcomes are improved. Future research should aim to further elucidate the relationship between how safety checklists are used and team skills in the OR using more consistent methodological approaches and utilizing validated measures of teamwork such that best practice guidelines can be established.

Integrated HTA-FMEA/FMECA methodology for the evaluation of robotic system in urology and general surgery.

PubMed

Frosini, Francesco; Miniati, Roberto; Grillone, Saverio; Dori, Fabrizio; Gentili, Guido Biffi; Belardinelli, Andrea

2016-11-14

The following study proposes and tests an integrated methodology involving Health Technology Assessment (HTA) and Failure Modes, Effects and Criticality Analysis (FMECA) for the assessment of specific aspects related to robotic surgery involving safety, process and technology. The integrated methodology consists of the application of specific techniques coming from the HTA joined to the aid of the most typical models from reliability engineering such as FMEA/FMECA. The study has also included in-site data collection and interviews to medical personnel. The total number of robotic procedures included in the analysis was 44: 28 for urology and 16 for general surgery. The main outcomes refer to the comparative evaluation between robotic, laparoscopic and open surgery. Risk analysis and mitigation interventions come from FMECA application. The small sample size available for the study represents an important bias, especially for the clinical outcomes reliability. Despite this, the study seems to confirm the better trend for robotics' surgical times with comparison to the open technique as well as confirming the robotics' clinical benefits in urology. More complex situation is observed for general surgery, where robotics' clinical benefits directly measured are the lowest blood transfusion rate.

Efficacy and safety of 1% ropivacaine for postoperative analgesia after lower third molar surgery: a prospective, randomized, double-blinded clinical study.

PubMed

Brković, Božidar; Andrić, Miroslav; Ćalasan, Dejan; Milić, Marija; Stepić, Jelena; Vučetić, Milan; Brajković, Denis; Todorović, Ljubomir

2017-04-01

The purpose of this study was to investigate postoperative analgesic effect of ropivacaine administered as main or supplemental injection for the inferior alveolar nerve block (IANB) in patients undergoing lower third molar surgery. The double-blind randomized study comprised 72 healthy patients. All patients received two blocks, the IANB for surgical procedure + IANB after surgery for postoperative pain control, and were divided into three groups: (1) 2 % lidocaine/epinephrine + 1 % ropivacaine, (2) 2 % lidocaine/epinephrine + saline, and (3) 1 % ropivacaine + saline. The occurrence of postoperative pain, pain intensity and analgesic requirements were recorded. Data were statistically analyzed using chi-square, Fisher, and Kruskal-Wallis tests and analysis of variance (ANOVA) with Bonferroni and Tukey correction. Ropivacaine was more successful than lidocaine/epinephrine in obtaining duration of postoperative analgesia, reduction of pain, and analgesic requirements whether ropivacaine was used for surgical block or administered as a supplemental injection after surgery. Ropivacaine (1 %, 2 ml) resulted in effective postoperative analgesia after lower third molar surgery. Since pain control related to third molar surgery requires the effective surgical anesthesia and postoperative analgesia, the use of 1 % ropivacaine could be clinically relevant in a selection of appropriate pain control regimen for both surgical procedure and early postsurgical treatment.

Safety of Nonoperative Management After Acute Diverticulitis

PubMed Central

Amoza Pais, Sonia; Batlle Marin, Xavi; Oronoz Martinez, Begoña; Balen Ribera, Enrique; Yarnoz Irazabal, Concepción

2014-01-01

Purpose The role of surgery in the management of diverticular disease after an episode of acute diverticulitis (AD) managed in a conservative form is evolving. Age, number of episodes of AD, type of episode, and symptoms after the episodes are factors related to the need for elective surgery. The aim of this study is to evaluate the safety of conservative management and the risk factors for emergency surgery after a first episode of AD managed without surgery. Methods We retrospectively evaluated 405 patients diagnosed as having had a first episode of AD. Sixty-nine patients underwent emergency surgery on the first admission, and 69 patients had an elective operation in the follow-up (group A). The remaining 267 patients were managed initially without surgery (group B). Thirteen of these 267 patients needed a further urgent surgical procedure. Factors involved in the decision of elective surgery and the probability of emergency surgery after the first episode of AD managed without surgery were evaluated in relation to demographic factors, risk factors, presence of recurrences, and type of the first episode. Results Patients, mean age was 62.7 years, 71 were aged less than 51, and 151 were males. The mean follow-up for patients with nonoperative management was 91.2 months. An elective operation was performed in 69 patients. Compared to patients in group B, those in group A more frequently had a first episode of complicated acute diverticulitis (CAD) (37.1% vs. 16.4%; P = 0.000) and were more likely to be smokers (46.3% vs. 19.3%; P = 0.000) and to suffer more than one episode of AD (42% vs. 26.9%; P = 0.027). Nonoperative management was chosen for 267 patients, but 13 patients needed an emergency operation later. In the multivariate analysis, we found a significant relation between the presence of CAD in the first episode and the need for emergency surgery. There were no differences in surgical mortality between the patients in the two groups, but patients treated with elective surgery had a higher rate of stoma than patients treated non-operatively (7.2% vs. 1.4%; P = 0.028); this difference was not observed in the subgroup of patients with CAD (15.3% vs. 6.8%; P = 0.458). Conclusion After an episode of AD, nonoperative management is safe because fewer than 5% of patients will need an emergent procedure in a subsequent attack of AD. A first episode of CAD is the only risk factor for emergency surgery in patients managed conservatively. PMID:25360428

Speeding Up Team Learning.

ERIC Educational Resources Information Center

Edmondson, Amy; Bohmer, Richard; Pisano, Gary

2001-01-01

A study of 16 cardiac surgery teams looked at how the teams adapted to new ways of working. The challenge of team management is to implement new processes as quickly as possible. Steps for creating a learning team include selecting a mix of skills and expertise, framing the challenge, and creating an environment of psychological safety. (JOW)

Cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery, the TimeToStop (TTS) trial: study protocol for a randomized controlled trial.

PubMed

Boshuisen, Kim; Lamberink, Herm J; van Schooneveld, Monique Mj; Cross, J Helen; Arzimanoglou, Alexis; van der Tweel, Ingeborg; Geleijns, Karin; Uiterwaal, Cuno Spm; Braun, Kees Pj

2015-10-26

The goals of intentional curative pediatric epilepsy surgery are to achieve seizure-freedom and antiepileptic drug (AED) freedom. Retrospective cohort studies have indicated that early postoperative AED withdrawal unmasks incomplete surgical success and AED dependency sooner, but not at the cost of long-term seizure outcome. Moreover, AED withdrawal seemed to improve cognitive outcome. A randomized trial is needed to confirm these findings. We hypothesized that early AED withdrawal in children is not only safe, but also beneficial with respect to cognitive functioning. This is a multi-center pragmatic randomized clinical trial to investigate whether early AED withdrawal improves cognitive function, in terms of attention, executive function and intelligence, quality of life and behavior, and to confirm safety in terms of eventual seizure freedom, seizure recurrences and "seizure and AED freedom." Patients will be randomly allocated in parallel groups (1:1) to either early or late AED withdrawal. Randomization will be concealed and stratified for preoperative IQ and medical center. In the early withdrawal arm reduction of AEDs will start 4 months after surgery, while in the late withdrawal arm reduction starts 12 months after surgery, with intended complete cessation of drugs after 12 and 20 months respectively. Cognitive outcome measurements will be performed preoperatively, and at 1 and 2 years following surgery, and consist of assessment of attention and executive functioning using the EpiTrack Junior test and intelligence expressed as IQ (Wechsler Intelligence Scales). Seizure outcomes will be assessed at 24 months after surgery, and at 20 months following start of AED reduction. We aim to randomize 180 patients who underwent anticipated curative epilepsy surgery below 16 years of age, were able to perform the EpiTrack Junior test preoperatively, and have no predictors of poor postoperative seizure prognosis (multifocal magnetic resonance imaging (MRI) abnormalities, incomplete resection of the lesion, epileptic postoperative electroencephalogram (EEG) abnormalities, or more than three AEDs at the time of surgery). Growing experience with epilepsy surgery has changed the view towards postoperative medication policy. In a European collaboration, we designed a multi-center pragmatic randomized clinical trial comparing early with late AED withdrawal to investigate benefits and safety of early AED withdrawal. The TTS trial is supported by the Dutch Epilepsy Fund (NL 08-10) ISRCTN88423240/ 08/05/2013.

Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials

PubMed Central

Santagostino, E; Lentz, S R; Misgav, M; Brand, B; Chowdary, P; Savic, A; Kilinc, Y; Amit, Y; Amendola, A; Solimeno, L P; Saugstrup, T; Matytsina, I

2015-01-01

Recombinant factor VIII (rFVIII) products provide a safe and efficacious replacement therapy for prevention and treatment of bleeding episodes in patients with haemophilia A. The present investigations from the multinational, open-label guardian™ clinical trials assessed the haemostatic response of turoctocog alfa (NovoEight®), a rFVIII product, in patients with severe haemophilia A (FVIII ≤ 1%) undergoing surgery. All patients had a minimum of 50 exposure days to any FVIII product prior to surgery and no history of inhibitors. A total of 41 procedures (13 orthopaedic, 19 dental and 9 general) were performed in 33 patients aged 4–59 years. Of the 41 procedures, 15 were major surgeries in 13 patients and 26 were minor surgeries in 21 patients. The success rate for haemostatic response was 100% (success was defined as ‘excellent’ or ‘good’ haemostatic outcome). Turoctocog alfa consumption on the day of surgery ranged from 27 to 153 IU kg−1. The mean daily dose declined over time, while retaining adequate FVIII coverage as measured by trough levels. Overall, no safety issues were identified. No thrombotic events were observed and none of the patients developed FVIII inhibitors. In conclusion, the present results show that turoctocog alfa was effective in controlling blood loss by obtaining a sufficient haemostatic response in patients with severe haemophilia A undergoing surgery. PMID:25273984

Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials.

PubMed

Santagostino, E; Lentz, S R; Misgav, M; Brand, B; Chowdary, P; Savic, A; Kilinc, Y; Amit, Y; Amendola, A; Solimeno, L P; Saugstrup, T; Matytsina, I

2015-01-01

Recombinant factor VIII (rFVIII) products provide a safe and efficacious replacement therapy for prevention and treatment of bleeding episodes in patients with haemophilia A. The present investigations from the multinational, open-label guardian(™) clinical trials assessed the haemostatic response of turoctocog alfa (NovoEight(®)), a rFVIII product, in patients with severe haemophilia A (FVIII ≤ 1%) undergoing surgery. All patients had a minimum of 50 exposure days to any FVIII product prior to surgery and no history of inhibitors. A total of 41 procedures (13 orthopaedic, 19 dental and 9 general) were performed in 33 patients aged 4-59 years. Of the 41 procedures, 15 were major surgeries in 13 patients and 26 were minor surgeries in 21 patients. The success rate for haemostatic response was 100% (success was defined as 'excellent' or 'good' haemostatic outcome). Turoctocog alfa consumption on the day of surgery ranged from 27 to 153 IU kg(-1). The mean daily dose declined over time, while retaining adequate FVIII coverage as measured by trough levels. Overall, no safety issues were identified. No thrombotic events were observed and none of the patients developed FVIII inhibitors. In conclusion, the present results show that turoctocog alfa was effective in controlling blood loss by obtaining a sufficient haemostatic response in patients with severe haemophilia A undergoing surgery. © 2014 The Authors. Haemophilia Published by John Wiley & Sons Ltd.

Perioperative complications and safety of type II thyroplasty (TPII) for adductor spasmodic dysphonia.

PubMed

Mizoguchi, Kenji; Hatakeyama, Hiromitsu; Yanagida, Saori; Nishizawa, Noriko; Oridate, Nobuhiko; Fukuda, Satoshi; Homma, Akihiro

2017-05-01

Type II thyroplasty (TPII) is one of the surgical options offered in the management of adductor spasmodic dysphonia (AdSD); however, there have been no detailed reports of its safety and associated complications during the perioperative period. Our aim was to assess the complications and safety of TPII. TPII was performed for consecutive 15 patients with AdSD from April 2012 through May 2014. We examined retrospectively the perioperative complications, the degree of surgical invasion, and recovery process from surgery. All patients underwent successful surgery under only local anesthesia. Vocal fold erythema was observed in 14 patients and vocal fold edema in 10 patients; however, all of them showed complete resolution within 1 month. No patient experienced severe complications such as acute airway distress or hemorrhage. Fourteen patients were able to have oral from the 1st postoperative morning, with the remaining patient able to have oral intake from the 2nd postoperative day. In addition, no patient experienced aspiration postoperatively. In conclusion, only minor complications were observed in association with TPII in this study. No dysphagia was observed postoperatively, which is an advantage over other treatments. The results of our study suggest that TPII is a safe surgical treatment for AdSD.

Efficacy and Safety of Transdermal Buprenorphine versus Oral Tramadol/Acetaminophen in Patients with Persistent Postoperative Pain after Spinal Surgery

PubMed Central

Kim, Jin-Hwan; Kim, Hak-Sun; Min, Woo-Kie; Park, Ye-Soo; Lee, Kyu-Yeol; Lee, Jung-Hee

2017-01-01

Purpose Control of persistent pain following spinal surgery is an unmet clinical need. This study compared the efficacy and safety of buprenorphine transdermal system (BTDS) to oral tramadol/acetaminophen (TA) in Korean patients with persistent, moderate pain following spinal surgery. Methods Open-label, interventional, randomized multicenter study. Adults with persistent postoperative pain (Numeric Rating Scale [NRS] ≥ 4 at 14–90 days postsurgery) were enrolled. Patients received once-weekly BTDS (n = 47; 5 μg/h titrated to 20 μg/h) or twice-daily TA (n = 40; tramadol 37.5 mg/acetaminophen 325 mg, one tablet titrated to 4 tablets) for 6 weeks. The study compared pain reduction with BTDS versus TA at week 6. Quality of life (QoL), treatment satisfaction, medication compliance, and adverse events (AEs) were assessed. Findings At week 6, both groups reported significant pain reduction (mean NRS change: BTDS −2.02; TA −2.76, both P < 0.0001) and improved QoL (mean EQ-5D index change: BTDS 0.10; TA 0.19, both P < 0.05). The BTDS group achieved better medication compliance (97.8% versus 91.0%). Incidence of AEs (26.1% versus 20.0%) and adverse drug reactions (20.3% versus 16.9%) were comparable between groups. Implications For patients with persistent pain following spinal surgery, BTDS is an alternative to TA for reducing pain and supports medication compliance. This trial is registered with Clinicaltrials.gov: NCT01983111. PMID:29056859

Safety of elective hand surgery following axillary lymph node dissection for breast cancer.

PubMed

Hershko, Dan D; Stahl, Shalom

2007-01-01

The development of lymphedema is the most feared complication shared by breast cancer survivors undergoing hand surgery after prior axillary lymph node dissection (ALND). Traditionally, these patients are advised to avoid any interventional procedures in the ipsilateral upper extremity. However, the appropriateness of some of these precautions was recently challenged by some surgeons claiming that elective hand operations can be safely performed in these patients. The purpose of this study was to evaluate our experience and determine the safety of elective hand operations in breast cancer survivors. The medical records of patients operated for different hand conditions after prior breast surgery and ALND at our institution between 1983 and 2002 were reviewed. The techniques and preventive measures performed, use of antibiotics, and upper extremity complications associated with the operations were analyzed. Overall, we operated on 27 patients after prior ALND performed for breast cancer. Follow-up was available for 25 patients. Four patients had pre-existing lymphedema. The surgical technique used was similar to that performed in patients without prior ALND and antibiotic prophylaxis was not given. Delayed wound healing was observed in one patient and finger joint stiffness in another. Two patients with pre-existing lymphedema developed temporary worsening of their condition. None of the patients developed new lymphedema. The results of the present study support the few previous studies, suggesting that hand surgery can be safely performed in patients with prior ALND. Based on these findings, the appropriateness of the rigorous precautions and prohibitions regarding the care and use of the ipsilateral upper extremity may need to be reconsidered.

Risk factors for postoperative complications in robotic general surgery.

PubMed

Fantola, Giovanni; Brunaud, Laurent; Nguyen-Thi, Phi-Linh; Germain, Adeline; Ayav, Ahmet; Bresler, Laurent

2017-03-01

The feasibility and safety of robotically assisted procedures in general surgery have been reported from various groups worldwide. Because postoperative complications may lead to longer hospital stays and higher costs overall, analysis of risk factors for postoperative surgical complications in this subset of patients is clinically relevant. The goal of this study was to identify risk factors for postoperative morbidity after robotic surgical procedures in general surgery. We performed an observational monocentric retrospective study. All consecutive robotic surgical procedures from November 2001 to December 2013 were included. One thousand consecutive general surgery patients met the inclusion criteria. The mean overall postoperative morbidity and major postoperative morbidity (Clavien >III) rates were 20.4 and 6 %, respectively. This included a conversion rate of 4.4 %, reoperation rate of 4.5 %, and mortality rate of 0.2 %. Multivariate analysis showed that ASA score >3 [OR 1.7; 95 % CI (1.2-2.4)], hematocrit value <38 [OR 1.6; 95 % CI (1.1-2.2)], previous abdominal surgery [OR 1.5; 95 % CI (1-2)], advanced dissection [OR 5.8; 95 % CI (3.1-10.6)], and multiquadrant surgery [OR 2.5; 95 % CI (1.7-3.8)] remained independent risk factors for overall postoperative morbidity. It also showed that advanced dissection [OR 4.4; 95 % CI (1.9-9.6)] and multiquadrant surgery [OR 4.4; 95 % CI (2.3-8.5)] remained independent risk factors for major postoperative morbidity (Clavien >III). This study identifies independent risk factors for postoperative overall and major morbidity in robotic general surgery. Because these factors independently impacted postoperative complications, we believe they could be taken into account in future studies comparing conventional versus robot-assisted laparoscopic procedures in general surgery.

Holmium: yttrium aluminum garnet laser-assisted endoscopic sinus surgery: laboratory experience.

PubMed

Shapshay, S M; Rebeiz, E E; Bohigian, R K; Hybels, R L; Aretz, H T; Pankratov, M M

1991-02-01

Endoscopic sinus surgery has gained wide acceptance since its introduction into the United States. Complex sinus anatomy and troublesome bleeding have been associated with complications, which vary in severity from synechia to blindness and leakage of cerebrospinal fluid. Endoscopic sinus surgery using a holmium: yttrium aluminum garnet pulsed solid-state laser oscillating at 2.1 microns with fiberoptic delivery was performed in the laboratory, and the results were compared with those of conventional endoscopic sinus surgery. Three beagle dogs, six human cadaver heads, and one calf head were used in the in vivo and in vitro studies to evaluate the bone ablation, tissue coagulation, and hemostatic properties of the holmium: yttrium aluminum garnet laser. Modified endoscopic telescopes for sinus surgery, a newly developed handpiece for fiberoptic delivery, and other surgical instruments were used. The results indicate that the holmium: yttrium aluminum garnet laser and new delivery instrumentation provide good hemostasis and controlled soft-tissue ablation and bone removal. The access to all sinuses in the human cadaver model was very good. The canine in vivo study showed delayed but complete healing on the laser-treated side. Clinical evaluation of the holmium: yttrium aluminum garnet laser is warranted to increase the precision and safety of endoscopic sinus surgery.

Preoperative immobility significantly impacts the risk of postoperative complications in bariatric surgery patients.

PubMed

Higgins, Rana M; Helm, Melissa; Gould, Jon C; Kindel, Tammy L

2018-06-01

Preoperative immobility in general surgery patients has been associated with an increased risk of postoperative complications. It is unknown if immobility affects bariatric surgery outcomes. The aim of this study was to determine the impact of immobility on 30-day postoperative bariatric surgery outcomes. This study took place at a university hospital in the United States. The Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program 2015 data set was queried for primary minimally invasive bariatric procedures. Preoperative immobility was defined as limited ambulation most or all the time. Logistic regression analysis was performed to determine if immobile patients are at increased risk (odds ratio [OR]) for 30-day complications. There were 148,710 primary minimally invasive bariatric procedures in 2015. Immobile patients had an increased risk of mortality (OR 4.59, P<.001) and greater operative times, length of stay, reoperation rates, and readmissions. Immobile patients had a greater risk of multiple complications, including acute renal failure (OR 6.42, P<.001), pulmonary embolism (OR 2.44, P = .01), cardiac arrest (OR 2.81, P = .05), and septic shock (OR 2.78, P = .02). Regardless of procedure type, immobile patients had a higher incidence of perioperative morbidity compared with ambulatory patients. This study is the first to specifically assess the impact of immobility on 30-day bariatric surgery outcomes. Immobile patients have a significantly increased risk of morbidity and mortality. This study provides an opportunity for the development of multiple quality initiatives to improve the safety and perioperative complication profile for immobile patients undergoing bariatric surgery. Copyright © 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Safety and efficacy of office-based surgery with monitored anesthesia care/sedation in 4778 consecutive plastic surgery procedures.

PubMed

Bitar, George; Mullis, William; Jacobs, William; Matthews, David; Beasley, Michael; Smith, Kevin; Watterson, Paul; Getz, Stanley; Capizzi, Peter; Eaves, Felmont

2003-01-01

Office-based surgery has several potential benefits over hospital-based surgery, including cost containment, ease of scheduling, and convenience to both patients and surgeons. Scrutiny of office-based surgery by regulators and state-licensing agencies has increased and must be addressed by improved documentation of safety and efficacy. To evaluate the safety and efficacy of the authors' office-based plastic surgery, a review was undertaken of 3615 consecutive patients undergoing 4778 outpatient plastic surgery procedures under monitored anesthesia care/sedation in a single office. The charts of 3615 consecutive patients who had undergone office-based surgery with monitored anesthesia care/sedation between May of 1995 and May of 2000 were reviewed. In all cases, the anesthesia protocol used included sedation with midazolam, propofol, and a narcotic administered by a board-certified registered nurse anesthetist with local anesthesia provided by the surgeon. Charts were reviewed for patient profile, types of procedures, multiple procedures, duration of anesthesia, American Society of Anesthesiologists class, and complications related to anesthesia. Outcomes measured included death, airway compromise, dyspnea, hypotension, venous thrombosis, pulmonary emboli, protracted nausea and vomiting lasting more than 24 hours, and unplanned hospital admissions. Statistical analyses were performed using the Microsoft Excel program and the SAS package. Results were as follows: 92.3 percent of the patients were female and 7.7 percent were male, with a mean age of 42.7 years (range, 3 to 83 years). Patients underwent aesthetic (95.6 percent) and reconstructive (4.4 percent) plastic surgery procedures. Same-session multiple procedures occurred in 24.8 percent of patients. The vast majority of patients were healthy: 84.3 percent of patients were American Society of Anesthesiologists class I, 15.6 percent were class II, and 0.1 percent were class III. The operations required a mean of 111 minutes. There were no deaths, ventilator requirements, deep venous thromboses, or pulmonary emboli. Complications were as follows: 0.05 percent (n = 2) of patients had dyspnea that resolved, 0.2 percent (n = 6) of patients had protracted nausea and vomiting, and 0.05 percent (n = 2) of patients had unplanned hospital admissions (<24 hours). One patient had an emergent intubation. No prolonged adverse effects were noted. There was a 30-day follow-up minimum. Outpatient surgery is an important aspect of plastic surgery. It was shown that office-based surgery with intravenous sedation, performed by board-certified plastic surgeons and nurse anesthetists, is safe. Appropriate accreditation, safe anesthesia protocols, and proper patient selection constitute the basis for safe and efficacious office-based outpatient plastic surgery.

Preventing Postoperative Atrial Fibrillation After Noncardiac Surgery: A Meta-analysis.

PubMed

Oesterle, Adam; Weber, Benjamin; Tung, Roderick; Choudhry, Niteesh K; Singh, Jagmeet P; Upadhyay, Gaurav A

2018-07-01

Although postoperative atrial fibrillation is common after noncardiac surgery, there is a paucity of data regarding prophylaxis. We sought to determine whether pharmacologic prophylaxis reduces the incidence of postoperative atrial fibrillation after noncardiac surgery. We performed an electronic search of Ovid MEDLINE, the Cochrane central register of controlled trials database, and SCOPUS from inception to September 7, 2016 and included prospective randomized studies in which patients in sinus rhythm underwent noncardiac surgery and examined the incidence of postoperative atrial fibrillation as well as secondary safety outcomes. Twenty-one studies including 11,608 patients were included. Types of surgery included vascular surgery (3465 patients), thoracic surgery (2757 patients), general surgery (2292 patients), orthopedic surgery (1756 patients), and other surgery (1338 patients). Beta-blockers (relative risk [RR] 0.32; 95% confidence interval [CI], 0.11-0.87), amiodarone (RR 0.42; 95% CI, 0.26 to 0.67), and statins (RR 0.43; 95% CI, 0.27 to 0.68) reduced postoperative atrial fibrillation compared with placebo or active controls. Calcium channel blockers (RR 0.55; 95% CI, 0.30 to 1.01), digoxin (RR 1.62; 95% CI, 0.95 to 2.76), and magnesium (RR 0.73; 95% CI, 0.23 to 2.33) had no statistically significant effect on postoperative atrial fibrillation incidence. The incidence of adverse events was comparable across agents, except for increased mortality (RR 1.33; 95% CI, 1.03 to 1.37) and bradycardia (RR 2.74; 95% CI, 2.19 to 3.43) in patients receiving beta-blockers. Pharmacologic prophylaxis with amiodarone, beta-blockers, or statins reduces the incidence of postoperative atrial fibrillation after noncardiac surgery. Amiodarone and statins have a relatively low overall risk of short-term adverse events. Copyright © 2018 Elsevier Inc. All rights reserved.

The structure, organisation and perioperative management of ambulatory surgery and anaesthesia in France: Methodology of the SFAR-OPERA study.

PubMed

Albaladejo, Pierre; Aubrun, Frédéric; Samama, Charles-Marc; Jouffroy, Laurent; Beaussier, Marc; Benhamou, Dan; Romegoux, Pauline; Skaare, Kristina; Bosson, Jean-Luc; Ecoffey, Claude

2017-10-01

The organization of health care establishments and perioperative care are essential for ensuring the quality of care and safety of patients undergoing outpatient surgery. In order to correctly inventory these organizations and practices, in 2013-2014, the French society of anaesthesia and intensive care organized an extensive practical survey in French ambulatory surgery units entitled the "OPERA" study (Organisation periopératoire de l'anesthésie en chirurgie ambulatoire). From among all of the ambulatory surgery centres listed by the Agences régionales de santé (Regional health agencies, France), 206 public and private centres were randomly selected. A structural (typology, organization) survey and a medical-practice survey (focusing on the management of postoperative pain, nausea and vomiting as well as the prevention of venous thromboembolism) were collected and managed by a prospective audit of practices occurring on two randomly selected days. The latter was further accompanied by an additional audit specifically focussing on ten representative procedures: (1) stomatology surgery (third molar removal); (2) knee arthroscopy; (3) surgery of the abdominal wall (including inguinal hernia); (4) perianal surgery; (5) varicose vein surgery; (6) digestive laparoscopy-cholecystectomy; (7) breast surgery (tumourectomy); (8) uterine surgery; (9) hallux valgus and (10) hand surgery (excluding carpal tunnel). Over the 2 days of observation, 7382 patients were included comprising 2174 patients who underwent one of the procedures from the above list. The analysis of these data will provide an overview of the organization of health establishments, the modalities thus supported and compliance with standards. Copyright © 2016 Société française d'anesthésie et de réanimation (Sfar). Published by Elsevier Masson SAS. All rights reserved.

Surgery combined with intraoperative hyperthermic intraperitoneal chemotherapy (IHIC) for gastric cancer: a systematic review and meta-analysis of randomised controlled trials.

PubMed

Mi, Deng-Hai; Li, Zheng; Yang, Ke-Hu; Cao, Nong; Lethaby, Anne; Tian, Jin-Hui; Santesso, Nancy; Ma, Bin; Chen, Yao-Long; Liu, Ya-Li

2013-01-01

Adjuvant intraoperative hyperthermic intraperitoneal chemotherapy (IHIC) is a therapy which combines thermotherapy and intraperitoneal chemotherapy. It is theoretically powerful for patients with advanced gastric cancer (AGC), but is there evident advantage in clinical practice? We need evidence to guide our decision-making. Meta-analysis was performed to assess the effectiveness and safety of adjuvant intraoperative hyperthermic intraperitoneal chemotherapy (IHIC) for patients with resectable locally advanced gastric cancer, and to provide the reference for clinical practice and study. We searched the Cochrane Library, PubMed, Embase, Web of Science and Chinese databases (Chinese BioMedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI) and Wanfang) electronically and also retrieved papers from other sources (tracing related references and communication with other authors). All relevant randomised controlled trials (RCTs) were collected to compare surgery combined with IHIC to surgery without IHIC for AGC. There were no language restrictions. After independent quality assessment and data extraction by two reviewers, meta-analysis was conducted by RevMan 5.1 software. 16 RCTs involving 1,906 patients were included. Compared with surgery alone, combination therapy (surgery plus IHIC) was associated with a significant improvement in survival rate at 1 year (hazard ratio (HR) = 2.99; 95% confidence interval (CI) = 2.21 to 4.05; p < 0.00001), 2 years (HR = 2.43; 95%CI = 1.81 to 3.26; p < 0.00001), 3 years (HR = 2.63; 95%CI = 2.17 to 3.20; p < 0.00001), 5 years (HR = 2.49; 95%CI = 1.97 to 3.14; p < 0.00001), and 9 years (HR = 2.14; 95%CI = 1.38 to 3.32; p = 0.0007). Compared with surgery alone, combination therapy was associated with a significant reduction in recurrence rate at 2 years (RR = 0.42; 95%CI = 0.29 to 0.61; p < 0.00001), 3 years (RR = 0.35; 95%CI = 0.24 to 0.51; p < 0.00001) and 5 years (RR = 0.47; 95%CI = 0.39 to 0.56; p < 0.00001). IHIC was not found to be associated with higher risks of anastomotic leakage, ileus, bowel perforation, myelosuppression, gastrointestinal reaction and hypohepatia, but it increased the incidence of abdominal pain (RR = 21.46; 95%CI = 5.24 to 87.78; p < 0.00001). Compared with surgery alone, surgery combined with IHIC can improve survival rate and reduce the recurrence rate, with acceptable safety. However, safety outcomes should be further evaluated by larger samples and high quality studies. Additionally, hyperthermia for the intraperitoneal chemotherapy needs more clinical research.

Laparoscopic colorectal surgery: Current status and implementation of the latest technological innovations.

PubMed

Pascual, Marta; Salvans, Silvia; Pera, Miguel

2016-01-14

The introduction of laparoscopy is an example of surgical innovation with a rapid implementation in many areas of surgery. A large number of controlled studies and meta-analyses have shown that laparoscopic colorectal surgery is associated with the same benefits than other minimally invasive procedures, including lesser pain, earlier recovery of bowel transit and shorter hospital stay. On the other hand, despite initial concerns about oncological safety, well-designed prospective randomized multicentre trials have demonstrated that oncological outcomes of laparoscopy and open surgery are similar. Although the use of laparoscopy in colorectal surgery has increased in recent years, the percentages of patients treated with surgery using minimally invasive techniques are still reduced and there are also substantial differences among centres. It has been argued that the limiting factor for the use of laparoscopic procedures is the number of surgeons with adequate skills to perform a laparoscopic colectomy rather than the tumour of patients' characteristics. In this regard, future efforts to increase the use of laparoscopic techniques in colorectal surgery will necessarily require more efforts in teaching surgeons. We here present a review of recent controversies of the use of laparoscopy in colorectal surgery, such as in rectal cancer operations, the possibility of reproducing complete mesocolon excision, and the benefits of intra-corporeal anastomosis after right hemicolectomy. We also describe the results of latest innovations such as single incision laparoscopic surgery, robotic surgery and natural orifice transluminal endoscopic surgery for colon and rectal diseases.

Laparoscopic colorectal surgery: Current status and implementation of the latest technological innovations

PubMed Central

Pascual, Marta; Salvans, Silvia; Pera, Miguel

2016-01-01

The introduction of laparoscopy is an example of surgical innovation with a rapid implementation in many areas of surgery. A large number of controlled studies and meta-analyses have shown that laparoscopic colorectal surgery is associated with the same benefits than other minimally invasive procedures, including lesser pain, earlier recovery of bowel transit and shorter hospital stay. On the other hand, despite initial concerns about oncological safety, well-designed prospective randomized multicentre trials have demonstrated that oncological outcomes of laparoscopy and open surgery are similar. Although the use of laparoscopy in colorectal surgery has increased in recent years, the percentages of patients treated with surgery using minimally invasive techniques are still reduced and there are also substantial differences among centres. It has been argued that the limiting factor for the use of laparoscopic procedures is the number of surgeons with adequate skills to perform a laparoscopic colectomy rather than the tumour of patients’ characteristics. In this regard, future efforts to increase the use of laparoscopic techniques in colorectal surgery will necessarily require more efforts in teaching surgeons. We here present a review of recent controversies of the use of laparoscopy in colorectal surgery, such as in rectal cancer operations, the possibility of reproducing complete mesocolon excision, and the benefits of intra-corporeal anastomosis after right hemicolectomy. We also describe the results of latest innovations such as single incision laparoscopic surgery, robotic surgery and natural orifice transluminal endoscopic surgery for colon and rectal diseases. PMID:26811618

Trabecular micro-bypass stent implantation during small-incision cataract surgery for open-angle glaucoma or ocular hypertension: Long-term results.

PubMed

Neuhann, Tobias H

2015-12-01

To evaluate long-term safety and efficacy of iStent trabecular micro-bypass stent implantation during cataract surgery in patients with primary open-angle, pseudo-exfoliation glaucoma, ocular hypertension, or secondary or post-traumatic glaucoma. AaM Augenklinik am Marienplatz, Munich, Germany. Prospective, open-label, non-randomized study. Preoperative and postoperative evaluations included intra-ocular pressure (IOP), topical ocular hypotensive medication use, cup/disc ratio, corrected-distance visual acuity (CDVA), complications, and adverse events. A single trabecular micro-bypass stent was implanted through the same temporal, limbal incision used for cataract surgery via phacoemulsification in a consecutive series of 62 eyes of 43 patients. To date, a total of 41 eyes have been followed for 3 years postoperatively, whereas long-term postoperative follow-up on the remaining patients is ongoing. Mean preoperative IOP was 24.1 ± 6.9 mm Hg on a mean of 1.8 medications (±0.9). Analyses of eyes with no secondary surgical intervention showed mean IOP reduction to 14.8 ± 4.2 mm Hg at 12 months (n = 61), 14.5 ± 2.2 mm Hg at 24 months (n = 42), and 14.9 ± 2.3 mm Hg at 36 months (n = 39). Medications were eliminated in 74% of eyes at 36 months. Five eyes, 4 with previous glaucoma surgeries and 1 with pseudo-exfoliation syndrome, required additional glaucoma surgery after stent implantation. No intra-operative or postoperative complications typically seen with conventional glaucoma surgeries occurred after stent implantation. At 36 months, CDVA was 20/40 or better in 38 eyes (93%). Trabecular micro-bypass stent implantation during cataract surgery was safe and effective in patients with ocular hypertension or glaucoma as measured by a sustained reduction in IOP and medication use and an excellent safety profile through 3 years after surgery. Dr. Neuhann has no financial or proprietary interest in any material or method mentioned. Glaukos Corp. provided editorial assistance in the preparation of the manuscript. Copyright © 2015 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Safe surgery: validation of pre and postoperative checklists 1

PubMed Central

Alpendre, Francine Taporosky; Cruz, Elaine Drehmer de Almeida; Dyniewicz, Ana Maria; Mantovani, Maria de Fátima; Silva, Ana Elisa Bauer de Camargo e; dos Santos, Gabriela de Souza

2017-01-01

ABSTRACT Objective: to develop, evaluate and validate a surgical safety checklist for patients in the pre and postoperative periods in surgical hospitalization units. Method: methodological research carried out in a large public teaching hospital in the South of Brazil, with application of the principles of the Safe Surgery Saves Lives Programme of the World Health Organization. The checklist was applied to 16 nurses of 8 surgical units and submitted for validation by a group of eight experts using the Delphi method online. Results: the instrument was validated and it was achieved a mean score ≥1, level of agreement ≥75% and Cronbach’s alpha >0.90. The final version included 97 safety indicators organized into six categories: identification, preoperative, immediate postoperative, immediate postoperative, other surgical complications, and hospital discharge. Conclusion: the Surgical Safety Checklist in the Pre and Postoperative periods is another strategy to promote patient safety, as it allows the monitoring of predictive signs and symptoms of surgical complications and the early detection of adverse events. PMID:28699994

Can povidone-iodine solution be used safely in a spinal surgery?

PubMed

Chang, Fang-Yeng; Chang, Ming-Chau; Wang, Shih-Tien; Yu, Wing-Kwang; Liu, Chien-Lin; Chen, Tain-Hsiung

2006-06-01

Intra-operative incidental contamination of surgical wounds is not rare. Povidone-iodine solution can be used to disinfect surgical wounds. Although povidone-iodine is a good broad-spectrum disinfecting agent, it has occasionally been reported to have a negative effect on wound healing and bone union. Therefore, its safety in a spinal surgery is unclear. A prospective, single-blinded, randomized study was accordingly conducted to evaluate the safety of povidone-iodine solution in spinal surgeries. Ascertained herein was the effect of wound irrigation with diluted povidone-iodine solution on wound healing, infection rate, fusion status and clinical outcome of spinal surgeries. From January 2002 to August 2003, 244 consecutive cases undergoing primary instrumented lumbosacral posterolateral fusion due to degenerative spinal disorder with segmental instability had been collected and randomly divided into two groups: the study group (120 cases, 212 fusion levels) and the control group (124 cases, 223 fusion levels). Excluded were those patients with a prior spinal surgery, spinal trauma, malignant tumor, infectious spondylitis, rheumatoid arthritis, ankylosing spondylitis, metabolic bone disease, skeletal immaturity or with an immunosuppressive treatment. In the former group, wounds were irrigated with 0.35% povidone-iodine solution followed by normal saline solution just before the bone-grafting and instrumentation procedure. However, only with normal saline solution in the latter. All the operations were done by the same surgeon with a standard technique. All the patients were treated in the same postoperative fashion as well. Later on, wound healing, infection rate, spinal bone fusion and clinical outcome were evaluated in both groups. A significant improvement of back and leg pain scores, modified Japanese Orthopedic Association function scores (JOA) and ambulatory capacity have been observed in both groups. One hundred and seven patients in the study group and one hundred and nine in the control group achieved solid union. There was no infection in the study group but six deep infections in the control group. Wound dehiscence was noted in one group 1 and two group 2 patients. A subsequent statistical analysis revealed higher infection rate in the control group (P<0.05), but no significant difference in fusion rate, wound healing, improvement of pain score, function score and ambulatory capacity between the two groups. Diluted povidone-iodine solution can be used safely in spinal surgeries, and it will not influence wound healing, bone union and clinical outcome.

Locating Errors Through Networked Surveillance: A Multimethod Approach to Peer Assessment, Hazard Identification, and Prioritization of Patient Safety Efforts in Cardiac Surgery.

PubMed

Thompson, David A; Marsteller, Jill A; Pronovost, Peter J; Gurses, Ayse; Lubomski, Lisa H; Goeschel, Christine A; Gosbee, John W; Wahr, Joyce; Martinez, Elizabeth A

2015-09-01

The objectives were to develop a scientifically sound and feasible peer-to-peer assessment model that allows health-care organizations to evaluate patient safety in cardiovascular operating rooms and to establish safety priorities for improvement. The locating errors through networked surveillance study was conducted to identify hazards in cardiac surgical care. A multidisciplinary team, composed of organizational sociology, organizational psychology, applied social psychology, clinical medicine, human factors engineering, and health services researchers, conducted the study. We used a transdisciplinary approach, which integrated the theories, concepts, and methods from each discipline, to develop comprehensive research methods. Multiple data collection was involved: focused literature review of cardiac surgery-related adverse events, retrospective analysis of cardiovascular events from a national database in the United Kingdom, and prospective peer assessment at 5 sites, involving survey assessments, structured interviews, direct observations, and contextual inquiries. A nominal group methodology, where one single group acts to problem solve and make decisions was used to review the data and develop a list of the top priority hazards. The top 6 priority hazard themes were as follows: safety culture, teamwork and communication, infection prevention, transitions of care, failure to adhere to practices or policies, and operating room layout and equipment. We integrated the theories and methods of a diverse group of researchers to identify a broad range of hazards and good clinical practices within the cardiovascular surgical operating room. Our findings were the basis for a plan to prioritize improvements in cardiac surgical care. These study methods allowed for the comprehensive assessment of a high-risk clinical setting that may translate to other clinical settings.

Blood glucose management in the patient undergoing cardiac surgery: A review

PubMed Central

Reddy, Pingle; Duggar, Brian; Butterworth, John

2014-01-01

Both diabetes mellitus and hyperglycemia per se are associated with negative outcomes after cardiac surgery. In this article, we review these associations, the possible mechanisms that lead to adverse outcomes, and the epidemiology of diabetes focusing on those patients requiring cardiac surgery. We also examine outpatient and perioperative management of diabetes with the same focus. Finally, we discuss our own efforts to improve glycemic management of patients undergoing cardiac surgery at our institution, including keys to success, results of implementation, and patient safety concerns. PMID:25429332

Impact of model-based risk analysis for liver surgery planning.

PubMed

Hansen, C; Zidowitz, S; Preim, B; Stavrou, G; Oldhafer, K J; Hahn, H K

2014-05-01

A model-based risk analysis for oncologic liver surgery was described in previous work (Preim et al. in Proceedings of international symposium on computer assisted radiology and surgery (CARS), Elsevier, Amsterdam, pp. 353–358, 2002; Hansen et al. Int I Comput Assist Radiol Surg 4(5):469–474, 2009). In this paper, we present an evaluation of this method. To prove whether and how the risk analysis facilitates the process of liver surgery planning, an explorative user study with 10 liver experts was conducted. The purpose was to compare and analyze their decision-making. The results of the study show that model-based risk analysis enhances the awareness of surgical risk in the planning stage. Participants preferred smaller resection volumes and agreed more on the safety margins’ width in case the risk analysis was available. In addition, time to complete the planning task and confidence of participants were not increased when using the risk analysis. This work shows that the applied model-based risk analysis may influence important planning decisions in liver surgery. It lays a basis for further clinical evaluations and points out important fields for future research.

The commercialization of plastic surgery.

PubMed

Swanson, Eric

2013-09-01

The last decade has brought a major challenge to the traditional practice of plastic surgery from corporations that treat plastic surgery as a commercial product and market directly to the public. This corporate medicine model may include promotion of a trademarked procedure or device, national advertising that promises stunning results, sales consultants, and claims of innovation, superiority, and improved safety. This article explores the ethics of this business practice and whether corporate medicine is a desirable model for patients and plastic surgeons.

Checklists in Neurosurgery to Decrease Preventable Medical Errors: A Review

PubMed Central

Enchev, Yavor

2015-01-01

Neurosurgery represents a zero tolerance environment for medical errors, especially preventable ones like all types of wrong site surgery, complications due to the incorrect positioning of patients for neurosurgical interventions and complications due to failure of the devices required for the specific procedure. Following the excellent and encouraging results of the safety checklists in intensive care medicine and in other surgical areas, the checklist was naturally introduced in neurosurgery. To date, the reported world experience with neurosurgical checklists is limited to 15 series with fewer than 20,000 cases in various neurosurgical areas. The purpose of this review was to study the reported neurosurgical checklists according to the following parameters: year of publication; country of origin; area of neurosurgery; type of neurosurgical procedure-elective or emergency; person in charge of the checklist completion; participants involved in completion; whether they prevented incorrect site surgery; whether they prevented complications due to incorrect positioning of the patients for neurosurgical interventions; whether they prevented complications due to failure of the devices required for the specific procedure; their specific aims; educational preparation and training; the time needed for checklist completion; study duration and phases; number of cases included; barriers to implementation; efforts to implementation; team appreciation; and safety outcomes. Based on this analysis, it could be concluded that neurosurgical checklists represent an efficient, reliable, cost-effective and time-saving tool for increasing patient safety and elevating the neurosurgeons’ self-confidence. Every neurosurgical department must develop its own neurosurgical checklist or adopt and modify an existing one according to its specific features and needs in an attempt to establish or develop its safety culture. The world, continental, regional and national neurosurgical societies could promote safety checklists and their benefits. PMID:26740891

Safety and effectiveness of a polyvinyl alcohol barrier in reducing risks of vascular tissue damage during anterior spinal revision surgery.

PubMed

Jeffords, Paul; Li, Jinsheng; Panchal, Deepal; Denoziere, Guilhem; Fetterolf, Donald

2012-05-01

This study was conducted as a controlled, prospective investigation to show the safety and efficacy of a polyvinyl alcohol (PVA) device in a sheep model. To evaluate the ability of a permanent PVA hydrogel barrier to reduce the risk of potential vessel damage during anterior vertebral revision surgery, to provide a nonadhesive barrier at the surgical site, and to create a surgical revision plane of dissection. The development of scar tissue and adhesions presents a significant postoperative problem in spine surgery, where adhesion involvement of overlying structures can cause pain, neurovascular complications, and present a difficult surgical environment during revisions. The devices were implanted onto the ventral surface of exposed lumbar intervertebral discs using an anterolateral approach. One disc separated from the study site was also exposed to serve as a control. Three sheep each were then evaluated with an explant procedure at 30 and 90 days. Extensive sampling was undertaken to evaluate gross anatomic, micropathologic, and biochemical environments and properties of the device. The structural properties and appearance of the device remained intact at both 30 and 90 days. The material remained flexible, hydrophilic, and soft, without visible resorption or decomposition. The material was well tolerated by the animal, with minimal histologic signs of inflammation or rejection. Tissue planes were easily able to be localized by the surgeon attempting to locate the prior surgical site at the time of resection. The PVA vessel shield effectively protected the structures overlying the sheep spine during revision, providing a clear dissection plane for resection at repeat surgery. The overlying structures separated from the previous surgical site with no adhesion, and allowed safe separation of adjacent tissues without the use of sharp dissection.

Electrocauterization and no packing may be comparable with nasal packing for postoperative hemorrhage after endoscopic sinus surgery.

PubMed

Kim, Dong-Kyu; Rhee, Chae Seo; Kim, Jeong-Whun

2016-05-01

Nasal packing is commonly performed after functional endoscopic sinus surgery (FESS). However, nasal packing is associated with higher cost (owing to the cost of packing materials), patient discomfort, delayed wound healing, and concern about toxic shock syndrome. Some surgeons have been performing FESS without packing, but there are few studies that show its safety. The purpose of this study was to evaluate the safety of electrocauterization and no packing. A total of 490 patients who underwent bilateral FESS for chronic rhinosinusitis were included in this retrospective study, 242 in the nasal packing group and 248 in the electrocauterization and no-packing group. Electrocauterization was performed by using a suction coagulator. Rates of immediate (first 24 hours after surgery) and delayed postoperative bleeding were compared. Patient characteristics, including concomitant disease and medication history, and Lund-Mackay computed tomography score were also assessed Results: There were no significant differences in age; sex; Lund-Mackay score; use of anticoagulant drugs; or prevalence of hypertension, diabetes, or asthma between the two groups. In the electrocauterization and no-packing group, there were fewer patients with allergic rhinitis and more smokers. Primary bleeding did not occur in the nasal packing group, but 11 patients (4.4%) had delayed bleeding. Primary bleeding occurred in four patients (1.7%) in the electrocauterization and no-packing group, and five patients (2.1%) had delayed bleeding. There were no significant differences in primary (p = 0.058) and secondary bleeding (p = 0.142) between the two groups. All bleeding was minor and easily controlled. Multivariate logistic regression analysis ruled out significant correlation between no packing and postoperative bleeding. This study provided evidence that, in terms of postoperative hemorrhage, the safety of the electrocauterization and no-packing technique after FESS was comparable with that of nasal packing.

An integrated safety analysis of intravenous ibuprofen (Caldolor®) in adults

PubMed Central

Southworth, Stephen R; Woodward, Emily J; Peng, Alex; Rock, Amy D

2015-01-01

Intravenous (IV) nonsteroidal anti-inflammatory drugs such as IV ibuprofen are increasingly used as a component of multimodal pain management in the inpatient and outpatient settings. The safety of IV ibuprofen as assessed in ten sponsored clinical studies is presented in this analysis. Overall, 1,752 adult patients have been included in safety and efficacy trials over 11 years; 1,220 of these patients have received IV ibuprofen and 532 received either placebo or comparator medication. The incidence of adverse events (AEs), serious AEs, and changes in vital signs and clinically significant laboratory parameters have been summarized and compared to patients receiving placebo or active comparator drug. Overall, IV ibuprofen has been well tolerated by hospitalized and outpatient patients when administered both prior to surgery and postoperatively as well as for nonsurgical pain or fever. The overall incidence of AEs is lower in patients receiving IV ibuprofen as compared to those receiving placebo in this integrated analysis. Specific analysis of hematological and renal effects showed no increased risk for patients receiving IV ibuprofen. A subset analysis of elderly patients suggests that no dose adjustment is needed in this higher risk population. This integrated safety analysis demonstrates that IV ibuprofen can be safely administered prior to surgery and continued in the postoperative period as a component of multimodal pain management. PMID:26604816

2D vs. 3D imaging in laparoscopic surgery-results of a prospective randomized trial.

PubMed

Buia, Alexander; Stockhausen, Florian; Filmann, Natalie; Hanisch, Ernst

2017-12-01

3D imaging is an upcoming technology in laparoscopic surgery, and recent studies have shown that the modern 3D technique is superior in an experimental setting. However, the first randomized controlled clinical trial in this context dates back to 1998 and showed no significant difference between 2D and 3D visualization using the first 3D generation technique, which is now more than 15 years old. Positive results measured in an experimental setting considering 3D imaging on surgical performance led us to initiate a randomized controlled pragmatic clinical trial to validate our findings in daily clinical routine. Standard laparoscopic operations (cholecystectomy, appendectomy) were preoperatively randomized to a 2D or 3D imaging system. We used a surgical comfort scale (Likert scale) and the Raw NASA Workload TLX for the subjective assessment of 2D and 3D imaging; the duration of surgery was also measured. The results of 3D imaging were statistically significant better than 2D imaging concerning the parameters "own felt safety" and "task efficiency"; the difficulty level of the procedures in the 2D and 3D groups did not differ. Overall, the Raw NASA Workload TLX showed no significance between the groups. 3D imaging could be a possible advantage in laparoscopic surgery. The results of our clinical trial show increased personal felt safety and efficiency of the surgeon using a 3D imaging system. Overall of the procedures, the findings assessed using Likert scales in terms of own felt safety and task efficiency were statistically significant for 3D imaging. The individually perceived workload assessed with the Raw NASA TLX shows no difference. Although these findings are subjective impressions of the performing surgeons without a clear benefit for 3D technology in clinical outcome, we think that these results show the capability that 3D laparoscopy can have a positive impact while performing laparoscopic procedures.

Epidural premotor cortical stimulation in primary focal dystonia: clinical and 18F-fluoro deoxyglucose positron emission tomography open study.

PubMed

Lalli, Stefania; Piacentini, Sylvie; Franzini, Angelo; Panzacchi, Andrea; Cerami, Chiara; Messina, Giuseppe; Ferré, Francesca; Perani, Daniela; Albanese, Alberto

2012-04-01

The aim of this study was to evaluate the efficacy and safety of epidural premotor stimulation in patients with primary focal dystonia. Seven patients were selected: 6 had cervical dystonia and 1 had right upper limb dystonia. In 2 patients, sustained muscle contractions led to a prevalently fixed head posture. Patients with cervical dystonia received a bilateral implant, whereas the patient with hand dystonia received a unilateral implant. Neurological and neuropsychological evaluations were performed before surgery (baseline), and 1, 3, 6, and 12 months afterward. The Burke-Fahn-Marsden scale (BFMS) and the Toronto Western spasmodic torticollis rating scale (TWSTRS) were administered at the same time points. Patients underwent resting (18)F-fluorodeoxyglucose (FDG) positron emission tomography (PET) scans, before and 12 months after surgery. No adverse events occurred. An overall improvement was observed on the BFMS and TWSTRS after surgery. Patients with prevalently fixed cervical dystonia had a reduced benefit. Presurgical neuroimaging revealed a significant bilateral metabolic increase in the sensorimotor areas, which was reduced after surgery. Copyright © 2012 Movement Disorder Society.

The dose of hydroxyethyl starch 6% 130/0.4 for fluid therapy and the incidence of acute kidney injury after cardiac surgery: A retrospective matched study

PubMed Central

Nkoy Ena, Lompoli; Van Dyck, Michel; Matta, Amine; Kahn, David; Thiry, Dominique; Grégoire, André; Watremez, Christine

2017-01-01

The safety of hydroxyethyl starches (HES) is still under debate. No studies have compared different dosing regimens of HES in cardiac surgery. We analyzed whether the incidence of Acute Kidney Injury (AKI) differed taking into account a weight-adjusted cumulative dose of HES 6% 130/0.4 for perioperative fluid therapy. This retrospective cohort study included all adult patients undergoing elective or emergency cardiac surgery with or without cardiopulmonary bypass. Exclusion criteria were patients on renal replacement therapy (RRT), cardiac trauma surgery, heart transplantation, patients with ventricular assist devices, subjects who required a surgical revision for bleeding and those whose medical records were incomplete. Primary endpoint was AKI following the creatinine based RIFLE classification. Secondary endpoints were 30-day mortality and RRT. Patients were divided into 2 groups whether they had received a cumulative HES dose of < 30 mL/kg (Low HES) or ≥ 30 mL/kg (High HES) during the intra- and postoperative period. A total of 1501 patients were analyzed with 983 patients in the Low HES and 518 subjects in the High HES group. 185 (18.8%) patients in the Low HES and 119 (23.0%) patients in the High HES group developed AKI (P = 0.06). In multivariable regression analysis the dose of HES administered per weight was not associated with AKI. After case-control matching 217 patients were analyzed in each group. AKI occurred in 39 (18.0%) patients in the Low HES and 50 (23.0%) patients in the High HES group (P = 0.19). In conditional regression analysis performed on the matched groups a lower weight-adjusted dose of HES was significantly associated with a reduced incidence of AKI [(Odds Ratio (95% CI) = 0.825 (0.727–0.936); P = 0.003]. In the absence of any safety study the cumulative dose of modern HES in cardiac surgery should be kept less than 30 mL/kg. PMID:29045467

Sentinel Node Biopsy for the Head and Neck Using Contrast-Enhanced Ultrasonography Combined with Indocyanine Green Fluorescence in Animal Models: A Feasibility Study.

PubMed

Kogashiwa, Yasunao; Sakurai, Hiroyuki; Akimoto, Yoshihiro; Sato, Dai; Ikeda, Tetsuya; Matsumoto, Yoshifumi; Moro, Yorihisa; Kimura, Toru; Hamanoue, Yasuhiro; Nakamura, Takehiro; Yamauchi, Koichi; Saito, Koichiro; Sugasawa, Masashi; Kohno, Naoyuki

2015-01-01

Sentinel node navigation surgery is gaining popularity in oral cancer. We assessed application of sentinel lymph node navigation surgery to pharyngeal and laryngeal cancers by evaluating the combination of contrast-enhanced ultrasonography and indocyanine green fluorescence in animal models. This was a prospective, nonrandomized, experimental study in rabbit and swine animal models. A mixture of indocyanine green and Sonazoid was used as the tracer. The tracer mixture was injected into the tongue, larynx, or pharynx. The sentinel lymph nodes were identified transcutaneously by infra-red camera and contrast-enhanced ultrasonography. Detection time and extraction time of the sentinel lymph nodes were measured. The safety of the tracer mixture in terms of mucosal reaction was evaluated macroscopically and microscopically. Sentinel lymph nodes were detected transcutaneously by contrast-enhanced ultrasonography alone. The number of sentinel lymph nodes detected was one or two. Despite observation of contrast enhancement of Sonazoid for at least 90 minutes, the number of sentinel lymph nodes detected did not change. The average extraction time of sentinel lymph nodes was 4.8 minutes. Indocyanine green fluorescence offered visual information during lymph node biopsy. The safety of the tracer was confirmed by absence of laryngeal edema both macro and microscopically. The combination method of indocyanine green fluorescence and contrast-enhanced ultrasonography for detecting sentinel lymph nodes during surgery for head and neck cancer seems promising, especially for pharyngeal and laryngeal cancer. Further clinical studies to confirm this are warranted.

Efficacy and safety of a diode laser in second-stage implant surgery: a comparative study.

PubMed

El-Kholey, K E

2014-05-01

For more than a decade, peri-implant tissues have been treated with soft tissue lasers to create a bloodless flap for implant placement and to uncover implants with minimal bleeding, trauma, and anaesthesia. This study was designed to assess if dental implant uncovering is possible with a diode laser without anaesthesia, and to compare its performance with traditional cold scalpel surgery. Thirty patients with a total of 45 completely osseointegrated implants participated in this study. Patients were divided into two groups. For the study group, second-stage implant surgery was done with a 970nm diode laser. For the control group, the implants were exposed with a surgical blade. Certain parameters were used for evaluation of the two techniques. The use of the diode laser obviated the need for local anaesthesia; there was a significant difference between the two groups regarding the need for anaesthesia (P<0.0001). However, there were no significant differences between the two techniques regarding duration of surgery, postoperative pain, time for healing, and success of the implants. The diode laser can be used effectively for second-stage implant surgery, providing both the dentist and the patient with additional advantages over the conventional methods used for implant exposure. Copyright © 2013 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Sensory subtraction in robot-assisted surgery: fingertip skin deformation feedback to ensure safety and improve transparency in bimanual haptic interaction.

PubMed

Meli, Leonardo; Pacchierotti, Claudio; Prattichizzo, Domenico

2014-04-01

This study presents a novel approach to force feedback in robot-assisted surgery. It consists of substituting haptic stimuli, composed of a kinesthetic component and a skin deformation, with cutaneous stimuli only. The force generated can then be thought as a subtraction between the complete haptic interaction, cutaneous, and kinesthetic, and the kinesthetic part of it. For this reason, we refer to this approach as sensory subtraction. Sensory subtraction aims at outperforming other nonkinesthetic feedback techniques in teleoperation (e.g., sensory substitution) while guaranteeing the stability and safety of the system. We tested the proposed approach in a challenging 7-DoF bimanual teleoperation task, similar to the Pegboard experiment of the da Vinci Skills Simulator. Sensory subtraction showed improved performance in terms of completion time, force exerted, and total displacement of the rings with respect to two popular sensory substitution techniques. Moreover, it guaranteed a stable interaction in the presence of a communication delay in the haptic loop.

Safety of remifentanil in transsphenoidal surgery: A single-center analysis of 540 patients.

PubMed

Cote, David J; Burke, William T; Castlen, Joseph P; King, Chih H; Zaidi, Hasan A; Smith, Timothy R; Laws, Edward R; Aglio, Linda S

2017-04-01

Although some studies have examined the efficacy and safety of remifentanil in patients undergoing neurosurgical procedures, none has examined its safety in transsphenoidal operations specifically. In this study, all transsphenoidal operations performed by a single author from 2008 to 2015 were retrospectively reviewed to evaluate the safety of remifentanil in a consecutive series of patients. During the study period, 540 transsphenoidal operations were identified. Of these, 443 (82.0%) patients received remifentanil intra-operatively; 97 (18.0%) did not. The two groups were well-matched with regard to demographic categories, comorbidities, and pre-operative medications (p>0.05), except pre-operative tobacco use (p=0.021). Patients were also well-matched with regard to radiographic features and surgical techniques. Patients who received remifentanil were more likely to harbor a macroadenoma (78.1% vs. 67.0%, p=0.025), and had slightly longer anesthesia time on average (269.2minvs. 239.4min, p=0.024). All pathologic diagnoses were well-matched between the two groups, except that patients receiving remifentanil were more likely to harbor a non-functioning adenoma (46.5% vs. 26.8%, p<0.001). Analysis of post-operative complications showed no significant difference between patients who received remifentanil and those who did not, and length of stay and prevalence of ICU stay did not differ between the two groups. In a well-matched series of 540 patients undergoing transsphenoidal surgery, remifentanil was found to be a safe anesthetic adjunct. There were no significant differences in post-operative hospital course or complications in patients who did and did not receive intra-operative remifentanil. Copyright © 2016 Elsevier Ltd. All rights reserved.

Use of fibrin sealants in cardiovascular surgery: a systematic review.

PubMed

Rousou, John A

2013-05-01

Fibrin sealants are used for hemostasis and tissue adherence. This systematic review summarizes published clinical data for fibrin sealant use in cardiovascular surgery. A literature search for the following terms was conducted using PubMed and EMBASE: (TISSEEL or Tissucol or Beriplast P or Evicel or Quixil or Crosseal or Reliseal or Fibringluraas or Bolheal or Tachosil or Vivostat or Vitagel or Artiss or "fibrin glue" or "fibrin sealant" or "fibrin tissue adhesive") and (cardiac or cardiovascular or vascular or heart or coronary or surgery). Case reports and series were excluded; although reports of controlled trials were preferred, uncontrolled trial data were also considered. Clinical trials and chart review analyses of fibrin sealants were identified and summarized. Although clinical trial data were available for other agents, the majority of published studies examined TISSEEL. Overall, TISSEEL and other fibrin sealants showed improvements over standard of care or control groups for a variety of predefined endpoints. Safety findings are also summarized. Data from these studies showed that fibrin sealants were well tolerated and provided effective hemostasis in a range of cardiac and aortic surgeries. © 2013 Wiley Periodicals, Inc.

A study of an assisting robot for mandible plastic surgery based on augmented reality.

PubMed

Shi, Yunyong; Lin, Li; Zhou, Chaozheng; Zhu, Ming; Xie, Le; Chai, Gang

2017-02-01

Mandible plastic surgery plays an important role in conventional plastic surgery. However, its success depends on the experience of the surgeons. In order to improve the effectiveness of the surgery and release the burden of surgeons, a mandible plastic surgery assisting robot, based on an augmented reality technique, was developed. Augmented reality assists surgeons to realize positioning. Fuzzy control theory was used for the control of the motor. During the process of bone drilling, both the drill bit position and the force were measured by a force sensor which was used to estimate the position of the drilling procedure. An animal experiment was performed to verify the effectiveness of the robotic system. The position error was 1.07 ± 0.27 mm and the angle error was 5.59 ± 3.15°. The results show that the system provides a sufficient accuracy with which a precise drilling procedure can be performed. In addition, under the supervision's feedback of the sensor, an adequate safety level can be achieved for the robotic system. The system realizes accurate positioning and automatic drilling to solve the problems encountered in the drilling procedure, providing a method for future plastic surgery.

Canaloplasty: A Minimally Invasive and Maximally Effective Glaucoma Treatment

PubMed Central

Khaimi, Mahmoud A.

2015-01-01

Canaloplasty is a highly effective, minimally invasive, surgical technique indicated for the treatment of open-angle glaucoma that works by restoring the function of the eye's natural outflow system. The procedure's excellent safety profile and long-term efficacy make it a viable option for the majority of glaucoma patient types. It can be used in conjunction with existing drug based glaucoma treatments, after laser or other types of incisional surgery, and does not preclude or affect the outcome of future surgery. Numerous scientific studies have shown Canaloplasty to be safe and effective in lowering IOP whilst reducing medication dependence. A recent refinement of Canaloplasty, known as ab-interno Canaloplasty (ABiC), maintains the IOP-lowering and safety benefits of traditional (ab-externo) Canaloplasty using a more efficient, simplified surgical approach. This paper presents a review of Canaloplasty indications, clinical data, and complications, as well as comparisons with traditional incisional glaucoma techniques. It also addresses the early clinical evidence for ABiC. PMID:26495135

Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery

PubMed Central

2010-01-01

Background Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures. Methods/Design Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study: Stakeholders - federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included. Ethics - beneficence, non-maleficence, autonomy, justice. Economics - scarcity of resources, choices, opportunity costs. For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material. Discussion The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy. PMID:20738887

Ethics, economics and the regulation and adoption of new medical devices: case studies in pelvic floor surgery.

PubMed

Ross, Sue; Weijer, Charles; Gafni, Amiram; Ducey, Ariel; Thompson, Carmen; Lafreniere, Rene

2010-08-26

Concern has been growing in the academic literature and popular media about the licensing, introduction and adoption of surgical devices before full effectiveness and safety evidence is available to inform clinical practice. Our research will seek empirical survey evidence about the roles, responsibilities, and information and policy needs of the key stakeholders in the introduction into clinical practice of new surgical devices for pelvic floor surgery, in terms of the underlying ethical principals involved in the economic decision-making process, using the example of pelvic floor procedures. Our study involves three linked case studies using, as examples, selected pelvic floor surgery devices representing Health Canada device safety risk classes: low, medium and high risk. Data collection will focus on stakeholder roles and responsibilities, information and policy needs, and perceptions of those of other key stakeholders, in seeking and using evidence about new surgical devices when licensing and adopting them into practice. For each class of device, interviews will be used to seek the opinions of stakeholders. The following stakeholders and ethical and economic principles provide the theoretical framework for the study: Stakeholders--federal regulatory body, device manufacturers, clinicians, patients, health care institutions, provincial health departments, and professional societies. Clinical settings in two centres (in different provinces) will be included. Ethics--beneficence, non-maleficence, autonomy, justice. Economics--scarcity of resources, choices, opportunity costs.For each class of device, responses will be analysed to compare and contrast between stakeholders. Applied ethics and economic theory, analysis and critical interpretation will be used to further illuminate the case study material. The significance of our research in this new area of ethics will lie in providing recommendations for regulatory bodies, device manufacturers, clinicians, health care institutions, policy makers and professional societies, to ensure surgical patients receive sufficient information before providing consent for pelvic floor surgery. In addition, we shall provide a wealth of information for future study in other areas of surgery and clinical management, and provide suggestions for changes to health policy.

Comparison of epsilon aminocaproic acid and tranexamic Acid in thoracic aortic surgery: clinical efficacy and safety.

PubMed

Makhija, Neeti; Sarupria, Anju; Kumar Choudhary, Shiv; Das, Sambhunath; Lakshmy, Ramakrishnan; Kiran, Usha

2013-12-01

To evaluate the efficacy and safety of tranexamic acid (TXA) versus epsilon aminocaproic acid (EACA) in patients undergoing thoracic aortic surgery. A prospective randomized study. A tertiary care center. The study was conducted on 64 consecutive adult patients undergoing thoracic aortic surgery with cardiopulmonary bypass (CPB). Group EACA received a bolus of 50 mg/kg of EACA after induction of anesthesia over 20 minutes followed by maintenance infusion of 25 mg/kg/h until chest closure. Group TXA received a bolus of 10 mg/kg of TXA after induction of anesthesia over 20 minutes followed by maintenance infusion of 1 mg/kg/h until chest closure. Cumulated mean blood loss, total packed red blood cells, and blood product requirement up to 24 h postoperatively were comparable between groups. A significant renal injury (EACA 40% v TXA 16%; p = 0.04) and increased tendency for renal failure (EACA 10% v TXA 0%, p = 0.11; relative risk 2.15) were observed with EACA compared to TXA. There was increased tendency of seizure with TXA (EACA v TXA: 3.3% v 10%; p>0.05, relative risk 1.53). There was significant increase in the D-dimer from preoperative to postoperative values in Group EACA. (p< 0.01). Both EACA and TXA were equally effective in reducing the perioperative blood loss and transfusion requirement in patients undergoing thoracic aortic surgery. While significant renal injury was observed with EACA, there was a tendency for higher incidence of seizure with TXA. Prospective placebo-controlled trials recruiting larger sample size using sensitive biomarkers are required before any recommendations. Copyright © 2013 Elsevier Inc. All rights reserved.

Laparoscopic surgery in the treatment of incarcerated indirect inguinal hernia in children.

PubMed

Yin, Yiyu; Zhang, Hongwei; Zhang, Xiang; Sun, Fang; Zou, Huaxin; Cao, Hui; Wen, Cheng

2016-12-01

We aimed to explore the feasibility and the safety of the laparoscopic surgery for incarcerated indirect inguinal hernia (IIH) in children. From January 2012 to December 2014, 64 children were enrolled into this study. All 64 patients received laparoscopic surgery and we reviewed their perioperative and postoperative follow-up studies. In addition, we enrolled 60 cases of children who received traditional surgery of IIH administered through minimally invasive surgery as the control group. Results from the present study showed that the mean operation time for the laparoscopic group was 41.5 min (range, 15-80 min) which was significantly shorter than the control group. Nine cases developed incarcerated intestine necrosis, expanded umbilical incision and parallel resection anastomosis. They received laparoscopic hernia sac high ligation. Only 5 cases developed scrotum edema after the surgery. The postoperative length of the stay ranged from 2 to 7 days (average, 3.2). The postoperative follow-up was from 6 months to 1 year and no relapse or secondary testicular atrophy was observed in the laparoscopic group. The operation time, incidence of postoperative complications and length of stay in the laparoscopic group were decreased compared to the control group, and differences were statistically significant (P<0.05). In conclusion, laparoscopic surgery treatment for incarcerated inguinal hernia is safe and feasible and produced better results compared with the alternative.

Vaginal delivery of carboplatin-loaded thermosensitive hydrogel to prevent local cervical cancer recurrence in mice.

PubMed

Wang, Xue; Wang, Jin; Wu, Wenbin; Li, Hongjun

2016-11-01

Local tumor recurrence after cervical cancer surgery remains a clinical problem. Vaginal delivery of thermosensitive hydrogel may be suited to reduce tumor relapse rate with more efficacy and safety. A pilot study was carried out to evaluate the efficacy of carboplatin-loaded poloxamer hydrogel to prevent local recurrence of cervical cancer after surgery. In vivo vaginal retention evaluation of 27% poloxamer hydrogel in mice was proven to be a suitable vaginal drug delivery formulation due to its low gelation temperature. A mimic orthotopic cervical/vaginal cancer recurrence model after surgery was established by injecting murine cervical cancer cell line U14 into the vaginal submucosa to simulate the residual tumor cells infiltrated in the surgical site, followed by drug administration 24 h later to interfere with the formation/recurrence of the tumor. By infusing fluorescein sodium-loaded hydrogel into the vagina of mice, a maximized accumulation of fluorescein sodium (Flu) in the vagina was achieved and few signals were observed in other organs. When used in the prevention of the cervical cancer formation/recurrence in mice, the carboplatin-loaded poloxamer hydrogel exhibited great efficacy and systemic safety. In conclusion, thermosensitive hydrogel presents a simple, practical approach for the local drug delivery via vagina against cervical cancer recurrence.

Analysis of photorefractive keratectomy (PRK) results at The Ohio State University

NASA Astrophysics Data System (ADS)

Roberts, Cynthia J.; Lembach, R. G.

1993-06-01

The Ohio State University (OSU) is one site of an FDA controlled investigational study to evaluate the safety and efficacy of excimer laser photorefractive keratectomy (PRK). This is a report of the current Phase III results at OSU for cases at 6 months post surgery as of 12/31/92.

Optimal ergonomics for laparoscopic surgery in minimally invasive surgery suites: a review and guidelines.

PubMed

van Det, M J; Meijerink, W J H J; Hoff, C; Totté, E R; Pierie, J P E N

2009-06-01

With minimally invasive surgery (MIS), a man-machine environment was brought into the operating room, which created mental and physical challenges for the operating team. The science of ergonomics analyzes these challenges and formulates guidelines for creating a work environment that is safe and comfortable for its operators while effectiveness and efficiency of the process are maintained. This review aimed to formulate the ergonomic challenges related to monitor positioning in MIS. Background and guidelines are formulated for optimal ergonomic monitor positioning within the possibilities of the modern MIS suite, using multiple monitors suspended from the ceiling. All evidence-based experimental ergonomic studies conducted in the fields of laparoscopic surgery and applied ergonomics for other professions working with a display were identified by PubMed searches and selected for quality and applicability. Data from ergonomic studies were evaluated in terms of effectiveness and efficiency as well as comfort and safety aspects. Recommendations for individual monitor positioning are formulated to create a personal balance between these two ergonomic aspects. Misalignment in the eye-hand-target axis because of limited freedom in monitor positioning is recognized as an important ergonomic drawback during MIS. Realignment of the eye-hand-target axis improves personal values of comfort and safety as well as procedural values of effectiveness and efficiency. Monitor position is an important ergonomic factor during MIS. In the horizontal plain, the monitor should be straight in front of each person and aligned with the forearm-instrument motor axis to avoid axial rotation of the spine. In the sagittal plain, the monitor should be positioned lower than eye level to avoid neck extension.

Submucosal tunneling techniques: current perspectives.

PubMed

Kobara, Hideki; Mori, Hirohito; Rafiq, Kazi; Fujihara, Shintaro; Nishiyama, Noriko; Ayaki, Maki; Yachida, Tatsuo; Matsunaga, Tae; Tani, Johji; Miyoshi, Hisaaki; Yoneyama, Hirohito; Morishita, Asahiro; Oryu, Makoto; Iwama, Hisakazu; Masaki, Tsutomu

2014-01-01

Advances in endoscopic submucosal dissection include a submucosal tunneling technique, involving the introduction of tunnels into the submucosa. These tunnels permit safer offset entry into the peritoneal cavity for natural orifice transluminal endoscopic surgery. Technical advantages include the visual identification of the layers of the gut, blood vessels, and subepithelial tumors. The creation of a mucosal flap that minimizes air and fluid leakage into the extraluminal cavity can enhance the safety and efficacy of surgery. This submucosal tunneling technique was adapted for esophageal myotomy, culminating in its application to patients with achalasia. This method, known as per oral endoscopic myotomy, has opened up the new discipline of submucosal endoscopic surgery. Other clinical applications of the submucosal tunneling technique include its use in the removal of gastrointestinal subepithelial tumors and endomicroscopy for the diagnosis of functional and motility disorders. This review suggests that the submucosal tunneling technique, involving a mucosal safety flap, can have potential values for future endoscopic developments.

Comparison of Continuous Femoral Nerve Block with and Without Combined Sciatic Nerve Block after Total Hip Arthroplasty: A Prospective Randomized Study.

PubMed

Nishio, Shoji; Fukunishi, Shigeo; Fukui, Tomokazu; Fujihara, Yuki; Okahisa, Shohei; Takeda, Yu; Yoshiya, Shinichi

2017-06-23

In association with the growing interests in pain management, several modalities to control postoperative pain have been proposed and examined for the efficacy in the recent studies. Various modes of peripheral nerve block have been proposed and the effectiveness and safety have been examined for each of those techniques. We have described our clinical experiences, showing that continuous femoral nerve block could provide a satisfactory analgesic effect after total hip arthroplasty (THA) procedure. In this study, we compared the effectiveness and safety of continuous femoral nerve block with and without sciatic nerve blockade on pain control after THA. Forty patients scheduled for THA were included in the study and randomly divided into 2 groups. Postoperative analgesic measure was continuous femoral nerve block alone, while the identical regimen of continuous femoral nerve block was combined with sciatic nerve block. The amount of postoperative pain was evaluated in the immediate postoperative period, 6 hours, and 12 hours after surgery. Moreover, postoperative complications as well as requirement of supplemental analgesics during the initial 12 hours after surgery were reviewed in the patient record. The obtained study results showed that the supplemental sciatic nerve blockade provided no significant effect on arrival at the postoperative recovery room, while the NRS pain score was significantly reduced by the combined application of sciatic nerve blockade at 6 and 12 hours after surgery. In the investigation of postoperative analgesiarelated complications, no major complication was encountered without significant difference in complication rate between the groups.

Health Care Worker Fatigue.

PubMed

Gardner, Lea Anne; Dubeck, Deborah

2016-08-01

The Pennsylvania Patient Safety Reporting System is a confidential, statewide Internet reporting system to which all Pennsylvania hospitals, outpatient-surgery facilities, birthing centers, and abortion facilities must file information on incidents and serious events.Safety Monitor is a column from Pennsylvania's Patient Safety Authority, the authority that informs nurses on issues that can affect patient safety and presents strategies they can easily integrate into practice. For more information on the authority, visit www.patientsafetyauthority.org. For the original article discussed in this column or for other articles on patient safety, click on "Patient Safety Advisories" and then "Advisory Library" in the left-hand navigation menu.

A Prospective, Randomized, Multicenter Clinical Trial on the Safety and Efficacy of a Ready-to-Use Fibrin Sealant as an Adjunct to Hemostasis during Vascular Surgery.

PubMed

Chetter, Ian; Stansby, Gerard; Sarralde, José Aurelio; Riambau, Vicente; Giménez-Gaibar, Antonio; MacKenzie, Kent; Acín, Francisco; Navarro-Puerto, Jordi

2017-11-01

Anastomotic or "stitch hole" bleeding is common during vascular surgery with synthetic material such as Dacron or polytetrafluoroethylene. Hemostatic adjuncts such as fibrin sealant (FS) may reduce blood loss and operating time in such circumstances. We evaluated the safety and the hemostatic effectiveness of a ready-to-use human plasma-derived FS in vascular surgery. Patients with mild/moderate suture line bleeding during elective, open, vascular surgery using synthetic grafts or patches were studied. In an initial Exploratory Study, all patients were treated with FS Grifols, and in a subsequent Primary Study were randomized in a 2:1 ratio to FS Grifols or manual compression (MC). The primary efficacy end point was time to hemostasis (TTH), assessed at defined intervals from the start of treatment application, during a 10-min observational period. Safety end points (in Exploratory + Primary Studies) included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests (coagulation, complete blood count, serum clinical chemistry parameters, microscopic urinalysis), viral markers, and immunogenicity. In the Primary Study, the proportion of patients who achieved hemostasis at the 3-min time point was higher in the FS Grifols group (46.4%, n = 51/110) than in the MC group (26.3%, n = 15/57) (P < 0.05). The benefit was maintained at successive time intervals: 69 FS Grifols patients (62.7%) and 18 MC patients (31.6%) at 4 min; 82 FS Grifols patients (74.5%) and 28 MC patients (49.1%) at 5 min. The differences between the groups persisted for TTH ≤ 7 min and TTH ≤ 10 min. Treatment failure was reported for 13 FS Grifols patients (11.8%) and 16 MC patients (28.1%). TTH was shorter after FS Grifols application than after MC application. Differences were statistically significant in favor of FS Grifols for each TTH category and for the overall comparison (P < 0.001) as well as for each TTH category (cumulative) and for treatment failure (P = 0.016). Overall, AE experience and types of AEs reported were those expected in this patient population and were similar between the 2 treatment groups. The most frequently reported AEs were procedural pain (59.9% and 69.2% of patients in the FS Grifols [n = 72 + 111] and MC [n = 57] groups, respectively) and nausea (23.5% and 19.2% of patients, respectively). FS Grifols was efficacious and safe as an adjunct to anastomotic hemostasis in patients undergoing arterial surgery using prosthetic material with mild to moderate bleeding. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

A randomised controlled pilot trial to evaluate and optimize the use of anti-platelet agents in the perioperative management in patients undergoing general and abdominal surgery--the APAP trial (ISRCTN45810007).

PubMed

Antolovic, D; Rakow, A; Contin, P; Ulrich, A; Rahbari, N N; Büchler, M W; Weitz, J; Koch, M

2012-02-01

Surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (ASA). However, owing to a lack of evidence-based data, a widely accepted consensus on the perioperative management of these patients in the setting of non-cardiac surgery has not yet been reached. Primary objective was to evaluate the safety of continuous versus discontinuous use of ASA in the perioperative period in elective general or abdominal surgery. Fifty-two patients undergoing elective cholecystectomy, inguinal hernia repair or colonic/colorectal surgery were recruited to this pilot study. According to cardiological evaluation, non-high-risk patients who were on long-term treatment with low-dose ASA were eligible for inclusion. Patients were allocated randomly to continuous use of ASA or discontinuation of ASA intake for 5 days before until 5 days after surgery. The primary outcome was the incidence of major haemorrhagic and thromboembolic complications within 30 days after surgery. A total of 26 patients were allocated to each study group. One patient (3.8%) in the ASA continuation group required re-operation due to post-operative haemorrhage. In neither study group, further bleeding complications occurred. No clinically apparent thromboembolic events were reported in the ASA continuation and the ASA discontinuation group. Furthermore, there were no significant differences between both study groups in the secondary endpoints. Perioperative intake of ASA does not seem to influence the incidence of severe bleeding in non-high-risk patients undergoing elective general or abdominal surgery. Further, adequately powered trials are required to confirm the findings of this study.

Natural orifice transluminal endoscopic surgery in urology: Review of the world literature.

PubMed

Bazzi, Wassim M; Raheem, Omer A; Cohen, Seth A; Derweesh, Ithaar H

2012-01-01

Natural orifice transluminal endoscopic surgery (NOTES) has gained momentum in the recent urologic literature as a new surgical approach for intra-abdominal organs with scarless and painless postoperative recoveries. We sought to review the published literature concerning the safety and reproducibility of NOTES in urology. PubMed literature review of articles published in the English language was performed over a 10-year period, i.e., between 2001 and 2011; all articles were critically reviewed and analyzed. Despite its novelty, pure or hybrid surgical approaches have been adapted in performing NOTES. NOTES essentially utilizes transluminal flexible endoscopic instruments along with laparoscopic instruments to gain access to abdominal, pelvic, and/or retroperitoneal cavities. The preliminary results of NOTES in surgery and to a limited extent in urology appear promising, yet further research in animal survival and human cadaveric models is requisite prior to human applications, especially for complex surgeries. Future innovative research, particularly biomedical engineering, should be directed to improving the technicality and mechanistic application of NOTES; hence, better safety and efficacy of NOTES.

Comparison of different doses of ε-aminocaproic acid in children for tetralogy of Fallot surgery: clinical efficacy and safety.

PubMed

Sarupria, Anju; Makhija, Neeti; Lakshmy, Ramakrishnan; Kiran, Usha

2013-02-01

The purpose of this study was to compare 2 different doses of ε-aminocaproic acid (EACA) and assess their relative efficacy and safety in children undergoing corrective surgery for tetralogy of Fallot (TOF). A prospective, randomized, controlled study. A tertiary care center. One hundred twenty children undergoing corrective surgery for TOF using cardiopulmonary bypass (CPB). Group 1 received 100 mg/kg of EACA after induction, upon initiation of CPB, and after protamine. Group 2 received 75 mg/kg of EACA after induction, followed by a maintenance infusion of 75 mg/kg/h until chest closure, and an additional 75 mg/kg upon initiation of CPB. Group 3 did not receive any antifibrinolytic agent or placebo. Cumulative mean blood loss, total packed red blood cells, and fresh frozen plasma requirements were significantly less in group 2 (p ≤ 0.01). There were no significant differences in the total platelet concentrate transfused, re-exploration rate, incidence of renal failure, arrhythmias, neurologic complications, mortality, or length of intensive care unit stay among the 3 groups. The incidences of perioperative ST/T changes and chest closure time were significantly less in group 1 and group 2 (p ≤ 0.01). The duration of mechanical ventilation was significantly less in group 2 (p ≤ 0.01). EACA was effective in reducing the postoperative blood loss and transfusion requirements in children undergoing corrective cardiac surgery on CPB for TOF. The dose regimen of 75 mg/kg after induction, followed by a maintenance infusion of 75 mg/kg/h until chest closure, and an additional 75 mg/kg upon initiation of CPB were more effective. Copyright © 2012 Elsevier Inc. All rights reserved.

Preoperative biliary drainage using a fully covered self-expandable metallic stent for pancreatic head cancer: A prospective feasibility study.

PubMed

Togawa, Osamu; Isayama, Hiroyuki; Kawakami, Hiroshi; Nakai, Yousuke; Mohri, Dai; Hamada, Tsuyoshi; Kogure, Hirofumi; Kawakubo, Kazumichi; Sakamoto, Naoya; Koike, Kazuhiko; Kita, Hiroto

2018-01-01

The role of endoscopic preoperative biliary drainage (PBD) for pancreatic head cancer is controversial because of the high incidence of stent occlusion before surgery. This study was performed to evaluate the feasibility and safety of PBD using a fully covered self-expandable metallic stent (FCSEMS). This multicenter prospective study involved 26 patients treated for pancreatic head cancer with distal bile duct obstruction from April 2011 to March 2013. An FCSEMS was endoscopically placed in 24 patients. Among these, 7 patients were diagnosed with unresectable cancer, and 17 underwent surgery at a median of 18 days after FCSEMS placement. The main outcome measure was preoperative and postoperative adverse events. Two adverse events (cholecystitis and insufficient resolution of jaundice) occurred between FCSEMS placement and surgery (12%). Postoperative adverse events occurred in eight patients (47%). The cumulative incidence of stent-related adverse events 4 and 8 weeks after FCSEMS placement among the 24 patients who underwent this procedure were 19%. PBD using an FCSEMS is feasible in patients with resectable pancreatic head cancer. Placement of an FCSEMS can be an alternative PBD technique when surgery without delay is impossible. A larger randomized controlled trial is warranted.

Safety of carotid endarterectomy while on clopidogrel (Plavix). Clinical article.

PubMed

Wait, Scott D; Abla, Adib A; Killory, Brendan D; Starke, Robert M; Spetzler, Robert F; Nakaji, Peter

2010-10-01

Many patients undergoing carotid endarterectomy (CEA) regularly take clopidogrel, a permanent platelet inhibitor. The authors sought to determine whether taking clopidogrel in the period before CEA leads to more bleeding or other complications. The authors performed a retrospective, institutional review board–approved review of 182 consecutive patients who underwent CEA. Clinical, radiographic, and surgical data were gleaned from hospital and clinic records. Analysis was based on the presence or absence of clopidogrel in patients undergoing CEA and was performed twice by considering clopidogrel use within 8 days and within 5 days of surgery to define the groups. Taking clopidogrel within 8 days before surgery resulted in no statistical increase in any measure of morbidity or death. Taking clopidogrel within 5 days was associated with a small but significant increase in operative blood loss and conservatively managed postoperative neck swelling. No measure of permanent morbidity or death was increased in either clopidogrel group. Findings in this study support the safety of preoperative clopidogrel in patients undergoing CEA.

A review of the iStent® trabecular micro-bypass stent: safety and efficacy

PubMed Central

Wellik, Sarah R; Dale, Elizabeth A

2015-01-01

There is a significant demand for procedures that can effectively treat glaucoma with low risk and good visual outcomes. To fill this void, procedures termed “minimally invasive glaucoma surgery”, are gaining in popularity. This review will focus on the safety and efficacy of one such minimally invasive glaucoma surgery procedure, the trabecular micro-bypass stent. This stent is intended to lower intraocular pressure by directly cannulating Schlemm’s canal and thereby enhancing aqueous outflow. Recent randomized controlled trials and case series have demonstrated the micro-bypass stent to be a relatively safe procedure, with limited complications and no serious adverse sequelae. The most common complication across all studies was stent obstruction or malposition, which generally did not result in any adverse outcome in vision or pressure control. In addition, increased rates of hypotony, choroidal hemorrhage, or infection were not seen with the micro-bypass stent in comparison to cataract surgery alone. PMID:25931808

Functional results in endoscopic Zenker's diverticulum surgery.

PubMed

Dissard, A; Gilain, L; Pastourel, R; Mom, T; Saroul, N

2017-10-01

The main objective of this retrospective study was to assess functional results in endoscopic Zenker's diverticulum surgery. The secondary objectives were to assess safety, identify recurrence risk factors, and determine optimal management of recurrence. From 2000 to 2014, 50 patients underwent endoscopic surgery for marsupialization of Zenker's diverticulum. Regurgitation and dysphagia were assessed on the FOIS scale, pre- and post-operatively. Recurrences and complications rates were determined retrospectively at a minimum 18 months' follow-up. Regurgitation and dysphagia improved in respectively 96% and 86% of patients. There was a 12% rate of complications, mostly minor. Mean hospital stay and time to return to oral feeding were 2.0 and 1.3 days respectively. Nine patients (18%) showed recurrence of symptoms, requiring revision surgery at a mean 2.7 years, performed endoscopically in the majority of cases. Only one recurrence risk factor was identified: small diverticulum size. Endoscopic Zenker's diverticulum surgery provided functional improvement in most cases. Safe and effective, it is currently the treatment of choice for Zenker's diverticulum. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

John M. Eisenberg Patient Safety Awards. System innovation: Concord Hospital.

PubMed

Uhlig, Paul N; Brown, Jeffrey; Nason, Anne K; Camelio, Addie; Kendall, Elise

2002-12-01

The Cardiac Surgery Program at Concord Hospital (Concord, NH) restructured clinical teamwork for improved safety and effectiveness on the basis of theory and practice from human factors science, aviation safety, and high-reliability organization theory. A team-based, collaborative rounds process--the Concord Collaborative Care Model--that involved use of a structured communications protocol was conducted daily at each patient's bedside. The entire care team agreed to meet at the same time each day (8:45 AM to 9:30 AM) to share information and develop a plan of care for each patient, with patient and family members as active participants. The cardiac surgery team developed a structured communications protocol adapted from human factors science. To provide a forum for discussion of team goals and progress and to address system-level concerns, a biweekly system rounds process was established. Following implementation of collaborative rounds, mortality of Concord Hospital's cardiac surgery patients declined significantly from expected rates. Satisfaction rates of open heart patients scores were consistently in the 97th-99th percentile nationally. A quality of work life survey indicated that in every category, providers expressed greater satisfaction with the collaborative care process than with the traditional rounds process. Practice patterns in the Cardiac Surgery Program at Concord Hospital have changed to a much more collaborative and participatory process, with improved outcomes, happier patients, and more satisfied practitioners. A culture of continuous program improvement has been implemented that continues to evolve and produce benefits.

Facilitators and barriers of implementing enhanced recovery in colorectal surgery at a safety net hospital: A provider and patient perspective.

PubMed

Alawadi, Zeinab M; Leal, Isabel; Phatak, Uma R; Flores-Gonzalez, Juan R; Holihan, Julie L; Karanjawala, Burzeen E; Millas, Stefanos G; Kao, Lillian S

2016-03-01

Enhanced Recovery After Surgery (ERAS) pathways are known to decrease complications and duration of stay in colorectal surgery patients. However, it is unclear whether an ERAS pathway would be feasible and effective at a safety-net hospital. The aim of this study was to identify local barriers and facilitators before the adoption of an ERAS pathway for patients undergoing colorectal operations at a safety-net hospital. Semistructured interviews were conducted to assess the perceived barriers and facilitators before ERAS adoption. Stratified purposive sampling was used. Interviews were audiotaped, transcribed verbatim, and analyzed using content analysis. Analytic and investigator triangulation were used to establish credibility. Interviewees included 8 anesthesiologists, 5 surgeons, 6 nurses, and 18 patients. Facilitators identified across the different medical professions were (1) feasibility and alignment with current practice, (2) standardization of care, (3) smallness of community, (4) good teamwork and communication, and (5) caring for patients. The barriers were (1) difficulty in adapting to change, (2) lack of coordination between different departments, (3) special needs of a highly comorbid and socioeconomically disadvantaged patient population, (4) limited resources, and (5) rotating residents. Facilitators identified by the patients were (1) welcoming a speedy recovery, (2) being well-cared for and satisfied with treatment, (3) adequate social support, (4) welcoming early mobilization, and (5) effective pain management. The barriers were (1) lack of quiet and private space, (2) need for more patient education and counseling, and (3) unforeseen complications. Although limited hospital resources are perceived as a barrier to ERAS implementation at a safety-net hospital, there is strong support for such pathways and multiple factors were identified that may facilitate change. Inclusion of patient perspectives is critical to identifying challenges and facilitators to implementing ERAS changes focused on optimizing patient perioperative health and outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

The Impact of Massage and Reading on Children's Pain and Anxiety After Cardiovascular Surgery: A Pilot Study.

PubMed

Staveski, Sandra L; Boulanger, Karen; Erman, Lee; Lin, Li; Almgren, Christina; Journel, Chloe; Roth, Stephen J; Golianu, Brenda

2018-06-14

The purpose of this pilot study was three-fold: 1) to evaluate the safety and feasibility of instituting massage therapy in the immediate postoperative period after congenital heart surgery, 2) to examine the preliminary results on effects of massage therapy versus standard of care plus three reading visits on postoperative pain and anxiety, and 3) to evaluate preliminary effects of opioid and benzodiazepine exposure in patients receiving massage therapy compared with reading controls. Prospective, randomized controlled trial. An academic children's hospital. Sixty pediatric heart surgery patients between ages 6 and 18 years. Massage therapy and reading. There were no adverse events related to massage or reading interventions in either group. Our investigation found no statistically significant difference in Pain or State-Trait Anxiety scores in the initial 24 hours after heart surgery (T1) and within 48 hours of transfer to the acute care unit (T2) after controlling for age, gender, and Risk Adjustment for Congenital Heart Surgery 1 score. However, children receiving massage therapy had significantly lower State-Trait Anxiety scores after receiving massage therapy at time of discharge (T3; p = 0.0075) than children receiving standard of care plus three reading visits. We found no difference in total opioid exposure during the first 3 postoperative days between groups (median [interquartile range], 0.80 mg/kg morphine equivalents [0.29-10.60] vs 1.13 mg/kg morphine equivalents [0.72-6.14]). In contrast, children receiving massage therapy had significantly lower total benzodiazepine exposure in the immediate 3 days following heart surgery (median [interquartile range], 0.002 mg/kg lorazepam equivalents [0-0.03] vs 0.03 mg/kg lorazepam equivalents [0.02-0.09], p = 0.0253, Wilcoxon rank-sum) and number of benzodiazepine PRN doses (0.5 [0-2.5] PRN vs 2 PRNs (1-4); p = 0.00346, Wilcoxon rank-sum). Our pilot study demonstrated the safety and feasibility of implementing massage therapy in the immediate postoperative period in pediatric heart surgery patients. We found decreased State-Trait Anxiety scores at discharge and lower total exposure to benzodiazepines. Preventing postoperative complications such as delirium through nonpharmacologic interventions warrants further evaluation.

Patient Safety Center Organization

DTIC Science & Technology

2006-06-01

Enterectomy Bariatric 7/20/05 4 hours/course (28 hours/year) Surgery R 7 Dr. Karen Horvath R5 Lap Enterectomy & Colectomy 11/30/05 4...areas in the UW Schools of Nursing and Dentistry, at the Harborview Research Center Microvascular Surgery lab, with the Seattle Children’s Hospital and...1 laboratory complex (2500 sq ft) has been designed within the University of Washington Medical Center, in the Surgery Pavilion complex

Applying aviation factors to oral and maxillofacial surgery--the human element.

PubMed

Seager, Leonie; Smith, Dave W; Patel, Anish; Brunt, Howard; Brennan, Peter A

2013-01-01

There are many similarities between flying commercial aircraft and surgery, particularly in relation to minimising risk, and managing potentially fatal or catastrophic complications, or both. Since 1979, the development of Crew Resource Management (CRM) has improved air safety significantly by reducing human factors that are responsible for error. Similar developments in the operating theatre have, to a certain extent, lagged behind aviation, and it is well recognised that we can learn much from the industry. An increasing number of publications on aviation factors relate to surgery but to our knowledge there is a lack of research in our own specialty. We discuss how aviation principles related to human factors can be translated to the operating theatre to improve teamwork and safety for patients. Clinical research is clearly needed to develop this fascinating area more fully. Copyright © 2011 The British Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

[Clinical safety and professional liability claims in Orthopaedic Surgery and Traumatology].

PubMed

Bori, G; Gómez-Durán, E L; Combalia, A; Trilla, A; Prat, A; Bruguera, M; Arimany-Manso, J

2016-01-01

The specialist in orthopaedic and traumatological surgery, like any other doctor, is subject to the current legal provisions while exercising their profession. Mandatory training in the medical-legal aspects of health care is essential. Claims against doctors are a reality, and orthopaedic and traumatological surgery holds first place in terms of frequency of claims according to the data from the General Council of Official Colleges of Doctors of Catalonia. Professionals must be aware of the fundamental aspects of medical professional liability, as well as specific aspects, such as defensive medicine and clinical safety. The understanding of these medical-legal aspects in the routine clinical practice can help to pave the way towards a satisfactory and safe professional career. The aim of this review is to contribute to this training, for the benefit of professionals and patients. Copyright © 2015 SECOT. Published by Elsevier Espana. All rights reserved.

Improving Patient Safety with X-Ray and Anesthesia Machine Ventilator Synchronization: A Medical Device Interoperability Case Study

NASA Astrophysics Data System (ADS)

Arney, David; Goldman, Julian M.; Whitehead, Susan F.; Lee, Insup

When a x-ray image is needed during surgery, clinicians may stop the anesthesia machine ventilator while the exposure is made. If the ventilator is not restarted promptly, the patient may experience severe complications. This paper explores the interconnection of a ventilator and simulated x-ray into a prototype plug-and-play medical device system. This work assists ongoing interoperability framework development standards efforts to develop functional and non-functional requirements and illustrates the potential patient safety benefits of interoperable medical device systems by implementing a solution to a clinical use case requiring interoperability.

Surgery via natural orifices in human beings: yesterday, today, tomorrow.

PubMed

Moris, Demetrios N; Bramis, Konstantinos J; Mantonakis, Eleftherios I; Papalampros, Efstathios L; Petrou, Athanasios S; Papalampros, Alexandros E

2012-07-01

We performed an evaluation of models, techniques, and applicability to the clinical setting of natural orifice surgery (mainly natural orifice transluminal endoscopic surgery [NOTES]) primarily in general surgery procedures. NOTES has attracted much attention recently for its potential to establish a completely alternative approach to the traditional surgical procedures performed entirely through a natural orifice. Beyond the potentially scar-free surgery and abolishment of dermal incision-related complications, the safety and efficacy of this new surgical technology must be evaluated. Studies were identified by searching MEDLINE, EMBASE, Cochrane Library, and Entrez PubMed from 2007 to February 2011. Most of the references were identified from 2009 to 2010. There were limitations as far as the population that was evaluated (only human beings, no cadavers or animals) was concerned, but there were no limitations concerning the level of evidence of the studies that were evaluated. The studies that were deemed applicable for our review were published mainly from 2007 to 2010 (see Methods section). All the evaluated studies were conducted only in human beings. We studied the most common referred in the literature orifices such as vaginal, oral, gastric, esophageal, anal, or urethral. The optimal access route and method could not be established because of the different nature of each procedure. We mainly studied procedures in the field of general surgery such as cholecystectomy, intestinal cancers, renal cancers, appendectomy, mediastinoscopy, and peritoneoscopy. All procedures were feasible and most of them had an uneventful postoperative course. A number of technical problems were encountered, especially as far as pure NOTES procedures are concerned, which makes the need of developing new endoscopic instruments, to facilitate each approach, undeniable. NOTES is still in the early stages of development and more robust technologies will be needed to achieve reliable closure and overcome technical challenges. Well-designed studies in human beings need to be conducted to determine the safety and efficacy of NOTES in a clinical setting. Among these NOTES approaches, the transvaginal route seems less complicated because it virtually eliminates concerns for leakage and fistulas. The transvaginal approach further favors upper-abdominal surgeries because it provides better maneuverability to upper-abdominal organs (eg, liver, gallbladder, spleen, abdominal esophagus, and stomach). The stomach is considered one of the most promising targets because this large organ, once adequately mobilized, can be transected easily with a stapler. The majority of the approaches seem to be feasible even with the equipment used nowadays, but to achieve better results and wider applications to human beings, the need to develop new endoscopic instruments to facilitate each approach is necessary. Copyright © 2012 Elsevier Inc. All rights reserved.

The effects of power, leadership and psychological safety on resident event reporting.

PubMed

Appelbaum, Nital P; Dow, Alan; Mazmanian, Paul E; Jundt, Dustin K; Appelbaum, Eric N

2016-03-01

Although the reporting of adverse events is a necessary first step in identifying and addressing lapses in patient safety, such events are under-reported, especially by frontline providers such as resident physicians. This study describes and tests relationships between power distance and leader inclusiveness on psychological safety and the willingness of residents to report adverse events. A total of 106 resident physicians from the departments of neurosurgery, orthopaedic surgery, emergency medicine, otolaryngology, neurology, obstetrics and gynaecology, paediatrics and general surgery in a mid-Atlantic teaching hospital were asked to complete a survey on psychological safety, perceived power distance, leader inclusiveness and intention to report adverse events. Perceived power distance (β = -0.26, standard error [SE] 0.06, 95% confidence interval [CI] -0.37 to 0.15; p < 0.001) and leader inclusiveness (β = 0.51; SE 0.07, 95% CI 0.38-0.65; p < 0.001) both significantly predicted psychological safety, which, in turn, significantly predicted intention to report adverse events (β = 0.34; SE 0.08, 95% CI 0.18-0.49; p < 0.001). Psychological safety significantly mediated the direct relationship between power distance and intention to report adverse events (indirect effect: -0.09; SE 0.02, 95% CI -0.13 to 0.04; p < 0.001). Psychological safety also significantly mediated the direct relationship between leader inclusiveness and intention to report adverse events (indirect effect: 0.17; SE 0.02, 95% CI 0.08-0.27; p = 0.001). Psychological safety was found to be a predictor of intention to report adverse events. Perceived power distance and leader inclusiveness both influenced the reporting of adverse events through the concept of psychological safety. Because adverse event reporting is shaped by relationships and culture external to the individual, it should be viewed as an organisational as much as a personal function. Supervisors and other leaders in health care should ensure that policies, procedures and leadership practices build psychological safety and minimise power distance between low- and high-status members in order to support greater reporting of adverse events. © 2016 John Wiley & Sons Ltd.

Less is sometimes more: a comparison of distance-control and navigated-control concepts of image-guided navigation support for surgeons.

PubMed

Luz, Maria; Manzey, Dietrich; Modemann, Susanne; Strauss, Gero

2015-01-01

Image-guided navigation (IGN) systems provide automation support of intra-operative information analysis and decision-making for surgeons. Previous research showed that navigated-control (NC) systems which represent high levels of decision-support and directly intervene in surgeons' workflow provide benefits with respect to patient safety and surgeons' physiological stress but also involve several cost effects (e.g. prolonged surgery duration, reduced secondary-task performance). It was hypothesised that less automated distance-control (DC) systems would provide a better solution in terms of human performance consequences. N = 18 surgeons performed a simulated mastoidectomy with NC, DC and without IGN assistance. Effects on surgical performance, physiological effort, workload and situation awareness (SA) were compared. As expected, DC technology had the same benefits as the NC system but also led to less unwanted side effects on surgery duration, subjective workload and SA. This suggests that IGN systems just providing information analysis support are overall more beneficial than higher automated decision-support. This study investigates human performance consequences of different concepts of IGN support for surgeons. Less automated DC systems turned out to provide advantages for patient safety and surgeons' stress similar to higher automated NC systems with, at the same time, reduced negative consequences on surgery time and subjective workload.

Long-term effectiveness and safety of stereotactic gamma knife surgery as a primary sole treatment in the management of glomus jagulare tumor.

PubMed

Hafez, Raef F A; Morgan, Magad S; Fahmy, Osama M; Hassan, Hamdy T

2018-05-01

This study aims to report and confirm long-term effectiveness and safety of stereotactic Gamma Knife Surgery as a primary sole treatment in the management of 40 glomus jagulare tumors patients. Retrospective analysis of clinical and radiological outcomes of 40 GJTs consecutive patients treated with GKS as primary sole treatment at International Medical Center (IMC), Cairo-Egypt from the beginning of 2005 till the end of 2014,with mean follow-up period of 84 months (range 36-156 months), mean tumor volume was 6.5 cc, and mean peripheral radiation dose of 15 Gy, to mean isodose curve of 38%. The most common neurological deficit at initial evaluation was bulbar symptoms in 24 patients, followed by pulsatile tinnitus in 22, deterioration of hearing in 20 patients. The overall clinical control achieved in 92.5% of patients, while actuarial tumor size control rate post- GKS was 97.5% at 3 years, 97% at 5 years and 92% at 10 years of follow-up period. Gamma knife surgery could be used effectively and safely as a primary sole treatment tool in the management of glomus jugulare tumors. Copyright © 2018 Elsevier B.V. All rights reserved.

A comparative analysis of readmission rates after outpatient cosmetic surgery.

PubMed

Mioton, Lauren M; Alghoul, Mohammed S; Kim, John Y S

2014-02-01

Despite the increasing scrutiny of surgical procedures, outpatient cosmetic surgery has an established record of safety and efficacy. A key measure in assessing surgical outcomes is the examination of readmission rates. However, there is a paucity of data on unplanned readmission following cosmetic surgery procedures. The authors studied readmission rates for outpatient cosmetic surgery and compared the data with readmission rates for other surgical procedures. The 2011 National Surgical Quality Improvement Program (NSQIP) data set was queried for all outpatient procedures. Readmission rates were calculated for the 5 surgical specialties with the greatest number of outpatient procedures and for the overall outpatient cosmetic surgery population. Subgroup analysis was performed on the 5 most common cosmetic surgery procedures. Multivariate regression models were used to determine predictors of readmission for cosmetic surgery patients. The 2879 isolated outpatient cosmetic surgery cases had an associated 0.90% unplanned readmission rate. The 5 specialties with the highest number of outpatient surgical procedures were general, orthopedic, gynecologic, urologic, and otolaryngologic surgery; their unplanned readmission rates ranged from 1.21% to 3.73%. The 5 most common outpatient cosmetic surgery procedures and their associated readmission rates were as follows: reduction mammaplasty, 1.30%; mastopexy, 0.31%; liposuction, 1.13%; abdominoplasty, 1.78%; and breast augmentation, 1.20%. Multivariate regression analysis demonstrated that operating time (in hours) was an independent predictor of readmission (odds ratio, 1.40; 95% confidence interval, 1.08-1.81; P=.010). Rates of unplanned readmission with outpatient cosmetic surgery are low and compare favorably to those of other outpatient surgeries.

Review of various liver retraction techniques in single incision laparoscopic surgery for the exposure of hiatus.

PubMed

Palanivelu, Praveenraj; Patil, Kedar Pratap; Parthasarathi, Ramakrishnan; Viswambharan, Jaiganesh K; Senthilnathan, Palanisami; Palanivelu, Chinnusamy

2015-01-01

The main aspect of concern for upper GI procedures has been the retraction of the liver especially large left lobes as commonly encountered in Bariatric surgery. Not doing so would compromise the view of the hiatus, hence theoretically reducing the quality of the surgery and increasing the possibility of complications. The aim of this study was to review the various liver retraction techniques in single incision surgery being done at our institute and analyze them. A retrospective study of the various techniques and a subsequent analysis was made based on advantages and disadvantages of each method. Objectively a quantitative measure of hiatal exposure was done using a scoring system based on the grade of exposure after reviewing the surgical videos. From January 2011 to January 2013 total 104 patients underwent single incision surgery with the various liver retraction techniques with following grades of exposure -liver suspension tube technique with naso gastric tubing (2.11) and with corrugated drain (2.09) needlescopic method (1.2), Umbilical tape sling (1.95), crural stitch method (2.5). Needeloscopic method has the best grade of exposure and is the easiest to start with. The average time to create the liver retraction was 2.8 to 8.6 min.There was no procedure related morbidity or mortality. The mentioned liver retraction techniques are cost effective and easy to learn. We recommend using these techniques to have a good exposure of hiatus, without compromising the safety of surgery in single incision surgery.

Laparoscopic-assisted Rectus Sheath Block as a Novel Technique is Effective and Safe: A Randomized Controlled Trial.

PubMed

Miyazaki, Dai; Shichinohe, Toshiaki; Ebihara, Yuma; Kurashima, Yo; Murakami, Soichi; Noji, Takehiro; Nakamura, Toru; Tsuchikawa, Takahiro; Okamura, Keisuke; Hirano, Satoshi

2017-02-01

We developed laparoscopic-assisted rectus sheath block (LRSB) as a novel technique and report on its safety and effectiveness. Patients were randomly enrolled to an LRSB or control group (n=19 each). In the LRSB group, after the umbilical wound was closed, local anesthetic was injected transcutaneous at each of 4 sites (3 cm above and below the umbilicus bilaterally) with 10 mL of 0.25% levobupivacaine, laparoscopically. The control group received conventional postoperative pain management. The primary endpoint was visual analogue scale (VAS) pain score at the end of surgery. Secondary endpoints were VAS and Prince Henry pain scale after surgery, number of administrations of analgesics, and side effects of anesthesia. No significant differences in background were seen between groups. VAS at the end of surgery was significantly lower in the LRSB group than in controls (P<0.01). VAS and Prince Henry pain scale were significantly lower in the LRSB group from soon after surgery to postoperative day 2. No complications related to LRSB were encountered. LRSB was particularly effective at the end of surgery and pain scores were significantly lower in the LRSB group long after surgery. Our study shows LRSB is effective and safe for laparoscopic abdominal surgery.

Systemic and Topical Use of Tranexamic Acid in Spinal Surgery: A Systematic Review

PubMed Central

Winter, Sebastian F.; Santaguida, Carlo; Wong, Jean; Fehlings, Michael G.

2015-01-01

Study Design Combination of narrative and systematic literature reviews. Objectives Massive perioperative blood loss in complex spinal surgery often requires blood transfusions and can negatively affect patient outcome. Systemic use of the antifibrinolytic agent tranexamic acid (TXA) has become widely used in the management of surgical bleeding. We review the clinical evidence for the use of intravenous TXA as a hemostatic agent in spinal surgery and discuss the emerging role for its complementary use as a topical agent to reduce perioperative blood loss from the surgical site. Through a systematic review of published and ongoing investigations on topical TXA for spinal surgery, we wish to make spine practitioners aware of this option and to suggest opportunities for further investigation in the field. Methods A narrative review of systemic TXA in spinal surgery and topical TXA in surgery was conducted. Furthermore, a systematic search (using PRISMA guidelines) of PubMed (MEDLINE), EMBASE, and Cochrane CENTRAL databases as well as World Health Organization International Clinical Trials Registry Platform, ClinicalTrials.gov (National Institutes of Health), and International Standard Randomized Controlled Trial Number registries was conducted to identify both published literature and ongoing clinical trials on topical TXA in spinal surgery. Results Of 1,631 preliminary search results, 2 published studies were included in the systematic review. Out of 285 ongoing clinical trials matching the search criteria, a total of 4 relevant studies were included and reviewed. Conclusion Intravenous TXA is established as an efficacious hemostatic agent in spinal surgery. Use of topical TXA in surgery suggests similar hemostatic efficacy and potentially improved safety as compared with intravenous TXA. For spinal surgery, the literature on topical TXA is sparse but promising, warranting further clinical investigation and consideration as a clinical option in cases with significant anticipated surgical site blood loss. PMID:27099820

Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis.

PubMed

Hussain, Nasir; Goldar, Ghazaleh; Ragina, Neli; Banfield, Laura; Laffey, John G; Abdallah, Faraj W

2017-12-01

Interscalene block provides optimal shoulder surgery analgesia, but concerns over its associated risks have prompted the search for alternatives. Suprascapular block was recently proposed as an interscalene block alternative, but evidence of its comparative analgesic effect is conflicting. This meta-analysis compares the analgesic effect and safety of suprascapular block versus interscalene block for shoulder surgery. Databases were searched for randomized trials comparing interscalene block with suprascapular block for shoulder surgery. Postoperative 24-h cumulative oral morphine consumption and the difference in the area under curve for pooled rest pain scores were designated as primary outcomes. Analgesic and safety outcomes, particularly block-related and respiratory complications, were evaluated as secondary outcomes. Results were pooled using random-effects modeling. Data from 16 studies (1,152 patients) were analyzed. Interscalene block and suprascapular block were not different in 24-h morphine consumption. The difference in area under the curve of pain scores for the 24-h interval favored interscalene block by 1.1 cm/h, but this difference was not clinically important. Compared with suprascapular block, interscalene block reduced postoperative pain but not opioid consumption during recovery room stay by a weighted mean difference (95% CI) of 1.5 cm (0.6 to 2.5 cm; P < 0.0001). Pain scores were not different at any other time. In contrast, suprascapular block reduced the odds of block-related and respiratory complications. This review suggests that there are no clinically meaningful analgesic differences between suprascapular block and interscalene block except for interscalene block providing better pain control during recovery room stay; however, suprascapular block has fewer side effects. These findings suggest that suprascapular block may be considered an effective and safe interscalene block alternative for shoulder surgery.

One-per-mil tumescent technique for upper extremity surgeries: broadening the indication.

PubMed

Prasetyono, Theddeus O H; Biben, Johannes A

2014-01-01

We studied the effect of 1:1,000,000 epinephrine concentration (1 per mil) to attain a bloodless operative field in hand and upper extremity surgery and to explore its effectiveness and safety profile. This retrospective observational study enrolled 45 consecutive patients with 63 operative fields consisting of various hand and upper extremity problems. One-per-mil solution was injected into the operative field with tumescent technique to create a bloodless operating field without tourniquet. The solution was formulated by adding a 1:1,000,000 concentration of epinephrine and 100 mg of lidocaine into saline solution to form 50 mL of tumescent solution. Observation was performed on the clarity of the operative field, which we described as totally bloodless, minimal bleeding, acceptable bleeding, or bloody. The volume of tumescent solution injected, duration of surgery, and surgical outcome were also reviewed. The tumescent technique with 1-per-mil solution achieved 29% totally bloodless, 48% minimal bleeding, 22% acceptable bleeding, and 2% bloody operative fields in cases that included burn contracture and congenital hand and upper extremity surgeries. One-per-mil tumescent solution created a clear operative field in hand and upper extremity surgery. It proved safe and effective for a wide range of indications. Therapeutic IV. Copyright © 2014 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Improving resident engagement in quality improvement and patient safety initiatives at the bedside: the Advocate for Clinical Education (ACE).

PubMed

Schleyer, Anneliese M; Best, Jennifer A; McIntyre, Lisa K; Ehrmantraut, Ross; Calver, Patty; Goss, J Richard

2013-01-01

Quality improvement (QI) and patient safety (PS) are essential competencies in residency training; however, the most effective means to engage physicians remains unclear. The authors surveyed all medicine and surgery physicians at their institution to describe QI/PS practices and concurrently implemented the Advocate for Clinical Education (ACE) program to determine if a physician-centered program in the context of educational structures and at the point of care improved performance. The ACE rounded with medicine and surgery teams and provided individual and team-level education and feedback targeting 4 domains: professionalism, infection control, interpreter use, and pain assessment. In a pilot, the ACE observed 2862 physician-patient interactions and 178 physicians. Self-reported compliance often was greater than the behaviors observed. Following ACE implementation, observed professionalism behaviors trended toward improvement; infection control also improved. Physicians were highly satisfied with the program. The ACE initiative is one coaching/feedback model for engaging residents in QI/PS that may warrant further study.

Polymer therapeutics in surgery: the next frontier

PubMed Central

Conlan, R. Steven; Whitaker, Iain S.

2016-01-01

Abstract Polymer therapeutics is a successful branch of nanomedicine, which is now established in several facets of everyday practice. However, to our knowledge, no literature regarding the application of the underpinning principles, general safety, and potential of this versatile class to the perioperative patient has been published. This study provides an overview of polymer therapeutics applied to clinical surgery, including the evolution of this demand‐oriented scientific field, cutting‐edge concepts, its implications, and limitations, illustrated by products already in clinical use and promising ones in development. In particular, the effect of design of polymer therapeutics on biophysical and biochemical properties, the potential for targeted delivery, smart release, and safety are addressed. Emphasis is made on principles, giving examples in salient areas of demand in current surgical practice. Exposure of the practising surgeon to this versatile class is crucial to evaluate and maximise the benefits that this established field presents and to attract a new generation of clinician–scientists with the necessary knowledge mix to drive highly successful innovation. PMID:27588210

Impact of the 2011 FDA transvaginal mesh safety update on AUGS members' use of synthetic mesh and biologic grafts in pelvic reconstructive surgery.

PubMed

Clemons, Jeffrey L; Weinstein, Milena; Guess, Marsha K; Alperin, Marianna; Moalli, Pamela; Gregory, William Thomas; Lukacz, Emily S; Sung, Vivian W; Chen, Bertha H; Bradley, Catherine S

2013-01-01

To describe the frequency of use and recent change in use of synthetic mesh and biologic grafts in pelvic organ prolapse (POP) and stress urinary incontinence surgery by American Urogynecology Society (AUGS) members. An electronic survey of AUGS members was conducted between December 2011 and January 2012. Frequency of graft use in POP (overall and by transvaginal and transabdominal approaches) and stress urinary incontinence surgery was queried relative to the timing of the 2011 Food and Drug Administration (FDA) safety update. Rates of materials' use before and after the statement were compared using Wilcoxon signed rank test. Fifty-three percent (507/962) of AUGS members responded and were included in analysis; 79% were urogynecologists. Before the FDA warning, in POP surgery, most (90%) used synthetic mesh and fewer (34%) used biologic grafts; 99% used synthetic mesh slings. After the FDA statement, respondents reported an overall decrease in the percent of POP cases in which they used synthetic mesh (P < 0.001) but no change in biologic graft use for POP (P = 0.37) or synthetic mesh sling use (P = 0.10). Specifically, transvaginal mesh use decreased: 40% reported decreased use and 12% stopped use. However, transvaginal mesh was still used by 61% of respondents in at least some cases. No change (62%) or increased use (12%) of mesh was reported for transabdominal POP procedures. Synthetic mesh use in transvaginal POP surgery decreased after the 2011 FDA safety update, but synthetic mesh use for transabdominal POP repair and sling procedures and overall biologic graft use in POP surgery did not decrease.

Minimally invasive right lateral thoracotomy without aortic cross-clamping: an attractive alternative to repeat sternotomy for reoperative mitral valve surgery.

PubMed

Umakanthan, Ramanan; Petracek, Michael R; Leacche, Marzia; Solenkova, Nataliya V; Eagle, Susan S; Thompson, Annemarie; Ahmad, Rashid M; Greelish, James P; Ball, Stephen K; Hoff, Steven J; Absi, Tarek S; Balaguer, Jorge M; Byrne, John G

2010-03-01

The study aim was to determine the safety and benefits of minimally invasive mitral valve surgery without aortic cross-clamping for mitral valve surgery after previous cardiac surgery. Between January 2006 and August 2008, a total of 90 consecutive patients (38 females, 52 males; mean age 66 +/- 9 years) underwent minimally invasive mitral valve surgery after having undergone previous cardiac surgery. Of these patients, 80 (89%) underwent mitral valve replacement and 10 (11%) mitral valve repair utilizing a small (5 cm) right lateral thoracotomy along the 4th or 5th intercostal space under fibrillatory arrest (mean temperature 28 +/- 2 degrees C). The predicted mortality, calculated using the Society of Thoracic Surgeons (STS) algorithm, was compared to the observed mortality. The mean ejection fraction was 45 +/- 13%, mean NYHA class 3 +/- 1, while 66 patients (73%) had previous coronary artery bypass grafting and 37 (41%) had previous valve surgery. Twenty-six patients (29%) underwent non-elective surgery. Cardiopulmonary bypass was instituted through axillary (n = 19), femoral (n = 70) or direct use aortic (n = 1) cannulation. Operative mortality was 2% (2/90), lower than the STS-predicted mortality of 7%. Three patients (3%) developed acute renal failure postoperatively, one patient (1%) required new-onset hemodialysis, and one (1%) developed postoperative stroke. No patients developed postoperative myocardial infarction. The mean postoperative packed red blood cell transfusion requirement at 48 h was 2 +/- 3 units. Minimally invasive right thoracotomy without aortic cross-clamping is an excellent alternative to conventional redo-sternotomy for reoperative mitral valve surgery. The present study confirmed that this technique is safe and effective in reducing operative mortality in high-risk patients undergoing reoperative cardiac surgery.

Robot-Assisted Transoral Odontoidectomy : Experiment in New Minimally Invasive Technology, a Cadaveric Study

PubMed Central

Yang, Moon Sul; Yoon, Tae Ho; Yoon, Do Heum; Kim, Keung Nyun; Pennant, William

2011-01-01

Objective In the field of spinal surgery, a few laboratory results or clinical cases about robotic spinal surgery have been reported. In vivo trials and development of related surgical instruments for spinal surgery are required before its clinical application. We investigated the use of the da Vinci® Surgical System in spinal surgery at the craniovertebral junction in a human cadaver to demonstrate the efficacy and pitfalls of robotic surgery. Methods Dissection of pharyngeal wall to the exposure of C1 and odontoid process was performed with full robotic procedure. Although assistance of another surgeon was necessary for drilling and removal of odontoid process due to the lack of appropriate end-effectors, successful robotic procedures for dural sutures and exposing spinal cord proved its safety and dexterity. Results Robot-assisted odontoidectomy was successfully performed in a human cadaver using the da Vinci® Surgical System with few robotic arm collisions and minimal soft tissue damages. Da Vinci® Surgical System manifested more dexterous movement than human hands in the deep and narrow oral cavity. Furthermore, sutures with robotic procedure in the oral cavity demonstrated the advantage over conventional procedure. Conclusion Presenting cadaveric study proved the probability of robot-assisted transoral approach. However, the development of robotic instruments specific to spinal surgery must first precede its clinical application. PMID:21607188

Effectiveness and Safety of Batroxobin, Tranexamic Acid and a Combination in Reduction of Blood Loss in Lumbar Spinal Fusion Surgery.

PubMed

Nagabhushan, Roopa M; Shetty, Ajoy P; Dumpa, Srikanth R; Subramanian, Balavenkat; Kanna, Rishi M; Shanmuganathan, Rajasekeran

2018-03-01

A prospective randomized double blind placebo controlled trail. To evaluate and compare the efficacy and safety of batroxobin (botropase), tranexamic acid (TXA), and their combination in reduction of perioperative blood loss in lumbar spine single level fusion surgeries. Spinal surgeries are associated with significant blood loss leading to perioperative anemia and increased need for allogenic transfusion. TXA competitively inhibits plasmin and batroxobin converts fibrinogen to fibrin and theoretically their combination is synergistic. Though TXA is widely studied in controlling blood loss, there is little information on use of batroxobin and their combination. Thus, we aimed to study effect and safety of individual drugs and their combination in controlling blood loss in spinal surgery. Hundred patients were randomized into four groups. Group B received batroxobin, group T received TXA, group BT received batroxobin and TXA and group P received placebo. Outcomes assessed are intraoperative and postoperative blood loss, hematocrit, allogenic blood transfusion, and deep vein thrombosis (DVT), postoperatively. Mean intraoperative blood loss in Group B, T, BT, and P were 268.32 ± 62.92 mL, 340.72 ± 182.75 mL, 256.96 ± 82.64 mL, and 448.44 ± 205.86 mL, respectively. Postoperative surgical site drain collection in Group B, T, BT, and P were 218.00 ± 100.54 mL, 260.40 ± 100.85 mL, 191.00 ± 87.84 mL, and 320.00 ± 125.83 mL, respectively. Intraoperative blood loss of Group P was statistically higher than Groups B and BT (P < 0.001). Mean postoperative surgical site drain collection was statistically significant (P < 0.001). No statistically significant differences in fluid administration (P = 0.751), blood transfusion (P = 1.000), preoperative and postoperative hemoglobin (P = 0.090, P = 0.134, respectively), and deep vein thrombosis (P = 1.000). Batroxobin and combination of batroxobin with tranexamic acid significantly reduced perioperative blood loss when compared with placebo. 2.

Conversional Weight Loss Surgery: an Australian Experience of Converting Laparoscopic Adjustable Gastric Bands to Laparoscopic Sleeve Gastrectomy.

PubMed

Devadas, M; Ku, D J

2018-02-17

Bariatric surgery is the most effective treatment for severe obesity, capable of producing more than 50% excess weight loss at 10-year follow-up (James Clin Dermatol 1; 22:276-80; O'Brien Br J Surg 2; 102:611-17; Buchwald et al. Metab Syndr 3; 347-56). The success of bariatric surgery extends far beyond weight loss, with up to 80-90% of patients having improvement or resolution of many of their weight-related co-morbidities including type II diabetes mellitus and hypertension (Puzziferri et al. JAMA 4; 312:934-42; Buchwald et al. Am J Med 5; 122:248-56). However, there is a paucity of data regarding conversional bariatric surgery. This study aims to explore the efficacy, safety and feasibility of conversional surgery. This study represents the largest Australasian series focusing on conversional bariatric surgery. The study was conducted in the Norwest Private Hospital and Hospital for Specialist Surgery (HSS), both private Hospitals in Sydney, Australia. Data was collected prospectively at regular intervals for more than 12 months from 1 January 2012 to 1st November 2015 for all patients requiring a laparoscopic sleeve gastrectomy (LSG) as secondary procedure after prior laparoscopic adjustable gastric band (LAGB). Excess weight loss (EWL), percentage total body weight loss (TWL) and excess BMI loss (EBMIL) as well as any complications were recorded. There were low rates of morbidity (1.1%) and no mortality at 12-month follow-up. Satisfactory EWL of 60% (95% CI: 56.6-63.4%), EBMIL of 60.1% (95% CI: 48.8-71.4%) and 16% TWL was achieved at 12-month follow-up. We therefore conclude that sleeve gastrectomy is a safe and valid option for conversional bariatric surgery following LAGB.

Volunteers in plastic surgery guidelines for providing surgical care for children in the less developed world: part II. Ethical considerations.

PubMed

Schneider, William J; Migliori, Mark R; Gosain, Arun K; Gregory, George; Flick, Randall

2011-09-01

Many international volunteer groups provide free reconstructive plastic surgery for the poor and underserved in developing countries. An essential issue in providing this care is that it meets consistent guidelines for both quality and safety-a topic that has been addressed previously. An equally important consideration is how to provide that care in an ethical manner. No literature presently addresses the various issues involved in making those decisions. With these ethical considerations in mind, the Volunteers in Plastic Surgery Committee of the American Society of Plastic Surgeons/Plastic Surgery Foundation undertook a project to create a comprehensive set of guidelines for volunteer groups planning to provide this type of reconstructive plastic surgery in developing countries. The committee worked in conjunction with the Society for Pediatric Anesthesia on this project. The Board of the American Society of Plastic Surgeons/Plastic Surgery Foundation has approved the ethical guidelines created for the delivery of care in developing countries. The guidelines address the variety of ethical decisions that may be faced by a team working in an underdeveloped country. These guidelines make it possible for a humanitarian effort to anticipate the types of ethical decisions that are often encountered and be prepared to deal with them appropriately. Any group seeking to undertake an international mission trip in plastic surgery should be able to go to one source to find a detailed discussion of the perceived needs in providing ethical humanitarian care. This document was created to satisfy that need and is a companion to our original guidelines addressing safety and quality.

Intracameral phenylephrine and ketorolac during cataract surgery to maintain intraoperative mydriasis and reduce postoperative ocular pain: Integrated results from 2 pivotal phase 3 studies.

PubMed

Hovanesian, John A; Sheppard, John D; Trattler, William B; Gayton, Johnny L; Malhotra, Ranjan P; Schaaf, David T; Ng, Edmund; Dunn, Steven H

2015-10-01

To evaluate the efficacy and safety of phenylephrine 1.0%-ketorolac 0.3% (Omidria) for maintenance of mydriasis during, and reduction of ocular pain after, cataract surgery. Twenty centers in the United States and the Netherlands. Prospective randomized clinical trials. Patients having cataract surgery or refractive lens exchange were enrolled in 2 clinical trials. Phenylephrine 1.0%-ketorolac 0.3% or placebo was added to irrigation solution and administered intracamerally during the procedure. Integrated analyses of primary and secondary endpoints were conducted. The clinical trials comprised 808 patients (403 treatment and 405 placebo). Phenylephrine 1.0%-ketorolac 0.3% was superior to placebo for the maintenance of mydriasis during, and reduction of ocular pain following, cataract surgery. The mean area under the curve (AUC) change from baseline in pupil diameter was 0.08 mm for treatment compared with -0.50 mm for placebo (P < .0001). The mean AUC of ocular pain visual analog scale scores within 12 hours postoperatively was 4.16 mm for the treatment group and 9.06 mm for the placebo group (P < .001). Results of all secondary efficacy analyses demonstrated a significant treatment effect associated with phenylephrine 1.0%-ketorolac 0.3%. Treatment-emergent adverse events were as expected for a population having cataract surgery; no clinically significant differences in safety measures were observed between treatment groups. In this integrated analysis, phenylephrine 1.0%-ketorolac 0.3% administered intracamerally with irrigation solution during cataract surgery was safe and effective for maintaining mydriasis during the procedure and reducing postoperative ocular pain. Dr. Schaaf is an employee and holds an equity interest in Omeros Corporation. Drs. Hovanesian, Sheppard, Trattler, Gayton, and Ng are consultants to Omeros Corporation. No other author has a financial or proprietary interest in any material or method mentioned. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

Transesophageal Echocardiography-Guided Epicardial Left Ventricular Lead Placement by Video-Assisted Thoracoscopic Surgery in Nonresponders to Biventricular Pacing and Previous Chest Surgery.

PubMed

Schroeder, Carsten; Chung, Jane M; Mackall, Judith A; Cakulev, Ivan T; Patel, Aaron; Patel, Sunny J; Hoit, Brian D; Sahadevan, Jayakumar

2018-06-14

The aim of the study was to study the feasibility, safety, and efficacy of transesophageal echocardiography-guided intraoperative left ventricular lead placement via a video-assisted thoracoscopic surgery approach in patients with failed conventional biventricular pacing. Twelve patients who could not have the left ventricular lead placed conventionally underwent epicardial left ventricular lead placement by video-assisted thoracoscopic surgery. Eight patients had previous chest surgery (66%). Operative positioning was a modified far lateral supine exposure with 30-degree bed tilt, allowing for groin and sternal access. To determine the optimal left ventricular location for lead placement, the left ventricular surface was divided arbitrarily into nine segments. These segments were transpericardially paced using a hand-held malleable pacing probe identifying the optimal site verified by transesophageal echocardiography. The pacing leads were screwed into position via a limited pericardiotomy. The video-assisted thoracoscopic surgery approach was successful in all patients. Biventricular pacing was achieved in all patients and all reported symptomatic benefit with reduction in New York Heart Association class from III to I-II (P = 0.016). Baseline ejection fraction was 23 ± 3%; within 1-year follow-up, the ejection fraction increased to 32 ± 10% (P = 0.05). The mean follow-up was 566 days. The median length of hospital stay was 7 days with chest tube removal between postoperative days 2 and 5. In patients who are nonresponders to conventional biventricular pacing, intraoperative left ventricular lead placement using anatomical and functional characteristics via a video-assisted thoracoscopic surgery approach is effective in improving heart failure symptoms. This optimized left ventricular lead placement is feasible and safe. Previous chest surgery is no longer an exclusion criterion for a video-assisted thoracoscopic surgery approach.

[Improvement of medical processes with Six Sigma - practicable zero-defect quality in preparation for surgery].

PubMed

Sobottka, Stephan B; Töpfer, Armin; Eberlein-Gonska, Maria; Schackert, Gabriele; Albrecht, D Michael

2010-01-01

Six Sigma is an innovative management- approach to reach practicable zero- defect quality in medical service processes. The Six Sigma principle utilizes strategies, which are based on quantitative measurements and which seek to optimize processes, limit deviations or dispersion from the target process. Hence, Six Sigma aims to eliminate errors or quality problems of all kinds. A pilot project to optimize the preparation for neurosurgery could now show that the Six Sigma method enhanced patient safety in medical care, while at the same time disturbances in the hospital processes and failure costs could be avoided. All six defined safety relevant quality indicators were significantly improved by changes in the workflow by using a standardized process- and patient- oriented approach. Certain defined quality standards such as a 100% complete surgical preparation at start of surgery and the required initial contact of the surgeon with the patient/ surgical record on the eve of surgery could be fulfilled within the range of practical zero- defect quality. Likewise, the degree of completion of the surgical record by 4 p.m. on the eve of surgery and their quality could be improved by a factor of 170 and 16, respectively, at sigma values of 4.43 and 4.38. The other two safety quality indicators "non-communicated changes in the OR- schedule" and the "completeness of the OR- schedule by 12:30 a.m. on the day before surgery" also show an impressive improvement by a factor of 2.8 and 7.7, respectively, corresponding with sigma values of 3.34 and 3.51. The results of this pilot project demonstrate that the Six Sigma method is eminently suitable for improving quality of medical processes. In our experience this methodology is suitable, even for complex clinical processes with a variety of stakeholders. In particular, in processes in which patient safety plays a key role, the objective of achieving a zero- defect quality is reasonable and should definitely be aspirated. Copyright © 2010. Published by Elsevier GmbH.

Risk-benefit analysis of navigation techniques for vertebral transpedicular instrumentation: a prospective study.

PubMed

Noriega, David C; Hernández-Ramajo, Rubén; Rodríguez-Monsalve Milano, Fiona; Sanchez-Lite, Israel; Toribio, Borja; Ardura, Francisco; Torres, Ricardo; Corredera, Raul; Kruger, Antonio

2017-01-01

Pedicle screws in spinal surgery have allowed greater biomechanical stability and higher fusion rates. However, malposition is very common and may cause neurologic, vascular, and visceral injuries and compromise mechanical stability. The purpose of this study was to compare the malposition rate between intraoperative computed tomography (CT) scan assisted-navigation and free-hand fluoroscopy-guided techniques for placement of pedicle screw instrumentation. This is a prospective, randomized, observational study. A total of 114 patients were included: 58 in the assisted surgery group and 56 in the free-hand fluoroscopy-guided surgery group. Analysis of screw position was assessed using the Heary classification. Breach severity was defined according to the Gertzbein classification. Radiation doses were evaluated using thermoluminescent dosimeters, and estimates of effective and organ doses were made based on scan technical parameters. Consecutive patients with degenerative disease, who underwent surgical procedures using the free-hand, or intraoperative navigation technique for placement of transpedicular instrumentation, were included in the study. Forty-four out of 625 implanted screws were malpositioned: 11 (3.6%) in the navigated surgery group and 33 (10.3%) in the free-hand group (p<.001). Screw position according to the Heary scale was Grade II (4 navigated surgery, 6 fluoroscopy guided), Grade III (3 navigated surgery, 11 fluoroscopy guided), Grade IV (4 navigated surgery, 16 fluoroscopy guided), and Grade V (1 fluoroscopy guided). There was only one symptomatic case in the conventional surgery group. Breach severity was seven Grade A and four Grade B in the navigated surgery group, and eight Grade A, 24 Grade B, and one Grade C in free-hand fluoroscopy-guided surgery group. Radiation received per patient was 5.8 mSv (4.8-7.3). The median dose received in the free-hand fluoroscopy group was 1 mGy (0.8-1.1). There was no detectable radiation level in the navigation-assisted surgery group, whereas the effective dose was 10 µGy in the free-hand fluoroscopy-guided surgery group. Malposition rate, both symptomatic and asymptomatic, in spinal surgery is reduced when using CT-guided placement of transpedicular instrumentation compared with placement under fluoroscopic guidance, with radiation values within the safety limits for health. Larger studies are needed to determine risk-benefit in these patients. Copyright © 2016 Elsevier Inc. All rights reserved.

Feasibility of a multicentre, randomised controlled trial of laparoscopic versus open colorectal surgery in the acute setting: the LaCeS feasibility trial protocol.

PubMed

Harji, Deena; Marshall, Helen; Gordon, Katie; Crow, Hannah; Hiley, Victoria; Burke, Dermot; Griffiths, Ben; Moriarty, Catherine; Twiddy, Maureen; O'Dwyer, John L; Verjee, Azmina; Brown, Julia; Sagar, Peter

2018-02-22

Acute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise. The LaCeS (randomised controlled trial of Laparoscopic versus open Colorectal Surgery in the acute setting) feasibility trial will determine the feasibility of conducting a definitive, phase III trial of laparoscopic versus open acute colorectal resection. The LaCeS feasibility trial is a prospective, multicentre, single-blinded, parallel group, pragmatic randomised controlled feasibility trial. Patients will be randomised on a 1:1 basis to receive eitherlaparoscopic or open surgery. The trial aims to recruit at least 66 patients from five acute general surgical units across the UK. Patients over the age of 18 with a diagnosis of acute colorectal pathology requiring resection on clinical and radiological/endoscopic investigations, with a National Confidential Enquiry into Patient Outcome and Death classification of urgent will be considered eligible for participation. The primary outcome is recruitment. Secondary outcomes include assessing the safety profile of laparoscopic surgery using intraoperative and postoperative complication rates, conversion rates and patient-safety indicators as surrogate markers. Clinical and patient-reported outcomes will also be reported. The trial will contain an embedded qualitative study to assess clinician and patient acceptability of trial processes. The LaCeS feasibility trial is approved by the Yorkshire and The Humber, Bradford Leeds Research Ethics Committee (REC reference: 15/ YH/0542). The results from the trial will be presented at national and international colorectal conferences and will be submitted for publication to peer-reviewed journals. ISRCTN15681041; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Internal Maxillary Artery Preoperative Embolization Using n-Butyl Cyanoacrylate and Pushable Coils for Temporomandibular Joint Ankylosis Surgery.

PubMed

Alderazi, Yazan J; Shastri, Darshan; Wessel, John; Mathew, Melvin; Kass-Hout, Tareq; Aziz, Shahid R; Prestigiacomo, Charles J; Gandhi, Chirag D

2017-05-01

Temporomandibular joint (TMJ) ankylosis causes disability through impaired digestion, mastication, speech, and appearance. Surgical treatment increases range of motion with resultant functional improvement. However, substantial perioperative blood loss can occur (up to 3 L) if the internal maxillary artery (IMAX) is injured as it traverses the ankylotic mass. Achieving hemostasis is difficult because of limited proximal IMAX access and poor visualization. Our aim is to investigate the technical feasibility and preliminary safety of preoperative IMAX embolization in patients undergoing TMJ ankylosis surgery. Case series using chart reviews of 2 patients who underwent preoperative embolization before TMJ ankylosis surgery. Both patients were women (28 and 51 years old) who had severely restricted mouth opening. Embolization was performed using general anesthesia with nasal intubation on the same day of TMJ surgery. Both patients underwent bilateral IMAX embolization using pushable coils (Vortex, Boston Scientific) of distal IMAX followed by n-butyl-cyanoacrylate (Trufill, Cordis) embolization from coil mass up to proximal IMAX. There were no complications from the embolization procedures. Both patients had normal neurologic examination results. TMJ surgery occurred with minimal operative blood loss (≤300 mL for each surgery). Maximum postoperative mouth opening was 35 mm and 34 mm, respectively. One patient had a postoperative TMJ wound infection that was managed with antibiotics. Preoperative IMAX embolization before TMJ ankylosis surgery is technically feasible with encouraging preliminary safety. There were no complications from the embolization procedures and surgeries occurred with low volumes of blood loss. Copyright © 2017 Elsevier Inc. All rights reserved.

78 FR 40740 - Agency Information Collection Activities: Proposed Collection; Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-08

... proposed information collection project: ``Pretest of the Ambulatory Surgery/Procedure Survey on [email protected] . SUPPLEMENTARY INFORMATION: Proposed Project Pretest of the Ambulatory Surgery... to improve their practices and their culture of patient safety. This survey is designed for use in...

A Review of Perioperative Complications of Outpatient Total Ankle Arthroplasty.

PubMed

Borenstein, Todd R; Anand, Kapil; Li, Quanlin; Charlton, Timothy P; Thordarson, David B

2018-02-01

Total ankle arthroplasty (TAA) is commonly pursued for patients with painful arthritis. Outpatient TAA are increasingly common and have been shown to decrease costs compared to inpatient surgery. However, there are very few studies examining the safety of outpatient TAA. In this study, we retrospectively reviewed 65 consecutive patients who received outpatient TAA to identify complication rates. The medical records of 65 consecutive outpatient TAA from October 2012 to May 2016 with a minimum 6-month follow-up were reviewed. All patients received popliteal and saphenous blocks prior to surgery and were managed with oral pain medication postoperatively. All received a STAR total ankle. Demographics, comorbidities, American Society of Anesthesiologists (ASA) class, and perioperative complications including wound breakdown, infection, revision, and nonrevision surgeries were observed. Mean follow-up was 16.6 ± 9.1 months (range, 6-42 months). There were no readmissions for pain control and 1 patient had a wound infection. The overall complication rate was 15.4%. One ankle (1.5%) had a wound breakdown requiring debridement and flap coverage. This patient thrombosed a popliteal artery stent 1 month postop. The 1 ankle (1.5%) with a wound infection occurred in a patient with diabetes, obesity, hypertension, and rheumatoid arthritis. This study demonstrates the safety of outpatient TAA. The combination of regional anesthesia and oral narcotics provided a satisfactory experience with no readmissions for pain control and 1 wound infection. The 1 wound breakdown complication (1.5%) was attributed to arterial occlusion and not outpatient management. Level IV, retrospective case series.

[Analgesic effect of acupuncture at Neimadian(Extra) in postoperation of abdominal surgery].

PubMed

Ding, Liu-Xin; Xing, Qun-Zhi; Sun, Jun-Jun; Li, Yu

2011-08-01

To observe the analgesia effectiveness and safety of electroacupuncture at Neimadian(Extra) for postoperation of abdominal surgery. One hundred and twenty patients with routine abdominal surgery were randomly divided into an acupuncture group and a medication group, 60 cases in each group. The acupuncture group was treated with electroacupuncture at Neimadian(Extra), which was located on the inside of lower leg, 7 cun above the internal malleolus and 0.5 cun from post edge of tibial. The medication group was treated with patient-controlled intravenous analgesia (PCIA) with Sufentanil. After the treatment, the Visual Analogue Scale (VAS), the security, the analgesic effect and beta-endorphin content were compared. The postoperative VAS score at 2, 4, 8, 16, 24 and 48 h in the acupuncture group was lower than those in the medication group (all P < 0.05). The analgesic effect at 2, 4, 16 and 24 h after surgery in the acupuncture group were superior to those in the medication group (P < 0.05, P < 0.01). The beta-endorphin content at 0, 8, 16 and 48 h after surgery in both groups were increased, and the acupuncture group was superior to the medication group (all P < 0.05). The security class after surgery in the acupuncture group was higher than that in the medication group (P < 0.05). The analgesic effect and safety of electroacupuncture at Neimadian(Extra) in postoperation of abdominal surgery are superior to those of the PCIA with Sufentanil.

Advantages of robotics in benign gynecologic surgery.

PubMed

Truong, Mireille; Kim, Jin Hee; Scheib, Stacey; Patzkowsky, Kristin

2016-08-01

The purpose of this article is to review the literature and discuss the advantages of robotics in benign gynecologic surgery. Minimally invasive surgery has become the preferred route over abdominal surgery. The laparoscopic or robotic approach is recommended when vaginal surgery is not feasible. Thus far, robotic gynecologic surgery data have demonstrated feasibility, safety, and equivalent clinical outcomes in comparison with laparoscopy and better clinical outcomes compared with laparotomy. Robotics was developed to overcome challenges of laparoscopy and has led to technological advantages such as improved ergonomics, visualization with three-dimensional capabilities, dexterity and range of motion with instrument articulation, and tremor filtration. To date, applications of robotics in benign gynecology include hysterectomy, myomectomy, endometriosis surgery, sacrocolpopexy, adnexal surgery, tubal reanastomosis, and cerclage. Though further data are needed, robotics may provide additional benefits over other approaches in the obese patient population and in higher complexity cases. Challenges that arose in the earlier adoption stage such as the steep learning curve, costs, and operative times are becoming more optimized with greater experience, with implementation of robotics in high-volume centers and with improved training of surgeons and robotic teams. Robotic laparoendoscopic single-site surgery, albeit still in its infancy where technical advantages compared with laparoscopic single-site surgery are still unclear, may provide a cost-reducing option compared with multiport robotics. The cost may even approach that of laparoscopy while still conferring similar perioperative outcomes. Advances in robotic technology such as the single-site platform and telesurgery, have the potential to revolutionize the field of minimally invasive gynecologic surgery. Higher quality evidence is needed to determine the advantages and disadvantages of robotic surgery in benign gynecologic surgery. Conclusions on the benefits and risks of robotic surgery should be made with caution given limited data, especially when compared with other routes. Route of surgery selection should take into consideration the surgeons' skill and comfort level that allows for the highest level of safety and efficiency. Ultimately, the robotic device is an additional minimally invasive surgical tool that can further the goal of minimizing laparotomy in gynecology.

Duke Surgery Patient Safety: an open-source application for anonymous reporting of adverse and near-miss surgical events

PubMed Central

Pietrobon, Ricardo; Lima, Raquel; Shah, Anand; Jacobs, Danny O; Harker, Matthew; McCready, Mariana; Martins, Henrique; Richardson, William

2007-01-01

Background Studies have shown that 4% of hospitalized patients suffer from an adverse event caused by the medical treatment administered. Some institutions have created systems to encourage medical workers to report these adverse events. However, these systems often prove to be inadequate and/or ineffective for reviewing the data collected and improving the outcomes in patient safety. Objective To describe the Web-application Duke Surgery Patient Safety, designed for the anonymous reporting of adverse and near-miss events as well as scheduled reporting to surgeons and hospital administration. Software architecture DSPS was developed primarily using Java language running on a Tomcat server and with MySQL database as its backend. Results Formal and field usability tests were used to aid in development of DSPS. Extensive experience with DSPS at our institution indicate that DSPS is easy to learn and use, has good speed, provides needed functionality, and is well received by both adverse-event reporters and administrators. Discussion This is the first description of an open-source application for reporting patient safety, which allows the distribution of the application to other institutions in addition for its ability to adapt to the needs of different departments. DSPS provides a mechanism for anonymous reporting of adverse events and helps to administer Patient Safety initiatives. Conclusion The modifiable framework of DSPS allows adherence to evolving national data standards. The open-source design of DSPS permits surgical departments with existing reporting mechanisms to integrate them with DSPS. The DSPS application is distributed under the GNU General Public License. PMID:17472749

Duke Surgery Patient Safety: an open-source application for anonymous reporting of adverse and near-miss surgical events.

PubMed

Pietrobon, Ricardo; Lima, Raquel; Shah, Anand; Jacobs, Danny O; Harker, Matthew; McCready, Mariana; Martins, Henrique; Richardson, William

2007-05-01

Studies have shown that 4% of hospitalized patients suffer from an adverse event caused by the medical treatment administered. Some institutions have created systems to encourage medical workers to report these adverse events. However, these systems often prove to be inadequate and/or ineffective for reviewing the data collected and improving the outcomes in patient safety. To describe the Web-application Duke Surgery Patient Safety, designed for the anonymous reporting of adverse and near-miss events as well as scheduled reporting to surgeons and hospital administration. SOFTWARE ARCHITECTURE: DSPS was developed primarily using Java language running on a Tomcat server and with MySQL database as its backend. Formal and field usability tests were used to aid in development of DSPS. Extensive experience with DSPS at our institution indicate that DSPS is easy to learn and use, has good speed, provides needed functionality, and is well received by both adverse-event reporters and administrators. This is the first description of an open-source application for reporting patient safety, which allows the distribution of the application to other institutions in addition for its ability to adapt to the needs of different departments. DSPS provides a mechanism for anonymous reporting of adverse events and helps to administer Patient Safety initiatives. The modifiable framework of DSPS allows adherence to evolving national data standards. The open-source design of DSPS permits surgical departments with existing reporting mechanisms to integrate them with DSPS. The DSPS application is distributed under the GNU General Public License.

Transcranial electric motor evoked potential monitoring during spine surgery: is it safe?

PubMed

Schwartz, Daniel M; Sestokas, Anthony K; Dormans, John P; Vaccaro, Alexander R; Hilibrand, Alan S; Flynn, John M; Li, P Mark; Shah, Suken A; Welch, William; Drummond, Denis S; Albert, Todd J

2011-06-01

Retrospective review. To report on the safety of repetitive transcranial electric stimulation (RTES) for eliciting motor-evoked potentials during spine surgery. Theoretical concerns over the safety of RTES have hindered broader acceptance of transcranial electric motor-evoked potentials (tceMEP), despite successful implementation of spinal cord monitoring with tceMEPs in many large spine centers, as well as their apparent superiority over mixed-nerve somatosensory-evoked potentials (SSEP) for detection of spinal cord injury. The records of 18,862 consecutive patients who met inclusion criteria and underwent spine surgery with tceMEP monitoring were reviewed for RTES-related complications. This large retrospective review identified only 26 (0.14%) cases with RTES-related complications; all but one of these were tongue lacerations, most of which were self-limiting. The results demonstrate that RTES is a highly safe modality for monitoring spinal cord motor tract function intraoperatively.

Surgeons' Perceptions of the Causes of Preventable Harm in Arterial Surgery: A Mixed-Methods Study.

PubMed

Lear, Rachael; Godfrey, Anthony D; Riga, Celia; Norton, Christine; Vincent, Charles; Bicknell, Colin D

2017-12-01

System factors contributing to preventable harm in vascular patients have not been previously reported in detail. The aim of this exploratory mixed-methods study was to describe vascular surgeons' perceptions of factors contributing to adverse events (AEs) in arterial surgery. A secondary aim was to report recommendations to improve patient safety. Vascular consultants/registrars working in the British National Health Service were questioned about the causes of preventable AEs through survey and semi-structured interview (response rates 77% and 83%, respectively). Survey respondents considered a recent AE, indicating on a 5 point Likert scale the extent to which various factors from a validated framework contributed toward the incident. Semi-structured interviews were conducted to obtain detailed accounts of contributory factors, and to elicit recommendations to improve safety. Seventy-seven surgeons completed the survey on 77 separate AEs occurring during open surgery (n = 41) and in endovascular procedures (n = 36). Ten interviewees described 15 AEs. The causes of AEs were multifactorial (median number of factors/AE = 5, IQR 3-9, range 0-25). Factors frequently reported by survey respondents were communication failures (36.4%; n = 28/77); inadequate staffing levels/skill mix (32.5%; n = 25/77); lack of knowledge/skill (37.3%; n = 28/75). Themes emerging from interviews were team factors (communication failure, lack of team continuity, lack of clarity over roles/responsibilities); work environment factors (poor staffing levels, equipment problems, distractions); inadequate training/supervision. Knowledge/skill (p = .034) and competence (p = .018) appeared to be more prominent in causing AEs in open procedures compared with endovascular procedures; organisational structure was more frequently implicated in AEs occurring in endovascular procedures (p = .017). To improve safety, interviewees proposed team training programmes (5/10 interviewees); additional protocols/checklists (4/10); improved escalation procedures (3/10). Vascular surgeons believe that AEs in arterial operations are caused by multiple, modifiable system factors. Larger studies are needed to establish the relative importance of these factors and to determine strategies that can effectively address system failures. Copyright © 2017 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

Disruption of Radiologist Workflow.

PubMed

Kansagra, Akash P; Liu, Kevin; Yu, John-Paul J

2016-01-01

The effect of disruptions has been studied extensively in surgery and emergency medicine, and a number of solutions-such as preoperative checklists-have been implemented to enforce the integrity of critical safety-related workflows. Disruptions of the highly complex and cognitively demanding workflow of modern clinical radiology have only recently attracted attention as a potential safety hazard. In this article, we describe the variety of disruptions that arise in the reading room environment, review approaches that other specialties have taken to mitigate workflow disruption, and suggest possible solutions for workflow improvement in radiology. Copyright © 2015 Mosby, Inc. All rights reserved.

Equivalent Treatment and Survival after Resection of Pancreatic Cancer at Safety-Net Hospitals.

PubMed

Dhar, Vikrom K; Hoehn, Richard S; Kim, Young; Xia, Brent T; Jung, Andrew D; Hanseman, Dennis J; Ahmad, Syed A; Shah, Shimul A

2018-01-01

Due to disparities in access to care, patients with Medicaid or no health insurance are at risk of not receiving appropriate adjuvant treatment following resection of pancreatic cancer. We have previously shown inferior short-term outcomes following surgery at safety-net hospitals. Subsequently, we hypothesized that safety-net hospitals caring for these vulnerable populations utilize less adjuvant chemoradiation, resulting in inferior long-term outcomes. The American College of Surgeons National Cancer Data Base was queried for patients diagnosed with pancreatic adenocarcinoma (n = 32,296) from 1998 to 2010. Hospitals were grouped according to safety-net burden, defined as the proportion of patients with Medicaid or no insurance. The highest quartile, representing safety-net hospitals, was compared to lower-burden hospitals with regard to patient demographics, disease characteristics, surgical management, delivery of multimodal systemic therapy, and survival. Patients at safety-net hospitals were less often white, had lower income, and were less educated. Safety-net hospital patients were just as likely to undergo surgical resection (OR 1.03, p = 0.73), achieving similar rates of negative surgical margins when compared to patients at medium and low burden hospitals (70% vs. 73% vs. 66%). Thirty-day mortality rates were 5.6% for high burden hospitals, 5.2% for medium burden hospitals, and 4.3% for low burden hospitals. No clinically significant differences were noted in the proportion of surgical patients receiving either chemotherapy (48% vs. 52% vs. 52%) or radiation therapy (26% vs. 30% vs. 29%) or the time between diagnosis and start of systemic therapy (58 days vs. 61 days vs. 53 days). Across safety-net burden groups, no difference was noted in stage-specific median survival (all p > 0.05) or receipt of adjuvant as opposed to neoadjuvant systemic therapy (82% vs. 85% vs. 85%). Multivariate analysis adjusting for cancer stage revealed no difference in survival for safety-net hospital patients who had surgery and survived > 30 days (HR 1.02, p = 0.63). For patients surviving the perioperative setting following pancreatic cancer surgery, safety-net hospitals achieve equivalent long-term survival outcomes potentially due to equivalent delivery of multimodal therapy at non-safety-net hospitals. Safety-net hospitals are a crucial resource that provides quality long-term cancer treatment for vulnerable populations.

A comparison of two methods of infiltration in breast reduction surgery.

PubMed

Armour, A D; Rotenberg, B W; Brown, M H

2001-08-01

The superwet technique has been shown in previous studies to dramatically reduce blood loss in breast reduction surgery, compared with standard infiltration. A retrospective chart review of 303 consecutive patients undergoing bilateral breast reduction surgery was undertaken to demonstrate additional differences in complication rate, operative time, or sponge use in the operating room. In this series, 132 consecutive patients received standard infiltration along incision lines (25 cc per breast of 1:100,000 epinephrine), and 171 patients received superwet infiltration with 240 cc per breast of 1:1,000,000 epinephrine. The average operative time was significantly reduced in the superwet group, from 78.5 minutes to 70.7 minutes (p < 0.01 level). The average number of sponges used intraoperatively was also decreased significantly (p < 0.01), from 26 to 20 sponges. Complication rates were equally low in both groups, demonstrating the safety of the superwet technique. In addition to limiting blood loss, the superwet infiltration effectively reduces operative time and sponge use without increasing complications in breast reduction surgery.

Effects of the Smartphone Application "Safe Patients" on Knowledge of Patient Safety Issues Among Surgical Patients.

PubMed

Cho, Sumi; Lee, Eunjoo

2017-12-01

Recently, the patient's role in preventing adverse events has been emphasized. Patients who are more knowledgeable about safety issues are more likely to engage in safety initiatives. Therefore, nurses need to develop techniques and tools that increase patients' knowledge in preventing adverse events. For this reason, an educational smartphone application for patient safety called "Safe Patients" was developed through an iterative process involving a literature review, expert consultations, and pilot testing of the application. To determine the effect of "Safe Patients," it was implemented for patients in surgical units in a tertiary hospital in South Korea. The change in patients' knowledge about patient safety was measured using seven true/false questions developed in this study. A one-group pretest and posttest design was used, and a total of 123 of 190 possible participants were tested. The percentage of correct answers significantly increased from 64.5% to 75.8% (P < .001) after implementation of the "Safe Patients" application. This study demonstrated that the application "Safe Patients" could effectively improve patients' knowledge of safety issues. This will ultimately empower patients to engage in safe practices and prevent adverse events related to surgery.

Robotics in Colorectal Surgery

PubMed Central

Weaver, Allison; Steele, Scott

2016-01-01

Over the past few decades, robotic surgery has developed from a futuristic dream to a real, widely used technology. Today, robotic platforms are used for a range of procedures and have added a new facet to the development and implementation of minimally invasive surgeries. The potential advantages are enormous, but the current progress is impeded by high costs and limited technology. However, recent advances in haptic feedback systems and single-port surgical techniques demonstrate a clear role for robotics and are likely to improve surgical outcomes. Although robotic surgeries have become the gold standard for a number of procedures, the research in colorectal surgery is not definitive and more work needs to be done to prove its safety and efficacy to both surgeons and patients. PMID:27746895

Predicting medical complications after spine surgery: a validated model using a prospective surgical registry.

PubMed

Lee, Michael J; Cizik, Amy M; Hamilton, Deven; Chapman, Jens R

2014-02-01

The possibility and likelihood of a postoperative medical complication after spine surgery undoubtedly play a major role in the decision making of the surgeon and patient alike. Although prior study has determined relative risk and odds ratio values to quantify risk factors, these values may be difficult to translate to the patient during counseling of surgical options. Ideally, a model that predicts absolute risk of medical complication, rather than relative risk or odds ratio values, would greatly enhance the discussion of safety of spine surgery. To date, there is no risk stratification model that specifically predicts the risk of medical complication. The purpose of this study was to create and validate a predictive model for the risk of medical complication during and after spine surgery. Statistical analysis using a prospective surgical spine registry that recorded extensive demographic, surgical, and complication data. Outcomes examined are medical complications that were specifically defined a priori. This analysis is a continuation of statistical analysis of our previously published report. Using a prospectively collected surgical registry of more than 1,476 patients with extensive demographic, comorbidity, surgical, and complication detail recorded for 2 years after surgery, we previously identified several risk factor for medical complications. Using the beta coefficients from those log binomial regression analyses, we created a model to predict the occurrence of medical complication after spine surgery. We split our data into two subsets for internal and cross-validation of our model. We created two predictive models: one predicting the occurrence of any medical complication and the other predicting the occurrence of a major medical complication. The final predictive model for any medical complications had a receiver operator curve characteristic of 0.76, considered to be a fair measure. The final predictive model for any major medical complications had receiver operator curve characteristic of 0.81, considered to be a good measure. The final model has been uploaded for use on SpineSage.com. We present a validated model for predicting medical complications after spine surgery. The value in this model is that it gives the user an absolute percent likelihood of complication after spine surgery based on the patient's comorbidity profile and invasiveness of surgery. Patients are far more likely to understand an absolute percentage, rather than relative risk and confidence interval values. A model such as this is of paramount importance in counseling patients and enhancing the safety of spine surgery. In addition, a tool such as this can be of great use particularly as health care trends toward pay-for-performance, quality metrics, and risk adjustment. To facilitate the use of this model, we have created a website (SpineSage.com) where users can enter in patient data to determine likelihood of medical complications after spine surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

SUBTOTAL THYROIDECTOMY IN THE MANAGEMENT OF GRAVE'S DISEASE.

PubMed

Vincent, P J; Garg, M K; Singh, Y; Bhalla, V P; Datta, S

2001-07-01

Treatment options for Grave's disease include radio-iodine ablation, which is the standard treatment in the USA, antithyroid drug therapy, which is popular in Japan, and surgery, which is commonly employed in Europe and India. There are very few reports about the outcome of surgery in Grave's disease in the Indian setting. Surgery for Grave's disease is an attractive option in under developed countries to cut short prolonged drug treatment, costly follow up and avoid the need for radio-isotope facilities for 1311 ablation. Aim of the present study was to assess the result of subtotal thyroidectomy in 32 cases of Grave's Disease referred for surgery by the endocrinologist in a teaching hospital. Patients were prepared for surgery with Lugol's iodine and propranalol. Subtotal thyroidectomy was performed by a standard technique, which included dissection and exposure of recurrent laryngeal nerves and parathyroid glands. Actual estimation of weight of the remnant gland was not part of the study. Duration of follow up ranged from 6 months to 4 years. 13 of 32 cases were males. Age ranged from 20 to 57 years. There was 1 death in the immediate post-operative period. There were no cases of permanent hypoparathyroidism or recurrent laryngeal nerve palsy. 1 patient developed temporary hypoparathyroidism. 1 patient developed recurrence of hyperthyroidism and 3 cases developed hypothyroidism all within 2 years of surgery. The study has demonstrated the safety and effectiveness of surgery for Grave's Disease in comparison to the reported high incidence of hypothyroidism following radio-iodine therapy and high recurrence rate after anti thyroid drug therapy.

Foot-controlled robotic-enabled endoscope holder for endoscopic sinus surgery: A cadaveric feasibility study.

PubMed

Chan, Jason Y K; Leung, Iris; Navarro-Alarcon, David; Lin, Weiyang; Li, Peng; Lee, Dennis L Y; Liu, Yun-hui; Tong, Michael C F

2016-03-01

To evaluate the feasibility of a unique prototype foot-controlled robotic-enabled endoscope holder (FREE) in functional endoscopic sinus surgery. Cadaveric study. Using human cadavers, we investigated the feasibility, advantages, and disadvantages of the robotic endoscope holder in performing endoscopic sinus surgery with two hands in five cadaver heads, mimicking a single nostril three-handed technique. The FREE robot is relatively easy to use. Setup was quick, taking less than 3 minutes from docking the robot at the head of the bed to visualizing the middle meatus. The unit is also relatively small, takes up little space, and currently has four degrees of freedom. The learning curve for using the foot control was short. The use of both hands was not hindered by the presence of the endoscope in the nasal cavity. The tremor filtration also aided in the smooth movement of the endoscope, with minimal collisions. The FREE endoscope holder in an ex-vivo cadaver test corroborated the feasibility of the robotic prototype, which allows for a two-handed approach to surgery equal to a single nostril three-handed technique without the holder that may reduce operating time. Further studies will be needed to evaluate its safety profile and use in other areas of endoscopic surgery. NA. Laryngoscope, 126:566-569, 2016. © 2015 The American Laryngological, Rhinological and Otological Society, Inc.

[Application of virtual reality in surgical treatment of complex head and neck carcinoma].

PubMed

Zhou, Y Q; Li, C; Shui, C Y; Cai, Y C; Sun, R H; Zeng, D F; Wang, W; Li, Q L; Huang, L; Tu, J; Jiang, J

2018-01-07

Objective: To investigate the application of virtual reality technology in the preoperative evaluation of complex head and neck carcinoma and he value of virtual reality technology in surgical treatment of head and neck carcinoma. Methods: The image data of eight patients with complex head and neck carcinoma treated from December 2016 to May 2017 was acquired. The data were put into virtual reality system to built the three-dimensional anatomical model of carcinoma and to created the surgical scene. The process of surgery was stimulated by recognizing the relationship between tumor and surrounding important structures. Finally all patients were treated with surgery. And two typical cases were reported. Results: With the help of virtual reality, surgeons could adequately assess the condition of carcinoma and the security of operation and ensured the safety of operations. Conclusions: Virtual reality can provide the surgeons with the sensory experience in virtual surgery scenes and achieve the man-computer cooperation and stereoscopic assessment, which will ensure the safety of surgery. Virtual reality has a huge impact on guiding the traditional surgical procedure of head and neck carcinoma.

Nonemergency PCI at hospitals with or without on-site cardiac surgery.

PubMed

Jacobs, Alice K; Normand, Sharon-Lise T; Massaro, Joseph M; Cutlip, Donald E; Carrozza, Joseph P; Marks, Anthony D; Murphy, Nancy; Romm, Iyah K; Biondolillo, Madeleine; Mauri, Laura

2013-04-18

Emergency surgery has become a rare event after percutaneous coronary intervention (PCI). Whether having cardiac-surgery services available on-site is essential for ensuring the best possible outcomes during and after PCI remains uncertain. We enrolled patients with indications for nonemergency PCI who presented at hospitals in Massachusetts without on-site cardiac surgery and randomly assigned these patients, in a 3:1 ratio, to undergo PCI at that hospital or at a partner hospital that had cardiac surgery services available. A total of 10 hospitals without on-site cardiac surgery and 7 with on-site cardiac surgery participated. The coprimary end points were the rates of major adverse cardiac events--a composite of death, myocardial infarction, repeat revascularization, or stroke--at 30 days (safety end point) and at 12 months (effectiveness end point). The primary end points were analyzed according to the intention-to-treat principle and were tested with the use of multiplicative noninferiority margins of 1.5 (for safety) and 1.3 (for effectiveness). A total of 3691 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery (2774 patients) or at a hospital with on-site cardiac surgery (917 patients). The rates of major adverse cardiac events were 9.5% in hospitals without on-site cardiac surgery and 9.4% in hospitals with on-site cardiac surgery at 30 days (relative risk, 1.00; 95% one-sided upper confidence limit, 1.22; P<0.001 for noninferiority) and 17.3% and 17.8%, respectively, at 12 months (relative risk, 0.98; 95% one-sided upper confidence limit, 1.13; P<0.001 for noninferiority). The rates of death, myocardial infarction, repeat revascularization, and stroke (the components of the primary end point) did not differ significantly between the groups at either time point. Nonemergency PCI procedures performed at hospitals in Massachusetts without on-site surgical services were noninferior to procedures performed at hospitals with on-site surgical services with respect to the 30-day and 1-year rates of clinical events. (Funded by the participating hospitals without on-site cardiac surgery; MASS COM ClinicalTrials.gov number, NCT01116882.).

Efficacy and safety of the C-Qur™ Film Adhesion Barrier for the prevention of surgical adhesions (CLIPEUS Trial): study protocol for a randomized controlled trial.

PubMed

Stommel, Martijn W J; Strik, Chema; ten Broek, Richard P G; van Goor, Harry

2014-09-26

Adhesions develop in over 90% of patients after intra-abdominal surgery. Adhesion barriers are rarely used despite the high morbidity caused by intra-abdominal adhesions. Only one of the currently available adhesion barriers has demonstrated consistent evidence for reducing adhesions in visceral surgery. This agent has limitations through poor handling characteristics because it is sticky on both sides. C-Qur™ Film is a novel thin film adhesion barrier and it is sticky on only one side, resulting in better handling characteristics. The objective of this study is to assess efficacy and safety of C-Qur™ Film to decrease the incidence of adhesions after colorectal surgery. This is a prospective, investigator initiated, randomized, double-blinded, multicenter trial. Eligible patients undergoing colorectal resection requiring temporary loop ileostomy or loop/split colostomy by laparotomy or hand assisted laparoscopy will be included in the trial. Before closure, patients are randomized 1:1 to either the treatment arm (C-Qur™ Film) or control arm (no adhesion barrier). Patients will return 8 to 16 weeks post-colorectal resection for take down of their ostomy. During ostomy takedown, adhesions will be evaluated for incidence, extent, and severity. The primary outcome evaluation will be assessment of adhesions to the incision site. It is hypothesized that the use of C-Qur™ Film underneath the primary incision reduces the incidence of adhesion at the incision by 30%. To demonstrate 30% reduction in the incidence of adhesions, a sample size of 84 patients (32 + 10 per group (25% drop out)) is required (two-sided test, α = 0.05, 80% power). Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic 'hand-assisted' colorectal surgery. We chose incidence of adhesions to the incision site as primary outcome measure since clinical outcomes such as small bowel obstruction, secondary infertility and adhesiolysis related complications are considered multifactorial and difficult to interpret. Incidence of adhesions at repeat surgery is believed to be the most valuable surrogate endpoint for clinically relevant adhesion prevention, since small bowel obstruction and adhesiolysis at repeat surgery are not likely to occur when complete adhesion reduction in a patient is accomplished. ClinicalTrials.gov Identifier NCT01872650, registration date 6 June 2013.

Pacemaker or defibrillator surgery without interruption of anticoagulation.

PubMed

Birnie, David H; Healey, Jeff S; Wells, George A; Verma, Atul; Tang, Anthony S; Krahn, Andrew D; Simpson, Christopher S; Ayala-Paredes, Felix; Coutu, Benoit; Leiria, Tiago L L; Essebag, Vidal

2013-05-30

Many patients requiring pacemaker or implantable cardioverter-defibrillator (ICD) surgery are taking warfarin. For patients at high risk for thromboembolic events, guidelines recommend bridging therapy with heparin; however, case series suggest that it may be safe to perform surgery without interrupting warfarin treatment. There have been few results from clinical trials to support the safety and efficacy of this approach. We randomly assigned patients with an annual risk of thromboembolic events of 5% or more to continued warfarin treatment or to bridging therapy with heparin. The primary outcome was clinically significant device-pocket hematoma, which was defined as device-pocket hematoma that necessitated prolonged hospitalization, interruption of anticoagulation therapy, or further surgery (e.g., hematoma evacuation). The data and safety monitoring board recommended termination of the trial after the second prespecified interim analysis. Clinically significant device-pocket hematoma occurred in 12 of 343 patients (3.5%) in the continued-warfarin group, as compared with 54 of 338 (16.0%) in the heparin-bridging group (relative risk, 0.19; 95% confidence interval, 0.10 to 0.36; P<0.001). Major surgical and thromboembolic complications were rare and did not differ significantly between the study groups. They included one episode of cardiac tamponade and one myocardial infarction in the heparin-bridging group and one stroke and one transient ischemic attack in the continued-warfarin group. As compared with bridging therapy with heparin, a strategy of continued warfarin treatment at the time of pacemaker or ICD surgery markedly reduced the incidence of clinically significant device-pocket hematoma. (Funded by the Canadian Institutes of Health Research and the Ministry of Health and Long-Term Care of Ontario; BRUISE CONTROL ClinicalTrials.gov number, NCT00800137.).

De Novo Upper Extremity Lymphedema After Elective Hand Surgery in Breast Cancer Survivors.

PubMed

Baltzer, Heather L; Harvey, Jamison; Fox, Paige M; Moran, Steven L

2017-07-01

The safety of elective hand surgery in breast cancer (BC) survivors is controversial because of concerns of developing upper extremity lymphedema. This study aimed to evaluate the risk of developing lymphedema after elective hand surgery among patients that underwent ipsilateral axillary lymph node dissection (ALND), sentinel lymph node biopsy (SLNB), and/or radiation therapy (RT). A retrospective cohort of BC patients treated with ALND, SLNB, and/or RT was identified (1997-2012). Patients with subsequent ipsilateral elective hand surgery were included if greater than 1 year of follow-up and no preexisting lymphedema. The primary outcome was lymphedema after hand surgery. Comparisons between patients with and without lymphedema were made to identify potential lymphedema risk factors. Dichotomous and continuous variables were compared with Fisher exact and Student t tests, respectively. The analysis included 103 patients, of which 4 (3.8%) had documented lymphedema after hand surgery. Lymphedema developed early and was self-limited. Lymphedema was not related to age and type of hand surgery. Tourniquet time was longer in the nonlymphedema group. The lymphedema group all received adjuvant chemotherapy and RT with either ALND or SLNB. Patients with lymphedema had a shorter interval between hand surgery and completion of BC surgery (2.1 vs 6.2 years) and RT (2.0 vs 3.3 years). Lymphedema is uncommon after elective hand surgery among survivors and was not associated with tourniquet use. The combination of adjuvant therapies and axillary procedures and a short temporal relationship of these to hand surgery may increase lymphedema risk.

Treatment using oxaliplatin and S-1 adjuvant chemotherapy for pathological stage III gastric cancer: a multicenter phase II study (TOSA trial) protocol.

PubMed

Namikawa, Tsutomu; Maeda, Hiromichi; Kitagawa, Hiroyuki; Oba, Koji; Tsuji, Akihito; Yoshikawa, Takaki; Kobayashi, Michiya; Hanazaki, Kazuhiro

2018-02-13

Recent studies demonstrated the efficacy of S-1-based adjuvant chemotherapy administered for six months after curative surgery for stage III gastric cancer; however, it is unproven whether this type of combination chemotherapy is more effective than the standard adjuvant chemotherapy of S-1 for one year. This multicenter phase II study evaluate the efficacy and safety of adjuvant chemotherapy using S-1 plus oxaliplatin followed by S-1 for up to one year for curatively resected stage III gastric cancer in patients aged over 20 years. Treatment initially comprises oral fluoropyrimidine S-1 (80 mg/m 2 ) administered twice daily for the first 2 weeks of a 3-week cycle. On day 1 of a second 3-week cycle, patients will receive 100 mg/m 2 of intravenous oxaliplatin followed by 80 mg/m 2 of S-1 (maximum 8 cycles). Then, the patients will receive 80 mg/m 2 of S-1 daily for 4 weeks, followed by 2 weeks of no chemotherapy. This 6-week cycle will be repeated during the first year after surgery. The primary endpoint is relapse-free survival for 3 years and secondary endpoints are safety, including the incidence of adverse events, and grading of neuropathy with each treatment cycle. The planned sample size of 75 patients is appropriate for this trial. The data will be analyzed on an intention-to-treat basis, assuming a two-sided test with a 5% level of significance. In contrast to previous trials, the current study involves administration of S-1 until one year after surgery in addition to prior S-1 plus oxaliplatin, and is the first study to evaluate the safety and efficacy of S-1 plus oxaliplatin followed by S-1 for up to one year in patients with curatively resected stage III gastric cancer. This trial is registered in the University Hospital Medical Information Network's Clinical Trials Registry (UMIN-CTR) registration number, R000029656  ( https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029656 ). Registered January 24, 2017.

New stapling devices in robotic surgery

PubMed Central

Casiraghi, Monica; Pardolesi, Alessandro; Borri, Alessandro; Spaggiari, Lorenzo

2017-01-01

Minimally invasive thoracic surgery is rapidly diffusing worldwide. Robotic anatomic pulmonary resection is gaining popularity and acceptance in the thoracic community for the reported feasibility, safety, and good outcomes. The last available robotic system, da Vinci Xi System, added new technical improvements on robotic device allowing best performances in robotic lung resection. We report our initial experience in the use of EndoWrist Stapler during robotic anatomic surgery for lung cancer. PMID:29078608

Essential surgery: key messages from Disease Control Priorities, 3rd edition.

PubMed

Mock, Charles N; Donkor, Peter; Gawande, Atul; Jamison, Dean T; Kruk, Margaret E; Debas, Haile T

2015-05-30

The World Bank will publish the nine volumes of Disease Control Priorities, 3rd edition, in 2015-16. Volume 1--Essential Surgery--identifies 44 surgical procedures as essential on the basis that they address substantial needs, are cost effective, and are feasible to implement. This report summarises and critically assesses the volume's five key findings. First, provision of essential surgical procedures would avert about 1·5 million deaths a year, or 6-7% of all avertable deaths in low-income and middle-income countries. Second, essential surgical procedures rank among the most cost effective of all health interventions. The surgical platform of the first-level hospital delivers 28 of the 44 essential procedures, making investment in this platform also highly cost effective. Third, measures to expand access to surgery, such as task sharing, have been shown to be safe and effective while countries make long-term investments in building surgical and anaesthesia workforces. Because emergency procedures constitute 23 of the 28 procedures provided at first-level hospitals, expansion of access requires that such facilities be widely geographically diffused. Fourth, substantial disparities remain in the safety of surgical care, driven by high perioperative mortality rates including anaesthesia-related deaths in low-income and middle-income countries. Feasible measures, such as WHO's Surgical Safety Checklist, have led to improvements in safety and quality. Fifth, the large burden of surgical disorders, cost-effectiveness of essential surgery, and strong public demand for surgical services suggest that universal coverage of essential surgery should be financed early on the path to universal health coverage. We point to estimates that full coverage of the component of universal coverage of essential surgery applicable to first-level hospitals would require just over US$3 billion annually of additional spending and yield a benefit-cost ratio of more than 10:1. It would efficiently and equitably provide health benefits, financial protection, and contributions to stronger health systems. Copyright © 2015 Elsevier Ltd. All rights reserved.

Single Incision Laparoscopic Assisted Appendectomy: Experience of 82 Cases

PubMed Central

Sinha, Anant Narayan; Deepak, Desh; Pandey, NK; Nandani

2016-01-01

Introduction Single Incision Laparoscopic Surgery (SILS) is one of the most recent developments which have been made in the field of minimal assesses surgery. It has potential advantages of less postoperative pain and better cosmesis, but at the same time, this procedure is time consuming and it increases the cost of surgery. Aim In this study, we evaluated the feasibility, safety and potential advantages of single incision laparoscopic assisted appendectomy. Materials and Methods Single incision laparoscopic assisted appendectomy was done in 82 patients who were diagnosed with acute or chronic appendicitis. A single 10mm incision made over right lower quadrant was used for placing two 5mm trocars and appendisectomy was done as in open surgery, after delivering out the appendix from the incision. Results Mean operative time was 32.56 ± 15.5 minutes. Mean post-operative pain scores as per visual analogue scalewere 6.5, 4.2 and 1.2 on 12 hours day 1 and day 2 after surgery respectively. Mean length of hospital stay was 1.4 ± 1.2 days. Conclusion Single incision laparoscopic appendectomy is safe and feasible. PMID:27437295

Which is the better timing between embolization and surgery for hypervascular spinal tumors, the same day or the next day?: A retrospective comparative study.

PubMed

Tang, Benqiang; Ji, Tao; Guo, Wei; Tang, Xiaodong; Jin, Long; Dong, Sen; Xie, Lu

2018-06-01

Previous series presented the timing between embolization and surgery in a wide range on the basis of their experience rather than supportive data. And comparative studies were limited to small samples. In addition, there is no study publishing the timing by considering both safety and efficacy of embolization. The aim of this study was to determine the better timing (the same day or the next day) between embolization and surgery for hypervascular spinal tumors by assessing the safety and efficacy of embolization.One hundred twenty-five embolizations with subsequent 120 operations for hypervascular spinal tumors between January 2010 and April 2013 were retrospectively reviewed. The time between embolization and surgery was mainly determined by interventional radiologist schedules and operating room available. Major complications of embolization were documented. The efficacy of embolization was compared between the same day and the next day group.Of the 125 embolizations, there were 4 major complications, all of which occurred on the same day of procedure. Of the 120 operations, 36 cases were operated on the same day of embolization, 74 on the next day, and 10 on the second day. When comparing the efficacy of embolization between the same day and the next day group, intraoperative blood loss (1483 ± 1475 vs 1548 ± 1099 mL, P = .80), intraoperative transfusion requirement (1011 ± 1200 vs 1112 ± 890 mL, P = .62), and postoperative blood loss (1146 ± 933 vs 1031 ± 777 mL, P = .50) were not significantly different.Embolization carries certain risks (4/125, 3.2%) for major complications, which may occur within the time window of 1 day. Two patient groups showed no difference on the efficacy of embolization. Operation should be scheduled on the next day of embolization if possible.

Early rehabilitation treatment combined with equinovarus foot deformity surgical correction in stroke patients: safety and changes in gait parameters.

PubMed

Giannotti, Erika; Merlo, Andrea; Zerbinati, Paolo; Longhi, Maria; Prati, Paolo; Masiero, Stefano; Mazzoli, Davide

2016-06-01

Equinovarus foot deformity (EVFD) compromises several prerequisites of walking and increases the risk of falling. Guidelines on rehabilitation following EVFD surgery are missing in current literature. The aim of this study was to analyze safety and adherence to an early rehabilitation treatment characterized by immediate weight bearing with an ankle-foot orthosis (AFO) in hemiplegic patients after EVFD surgery and to describe gait changes after EVFD surgical correction combined with early rehabilitation treatment. Retrospective observational cohort study. Inpatient rehabilitation clinic. Forty-seven adult patients with hemiplegia consequent to ischemic or haemorrhagic stroke (L/R 20/27, age 56±15 years, time from lesion 6±5 years). A specific rehabilitation protocol with a non-articulated AFO, used to allow for immediate gait training, started one day after EVFD surgery. Gait analysis (GA) data before and one month after surgery were analyzed. The presence of differences in GA space-time parameters, in ankle dorsiflexion (DF) values and peaks at initial contact (DF at IC), during stance (DF at St) and swing (DF at Sw) were assessed by the Wilcoxon Test while the presence of correlations between pre- and post-operative values by Spearman's correlation coefficient. All patients completed the rehabilitation protocol and no clinical complications occurred in the sample. Ankle DF increased one month after surgery at all investigated gait phases (Wilcoxon Test, P<0.0001), becoming neutral at IC. Significant (P<0.05) variations were found for stride length, stride width, anterior step length of the affected side and for the duration of the double support phase of the contralateral side. The postsurgery ankle DF at St was found to be correlated (R=0.81, P<0.0001) with its pre-surgery value, thus being predictable. Weaker significant correlations were found for DF at Sw and DF at IC, where contribution from the dorsiflexor muscles is required in addition to calf muscle passive lengthening. An orthosis-assisted immediate rehabilitation associated with surgical procedure is safe and may be suitable to correct EVFD by restoring both the neutral heel foot-ground contact and the ankle DF peaks during stance and swing at one month from surgery. The proposed protocol is a safe and potentially useful rehabilitative approach after EVFD surgical correction in stroke patients.

Safely re-integrating silicone breast implants into the plastic surgery practice.

PubMed

Gladfelter, Joanne

2006-01-01

In the early 1990s, it was reported that silicone breast implants were possibly responsible for serious damage to women's health. In January 1992, the Food and Drug Administration issued a voluntary breast implant moratorium and, in April, issued a ban on the use of silicone gel-filled implants for cosmetic breast augmentation. Since that time, silicone gel-filled breast implants have been available to women only for select cases: women seeking breast reconstruction or revision of an existing breast implant, women who have had breast cancer surgery, a severe injury to the breast, a birth defect that affects the breast, or a medical condition causing a severe breast deformity. Since the ban on the use of silicone gel-filled breast implants for cosmetic breast augmentation, numerous scientific studies have been conducted. To ensure patient safety, the American Board of Plastic Surgery believes that these scientific studies and the Food and Drug Administration's scrutiny of silicone gel-filled breast implants have been appropriate and necessary.

Safety of gelatin solutions for the priming of cardiopulmonary bypass in cardiac surgery: a systematic review and meta-analysis.

PubMed

Ghijselings, Idris; Himpe, Dirk; Rex, Steffen

2017-07-01

This systematic review and meta-analysis was conducted to evaluate the safety of gelatin versus hydroxyethyl starches (HES) and crystalloids when used for cardiopulmonary bypass (CPB)-priming in cardiac surgery. MEDLINE (Pubmed), Embase and CENTRAL were searched. We included only randomized, controlled trials comparing CPB-priming with gelatin with either crystalloids or HES-solutions of the newest generation. The primary endpoint was the blood loss during the first 24 hours. Secondary outcomes included perioperative transfusion requirements, postoperative kidney function, postoperative ventilation times and length of stay on the intensive care unit. Sixteen studies were identified, of which only ten met the inclusion criteria, representing a total of 824 adult patients: 4 studies compared gelatin with crystalloid, and 6 studies gelatin with HES priming. Only 2 of the studies comparing HES and gelatin reported postoperative blood loss after 24 hours. No significant difference in postoperative blood loss was found when results of both studies were pooled (SMD -0.12; 95% CI: -0.49, 0.25; P=0.52). Likewise, the pooled results of 3 studies comparing gelatin and crystalloids as a priming solution could not demonstrate significant differences in postoperative bleeding after 24 hours (SMD -0.07; 95% CI: -0.40, 0.26; P=0.68). No differences regarding any of the secondary outcomes could be identified. This systematic review suggests gelatins to have a safety profile which is non-inferior to modern-generation tetrastarches or crystalloids. However, the grade of evidence is rated low owing to the poor methodological quality of the included studies, due to inconsistent outcome reporting and lack of uniform endpoint definitions.

Caring for class III obese patients.

PubMed

Gardner, Lea Anne

2013-11-01

The Pennsylvania Patient Safety Reporting System is a confidential, statewide Internet reporting system to which all Pennsylvania hospitals, outpatient-surgery facilities, and birthing centers, as well as some abortion facilities, must file information on medical errors.Safety Monitor is a column from Pennsylvania's Patient Safety Authority, the authority that informs nurses on issues that can affect patient safety and presents strategies they can easily integrate into practice. For more information on the authority, visit www.patientsafetyauthority.org. For the original article discussed in this column or for other articles on patient safety, click on "Patient Safety Advisories" and then "Advisory Library" in the left-hand navigation menu.

Rehabilitation program after mesenchymal stromal cell transplantation augmented by vascularized bone grafts for idiopathic osteonecrosis of the femoral head: a preliminary study.

PubMed

Aoyama, Tomoki; Fujita, Yasuko; Madoba, Katsuyuki; Nankaku, Manabu; Yamada, Minoru; Tomita, Motoko; Goto, Koji; Ikeguchi, Ryosuke; Kakinoki, Ryosuke; Matsuda, Shuichi; Nakamura, Takashi; Toguchida, Junya

2015-03-01

To determine the feasibility and safety of implementing a 12-week rehabilitation program after mesenchymal stromal cell (MSC) transplantation augmented by vascularized bone grafting for idiopathic osteonecrosis (ION) of the femoral head. A prospective case series. University clinical research laboratory. Participants (N=10) with ION who received MSC transplantation augmented by vascularized bone grafting. A 12-week exercise program, which included range-of-motion (ROM) exercises, muscle-strengthening exercises, and aerobic training. Measures of ROM, muscle strength, Timed Up and Go test, and Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) were collected before surgery and again at 6 and 12 months after surgery. All participants completed the 12-week program. External rotation ROM as well as extensor and abductor muscle strength significantly improved 6 months after treatment compared with that before treatment (P<.05). Significant improvements were also seen in physical function, role physical, and bodily pain subgroup scores of the SF-36 (P<.05). No serious adverse events occurred. This study demonstrates the feasibility and safety of a multiplex rehabilitation program after MSC transplantation and provides support for further study on the benefits of rehabilitation programs in regenerative medicine. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Percutaneous repair or surgery for mitral regurgitation.

PubMed

Feldman, Ted; Foster, Elyse; Glower, Donald D; Glower, Donald G; Kar, Saibal; Rinaldi, Michael J; Fail, Peter S; Smalling, Richard W; Siegel, Robert; Rose, Geoffrey A; Engeron, Eric; Loghin, Catalin; Trento, Alfredo; Skipper, Eric R; Fudge, Tommy; Letsou, George V; Massaro, Joseph M; Mauri, Laura

2011-04-14

Mitral-valve repair can be accomplished with an investigational procedure that involves the percutaneous implantation of a clip that grasps and approximates the edges of the mitral leaflets at the origin of the regurgitant jet. We randomly assigned 279 patients with moderately severe or severe (grade 3+ or 4+) mitral regurgitation in a 2:1 ratio to undergo either percutaneous repair or conventional surgery for repair or replacement of the mitral valve. The primary composite end point for efficacy was freedom from death, from surgery for mitral-valve dysfunction, and from grade 3+ or 4+ mitral regurgitation at 12 months. The primary safety end point was a composite of major adverse events within 30 days. At 12 months, the rates of the primary end point for efficacy were 55% in the percutaneous-repair group and 73% in the surgery group (P=0.007). The respective rates of the components of the primary end point were as follows: death, 6% in each group; surgery for mitral-valve dysfunction, 20% versus 2%; and grade 3+ or 4+ mitral regurgitation, 21% versus 20%. Major adverse events occurred in 15% of patients in the percutaneous-repair group and 48% of patients in the surgery group at 30 days (P<0.001). At 12 months, both groups had improved left ventricular size, New York Heart Association functional class, and quality-of-life measures, as compared with baseline. Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes. (Funded by Abbott Vascular; EVEREST II ClinicalTrials.gov number, NCT00209274.).

News media reports of patient deaths following 'medical tourism' for cosmetic surgery and bariatric surgery.

PubMed

Turner, Leigh

2012-04-01

Contemporary scholarship examining clinical outcomes in medical travel for cosmetic surgery identifies cases in which patients traveled abroad for medical procedures and subsequently returned home with infections and other surgical complications. Though there are peer-reviewed articles identifying patient deaths in cases where patients traveled abroad for commercial kidney transplantation or stem cell injections, no scholarly publications document deaths of patients who traveled abroad for cosmetic surgery or bariatric surgery. Drawing upon news media reports extending from 1993 to 2011, this article identifies and describes twenty-six reported cases of deaths of individuals who traveled abroad for cosmetic surgery or bariatric surgery. Over half of the reported deaths occurred in two countries. Analysis of these news reports cannot be used to make causal claims about why the patients died. In addition, cases identified in news media accounts do not provide a basis for establishing the relative risk of traveling abroad for care instead of seeking elective cosmetic surgery at domestic health care facilities. Acknowledging these limitations, the case reports suggest the possibility that contemporary peer-reviewed scholarship is underreporting patient mortality in medical travel. The paper makes a strong case for promoting normative analyses and empirical studies of medical travel. In particular, the paper argues that empirically informed ethical analysis of 'medical tourism' will benefit from rigorous studies tracking global flows of medical travelers and the clinical outcomes they experience. The paper contains practical recommendations intended to promote debate concerning how to promote patient safety and quality of care in medical travel. © 2012 Blackwell Publishing Ltd.

Endoscopic Evacuation of Basal Ganglia Hemorrhage via Keyhole Approach Using an Adjustable Cannula in Comparison with Craniotomy

PubMed Central

Zhang, Heng-Zhu; Li, Yu-Ping; Yan, Zheng-cun; Wang, Xing-dong; She, Lei; Wang, Xiao-dong; Dong, Lun

2014-01-01

Neuroendoscopic (NE) surgery as a minimal invasive treatment for basal ganglia hemorrhage is a promising approach. The present study aims to evaluate the efficacy and safety of NE approach using an adjustable cannula to treat basal ganglia hemorrhage. In this study, we analysed the clinical and radiographic outcomes between NE group (21 cases) and craniotomy group (30 cases). The results indicated that NE surgery might be an effective and safe approach for basal ganglia haemorrhage, and it is also suggested that NE approach may improve good functional recovery. However, NE approach only suits the selected patient, and the usefulness of NE approach needs further randomized controlled trials (RCTs) to evaluate. PMID:24949476

The aim of this retrospective study is to evaluate the efficacy and safety of posterior-only vertebral column resection (PVCR) for the treatment of angular and isolated congenital kyphosis.

PubMed

Wang, Shengru; Aikenmu, Kahaer; Zhang, Jianguo; Qiu, Guixing; Guo, Jianwei; Zhang, Yanbin; Weng, Xisheng

2017-07-01

The aim of this retrospective study is to evaluate the efficacy and safety of posterior-only vertebral column resection (PVCR) for the treatment of angular and isolated congenital kyphosis. 24 patients with isolated angular congenital kyphosis treated by PVCR in our hospital were retrospectively studied. The patients' radiographs and hospital records were reviewed. Deformity in sagittal planes and global sagittal alignment were analyzed for correction and maintenance of the correction in preoperative, postoperative, and follow-up radiographs. The complications and related risk factors were analyzed. The average age was 13.9 (4-40) years. Three of them were revision surgeries. Two patients have intraspinal anomalies. The mean follow-up is 56.9 (26-129) months. The mean operation time was 293.1 (170-480) min. The averaged blood loss was 993.8 (250-3000) ml. The segmental kyphosis was 87.3° before surgery, 17.6° post surgery and 20.4° at the latest the follow-up. And the sagittal vertical axis was improved from 43.1 mm to 9.2 mm. Mean total score of SRS-22 was 89.3. Complications occurred in 4 patients, including 1 screw pullout due to pseudarthrosis, 1 proximal junctional kyphosis, 1 incomplete spinal cord injury and 1 root injuries. Posterior-only vertebral column resection is an ideal procedure for severe rigid congenital kyphosis. However, it is still a highly technical demanding procedure. Neurological compromises still remain the biggest challenges. Sufficient height of anterior reconstruction, avoidance sacrifice of bilateral roots in the same level in the thoracic spine, avoidance of the sagittal translation of the upper and lower vertebras, intra-operative neuromonitoring, and preoperative surgical release of diastematomyelia and tethered cord may help to improve the safety.

Transcatheter aortic valve replacement using a self-expanding bioprosthesis in patients with severe aortic stenosis at extreme risk for surgery.

PubMed

Popma, Jeffrey J; Adams, David H; Reardon, Michael J; Yakubov, Steven J; Kleiman, Neal S; Heimansohn, David; Hermiller, James; Hughes, G Chad; Harrison, J Kevin; Coselli, Joseph; Diez, Jose; Kafi, Ali; Schreiber, Theodore; Gleason, Thomas G; Conte, John; Buchbinder, Maurice; Deeb, G Michael; Carabello, Blasé; Serruys, Patrick W; Chenoweth, Sharla; Oh, Jae K

2014-05-20

This study sought to evaluate the safety and efficacy of the CoreValve transcatheter heart valve (THV) for the treatment of severe aortic stenosis in patients at extreme risk for surgery. Untreated severe aortic stenosis is a progressive disease with a poor prognosis. Transcatheter aortic valve replacement (TAVR) with a self-expanding bioprosthesis is a potentially effective therapy. We performed a prospective, multicenter, nonrandomized investigation evaluating the safety and efficacy of self-expanding TAVR in patients with symptomatic severe aortic stenosis with prohibitive risks for surgery. The primary endpoint was a composite of all-cause mortality or major stroke at 12 months, which was compared with a pre-specified objective performance goal (OPG). A total of 41 sites in the United States recruited 506 patients, of whom 489 underwent attempted treatment with the CoreValve THV. The rate of all-cause mortality or major stroke at 12 months was 26.0% (upper 2-sided 95% confidence bound: 29.9%) versus 43.0% with the OPG (p < 0.0001). Individual 30-day and 12-month events included all-cause mortality (8.4% and 24.3%, respectively) and major stroke (2.3% and 4.3%, respectively). Procedural events at 30 days included life-threatening/disabling bleeding (12.7%), major vascular complications (8.2%), and need for permanent pacemaker placement (21.6%). The frequency of moderate or severe paravalvular aortic regurgitation was lower 12 months after self-expanding TAVR (4.2%) than at discharge (10.7%; p = 0.004 for paired analysis). TAVR with a self-expanding bioprosthesis was safe and effective in patients with symptomatic severe aortic stenosis at prohibitive risk for surgical valve replacement. (Safety and Efficacy Study of the Medtronic CoreValve System in the Treatment of Symptomatic Severe Aortic Stenosis in High Risk and Very High Risk Subjects Who Need Aortic Valve Replacement; NCT01240902). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method] demonstrates efficacy, safety and low-risk for immunogenicity in routine clinical practice.

PubMed

Oldenburg, J; Goudemand, J; Valentino, L; Richards, M; Luu, H; Kriukov, A; Gajek, H; Spotts, G; Ewenstein, B

2010-11-01

  Postauthorization safety surveillance of factor VIII (FVIII) concentrates is essential for assessing rare adverse event incidence. We determined safety and efficacy of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method, (rAHF-PFM)] during routine clinical practice. Subjects with differing haemophilia A severities and medical histories were monitored during 12 months of prophylactic and/or on-demand therapy. Among 408 evaluable subjects, 386 (95%) received excellent/good efficacy ratings for all on-demand assessments; the corresponding number for subjects with previous FVIII inhibitors was 36/41 (88%). Among 276 evaluable subjects receiving prophylaxis continuously in the study, 255 (92%) had excellent/good ratings for all prophylactic assessments; the corresponding number for subjects with previous FVIII inhibitors was 41/46 (89%). Efficacy of surgical prophylaxis was excellent/good in 16/16 evaluable procedures. Among previously treated patients (PTPs) with >50 exposure days (EDs) and FVIII≤2%, three (0.75%) developed low-titre inhibitors. Two of these subjects had a positive inhibitor history; thus, the incidence of de novo inhibitor formation in PTPs with FVIII≤2% and no inhibitor history was 1/348 (0.29%; 95% CI, 0.01-1.59%). A PTP with moderate haemophilia developed a low-titre inhibitor. High-titre inhibitors were reported in a PTP with mild disease (following surgery), a previously untreated patient (PUP) with moderate disease (following surgery) and a PUP with severe disease. The favourable benefit/risk profile of rAHF-PFM previously documented in prospective clinical trials has been extended to include a broader range of haemophilia patients, many of whom would have been ineligible for registration studies. © 2010 Blackwell Publishing Ltd.

A first-in-human, randomized, controlled, subject- and reviewer-blinded multicenter study of Actamax™ Adhesion Barrier.

PubMed

Trew, Geoffrey H; Pistofidis, George A; Brucker, Sara Y; Krämer, Bernhard; Ziegler, Nicole M; Korell, Matthias; Ritter, Henning; McConnachie, Alex; Ford, Ian; Crowe, Alison M; Estridge, Trudy D; Diamond, Michael P; De Wilde, Rudy L

2017-02-01

Post-surgical adhesions remain a significant concern following abdominopelvic surgery. This study was to assess safety, manageability and explore preliminary efficacy of applying a degradable hydrogel adhesion barrier to areas of surgical trauma following gynecologic laparoscopic abdominopelvic surgery. This first-in-human, prospective, randomized, multicenter, subject- and reviewer-blinded clinical study was conducted in 78 premenopausal women (18-46 years) wishing to maintain fertility and undergoing gynecologic laparoscopic abdominopelvic surgery with planned clinically indicated second-look laparoscopy (SLL) at 4-12 weeks. The first two patients of each surgeon received hydrogel, up to 30 mL sprayed over all sites of surgical trauma, and were assessed for safety and application only (n = 12). Subsequent subjects (n = 66) were randomized 1:1 to receive either hydrogel (Treatment, n = 35) or not (Control, n = 31); 63 completed the SLL. No adverse event was assessed as serious, or possibly device related. None was severe or fatal. Adverse events were reported for 17 treated subjects (17/47, 36.2%) and 13 Controls (13/31, 41.9%). For 95.7% of treated subjects, surgeons found the device "easy" or "very easy" to use; in 54.5%, some residual material was evident at SLL. For 63 randomized subjects who completed the SLL, adjusted between-group difference in the change from baseline adhesion score demonstrated a 41.4% reduction for Treatment compared with Controls (p = 0.017), with a 49.5% reduction (p = 0.008) among myomectomy subjects (n = 34). Spray application of a degradable hydrogel adhesion barrier during gynecologic laparoscopic abdominopelvic surgery was performed easily and safely, without evidence of clinically significant adverse outcomes. Data suggest the hydrogel was effective in reducing postoperative adhesion development, particularly following myomectomy.

Safety of continuing aspirin therapy during spinal surgery: A systematic review and meta-analysis.

PubMed

Zhang, Chenggui; Wang, Guodong; Liu, Xiaoyang; Li, Yang; Sun, Jianmin

2017-11-01

Questions whether to continue or discontinue aspirin administration in the perioperative period of spinal surgery has not been systematically evaluated. The present systematic review is carried out to assess the impact of continuing aspirin administration on the bleeding and cardiovascular events in perispinal surgery period. Studies were retrieved through MEDLINE, EMBASE, and Springer Link Databases (search terms, aspirin, continue or discontinue, and spinal fusion), bibliographies of the articles retrieved, and the authors' reference files. We included studies that enrolled patients who underwent spinal surgery who were anticoagulated with aspirin alone and that reported bleeding or cardiovascular events as an outcome. Study quality was assessed using a validated form. 95% confidence interval (95% CI) was pooled to give summary estimates of bleeding and cardiovascular risk. We identified 4 studies assessing bleeding risk associated with aspirin continuation or cardiovascular risk with aspirin discontinuation during spinal surgery. The continuation of aspirin will not increase the risk of blood loss during the spinal surgery (95% CI, -111.72 to -0.59; P = .05). Also, there was no observed increase in the operative time (95% CI, -33.29 to -3.89; P = .01) and postoperative blood transfusion (95% CI, 0.00-0.27; P = .05). But as for the cardiovascular risk without aspirin continuation and mean hospital length of stay with aspirin continuation, we did not get enough samples to make an accurate decision about their relations with aspirin. Patients undergoing spinal surgery with continued aspirin administration do not have an increased risk for bleeding. In addition, there is no observed increase in the operation time and postoperative blood transfusion.

Adolescent bariatric surgery program characteristics: the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study experience.

PubMed

Michalsky, Marc P; Inge, Thomas H; Teich, Steven; Eneli, Ihuoma; Miller, Rosemary; Brandt, Mary L; Helmrath, Michael; Harmon, Carroll M; Zeller, Meg H; Jenkins, Todd M; Courcoulas, Anita; Buncher, Ralph C

2014-02-01

The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Data were obtained from the Teen-LABS database, and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. All centers had extensive multidisciplinary involvement in the assessment, pre-operative education, and post-operative management of adolescents undergoing WLS. Eligibility criteria and pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well-developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. The composition of clinical team and institutional resources is consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS. © 2013 Published by Elsevier Inc.

Adolescent Bariatric Surgery Program Characteristics: The Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Study Experience

PubMed Central

Michalsky, M.P.; Inge, T.H.; Teich, S.; Eneli, I.; Miller, R.; Brandt, M.L.; Helmrath, M.; Harmon, C.M.; Zeller, M.H.; Jenkins, T.M.; Courcoulas, A.; Buncher, C.R.

2013-01-01

Background The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Methods Data were obtained from the Teen-LABS database and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. Results All centers had extensive multidisciplinary involvement in the assessment, preoperative education and post-operative management of adolescents undergoing WLS. Eligibility criteria, pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. Conclusions The composition of clinical team and institutional resources are consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS. PMID:24491361

Lateral hypothalamic area deep brain stimulation for refractory obesity: a pilot study with preliminary data on safety, body weight, and energy metabolism

PubMed Central

Whiting, Donald M.; Tomycz, Nestor D.; Bailes, Julian; De Jonge, Lilian; Lecoultre, Virgile; Wilent, Bryan; Alcindor, Dunbar; Prostko, E. Richard; Cheng, Boyle C.; Angle, Cynthia; Cantella, Diane; Whiting, Benjamin B.; Mizes, J. Scott; Finnis, Kirk W.; Ravussin, Eric; Oh, Michael Y.

2017-01-01

Object Deep brain stimulation (DBS) of the lateral hypothalamic area (LHA) has been suggested as a potential treatment for intractable obesity. The authors present the 2-year safety results as well as early efficacy and metabolic effects in 3 patients undergoing bilateral LHA DBS in the first study of this approach in humans. Methods Three patients meeting strict criteria for intractable obesity, including failed bariatric surgery, under-went bilateral implantation of LHA DBS electrodes as part of an institutional review board– and FDA-approved pilot study. The primary focus of the study was safety; however, the authors also received approval to collect data on early efficacy including weight change and energy metabolism. Results No serious adverse effects, including detrimental psychological consequences, were observed with continuous LHA DBS after a mean follow-up of 35 months (range 30–39 months). Three-dimensional nonlinear transformation of postoperative imaging superimposed onto brain atlas anatomy was used to confirm and study DBS contact proximity to the LHA. No significant weight loss trends were seen when DBS was programmed using standard settings derived from movement disorder DBS surgery. However, promising weight loss trends have been observed when monopolar DBS stimulation has been applied via specific contacts found to increase the resting metabolic rate measured in a respiratory chamber. Conclusions Deep brain stimulation of the LHA may be applied safely to humans with intractable obesity. Early evidence for some weight loss under metabolically optimized settings provides the first “proof of principle” for this novel antiobesity strategy. A larger follow-up study focused on efficacy along with a more rigorous metabolic analysis is planned to further explore the benefits and therapeutic mechanism behind this investigational therapy. PMID:23560573

[Comparison of robotic surgery documentary in gynecological cancer].

PubMed

Vargas-Hernández, Víctor Manuel

2012-01-01

Robotic surgery is a surgical technique recently introduced, with major expansion and acceptance among the medical community is currently performed in over 1,000 hospitals around the world and in the management of gynecological cancer are being developed comprehensive programs for implementation. The objectives of this paper are to review the scientific literature on robotic surgery and its application in gynecological cancer to verify its safety, feasibility and efficacy when compared with laparoscopic surgery or surgery classical major surgical complications, infections are more common in traditional radical surgery compared with laparoscopic or robotic surgery and with these new techniques surgical and staying hospital are lesser than the former however, the disadvantages are the limited number of robot systems, their high cost and applies only in specialized centers that have with equipment and skilled surgeons. In conclusion robotic surgery represents a major scientific breakthrough and surgical management of gynecological cancer with better results to other types of conventional surgery and is likely in the coming years is become its worldwide.

Is radiofrequency ablation of varicose veins a valuable option? A systematic review of the literature with a cost analysis

PubMed Central

Fisette, Jean-François; Bédard, Suzanne K.; Despatis, Marc-Antoine

2018-01-01

Background Since the 1990s, new techniques for the treatment of varicose veins have emerged, including radiofrequency ablation (RFA) and laser treatment. We performed a study to compare the safety, efficacy and outcomes of RFA compared to those of open surgery and laser ablation for the treatment of varicose veins. We also carried out a cost analysis of RFA compared to open surgery to assess whether RFA could help free up operating room time by being performed in an outpatient context. Methods We conducted a systematic literature review (publication date May 2010–September 2013 for articles in English, January 1991–September 2013 for those in French). We used several checklists to measure the quality of the studies. We also collected data on costing. Results The literature search identified 924 publications, of which 38 were retained for analysis: 15 literature reviews, 1 good-practice guideline and 22 new primary studies. The overall level of evidence was low to moderate owing to the limited sample sizes, lack of information on patient characteristics and lack of standardization of the outcome measures. However, the results obtained are consistent from study to study. In the short and medium term, RFA is considered as effective as open surgery or laser treatment (moderate level of evidence) and presents fewer major and minor complications than open surgery (low level of evidence). Radiofrequency ablation can be performed on an outpatient basis. We calculated that RFA would be about $110–$220 more expensive per patient than open surgery. Conclusion Radiofrequency ablation is a valuable alternative to open surgery and would free up operating room time in a context of low accessibility. PMID:29582749

Is radiofrequency ablation of varicose veins a valuable option? A systematic review of the literature with a cost analysis.

PubMed

Poder, Thomas G; Fisette, Jean-François; Bédard, Suzanne K; Despatis, Marc-Antoine

2018-04-01

Since the 1990s, new techniques for the treatment of varicose veins have emerged, including radiofrequency ablation (RFA) and laser treatment. We performed a study to compare the safety, efficacy and outcomes of RFA compared to those of open surgery and laser ablation for the treatment of varicose veins. We also carried out a cost analysis of RFA compared to open surgery to assess whether RFA could help free up operating room time by being performed in an outpatient context. We conducted a systematic literature review (publication date May 2010-September 2013 for articles in English, January 1991-September 2013 for those in French). We used several checklists to measure the quality of the studies. We also collected data on costing. The literature search identified 924 publications, of which 38 were retained for analysis: 15 literature reviews, 1 good-practice guideline and 22 new primary studies. The overall level of evidence was low to moderate owing to the limited sample sizes, lack of information on patient characteristics and lack of standardization of the outcome measures. However, the results obtained are consistent from study to study. In the short and medium term, RFA is considered as effective as open surgery or laser treatment (moderate level of evidence) and presents fewer major and minor complications than open surgery (low level of evidence). Radiofrequency ablation can be performed on an outpatient basis. We calculated that RFA would be about $110-$220 more expensive per patient than open surgery. Radiofrequency ablation is a valuable alternative to open surgery and would free up operating room time in a context of low accessibility.

Safety and efficacy of hysteroscopic sterilization compared with laparoscopic sterilization: an observational cohort study

PubMed Central

Mao, Jialin; Pfeifer, Samantha; Schlegel, Peter

2015-01-01

Objective To compare the safety and efficacy of hysteroscopic sterilization with the “Essure” device with laparoscopic sterilization in a large, all-inclusive, state cohort. Design Population based cohort study. Settings Outpatient interventional setting in New York State. Participants Women undergoing interval sterilization procedure, including hysteroscopic sterilization with Essure device and laparoscopic surgery, between 2005 and 2013. Main outcomes measures Safety events within 30 days of procedures; unintended pregnancies and reoperations within one year of procedures. Mixed model accounting for hospital clustering was used to compare 30 day and 1 year outcomes, adjusting for patient characteristics and other confounders. Time to reoperation was evaluated using frailty model for time to event analysis. Results We identified 8048 patients undergoing hysteroscopic sterilization and 44 278 undergoing laparoscopic sterilization between 2005 and 2013 in New York State. There was a significant increase in the use of hysteroscopic procedures during this period, while use of laparoscopic sterilization decreased. Patients undergoing hysteroscopic sterilization were older than those undergoing laparoscopic sterilization and were more likely to have a history of pelvic inflammatory disease (10.3% v 7.2%, P<0.01), major abdominal surgery (9.4% v 7.9%, P<0.01), and cesarean section (23.2% v 15.4%, P<0.01). At one year after surgery, hysteroscopic sterilization was not associated with a higher risk of unintended pregnancy (odds ratio 0.84 (95% CI 0.63 to 1.12)) but was associated with a substantially increased risk of reoperation (odds ratio 10.16 (7.47 to 13.81)) compared with laparoscopic sterilization. Conclusions Patients undergoing hysteroscopic sterilization have a similar risk of unintended pregnancy but a more than 10-fold higher risk of undergoing reoperation compared with patients undergoing laparoscopic sterilization. Benefits and risks of both procedures should be discussed with patients for informed decisions making. PMID:26462857

The voice of Holland: Dutch public and patient's opinion favours single-port laparoscopy.

PubMed

Fransen, Sofie Af; Broeders, Epm; Stassen, Lps; Bouvy, Nd

2014-07-01

Single-port laparoscopy is prospected as the future of minimal invasive surgery. It is hypothesised to cause less post operative pain, with a shorter hospitalisation period and improved cosmetic results. Population- and patient-based opinion is important for the adaptation of new techniques. This study aimed to assess the opinion and perception of a healthy population and a patient population on single-port laparoscopy compared with conventional laparoscopy. An anonymous 33-item questionnaire, describing conventional and single-port laparoscopy, was given to 101 patients and 104 healthy volunteers. The survey participants (median age 44 years; range 17-82 years) were asked questions about their personal situation and their expectations and perceptions of the two different surgical techniques; conventional multi-port laparoscopy and single-port laparoscopy. A total of 72% of the participants had never heard of single-port laparoscopy before. The most important concern in both groups was the risk of surgical complications. When complication risks remain similar, 80% prefers single-port laparoscopy to conventional laparoscopy. When the risk of complications increases from 1% to 10%, 43% of all participants prefer single-port laparoscopy. A total of 70% of the participants are prepared to receive treatment in another hospital if single-port surgery is not performed in their hometown hospital. The preference for single-port approach was higher in the female population. Although cure and safety remain the main concerns, the population and patients group have a favourable perception of single-port surgery. The impact of public opinion and patient perception towards innovative techniques is undeniable. If the safety of the two different procedures is similar, this study shows a positive attitude of both participant groups in favour of single-port laparoscopy. However, solid scientific proof for the safety and feasibility of this new surgical technique needs to be obtained before this procedure can be implemented into everyday practice.

Training and outcome monitoring in robotic urologic surgery.

PubMed

Liberman, Daniel; Trinh, Quoc-Dien; Jeldres, Claudio; Valiquette, Luc; Zorn, Kevin C

2011-11-08

The use of robot-assisted laparoscopic technology is rapidly expanding, with applicability in numerous disciplines of surgery. Training to perform robot-assisted laparoscopic urological procedures requires a motivated learner, a motivated teacher or proctor, a curriculum with stepwise learning objectives, and regular access to a training robot. In light of the many constraints that limit surgical training, animal models should be utilized to quantifiably improve the surgical skills of residents and surgical fellows, before these skills are put into practice on patients. A system based on appropriate supervision, graduated responsibility, real-time feedback, and objective measure of progress has proven to be safe and effective. Surgical team education directed towards cohesion is perhaps the most important aspect of training. At present, there are very few published guidelines for the safe introduction of robotic urologic surgery at an institution. Increasing evidence demonstrates the effects of learning curve and surgical volume on oncological and functional outcomes in robotic surgery (RS). This necessitates the introduction of mechanisms and guidelines by which trainee surgeons can attain a sufficient level of skill, without compromising the safety of patients. Guidelines for outcome monitoring following RS should be developed, to ensure patient safety and sufficient baseline surgeon skill.

Combining Systems and Teamwork Approaches to Enhance the Effectiveness of Safety Improvement Interventions in Surgery: The Safer Delivery of Surgical Services (S3) Program.

PubMed

McCulloch, Peter; Morgan, Lauren; New, Steve; Catchpole, Ken; Roberston, Eleanor; Hadi, Mohammed; Pickering, Sharon; Collins, Gary; Griffin, Damian

2017-01-01

Patient safety improvement interventions usually address either work systems or team culture. We do not know which is more effective, or whether combining approaches is beneficial. To compare improvement in surgical team performance after interventions addressing teamwork culture, work systems, or both. Suite of 5 identical controlled before-after intervention studies, with preplanned analysis of pooled data for indirect comparisons of strategies. Operating theatres in 5 UK hospitals performing elective orthopedic, plastic, or vascular surgery PARTICIPANTS:: All operating theatres staff, including surgeons, nurses, anaesthetists, and others INTERVENTIONS:: 4-month safety improvement interventions, using teamwork training (TT), systems redesign and standardization (SOP), Lean quality improvement, SOP + TT combination, or Lean + TT combination. Team technical and nontechnical performance and World Health Organization (WHO) checklist compliance, measured for 3 months before and after intervention using validated scales. Pooled data analysis of before-after change in active and control groups, comparing combined versus single and systems versus teamwork interventions, using 2-way ANOVA. We studied 453 operations, (255 intervention, 198 control). TT improved nontechnical skills and WHO compliance (P < 0.001), but not technical performance; systems interventions (Lean & SOP, 2 & 3) improved nontechnical skills and technical performance (P < 0.001) but improved WHO compliance less. Combined interventions (4 & 5) improved all performance measures except WHO time-out attempts, whereas single approaches (1 & 2 & 3) improved WHO compliance less (P < 0.001) and failed to improve technical performance. Safety interventions combining teamwork training and systems rationalization are more effective than those adopting either approach alone. This has important implications for safety improvement strategies in hospitals.

Quality and Safety in Health Care, Part XXX: Transcatheter Aortic Valve Therapy.

PubMed

Harolds, Jay A

2017-12-01

Initially, the transcatheter aortic valve replacement procedure was approved only for patients with aortic stenosis that was both severe and symptomatic who either also had too high a risk of aortic valve replacement surgery to have the surgery or who had a high risk for the surgery. Between the years 2012 and 2015, the death rate at 30 days declined from an initial rate of 7.5% to 4.6%. There has also been more use of the transfemoral approach over the years. In 2016, the transcatheter aortic valve replacement was approved for patients with aortic stenosis at intermediate risk of surgery.

[Pediatric anesthesia emergence delirium after elective ambulatory surgery: etiology, risk factors and prevalence].

PubMed

Gololobov, Alik; Todris, Liat; Berman, Yakov; Rosenberg-Gilad, Zipi; Schlaeffer, Pnina; Kenett, Ron; Ben-Jacob, Ron; Segal, Eran

2015-04-01

Emergence delirium (ED) is a common problem among children and adults recovering from general anesthesia after surgery. Its symptoms include psychomotor agitation, hallucinations, and aggressive behavior. The phenomenon, which is most probably an adverse effect of general anesthesia agents, harms the recovery process and endangers the physical safety of patients and their health. Ranging between 10% and 80%, the exact prevalence of ED is unknown, and the risk factors of the phenomenon are unclear. The aim of the current retrospective study was to determine the prevalence rate of ED in 3947 children recovering from general anesthesia after short elective ambulatory surgery, and to map the influence of various risk factors on this phenomenon. Data were collected using electronic medical records. ED severity was assessed using the Pediatric Anesthesia Emergence Delirium Scale. Results showed the prevalence of ED among children. ED was significantly correlated with patients' age, type of surgery and premedication. ED was not correlated with severity of pain, type of anesthesia or with patients' sex.

[Perforated peptic ulcer closure: laparoscopic or open?

PubMed

Alekberzade, A V; Krylov, N N; Rustamov, E A; Badalov, D A; Popovtsev, M A

To compare laparoscopic and open closure of perforated peptic ulcer (PPU). The study included 153 patients who underwent PPU suturing. 78 patients underwent laparoscopic closure (laparoscopic group) and open suturing via upper midline laparotomy was performed in 75 cases (open group). Surgery time, postoperative pain severity, time of analgesics intake, postoperative complications, hospital-stay and and cosmetic effect were compared. Laparoscopic PPU closure may be effective and accessible in experienced endoscopic surgeon. It significantly reduces postoperative pain severity, need for analgesics, incidence of postoperative complications and provides excellent cosmetic effect. However, there is greater time of surgery compared with open intervention. There were no significant differences in hspital-stay between groups. Laparoscopic PPU suturing can be considered a good alternative to open surgery. Further researches are needed for standardization, assessment of safety, real advantages and disadvantages of laparoscopic technique.

Risk factors for acute cholecystitis and for intraoperative complications.

PubMed

Andercou, Octavian; Olteanu, Gabriel; Mihaileanu, Florin; Stancu, Bogdan; Dorin, Marian

2017-01-01

Acute cholecystitis is still frequent in emergency surgical departments. As surgical technique, nowadays laparoscopy is widely used and with low complications and with low postoperative morbidity. We perform an analytical study about the safety of laparoscopic surgery in patients with acute cholecystitis in a single Surgical Department with an experience of over 20 years in laparoscopic surgery. We included 193 patient admitted in our department during 2014 and 2015. Of the 193 patients, 43% were diagnosed with acute lithiasic cholecystitis (ALC) whereas 56% had chronic lithiasic cholecystitis (CLC). We assessed the comorbidities of the patient via Pearson's Chi-Square test and we found out that there is a significant relationship between acute cholecystitis and high blood tension, obesity and diabetes. Surgical techniques performed were in 95% of cases laparoscopic cholecystectomy and only in 5% we performed open surgery. Experienced surgeons have a lower conversion rate as compared to less experienced surgeons. For this reason, postoperative assessment criteria have been proposed, with a view to identify the risk of conversion CONCLUSION: In our study laparoscopic surgery for acute cholecystitis is a safe procedure with low intraoperative complication rate and with a reduced hospital stay. Acute cholecystitis, Intraoperative adhesion, Intraoperative bleeding, Laparoscopic cholecystectomy.

Understanding the Multidimensional Effects of Resident Duty Hours Restrictions: A Thematic Analysis of Published Viewpoints in Surgery.

PubMed

Devitt, Katharine S; Kim, Michael J; Gotlib Conn, Lesley; Wright, Frances C; Moulton, Carol-Anne; Keshet, Itay; Ahmed, Najma

2018-02-01

Individuals representing various surgical disciplines have expressed concerns with the impact of resident duty hours (RDH) restrictions on resident education and patient outcomes. This thematic review of published viewpoints aimed to describe the effects of these restrictions in surgery. The authors conducted a qualitative systematic review of non-research-based literature published between 2003 and 2015. Articles were included if they focused on the RDH restrictions in surgery and resident wellness, health promotion, resident safety, resident education and/or training, patient safety, medical errors, and/or heterogeneity regarding training or disciplines. A thematic analysis approach guided data extraction. Contextual data were abstracted from the included articles to aid in framing the identified themes. Of 1,482 identified articles, 214 were included in the review. Most were from authors in the United States (144; 67%) and focused on the 80-hour workweek (164; 77%). The emerging themes were organized into three overarching categories: (1) impact of the RDH restrictions, (2) surgery has its own unique culture, and (3) strategies going forward. Published opinions suggested that RDH restrictions alone are insufficient to achieve the desired outcomes and that careful consideration of the surgical training model is needed to maintain the integrity of educational outcomes. Opinions from the surgical community highlight the complexity of issues surrounding the RDH restrictions and suggest that recent changes are not achieving all the desired outcomes and have resulted in unintended outcomes. From the perceptions of the various stakeholders in surgical education studied, areas for new policies were identified.

Safety and Effectiveness of Cataract Surgery with Simultaneous Intravitreal Anti-VEGF in Patients with Previously Treated Exudative Age-Related Macular Degeneration.

PubMed

Falcão, Manuel Sousa; Freitas-Costa, Paulo; Beato, João Nuno; Pinheiro-Costa, João; Rocha-Sousa, Amândio; Carneiro, Ângela; Brandão, Elisete Maria; Falcão-Reis, Fernando

2017-02-27

To evaluate the safety and impact on visual acuity, retinal and choroidal morphology of simultaneous cataract surgery and intravitreal anti-vascular endothelial growth factor on patients with visually significant cataracts and previously treated exudative age-related macular degeneration. Prospective study, which included 21 eyes of 20 patients with exudative age-related macular degeneration submitted to simultaneous phacoemulsification and intravitreal ranibizumab or bevacizumab. The patients were followed for 12 months after surgery using a pro re nata strategy. Visual acuity, foveal and choroidal thickness changes were evaluated 1, 6 and 12 months post-operatively. There was a statistically significant increase in mean visual acuity at one (13.4 letters, p < 0.05), six (11.5 letters, p < 0.05) and twelve months (11.3 letters, p < 0.05) without significant changes in retinal or choroidal morphology. At 12 months, 86% of eyes were able to maintain visual acuity improvement. There were no significant differences between the two anti-vascular endothelial growth factor drugs and no complications developed during follow-up. Simultaneous phacoemulsification and intravitreal anti- vascular endothelial growth factor is safe and allows improvement in visual acuity in patients with visually significant cataracts and exudative age-related macular degeneration. Visual acuity gains were maintained with a pro re nata strategy showing that in this subset of patients, phacoemulsification may be beneficial. Cataract surgery and simultaneous anti-vascular endothelial growth factor therapy improves visual acuity in patients with exudative age-related macular degeneration.

One-year visual outcome of small incision lenticule extraction (SMILE) surgery in high myopic eyes: retrospective cohort study

PubMed Central

Wu, Wenjing; Wang, Yan; Zhang, Hui; Zhang, Jiamei; Li, Hua; Dou, Rui

2016-01-01

Objective To determine whether the long-term visual outcome of small incision lenticule extraction (SMILE) surgery is consistent with the short-term results in high myopic eyes. Design Retrospective cohort study; data collected from 8 August 2011 to 31 August 2015. Setting Single refractive surgery centre. Participants A total of 156 eyes were studied: 65 eyes of 39 subjects (22 female/17 male) in the high myopic group (manifest refraction spherical equivalent (MRSE) ≥−6.0 D), and 91 eyes of 54 subjects (29 female/25 male) in the control group (MRSE <−6.0 D). The inclusion criteria were subjects who had follow-ups after 1 day, 1 week, 1 month, 3, 6 months and 1 year with the manifest refraction, uncorrected and corrected distance visual acuity (UDVA/CDVA). There were no statistically significant differences between the two groups in the subjects' gender, age, or cylindrical dioptre, preoperatively (p=0.835, p=0.055, p=0.341, respectively). Primary and secondary outcome measures UDVA, refractive stability, safety index (postoperative CDVA/preoperative CDVA), and predictability (the percentage of eyes within ±0.50 D). Results In both groups, the 1-year UDVA and safety index were significantly better than results at 1 day (high myopic group: p=0.035, p<0.001; control group: p<0.016, p<0.001); the 1-year predictability showed no significant difference with the short-term results (p=1.00 in both groups). In the high myopic eyes, the 1-year MRSE was significantly worse than the short-term result (p=0.048). To correct it, the added magnitude (D) for the high myopic eyes may equal 0.13×Attempted SE (D)−0.66 D. However, the postoperative MRSE showed no differences from 1 day to 1 year (p=0.612) in the control group. Conclusions The 1-year visual outcomes were better than the short-term results after the SMILE surgery on the visual acuity and safety. However, the high myopic eyes suffered a significant regression at 1 year, which may be corrected by adding additional magnitude to the SE for high myopic eyes. PMID:27655258

Application of fluorescence in robotic general surgery: review of the literature and state of the art.

PubMed

Marano, Alessandra; Priora, Fabio; Lenti, Luca Matteo; Ravazzoni, Ferruccio; Quarati, Raoul; Spinoglio, Giuseppe

2013-12-01

The initial use of the indocyanine green fluorescence imaging system was for sentinel lymph node biopsy in patients with breast or colorectal cancer. Since then, application of this method has received wide acceptance in various fields of surgical oncology, and it has become a valid diagnostic tool for guiding cancer treatment. It has also been employed in numerous conventional surgical procedures with much success and benefit to the patient. The advent of minimally invasive surgery brought with it a new use for fluorescence in helping to improve the safety of these procedures, particularly for single-site procedures. In 2010, a near-infrared camera was integrated into the da Vinci Si System, creating a combination of technical and minimally invasive advantages that have been embraced by several experienced surgeons. The use of fluorescence, although useful, is considered challenging. Only a few studies are currently available on the use of fluorescence in robotic general surgery, whereas many articles have focused on its application in open and laparoscopic surgery. Many of these reports describe promising and satisfactory results, although with some shortcomings. The purpose of this article is to review the current status of the use of fluorescence in general surgery and particularly its role in robotic surgery. We also review potential uses in the future.

Improving Patient Safety in Anesthesia: A Success Story?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Botney, Richard

2008-05-01

Anesthesia is necessary for surgery; however, it does not deliver any direct therapeutic benefit. The risks of anesthesia must therefore be as low as possible. Anesthesiology has been identified as a leader in improving patient safety. Anesthetic mortality has decreased, and in healthy patients can be as low as 1:250,000. Trends in anesthetic morbidity have not been as well defined, but it appears that the risk of injury is decreasing. Studies of error during anesthesia and Closed Claims studies have identified sources of risk and methods to reduce the risks associated with anesthesia. These include changes in technology, such asmore » anesthetic delivery systems and monitors, the application of human factors, the use of simulation, and the establishment of reporting systems. A review of the important events in the past 50 years illustrates the many steps that have contributed to the improvements in anesthesia safety.« less

Early Re-Do Surgery for Glioblastoma Is a Feasible and Safe Strategy to Achieve Complete Resection of Enhancing Tumor

PubMed Central

Schucht, Philippe; Murek, Michael; Jilch, Astrid; Seidel, Kathleen; Hewer, Ekkehard; Wiest, Roland; Raabe, Andreas; Beck, Jürgen

2013-01-01

Background Complete resection of enhancing tumor as assessed by early (<72 hours) postoperative MRI is regarded as the optimal result in glioblastoma surgery. As yet, there is no consensus on standard procedure if post-operative imaging reveals unintended tumor remnants. Objective The current study evaluated the feasibility and safety of an early re-do surgery aimed at completing resections with the aid of 5-ALA fluorescence and neuronavigation after detection of enhancing tumor remnants on post-operative MRI. Methods From October 2008 to October 2012 a single center institutional protocol offered a second surgery within one week to patients with unintentional incomplete glioblastoma resection. We report on the feasibility of the use 5-ALA fluorescence guidance, the extent of resection (EOR) rates and complications of early re-do surgery. Results Nine of 151 patients (6%) with glioblastoma resections had an unintentional tumor remnant with a volume >0.175 cm3. 5-ALA guided re-do surgery completed the resection (CRET) in all patients without causing neurological deficits, infections or other complications. Patients who underwent a re-do surgery remained hospitalized between surgeries, resulting in a mean length of hospital stay of 11 days (range 7-15), compared to 9 days for single surgery (range 3-23; p=0.147). Conclusion Our early re-do protocol led to complete resection of all enhancing tumor in all cases without any new neurological deficits and thus provides a similar oncological result as intraoperative MRI (iMRI). The repeated use of 5-ALA induced fluorescence, used for identification of small remnants, remains highly sensitive and specific in the setting of re-do surgery. Early re-do surgery is a feasible and safe strategy to complete unintended subtotal resections. PMID:24348904

The impact of first eye cataract surgery on mental health contacts for depression and/or anxiety: a population-based study using linked data.

PubMed

Meuleners, Lynn B; Hendrie, Delia; Fraser, Michelle L; Ng, Jonathon Q; Morlet, Nigel

2013-09-01

Cataract is the leading cause of reversible blindness worldwide, and the incidence of cataract surgery is projected to increase as the population ages. Gaining an understanding of the effects of cataract surgery on a range of health outcomes is important for maintaining the health and safety of older adults. A before and after cohort study was conducted using the Western Australian Hospital Morbidity Data System, Mental Health Information System and the Western Australian Death Registry. Of the 21 110 patients who underwent cataract surgery in one eye only, 295 had mental health contacts for depression and/or anxiety 1 year before (n = 158) or 1 year after (n = 137) surgery. Results from Poisson generalized estimating equations showed a significant decrease of 18.80% (p ≤ 0.001) in the number of mental health contacts for depression and/or anxiety the year after cataract surgery after accounting for potential confounding factors. A 27.46% increase in mental health contacts the year after cataract surgery was reported by women compared with men (95% CI: 1.08-1.50). Those living in remote areas had less contact with mental health services compared with those living in metropolitan areas (adjusted risk ratio 0.62, 95% CI: 0.46-0.84). The corresponding reduction in health care costs for treatment of depression and/or anxiety was 28%. Further research should be conducted to collect information on the utilization of health care resources not captured in this study, namely community-based services, visits to general practitioners and/or emergency departments as well as medication usage such as antidepressants. © 2013 Acta Ophthalmologica Scandinavica Foundation. Published by Blackwell Publishing Ltd.

Identification of Best Practices for Resident Aesthetic Clinics in Plastic Surgery Training: The ACAPS National Survey

PubMed Central

Wu, Cindy; Bentz, Michael L.; Redett, Richard J.; Shack, R. Bruce; David, Lisa R.; Taub, Peter J.; Janis, Jeffrey E.

2015-01-01

Introduction: Resident aesthetic clinics (RACs) have demonstrated good outcomes and acceptable patient satisfaction, but few studies have evaluated their educational, financial, or medicolegal components. We sought to determine RAC best practices. Methods: We surveyed American Council of Academic Plastic Surgeon members (n = 399), focusing on operational details, resident supervision, patient safety, medicolegal history, financial viability, and research opportunities. Of the 96 respondents, 63 reported having a RAC, and 56% of plastic surgery residency program directors responded. Results: RACs averaged 243 patient encounters and 53.9 procedures annually, having been in existence for 19.6 years (mean). Full-time faculty (73%) supervised chief residents (84%) in all aspects of care (65%). Of the 63 RACs, 45 were accredited, 40 had licensed procedural suites, 28 had inclusion/exclusion criteria, and 31 used anesthesiologists. Seventeen had overnight capability, and 17 had a Life Safety Plan. No cases of malignant hyperthermia occurred, but 1 facility death was reported. Sixteen RACs had been involved in a lawsuit, and 33 respondents reported financial viability of the RACs. Net revenue was transferred to both the residents’ educational fund (41%) and divisional/departmental overhead (37%). Quality measures included case logs (78%), morbidity/mortality conference (62%), resident surveys (52%), and patient satisfaction scores (46%). Of 63 respondents, 14 have presented or published RAC-specific research; 80 of 96 of those who were surveyed believed RACs enhanced education. Conclusions: RACs are an important component of plastic surgery education. Most clinics are financially viable but carry high malpractice risk and consume significant resources. Best practices, to maximize patient safety and optimize resident education, include use of accredited procedural rooms and direct faculty supervision of all components of care. PMID:26146599

Iris-fixated phakic intraocular lens implantation after retinal detachment surgery: long-term clinical results.

PubMed

Chung, Jin Kwon; Kim, Jin Kook; Lee, Jae Bum; Lee, Sung Jin

2013-10-01

To assess the efficacy and safety of iris-fixated phakic intraocular lens (pIOL) implantation to correct myopia in eyes with previous retinal detachment (RD) surgery. Department of Ophthalmology, Soonchunhyang University College of Medicine, Seoul, South Korea. Retrospective case series. Patients having pIOL implantation in both eyes were enrolled. Eyes that had scleral buckling or encircling (RD group) and healthy fellow eyes (non-RD group) were evaluated over a 6-year follow-up. The corrected distance visual acuity (CDVA), endothelial cell density (ECD), intraoperative complications, and long-term complications were safety outcomes. Uncorrected distance visual acuity (UDVA), predictability, and stability of refraction were efficacy outcomes. The study comprised 34 eyes (17 patients). The mean postoperative CDVA and ECD were not significantly different between groups, and no patient lost CDVA. The rate of transient intraocular pressure spike was significantly higher in the RD group (P=.043). After 3 years and 6 years, the mean postoperative UDVA was 0.06 logMAR ± 0.09 (SD) and 0.08 ± 0.10 logMAR, respectively, in the RD group and 0.04 ± 0.08 logMAR and 0.04 ± 0.09 logMAR, respectively, in the non-RD group (P=.518 and P=.478, respectively). The rate of eyes within ±0.50 diopter of the desired refraction and the postoperative refraction was not significantly different between groups. No eye had vitreoretinal changes requiring secondary surgical intervention. Iris-fixated pIOL implantation corrected the myopic refractive error in patients who had scleral buckling or encircling surgery for RD with a high degree of efficacy, safety, and long-term stability. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2013 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Echocardiography-based hemodynamic management of left ventricular diastolic dysfunction: a feasibility and safety study.

PubMed

Shillcutt, Sasha K; Montzingo, Candice R; Agrawal, Ankit; Khaleel, Maseeha S; Therrien, Stacey L; Thomas, Walker R; Porter, Thomas R; Brakke, Tara R

2014-11-01

Patients with left ventricular diastolic dysfunction (LVDD) are at increased risk of postoperative adverse events. The primary aim of this study was to evaluate the safety and feasibility of using echocardiography-guided hemodynamic management (EGHEM) during surgery in subjects with LVDD compared to conventional management. The feasibility of using echocardiography to direct a treatment algorithm and clinical outcomes were compared for safety between groups. Subjects were screened for LVDD by preoperative transthoracic echocardiography (TTE) and randomized to the conventional or EGHEM group. Subjects in EGHEM received hemodynamic management based on left ventricular filling patterns on transesophageal echocardiography (TEE). Primary outcomes measured were the feasibility to obtain TEE images and follow a TEE-based treatment algorithm. Safety outcomes also compared the following clinical differences between groups: length of hospitalization, incidence of atrial fibrillation, congestive heart failure (CHF), myocardial infarction, cerebrovascular accident, transient ischemic attack and renal failure measured 30 days postoperatively. Population consisted of 28 surgical subjects (14 in conventional group and 14 in EGHEM group). Mean subject age was 73.4 ± 6.7 years (36% male) in conventional group and 65.9 ± 14.4 years (36% male) in EGHEM group. Procedures included orthopedic (conventional = 29%, EGHEM 36%), general (conventional = 50%, EGHEM = 36%), vascular (conventional = 7%, EGHEM = 21%), and thoracic (conventional = 14%, EGHEM = 7%). There was no statistically significant difference in adverse clinical events between the 2 groups. The EGHEM group had less CHF, atrial fibrillation, and shorter length of stay. Echocardiography-guided hemodynamic management of patients with LVDD during surgery is feasible and may be a safe alternative to conventional management. © 2014, Wiley Periodicals, Inc.

Surgical process improvement tools: defining quality gaps and priority areas in gastrointestinal cancer surgery.

PubMed

Wei, A C; Devitt, K S; Wiebe, M; Bathe, O F; McLeod, R S; Urbach, D R

2014-04-01

Surgery is a cornerstone of cancer treatment, but significant differences in the quality of surgery have been reported. Surgical process improvement tools (spits) modify the processes of care as a means to quality improvement (qi). We were interested in developing spits in the area of gastrointestinal (gi) cancer surgery. We report the recommendations of an expert panel held to define quality gaps and establish priority areas that would benefit from spits. The present study used the knowledge-to-action cycle was as a framework. Canadian experts in qi and in gi cancer surgery were assembled in a nominal group workshop. Participants evaluated the merits of spits, described gaps in current knowledge, and identified and ranked processes of care that would benefit from qi. A qualitative analysis of the workshop deliberations using modified grounded theory methods identified major themes. The expert panel consisted of 22 participants. Experts confirmed that spits were an important strategy for qi. The top-rated spits included clinical pathways, electronic information technology, and patient safety tools. The preferred settings for use of spits included preoperative and intraoperative settings and multidisciplinary contexts. Outcomes of interest were cancer-related outcomes, process, and the technical quality of surgery measures. Surgical process improvement tools were confirmed as an important strategy. Expert panel recommendations will be used to guide future research efforts for spits in gi cancer surgery.

Surgical process improvement tools: defining quality gaps and priority areas in gastrointestinal cancer surgery

PubMed Central

Wei, A.C.; Devitt, K.S.; Wiebe, M.; Bathe, O.F.; McLeod, R.S.; Urbach, D.R.

2014-01-01

Background Surgery is a cornerstone of cancer treatment, but significant differences in the quality of surgery have been reported. Surgical process improvement tools (spits) modify the processes of care as a means to quality improvement (qi). We were interested in developing spits in the area of gastrointestinal (gi) cancer surgery. We report the recommendations of an expert panel held to define quality gaps and establish priority areas that would benefit from spits. Methods The present study used the knowledge-to-action cycle was as a framework. Canadian experts in qi and in gi cancer surgery were assembled in a nominal group workshop. Participants evaluated the merits of spits, described gaps in current knowledge, and identified and ranked processes of care that would benefit from qi. A qualitative analysis of the workshop deliberations using modified grounded theory methods identified major themes. Results The expert panel consisted of 22 participants. Experts confirmed that spits were an important strategy for qi. The top-rated spits included clinical pathways, electronic information technology, and patient safety tools. The preferred settings for use of spits included preoperative and intraoperative settings and multidisciplinary contexts. Outcomes of interest were cancer-related outcomes, process, and the technical quality of surgery measures. Conclusions Surgical process improvement tools were confirmed as an important strategy. Expert panel recommendations will be used to guide future research efforts for spits in gi cancer surgery. PMID:24764704

Detection of medical errors in kidney transplantation: a pilot study comparing proactive clinician debriefings to a hospital-wide incident reporting system.

PubMed

McElroy, Lisa M; Daud, Amna; Lapin, Brittany; Ross, Olivia; Woods, Donna M; Skaro, Anton I; Holl, Jane L; Ladner, Daniela P

2014-11-01

Rates of medical errors and adverse events remain high for patients who undergo kidney transplantation; they are particularly vulnerable because of the complexity of their disease and the kidney transplantation procedure. Although institutional incident-reporting systems are used in hospitals around the country, they often fail to capture a substantial proportion of medical errors. The goal of this study was to assess the ability of a proactive, web-based clinician safety debriefing to augment the information about medical errors and adverse events obtained via traditional incident reporting systems. Debriefings were sent to all individuals listed on operating room personnel reports for kidney transplantation surgeries between April 2010 and April 2011, and incident reports were collected for the same time period. The World Health Organization International Classification for Patient Safety was used to classify all issues reported. A total of 270 debriefings reported 334 patient safety issues (179 safety incidents, 155 contributing factors), and 57 incident reports reported 92 patient safety issues (56 safety incidents, 36 contributing factors). Compared with incident reports, more attending physicians completed the debriefings (32.0 vs 3.5%). The use of a proactive, web-based debriefing to augment an incident reporting system in assessing safety risks in kidney transplantation demonstrated increased information, more perspectives of a single safety issue, and increased breadth of participants. Copyright © 2014 Elsevier Inc. All rights reserved.

A randomized study comparing outcomes of stapled and hand-sutured anastomoses in patients undergoing open gastrointestinal surgery.

PubMed

Chandramohan, S M; Gajbhiye, Raj Narenda; Agwarwal, Anil; Creedon, Erin; Schwiers, Michael L; Waggoner, Jason R; Tatla, Daljit

2013-08-01

Although stapling is an alternative to hand-suturing in gastrointestinal surgery, recent trials specifically designed to evaluate differences between the two in surgery time, anastomosis time, and return to bowel activity are lacking. This trial compared the outcomes of the two in subjects undergoing open gastrointestinal surgery. Adult subjects undergoing emergency or elective surgery requiring a single gastric, small, or large bowel anastomosis were enrolled into this open-label, prospective, randomized, interventional, parallel, multicenter, controlled trial. Randomization was assigned in a 1:1 ratio between the hand-sutured group (n = 138) and the stapled group (n = 142). Anastomosis time, surgery time, and time to bowel activity were collected and compared as primary endpoints. A total of 280 subjects were enrolled from April 2009 to September 2010. Only the time of anastomosis was significantly different between the two arms: 17.6 ± 1.90 min (stapled) and 20.6 ± 1.90 min (hand-sutured). This difference was deemed not clinically or economically meaningful. Safety outcomes and other secondary endpoints were similar between the two arms. Mechanical stapling is faster than hand-suturing for the construction of gastrointestinal anastomoses. Apart from this, stapling and hand-suturing are similar with respect to the outcomes measured in this trial.

The surgical safety checklist and patient outcomes after surgery: a prospective observational cohort study, systematic review and meta-analysis.

PubMed

Abbott, T E F; Ahmad, T; Phull, M K; Fowler, A J; Hewson, R; Biccard, B M; Chew, M S; Gillies, M; Pearse, R M

2018-01-01

The surgical safety checklist is widely used to improve the quality of perioperative care. However, clinicians continue to debate the clinical effectiveness of this tool. Prospective analysis of data from the International Surgical Outcomes Study (ISOS), an international observational study of elective in-patient surgery, accompanied by a systematic review and meta-analysis of published literature. The exposure was surgical safety checklist use. The primary outcome was in-hospital mortality and the secondary outcome was postoperative complications. In the ISOS cohort, a multivariable multi-level generalized linear model was used to test associations. To further contextualise these findings, we included the results from the ISOS cohort in a meta-analysis. Results are reported as odds ratios (OR) with 95% confidence intervals. We included 44 814 patients from 497 hospitals in 27 countries in the ISOS analysis. There were 40 245 (89.8%) patients exposed to the checklist, whilst 7508 (16.8%) sustained ≥1 postoperative complications and 207 (0.5%) died before hospital discharge. Checklist exposure was associated with reduced mortality [odds ratio (OR) 0.49 (0.32-0.77); P<0.01], but no difference in complication rates [OR 1.02 (0.88-1.19); P=0.75]. In a systematic review, we screened 3732 records and identified 11 eligible studies of 453 292 patients including the ISOS cohort. Checklist exposure was associated with both reduced postoperative mortality [OR 0.75 (0.62-0.92); P<0.01; I 2 =87%] and reduced complication rates [OR 0.73 (0.61-0.88); P<0.01; I 2 =89%). Patients exposed to a surgical safety checklist experience better postoperative outcomes, but this could simply reflect wider quality of care in hospitals where checklist use is routine. Copyright © 2017 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

Parecoxib Provides Analgesic and Opioid-Sparing Effects Following Major Orthopedic Surgery: A Subset Analysis of a Randomized, Placebo-Controlled Clinical Trial.

PubMed

Diaz-Borjon, Efrain; Torres-Gomez, Armando; Essex, Margaret Noyes; Salomon, Patricia; Li, Chunming; Cheung, Raymond; Parsons, Bruce

2017-06-01

Orthopedic surgeries are among the most common and most painful surgeries performed. A multimodal analgesic approach is recommended to reduce opioid consumption, provide effective pain relief, and improve outcomes following surgery. This study examined the efficacy and opioid-sparing effects of parecoxib following major orthopedic surgery. This subset analysis of a large, multicenter, randomized, double-blind, placebo-controlled study of parecoxib examined treatment effects on postoperative pain severity, pain interference with function, opioid consumption, occurrence of opioid-related symptoms, safety, and patient satisfaction following major orthopedic surgery. Pain scores were significantly lower in the parecoxib group (n = 142) compared with placebo (n = 139) on day 2 (-22%; p < 0.001) and day 3 (-17%; p = 0.004). Pain interference with function scores were also significantly lower in the parecoxib group on day 2 (-32%; p < 0.001) and day 3 (-27%; p = 0.003) relative to placebo. Additionally, significantly less supplemental morphine was required in the parecoxib group relative to placebo through 24 h (-28%; p = 0.008) and 48 h (-33%; p < 0.001). Patients in the parecoxib group had a reduced risk of experiencing opioid-related symptoms including fatigue, drowsiness, inability to concentrate, confusion, nausea, constipation, and confusion on day 2 and/or day 3. Finally, more patients receiving parecoxib (42%) rated treatment as "excellent" compared to those receiving placebo (21%). These findings support the use of parecoxib for the management of pain following major orthopedic surgery.

Comparative outcomes of femtosecond laser-assisted cataract surgery and manual phacoemusification: a six-month follow-up.

PubMed

Yu, Yinhui; Chen, Xinyi; Hua, Huixia; Wu, Menghan; Lai, Kairan; Yao, Ke

2016-08-01

To explore efficacy and safety outcomes in patients undergoing femtosecond laser-assisted cataract surgery (FLACS) versus manual phacoemulsification cataract surgery (PCS). Prospective consecutive nonrandomized comparative cohort study. A total of 124 eyes from 106 patients (70 in FLACS and 54 in PCS). Comparison of FLACS with PCS over 6 months. Macular central subfield thickness (CST), cube volume (CV), cube average thickness (CAT), endothelial cell density (ECD), central corneal thickness (CCT) and photon count value (PCV). CST, CV and CAT increased postoperatively, which did not return to preoperative levels by 6 months. The values were similar between groups throughout the follow-up, and comparison of changes from baseline also showed no significant difference. Preoperative ECD showed significant difference, which decreased postoperatively and remained stable during follow-up, being lowest at 1 month. FLACS had greater endothelial cell loss than PCS, which was not significant. CCT in both groups increased, reaching maximum on day one and tended to decrease thereafter. No significant differences were found regarding postoperative values and the mean increase. In both groups, mean PCV increased from preoperatively to day one, week one and month one. Flare values in FLACS were lower than PCS, reaching statistical significance at 6 months (P = 0.001). However, the differences in changes of PCV were not significantly different at any visit. Both FLACS and PCS achieved similar safety and efficacy outcomes for performing cataract surgery. Flare values in eyes with FLACS were lower than those with PCS at 6 months postoperatively. © 2015 Royal Australian and New Zealand College of Ophthalmologists.

The electronic cigarette. Official statement of the Spanish Society of Pneumology and Thoracic Surgery (SEPAR) on the efficacy, safety and regulation of electronic cigarettes.

PubMed

Jimenez Ruiz, Carlos A; Solano Reina, Segismundo; de Granda Orive, Jose Ignacio; Signes-Costa Minaya, Jaime; de Higes Martinez, Eva; Riesco Miranda, Juan Antonio; Altet Gómez, Neus; Lorza Blasco, Jose Javier; Barrueco Ferrero, Miguel; de Lucas Ramos, Pilar

2014-08-01

The electronic cigarette (EC) is a device formed by three basic elements: battery, atomizer and cartridge. When assembled, it looks like a cigarette. The cartridge contains different substances: propylene glycol, glycerine and, sometimes, nicotine. When the user "vapes", the battery is activated, the atomizer is heated and the liquid is drawn in and vaporized. The smoker inhales the mist produced. Various substances have been detected in this mist: formaldehyde, acetaldehyde and acrolein and some heavy metals. Although these are found in lower concentrations than in cigarettes, they may still be harmful for the human body. Several surveys show that 3-10% of smokers regularly use e-cigarettes. A randomized study has shown that the efficacy of e-cigarettes for helping smokers to quit is similar to nicotine patches. Nevertheless, the study has relevant methodological limitations and reliable conclusions cannot be deduced. This report sets down the Position Statement of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) on the efficacy and safety of e-cigarettes. This statement declares that e-cigarettes should be regulated as medicinal products. Copyright © 2013 SEPAR. Published by Elsevier Espana. All rights reserved.

Narcotics reduction, quality and safety in gynecologic oncology surgery in the first year of enhanced recovery after surgery protocol implementation.

PubMed

Bergstrom, Jennifer E; Scott, Marla E; Alimi, Yewande; Yen, Ting-Tai; Hobson, Deborah; Machado, Karime K; Tanner, Edward J; Fader, Amanda N; Temkin, Sarah M; Wethington, Stephanie; Levinson, Kimberly; Sokolinsky, Sam; Lau, Brandyn; Stone, Rebecca L

2018-06-01

Enhanced Recovery After Surgery (ERAS) programs are mechanisms for achieving value-based improvements in surgery. This report provides a detailed analysis of the impact of an ERAS program on patient outcomes as well as quality and safety measures during implementation on a gynecologic oncology service at a major academic medical center. A retrospective review of gynecologic oncology patients undergoing elective laparotomy during the implementation phase of an ERAS program (January 2016 through December 2016) was performed. Patient demographics, surgical variables, postoperative outcomes, and adherence to core safety measures, including antimicrobial and venous thromboembolism (VTE) prophylaxis, were compared to a historical patient cohort (January 2015 through December 2015). Statistical analyses were performed using t-tests, Wilcoxon rank sum tests, and Chi squared tests. The inaugural 109 ERAS program participants were compared to a historical patient cohort (n=158). There was no difference in BMI, race, malignancy, or complexity of procedure between cohorts. ERAS patients required less narcotics (70.7 vs 127.4, p=0.007, oral morphine equivalents) and PCA use (32.1% vs. 50.6%, p=0.002). Despite this substantial reduction in narcotics, ERAS patients did not report more pain and in fact reported significantly less pain by postoperative day 3. There were no differences in length of stay (5days), complication rates (13.8% vs. 20.3%, p=0.17) or 30-day readmission rates (9.5 vs 11.9%, p=0.54) between ERAS and historical patients, respectively. Compliance with antimicrobial prophylaxis was 97.2%. However, 33.9% of ERAS patients received substandard preoperative VTE prophylaxis. ERAS program implementation resulted in reductions in narcotic requirements and PCA use without changes in length of stay or readmission rates. Compliance should be diligently audited during the implementation phase of ERAS programs, with special attention to adherence to pre-existing core safety measures. Copyright © 2018 Elsevier Inc. All rights reserved.

Fluid collection after partial pancreatectomy: EUS drainage and long-term follow-up.

PubMed

Caillol, Fabrice; Godat, Sebastien; Turrini, Olivier; Zemmour, Christophe; Bories, Erwan; Pesenti, Christian; Ratone, Jean Phillippe; Ewald, Jacques; Delpero, Jean Robert; Giovannini, Marc

2018-03-29

Postoperative fluid collection due to pancreatic leak is the most frequent complication after pancreatic surgery. Endoscopic ultrasound (EUS)-guided drainage of post-pancreatic surgery fluid collection is the gold standard procedure; however, data on outcomes of this procedure are limited. The primary endpoint of our study was relapse over longterm followup, and the secondary endpoint was the efficiency and safety of EUS-guided drainage of post-pancreatic surgery fluid collection. This retrospective study was conducted at a single center from December 2008 to April 2016. Global morbidity was defined as the occurrence of an event involving additional endoscopic procedures, hospitalization, or interventional radiologic or surgical procedures. EUS-guided drainage was considered a clinical failure if surgery was required to treat a relapse after stent removal. Fortyone patients were included. The technical success rate was 100%. Drainage was considered a clinical success in 93% (39/41) of cases. Additionally, 19 (46%) complications were identified as global morbidity. The duration between surgery and EUS-guided drainage was not a significantly related factor for morbidity rate (P = 0.8); however, bleeding due to arterial injuries (splenic artery and gastroduodenal artery) from salvage drainage procedures occurred within 25 days following the initial surgery. There was no difference in survival between patients with and without complications. No relapse was reported during the followup (median: 44.75 months; range: 29.24 to 65.74 months). EUSguided drainage for post-pancreatic surgery fluid collection was efficient with no relapse during longterm followup. Morbidity rate was independent of the duration between the initial surgery and EUS-guided drainage; however, bleeding risk was likely more important in cases of early drainage.

Current Status of Bariatric and Metabolic Surgery in Korea

PubMed Central

2016-01-01

Bariatric surgery is considered to be the most effective treatment modality in maintaining long-term weight reduction and improving obesity-related conditions in morbidly obese patients. In Korea, surgery for morbid obesity was laparoscopic sleeve gastrectomy first performed in 2003. Since 2003, the annual number of bariatric surgeries has markedly increased, including adjustable gastric banding (AGB), Roux-en-Y gastric bypass, sleeve gastrectomy, mini-gastric bypass, and others. In Korea, AGB is much more common than in others countries. A large proportion of doctors, the public, and government misunderstand the necessity and effectiveness of bariatric surgery, believing that bariatric surgery has an unacceptably high morbidity, and that it is not superior to non-surgical treatments to improve obesity and obesity-related diseases. The effectiveness, safety, and cost-effectiveness of bariatric surgery have been well demonstrated. The Korean Society of Metabolic and Bariatric Surgery recommend bariatric surgery confining to morbidly obese patients (body mass index ≥40 or >35 in the presence of significant comorbidities). PMID:27834081

Use of a surgical rehearsal platform and improvement in aneurysm clipping measures: results of a prospective, randomized trial.

PubMed

Chugh, A Jessey; Pace, Jonathan R; Singer, Justin; Tatsuoka, Curtis; Hoffer, Alan; Selman, Warren R; Bambakidis, Nicholas C

2017-03-01

OBJECTIVE The field of neurosurgery is constantly undergoing improvements and advances, both in technique and technology. Cerebrovascular neurosurgery is no exception, with endovascular treatments changing the treatment paradigm. Clipping of aneurysms is still necessary, however, and advances are still being made to improve patient outcomes within the microsurgical treatment of aneurysms. Surgical rehearsal platforms are surgical simulators that offer the opportunity to rehearse a procedure prior to entering the operative suite. This study is designed to determine whether use of a surgical rehearsal platform in aneurysm surgery is helpful in decreasing aneurysm dissection time and clip manipulation of the aneurysm. METHODS The authors conducted a blinded, prospective, randomized study comparing key effort and time variables in aneurysm clip ligation surgery with and without preoperative use of the SuRgical Planner (SRP) surgical rehearsal platform. Initially, 40 patients were randomly assigned to either of two groups: one in which surgery was performed after use of the SRP (SRP group) and one in which surgery was performed without use of the SRP (control group). All operations were videotaped. After exclusion of 6 patients from the SRP group and 9 from the control group, a total of 25 surgical cases were analyzed by a reviewer blinded to group assignment. The videos were analyzed for total microsurgical time, number of clips used, and number of clip placement attempts. Means and standard deviations (SDs) were calculated and compared between groups. RESULTS The mean (± SD) amount of operative time per clip used was 920 ± 770 seconds in the SRP group and 1294 ± 678 seconds in the control group (p = 0.05). In addition, the mean values for the number of clip attempts, total operative time, ratio of clip attempts to clips used, and time per clip attempt were all lower in the SRP group, although the between-group differences were not statistically significant. CONCLUSIONS Preoperative rehearsal with SRP increased efficiency and safety in aneurysm microsurgery as demonstrated by the statistically significant improvement in time per clip used. Although the rest of the outcomes did not demonstrate statistically significant between-group differences, the fact that the SRP group showed improvement in mean values for all measures studied suggests that preoperative rehearsal may increase the efficiency and safety of aneurysm microsurgery. Future studies aimed at improving patient outcome and safety during surgical clipping of aneurysms will be needed to keep pace with the quickly advancing endovascular field.

Thirty-day outcomes of sleeve gastrectomy versus Roux-en-Y gastric bypass: first report based on Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program database.

PubMed

Chaar, Maher El; Lundberg, Peter; Stoltzfus, Jill

2018-05-01

According to recent American Society for Metabolic and Bariatric Surgery estimates, sleeve gastrectomy (SG) is now the most commonly performed procedure in the United States (~53.8% of all bariatric procedures), followed by Roux-en-Y gastric bypass (RYGB; 23.1% of all procedures). The objective of this study was to evaluate outcomes and safety of these 2 procedures in the first 30 days postoperatively using the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program data registry. University health network, United States. We reviewed all SG and RYGB cases entered between January 1 and December 31, 2015 in the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program data registry. Demographic characteristics and 30-day outcomes were analyzed based on separate Mann-Whitney rank sums tests, χ 2 , or Fisher's exact tests as appropriate, with P<.05 denoting statistical significance and no adjustment for multiple testing. A total of 141,646 patients were analyzed; 98,292 underwent SG and 43,354 underwent RYGB. Average age was 44.5 and 45.4 years for SG and RYGB, respectively. Preoperative body mass index was 45.1 and 46.1 for SG and RYGB, respectively. The 30-day mortality was .1% for SG and .2% for RYGB (P<.05). The incidence of unplanned intensive care unit admission after RYGB was twice as high compared with SG (1.3% versus .6%, respectively, P<.05). The incidence of at least 1 intervention or reoperation after RYGB was significantly higher compared with SG (2.8% and 2.5% for GB versus 1.2% and 1% for SG, P<.05). After RYGB, .4% of patients had a drain left in place at 30 days postoperatively versus .3% for SG (P<.05). The incidence of readmission was 2.8% for RYGB and 1.2% for SG (P<.05). The incidence of postoperative complications in the first 30 days after surgery is low for both RYGB and SG. However, SG seems to have a better safety profile in the first 30 days postoperatively compared with RYGB. These findings should be considered in the preoperative evaluation and counseling of bariatric patients. Long-term follow-up is needed to compare safety and efficacy of SG versus RYGB. Copyright © 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Robotically performed total mesorectal excision for rectal cancer.

PubMed

Alecu, L; Stănciulea, O; Poesina, D; Tomulescu, V; Vasilescu, C; Popescu, I

2015-01-01

Rectal cancer is an important health problem, due to the increasing number of new cases and the quality of life issues brought forth by surgical treatment in these patients. The aim of the study was to analyse the results of robotic surgery in the treatment of lower and middle rectal cancer,locations in which TME is performed. Patients diagnosed with and operated on for rectal cancer by the means of robotic surgery between 2008-2012 at the Fundeni Clinical Institute were retrospectively analysed. A number of 117 patients with rectal cancer were operated on by robotic surgery, of which 79 (67.52%) were submitted to total mesorectal excision (TME). The most frequently performed surgery was low anterior resection, followed by rectal amputation through abdominoperineal approach.Anastomosis fistula was observed in 9 (11.39%) patients. Local recurrence was encountered in 2 (2.53%) of the robotically performed surgeries. 1. Robotically assisted total mesorectal excision is feasible, safe and can be performed with a small number of complications and a low local recurrence rate; 2. The main advantages are oncological safety and quality of life; 3.Conversion to open surgery is rarely encountered; 4. Protection loop ileostomy existence allows avoiding reintervention in case anastomotic fistula occurs in patients with low anterior resection. 5. Robotic surgery may become gold standard in the surgical treatment of rectal cancer. Celsius.

Current Practices and Barriers to the Integration of Oncoplastic Breast Surgery: A Canadian Perspective.

PubMed

Maxwell, Jessica; Roberts, Amanda; Cil, Tulin; Somogyi, Ron; Osman, Fahima

2016-10-01

Despite the safety and popularity of oncoplastic surgery, there is limited data examining utilization and barriers associated with its incorporation into practice. This study examines the use of oncoplastic techniques in breast conserving surgery and determines the barriers associated with their implementation. A 13-item survey was mailed to all registered general surgeons in Ontario, Canada. The survey assessed surgeon demographics, utilization of specific oncoplastic techniques, and perceived barriers. A total of 234 survey responses were received, representing a response rate of 32.2 % (234 of 725). Of the respondents, 166 surgeons (70.9 %) reported a practice volume of at least 25 % breast surgery. Comparison was made between general surgeons performing oncoplastic breast surgery (N = 79) and those who did not use these techniques (N = 87). Surgeon gender, years in practice, fellowship training, and access to plastic surgery were similar across groups. Both groups rated the importance of breast cosmesis similarly. General surgeons with a practice volume involving >50 % breast surgery were more likely to use oncoplastic techniques (OR 8.82, p < .001) and involve plastic surgeons in breast conserving surgery (OR 2.21, p = .02). For surgeons not performing oncoplastic surgery, a lack of training and access to plastic surgeons were identified as significant barriers. For those using oncoplastic techniques, the absence of specific billing codes was identified as a limiting factor. Lack of training, access to plastic surgeons, and absence of appropriate reimbursement for these cases are significant barriers to the adoption of oncoplastic techniques.

Bretschneider and del Nido solutions: Are they safe for coronary artery bypass grafting? If so, how should we use them?

PubMed

Siddiqi, Shirin; Blackstone, Eugene H; Bakaeen, Faisal G

2018-05-01

A variety of cardioplegic solutions are being used widely today to arrest the heart during coronary artery bypass grafting (CABG) and other cardiac operations. To minimize interruptions during the surgery for intermittent dosing of the cardioplegia and to facilitate less invasive cardiac procedures, single-shot solutions, including Bretschneider and del Nido solutions, have been introduced. This review examines the evidence regarding the safety and efficacy of Bretschneider and del Nido cardioplegia during CABG. The findings support their use in routine low-risk CABG, but finds insufficient evidence to support their safety in high-risk surgeries. © 2018 Wiley Periodicals, Inc.

Colonic Marking With Near-Infrared, Light-Emitting, Diode-Activated Indocyanine Green for Laparoscopic Colorectal Surgery.

PubMed

Nagata, Jun; Fukunaga, Yosuke; Akiyoshi, Takashi; Konishi, Tsuyoshi; Fujimoto, Yoshiya; Nagayama, Satoshi; Yamamoto, Noriko; Ueno, Masashi

2016-02-01

Accurate identification of the location of colorectal lesions is crucial during laparoscopic surgery. Endoscopic marking has been used as an effective preoperative marker for tumor identification. We investigated the feasibility and safety of an imaging method using near-infrared, light-emitting, diode-activated indocyanine green fluorescence in colorectal laparoscopic surgery. This was a single-institution, prospective study. This study was conducted in a tertiary referral hospital. We enrolled 24 patients who underwent laparoscopic surgery. Indocyanine green and India ink were injected into the same patients undergoing preoperative colonoscopy for colon cancer. During subsequent laparoscopic resection of colorectal tumors, the colon was first observed with white light. Then, indocyanine green was activated with a light-emitting diode at 760 nm as the light source. Near-infrared-induced fluorescence showed tumor location clearly and accurately in all 24 of the patients. All of the patients who underwent laparoscopic surgery after marking had positive indocyanine green staining at the time of surgery. Perioperative complications attributed to dye use were not observed. This study is limited by the cost of indocyanine green detection, the timing of the colonoscopy and tattooing in relation to the operation and identification with indocyanine green, and the small size of the series. These data suggest that our novel method for colonic marking with fluorescence imaging of near-infrared, light-emitting, diode-activated indocyanine green is feasible and safe. This method is useful, has no adverse effects, and can be used for perioperative identification of tumor location. Near-infrared, light-emitting, diode-activated indocyanine green has potential use as a colonic marking agent.

Current status of cardiovascular surgery in Japan, 2013 and 2014: A report based on the Japan Cardiovascular Surgery Database (JCVSD). 1: Mission and history of JCVSD.

PubMed

Takamoto, Shinichi; Motomura, Noboru; Miyata, Hiroaki; Tsukihara, Hiroyuki

2018-01-01

The Japan Cardiovascular Surgery Database (JCVSD) was created in 2000 with the support of the Society of Thoracic Surgeons (STS). The STS database content was translated to Japanese using the same disease criteria and in 2001, data entry for adult cardiac surgeries was initiated online using the University Hospital Medical Information Network (UMIN). In 2008, data entry for congenital heart surgeries was initiated in the congenital section of JCVSD and preoperative expected mortality (JapanSCORE) in adult cardiovascular surgeries was first calculated using the risk model of JCVSD. The Japan Surgical Board system merged with JCVSD in 2011, and all cardiovascular surgical data were registered in the JCVSD from 2012 onward. The reports resulting from the data analyses of the JCVSD will encourage further improvements in the quality of cardiovascular surgeries, patient safety, and medical care in Japan.

Self-expandable metal stents for relieving malignant colorectal obstruction: short-term safety and efficacy within 30 days of stent procedure in 447 patients.

PubMed

Meisner, Søren; González-Huix, Ferran; Vandervoort, Jo G; Goldberg, Paul; Casellas, Juan A; Roncero, Oscar; Grund, Karl E; Alvarez, Alberto; García-Cano, Jesús; Vázquez-Astray, Enrique; Jiménez-Pérez, Javier

2011-10-01

The self-expandable metal stent (SEMS) can alleviate malignant colonic obstruction and avoid emergency decompressive surgery. To document performance, safety, and effectiveness of colorectal stents used per local standards of practice in patients with malignant large-bowel obstruction to avoid palliative stoma surgery in incurable patients (PAL) and facilitate bowel decompression as a bridge to surgery for curable patients (BTS). Prospective clinical cohort study. Two global registries with 39 academic and community centers. This study involved 447 patients with malignant colonic obstruction who received stents (255 PAL, 182 BTS, 10 no indication specified). Colorectal through-the-scope SEMS placement. The primary endpoint was clinical success at 30 days, defined as the patient's ability to maintain bowel function without adverse events related to the procedure or stent. Secondary endpoints were procedural success, defined as successful stent placement in the correct position, symptoms of persistent or recurrent colonic obstruction, and complications. The procedural success rate was 94.8% (439/463), and the clinical success rates were 90.5% (313/346) as assessed on a per protocol basis and 71.6% (313/437) as assessed on an intent-to-treat basis. Complications included 15 (3.9%) perforations, 3 resulting in death, 7 (1.8%) migrations, 7 (1.8%) cases of pain, and 2 (0.5%) cases of bleeding. No control group. No primary endpoint analysis data for 25% of patients. This largest multicenter, prospective study of colonic SEMS placement demonstrates that colonic SEMSs are safe and highly effective for the short-term treatment of malignant colorectal obstruction, allowing most curable patients to have 1-step resection without stoma and providing most incurable patients minimally invasive palliation instead of surgery. The risk of complications, including perforation, was low. Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

The Spanish national health care-associated infection surveillance network (INCLIMECC): data summary January 1997 through December 2006 adapted to the new National Healthcare Safety Network Procedure-associated module codes.

PubMed

Pérez, Cristina Díaz-Agero; Rodela, Ana Robustillo; Monge Jodrá, Vincente

2009-12-01

In 1997, a national standardized surveillance system (designated INCLIMECC [Indicadores Clínicos de Mejora Continua de la Calidad]) was established in Spain for health care-associated infection (HAI) in surgery patients, based on the National Nosocomial Infection Surveillance (NNIS) system. In 2005, in its procedure-associated module, the National Healthcare Safety Network (NHSN) inherited the NNIS program for surveillance of HAI in surgery patients and reorganized all surgical procedures. INCLIMECC actively monitors all patients referred to the surgical ward of each participating hospital. We present a summary of the data collected from January 1997 to December 2006 adapted to the new NHSN procedures. Surgical site infection (SSI) rates are provided by operative procedure and NNIS risk index category. Further quality indicators reported are surgical complications, length of stay, antimicrobial prophylaxis, mortality, readmission because of infection or other complication, and revision surgery. Because the ICD-9-CM surgery procedure code is included in each patient's record, we were able to reorganize our database avoiding the loss of extensive information, as has occurred with other systems.

Study Protocol: Early Stereotactic Gamma Knife Radiosurgery to Residual Tumor After Surgery of Newly Diagnosed Glioblastoma (Gamma-GBM).

PubMed

Brehmer, Stefanie; Grimm, Mario Alexander; Förster, Alex; Seiz-Rosenhagen, Marcel; Welzel, Grit; Stieler, Florian; Wenz, Frederik; Groden, Christoph; Mai, Sabine; Hänggi, Daniel; Giordano, Frank Anton

2018-04-24

Glioblastoma (GBM) is the most common malignant brain tumor in adult patients. Tumor recurrence commonly occurs around the resection cavity, especially after subtotal resection (STR). Consequently, the extent of resection correlates with overall survival (OS), suggesting that depletion of postoperative tumor remnants will improve outcome. To assess safety and efficacy of adding stereotactic radiosurgery (SRS) to the standard treatment of GBM in patients with postoperative residual tumor. Gamma-GBM is a single center, open-label, prospective, single arm, phase II study that includes patients with newly diagnosed GBM (intraoperative via frozen sections) who underwent STR (residual tumor will be identified by native and contrast enhanced T1-weighted magnetic resonance imaging scans). All patients will receive SRS with 15 Gy (prescribed to the 50% isodose enclosing all areas of residual tumor) early (within 24-72 h) after surgery. Thereafter, all patients undergo standard-of-care therapy for GBM (radiochemotherapy with 60 Gy external beam radiotherapy [EBRT] plus concomitant temozolomide and 6 cycles of adjuvant temozolomide chemotherapy). The primary outcome is median progression-free survival, secondary outcomes are median OS, occurrence of radiation induced acute (<3 wk), early delayed (<3 mo), and late (>3 mo post-SRS) neurotoxicity and incidence of symptomatic radionecrosis. We expect to detect efficacy and safety signals by the immediate application of SRS to standard-of-care therapy in newly diagnosed GBM. Early postoperative SRS to areas of residual tumor could bridge the therapeutic gap between surgery and adjuvant therapies.

Managing Drawbacks in Unconventional Successful Glaucoma Surgery: A Case Report of Stent Exposure

PubMed Central

Fea, Antonio; Cannizzo, Paola Maria Loredana; Consolandi, Giulia; Lavia, Carlo Alessandro; Pignata, Giulia; Grignolo, Federico M.

2015-01-01

Traditional options in managing failed trabeculectomy (bleb needling, revision, additional incisional surgery and tube surgery) have a relatively high failure and complication rate. The use of microinvasive glaucoma surgery (MIGS) has generally been reserved to mild to moderate glaucoma cases, proving good safety profiles but significant limitations in terms of efficacy. We describe a patient who underwent MIGS (XEN Aquesys subconjunctival shunt implantation) after a prior failed trabeculectomy. After the surgery, the IOP was well controlled but as the stent was close to an area of scarred conjunctiva of the previous trabeculectomy, it became partially exposed. As a complete success was achieved, we decided to remove the conjunctiva over the exposed area and replace it by an amniotic membrane transplantation and a conjunctiva autograft. Six months after surgery, the unmedicated IOP is still well controlled with complete visual acuity recovery. PMID:26294994

A Review of the Ahmed Glaucoma Valve Implant and Comparison with Other Surgical Operations.

PubMed

Riva, Ivano; Roberti, Gloria; Katsanos, Andreas; Oddone, Francesco; Quaranta, Luciano

2017-04-01

The Ahmed glaucoma valve (AGV) is a popular glaucoma drainage implant used for the control of intraocular pressure in patients with glaucoma. While in the past AGV implantation was reserved for glaucoma patients poorly controlled after one or more filtration procedures, mounting evidence has recently encouraged its use as a primary surgery in selected cases. AGV has been demonstrated to be safe and effective in reducing intraocular pressure in patients with primary or secondary refractory glaucoma. Compared to other glaucoma surgeries, AGV implantation has shown favorable efficacy and safety. The aim of this article is to review the results of studies directly comparing AGV with other surgical procedures in patients with glaucoma.

Bariatric surgery in patients with inflammatory bowel disease: an accessible path? Report of a case series and review of the literature.

PubMed

Colombo, Francesco; Rizzi, Andrea; Ferrari, Carlo; Frontali, Alice; Casiraghi, Silvia; Corsi, Fabio; Sampietro, Gianluca M; Foschi, Diego

2015-02-01

Morbid obesity is an emerging problem in the inflammatory bowel disease [IBD] population. Bariatric and IBD surgeries share technical difficulties and elevated morbidity. However, nothing is known about the possibility of performing bariatric surgery in patients with a definite diagnosis of IBD. The aim of this study was to evaluate safety and efficacy of restrictive bariatric surgical procedures in IBD patients. Six patients with morbid obesity and IBD were operated on with restrictive bariatric surgery and concomitant or deferred IBD surgery. We compared BMI, excess weight loss, and perioperative complications of restrictive bariatric surgery in IBD with a control group of 95 bariatric patients. We also evaluated clinical, biochemical, pharmacological, and endoscopic characteristics before and after surgery in IBD patients. Perioperative results, in terms of BMI, excess weight loss, and complications after restrictive bariatric surgery, were comparable between obese IBD and control patients. IBD patients experienced a significant postoperative reduction in BMI, CRP levels, WCC, and systolic blood pressure and a significant increment in hemoglobin levels. None of the patients reported signs of malabsorption. All the patients except one were able to discontinue steroids, were in endoscopic remission at 1 year, and were in clinical remission at the latest follow-up visit. Two patients halved azathioprine dosage. One patient had a postoperative clinical recurrence treated with adalimumab. Bariatric surgery seems to be safe and effective in IBD patients. Concomitant ileocolic resection does not increase perioperative complications. Relationship between IBD and obesity remains unclear, but weight loss could be useful in the pharmacological control of IBD.

Does a thrombin-based topical haemostatic agent reduce blood loss and transfusion requirements after total knee revision surgery? A randomized, controlled trial.

PubMed

Romanò, Carlo L; Monti, Lorenzo; Logoluso, Nicola; Romanò, Delia; Drago, Lorenzo

2015-11-01

The aim of the present study was to assess the efficacy of a thrombin-based topical haemostatic in reducing blood requirements after total knee replacement (TKR) revision surgery. This prospective, randomized, controlled study was designed to evaluate the haemostatic efficacy and safety of a thrombin-based topical haemostatic (Floseal) versus standard treatment in patients receiving total knee revision arthroplasty. The decrease in haemoglobin values postsurgery and the blood units transfused were recorded. The decision to transfuse was made by a surgeon blinded to the patient's group allocation. Forty-eight patients were enroled in the study; twenty-four patients each were randomized to the treatment and control groups, respectively. The median decrease in haemoglobin concentration on the first postoperative day was 2.2 g/dL in the treatment group and 2.7 g/dL in the control group. A significant reduction in units of blood transfused was also observed in the treatment group compared with the control group [1.1 ± 1.13 (range 0-4) vs. 1.9 ± 1.41 (range 0-5) blood units; P = 0.04]. No major treatment-related adverse events were recorded in the study. This study shows that a thrombin-based topical haemostatic reduces the need for blood transfusion in TKR revision surgery. A thrombin-based topical haemostatic agent can be an appropriate solution to enhance haemostasis and vessel sealing at the operative site in TKR revision surgery, in order to reduce the need for blood transfusion after surgery. II.

Study of five cell salvage machines in coronary artery surgery.

PubMed

Burman, J F; Westlake, A S; Davidson, S J; Rutherford, L C; Rayner, A S; Wright, A M; Morgan, C J; Pepper, J R

2002-06-01

We evaluated the effectiveness, ease of use and safety of five machines for blood salvage during coronary artery surgery. All were equally effective in concentrating red cells. We measured haemoglobin, packed cell volume, free haemoglobin, white cells, neutrophil elastase, platelets, thrombin-antithrombin complex (TAT), prothrombin activation peptide F1.2, fibrin degradation product (d-dimers), tissue plasminogen activator (tPA) and heparin in wound blood, in washed cell suspensions and in a unit of bank blood prepared for each patient. All machines were equally safe and easy to use and were equally effective in removing heparin and the physiological components measured. There were no adverse effects on patients. Clotting factors are severely depleted both in salvaged blood, even before washing, and in bank blood. Cell savers are a valuable adjunct to coronary artery surgery, but careful monitoring of coagulation is required when the volumes of either bank blood or salvaged blood are large.

Telepresence and telementoring in surgery.

PubMed

Latifi, Rifat; Peck, Kim; Satava, Richard; Anvari, Mehran

2004-01-01

Telesurgical mentoring has evolved as an important subset of telemedicine, yet has remained an underutilized technique when all its potential is considered. As applied to surgery, telementoring is used when an experienced surgeon assists or directs another less experienced surgeon who is operating at a distance. Two- and three-dimensional, video-based laparoscopic procedures are an ideal platform for real-time transmission and thus for applying telementoring to surgery. The images viewed by the operating surgeon can easily be transmitted to a central "telesurgical mentor" and permit an intraoperative interaction. Several studies have demonstrated the practicality, effectiveness and safety of surgical telementoring. The goal of this application of telemedicine is to improve surgical education and training, expand patient care and improve health care delivery by allowing access to surgical specialists. Eventually, surgical telementoring could assist in the provision of surgical care to underserved areas and potentially facilitate the teaching of advanced surgical skills worldwide.

Clinical outcome after the use of a new craniocaudal expandable implant for vertebral compression fracture treatment: one year results from a prospective multicentric study.

PubMed

Noriega, David; Krüger, Antonio; Ardura, Francisco; Hansen-Algenstaedt, Nils; Hassel, Frank; Barreau, Xavier; Beyerlein, Jörg

2015-01-01

The purpose of this prospective multicentric observational study was to confirm the safety and clinical performance of a craniocaudal expandable implant used in combination with high viscosity PMMA bone cement for the treatment of vertebral compression fractures. Thirty-nine VCFs in 32 patients were treated using the SpineJack minimally invasive surgery protocol. Outcome was determined by using the Visual Analogue Scale for measuring pain, the Oswestry Disability Index for scoring functional capacity, and the self-reporting European Quality of Life scores for the quality of life. Safety was evaluated by reporting all adverse events. The occurrence of cement leakages was assessed by either radiographs or CT scan or both. Statistically significant improvements were found regarding pain, function, and quality of life. The global pain score reduction at 1 year was 80.9% compared to the preoperative situation and the result of the Oswestry Disability Index showed a decrease from 65.0% at baseline to 10.5% at 12 months postoperatively. The cement leakage rate was 30.8%. No device- or surgery-related complications were found. This observational study demonstrates promising and persistent results consisting of immediate and sustained pain relief and durable clinical improvement after the procedure and throughout the 1-year follow-up period.

Safety and Efficacy of the Off-Label Use of Milrinone in Pediatric Patients with Heart Diseases

PubMed Central

Lee, Joowon; Kwon, Hye Won; Kwon, Bo Sang; Bae, Eun Jung; Noh, Chung Il; Lim, Hong Gook; Kim, Woong Han; Lee, Jeong Ryul; Kim, Yong Jin

2014-01-01

Background and Objectives Milrinone is often used in children to treat acute heart failure and prevent low cardiac output syndrome after cardiac surgery. Due to the lack of studies on the long-term milrinone use in children, the objective of this study was to assess the safety and efficacy of the current patterns of milrinone use for ≥3 days in infants and children with heart diseases. Subjects and Methods We retrospectively reviewed the medical records of patients aged <13 years who received milrinone for ≥3 days from January 2005 to December 2012. Patients' characteristics including age, sex, height, weight, and body surface area were recorded. The following parameters were analyzed to identify the clinical application of milrinone: initial infusion rate, maintenance continuous infusion rate, total duration of milrinone therapy, and concomitantly infused inotropes. The safety of milrinone was determined based on the occurrence of adverse events such as hypotension, arrhythmia, chest pain, headache, hypokalemia, and thrombocytopenia. Results We assessed 730 admissions (684 patients) during this period. Ventricular septal defects were the most common diagnosis (42.4%) in these patients. Milrinone was primarily used after cardiac surgery in 715 admissions (97.9%). The duration of milrinone treatment varied from 3 to 64.4 days (≥7 days in 149 admissions). Ejection fraction and fractional shortening of the left ventricle improved in patients receiving milrinone after cardiac surgery. Dose reduction of milrinone due to hypotension occurred in only 4 admissions (0.5%). Although diverse arrhythmias occurred in 75 admissions (10.3%), modification of milrinone infusion to manage arrhythmia occurred in only 3 admissions (0.4%). Multivariate analysis indicated that the development of arrhythmia was not influenced by the pattern of milrinone use. Conclusion Milrinone was generally administered for ≥3 days in children with heart diseases. The use of milrinone for ≥3 days was effective in preventing low cardiac output after cardiac surgery when combined with other inotropes, suggesting that milrinone could be safely employed in pediatric patients with heart diseases. PMID:25278985

Accuracy of computer-guided surgery for dental implant placement in fully edentulous patients: A systematic review

PubMed Central

Marlière, Daniel Amaral Alves; Demétrio, Maurício Silva; Picinini, Leonardo Santos; De Oliveira, Rodrigo Guerra; Chaves Netto, Henrique Duque De Miranda

2018-01-01

Assess clinical studies regarding accuracy between virtual planning of computer-guided surgery and actual outcomes of dental implant placements in total edentulous alveolar ridges. A PubMed search was performed to identify only clinical studies published between 2011 and 2016, searching the following combinations of keywords: “Accuracy AND Computer-Assisted Surgery AND Dental Implants.” Study designs were identified using the terms: Case Reports, Clinical study, Randomized Controlled Trial, Systematic Reviews, Meta-Analysis, humans. Level of agreement between the authors in the study selection process was substantial (k = 0.767), and the study eligibility was considered excellent (k = 0.863). Seven articles were included in this review. They describe the use of bone and muco-supported guides, demonstrating angular deviations cervically and apically ranging from (minimum and maximum means), respectively, 1.85–8.4 (°), 0.17–2.17 (mm), and 0.77–2.86 (mm). Angular deviations obtained most inaccuracy in maxila. For cervical and apical deviations, accuracy was preponderantly lower in maxilla. Despite the similar deviations measurement approaches described, clinical relevance of this study may be useful to warn the surgeon that safety margins in clinical situations. PMID:29657542

Quality Improvement in Surgery Combining Lean Improvement Methods with Teamwork Training: A Controlled Before-After Study

PubMed Central

Robertson, Eleanor; Morgan, Lauren; New, Steve; Pickering, Sharon; Hadi, Mohammed; Collins, Gary; Rivero Arias, Oliver; Griffin, Damian; McCulloch, Peter

2015-01-01

Background To investigate the effectiveness of combining teamwork training and lean process improvement, two distinct approaches to improving surgical safety. We conducted a controlled interrupted time series study in a specialist UK Orthopaedic hospital incorporating a plastic surgery team (which received the intervention) and an Orthopaedic theatre team acting as a control. Study Design We used a 3 month intervention with 3 months data collection period before and after it. A combined teamwork training and lean process improvement intervention was delivered by an experienced specialist team. Before and after the intervention we evaluated team non-technical skills using NOTECHS II, technical performance using the glitch rate and WHO checklist compliance using a simple 3 point scale. We recorded complication rate, readmission rate and length of hospital stay data for 6 months before and after the intervention. Results In the active group, but not the control group, full compliance with WHO Time Out (T/O) increased from 14 to 71% (p = 0.032), Sign Out attempt rate (S/O) increased from 0% to 50% (p<0.001) and Oxford NOTECHS II scores increased after the intervention (P = 0.058). Glitch rate decreased in the active group and increased in the control group (p = 0.001). Complications and length of stay appeared to rise in the control group and fall in the active group. Conclusions Combining teamwork training and systems improvement enhanced both technical and non-technical operating team process measures, and were associated with a trend to better safety outcome measures in a controlled study comparison. We suggest that approaches which address both system and culture dimensions of safety may prove valuable in reducing risks to patients. PMID:26381643

Reduction of Surgical Site Infections after Implementation of a Bundle of Care

PubMed Central

Crolla, Rogier M. P. H.; van der Laan, Lijckle; Veen, Eelco J.; Hendriks, Yvonne; van Schendel, Caroline; Kluytmans, Jan

2012-01-01

Background Surgical Site Infections (SSI) are relatively frequent complications after colorectal surgery and are associated with substantial morbidity and mortality. Objective Implementing a bundle of care and measuring the effects on the SSI rate. Design Prospective quasi experimental cohort study. Methods A prospective surveillance for SSI after colorectal surgery was performed in the Amphia Hospital, Breda, from January 1, 2008 until January 1, 2012. As part of a National patient safety initiative, a bundle of care consisting of 4 elements covering the surgical process was introduced in 2009. The elements of the bundle were perioperative antibiotic prophylaxis, hair removal before surgery, perioperative normothermia and discipline in the operating room. Bundle compliance was measured every 3 months in a random sample of surgical procedures. Results Bundle compliance improved significantly from an average of 10% in 2009 to 60% in 2011. 1537 colorectal procedures were performed during the study period and 300 SSI (19.5%) occurred. SSI were associated with a prolonged length of stay (mean additional length of stay 18 days) and a significantly higher 6 months mortality (Adjusted OR: 2.71, 95% confidence interval 1.76–4.18). Logistic regression showed a significant decrease of the SSI rate that paralleled the introduction of the bundle. The adjusted Odds ratio of the SSI rate was 36% lower in 2011 compared to 2008. Conclusion The implementation of the bundle was associated with improved compliance over time and a 36% reduction of the SSI rate after adjustment for confounders. This makes the bundle an important tool to improve patient safety. PMID:22962619

Brain Magnetic Resonance Immediately Prior To Surgery In Single Ventricles and Surgical Postponement

PubMed Central

Fogel, Mark A.; Pawlowski, Tom; Schwab, Peter J.; Nicolson, Susan C.; Montenegro, Lisa M.; Berenstein, Laura Diaz; Spray, Thomas L.; Gaynor, J William; Fuller, Stephanie; Keller, Marc S.; Harris, Matthew A.; Whitehead, Kevin K.; Vossough, Arastoo; Licht, Daniel J.

2014-01-01

Background Single ventricle patients undergoing surgical reconstruction experience a high rate of brain injury; incidental findings on pre-operative brain scans may result in safety considerations involving hemorrhage extension during cardiopulmonary bypass that result in surgical postponement. Methods Single ventricle patients were studied with brain scans immediately preoperatively as part of a National Institute of Health study and were reviewed by neuroradiology immediately prior to cardiopulmonary bypass. Results One hundred and thirty four consecutive subjects recruited into the project were studied: 33 prior to stage I (3.7±1.8 days), 34 prior to bidirectional Glenn (5.8±3.5 months) and 67 prior to Fontan (3.3±1.1 years). Six (4.5%) surgeries were postponed because of concerning imaging findings on brain MRI; 2 prior to stage I, 3 prior to bidirectional Glenn and 1 prior to Fontan. Five were due to unexpected incidental findings of acute intracranial hemorrhage and one due to diffuse cerebellar cytotoxic edema; none who proceeded to surgery had these lesions. Prematurity as well as genetic syndromes were not present in any with postponed surgery. Four of 4 prior to bidirectional Glenn/Fontan with surgical delays had hypoplastic left heart syndrome compared with 44/97 who did not (P=0.048). After observation and follow up, all eventually had successful surgeries with bypass. Conclusion Preoperative brain MRI performed in children with single ventricles disclosed injuries in 4.5% leading to surgical delay; hemorrhagic lesions were most common and raised concerns for extension during surgery. The true risk of progression and need for delay of surgery due to heparinization associated with these lesions remains uncertain. PMID:25149046

A Review of Recent Advances in Perioperative Patient Safety.

PubMed

Fowler, Alexander J

2013-01-01

Major complications in surgery affect up to 16% of surgical procedures. Over the past 50 years, many patient safety initiatives have attempted to reduce such complications. Since the formation of the National Patient Safety Agency in 2001, there have been major advances in patient safety. Most recently, the production and implementation of the Surgical Safety Checklist by the World Health Organisation (WHO), a checklist ensuring that certain 'never events' (wrong-site surgery, wrong operation etc.) do not occur, irrespective of healthcare allowance. In this review, a summary of recent advances in patient safety are considered - including improvements in communication, understanding of human factors that cause mistakes, and strategies developed to minimise these. Additionally, the synthesis of best medical practice and harm minimisation is examined, with particular emphasis on communication and appreciation of human factors in the operating theatre. This is based on the resource management systems developed in other high risk industries (e.g. nuclear), and has also been adopted for other high risk medical areas. The WHO global movement to reduce surgical mortality has been highly successful, especially in the healthcare systems of developing nations where mortality reductions of up to 50% have been observed, and reductions in patient complications of 4%. Incident reporting has long been a key component of patient safety and continues to be so; allowing reflection and improved guideline formation. All patients are placed at risk in the surgical environment. It is crucial that this risk is minimised, whilst optimising the patient's outcome. In this review, recent advances in perioperative patient safety are examined and placed in context.

The focus of Langenbeck's Archives of Surgery in the 21st century.

PubMed

Schneider, Martin; Weitz, Jürgen; Büchler, Markus W

2010-04-01

The Langenbeck's Archives of Surgery has been serving as a publication platform for clinical and scientific progress in the field of surgery for 150 years. In order to maintain this long-standing tradition throughout the coming decades, it will be mandatory to face the challenges posed by increasing specialization of surgical subdisciplines, modern technologies, and interdisciplinary treatment options. Continued efforts need to be directed at minimizing surgical trauma, not at least with respect to current demographic development. Adoption of progressive technologies from the fields of biophysics, mechatronics, and biomedical imaging solutions will likely gain a major impact on the further development of surgical operation techniques. Expanding insight from genomic and molecular medicine will facilitate personalized, interdisciplinary treatment concepts for malignant disease, in which surgical resection techniques will need to be integrated. The introduction of novel diagnostic and treatment concepts will mandate solid evaluation of their clinical effectiveness and safety, which can only be achieved by randomized, controlled trials in the field of surgery. Extracting study ideas from the contributions by clinicians and basic scientists, and promoting the conduction of clinical trials will therefore range among the most important tasks for the Langenbeck's Archives of Surgery in the 21st century.

Safety and efficacy of bariatric surgery in Mexico: A detailed analysis of 500 surgeries performed at a high-volume center.

PubMed

Guilbert, L; Joo, P; Ortiz, C; Sepúlveda, E; Alabi, F; León, A; Piña, T; Zerrweck, C

2018-06-19

Bariatric surgery is the best method for treating obesity and its comorbidities. Our aim was to provide a detailed analysis of the perioperative outcomes in Mexican patients that underwent surgery at a high-volume hospital center. A retrospective study was conducted on all the patients that underwent bariatric surgery at a single hospital center within a time frame of 4 and one-half years. Demographics, the perioperative variables, complications (early and late), weight loss, failure, and type 2 diabetes mellitus remission were all analyzed. Five hundred patients were included in the study, 83.2% of whom were women. Mean patient age was 38.8 years and BMI was 44.1kg/m 2 . The most common comorbidities were high blood pressure, dyslipidemia, and diabetes. Laparoscopic gastric bypass surgery was performed in 85.8% of the patients, sleeve gastrectomy in 13%, and revision surgeries in 1%. There were 9.8% early complications and 12.2% late ones, with no deaths. Overall weight loss as the excess weight loss percentage at 12 and 24 months was 76.9 and 77.6%. The greatest weight loss at 12 months was seen in the patients that underwent laparoscopic gastric bypass. A total of 11.4% of the patients had treatment failure. In the patients with type 2 diabetes mellitus, 68.7% presented with complete disease remission and 9.3% with partial remission. There was improvement in 21.8% of the cases. In our experience at a high-volume hospital center, bariatric surgery is safe and effective, based on the low number of adverse effects and consequent weight loss and type 2 diabetes mellitus control. Long-term studies with a larger number of patients are needed to determine the final impact of those procedures. Copyright © 2018 Asociación Mexicana de Gastroenterología. Publicado por Masson Doyma México S.A. All rights reserved.

Patient Safety in Interventional Radiology: A CIRSE IR Checklist

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee, M. J., E-mail: mlee@rcsi.ie; Fanelli, F.; Haage, P.

2012-04-15

Interventional radiology (IR) is an invasive speciality with the potential for complications as with other invasive specialities. The World Health Organization (WHO) produced a surgical safety checklist to decrease the morbidity and mortality associated with surgery. The Cardiovascular and Interventional Society of Europe (CIRSE) set up a task force to produce a checklist for IR. Use of the checklist will, we hope, reduce the incidence of complications after IR procedures. It has been modified from the WHO surgical safety checklist and the RAD PASS from Holland.

Comparison of the clinical efficacy and safety of retroperitoneal laparoscopic ureterolithotomy and ureteroscopic holmium laser lithotripsy in the treatment of obstructive upper ureteral calculi with concurrent urinary tract infections.

PubMed

Jiang, Jun-Tao; Li, Wei-Guo; Zhu, Yi-Ping; Sun, Wen-Lan; Zhao, Wei; Ruan, Yuan; Zhong, Chen; Wood, Kristofer; Wei, Hai-Bin; Xia, Shu-Jie; Sun, Xiao-Wen

2016-07-01

The aim of this study is to compare the clinical efficacy and safety of retroperitoneal laparoscopic ureterolithotomy (RPLU) and ureteroscopic holmium laser lithotripsy (UHLL) as two minimally invasive procedures in managing obstructive upper ureteral calculi with concurrent urinary tract infections (UTI). The retrospective study included 189 patients who underwent unilateral obstructive upper ureteral stones with concurrent UTI from January 2007 to November 2014 at our institution. Patients received RPLU (81 cases) or UHLL (108 cases). All patients received preoperative anti-infection treatment (indwelling ureteral stent and/or preoperative antibiotics). Collected data, including sex, age, stone size, success rate, operation duration, post-operation hospitalization time, and post-operation complications, were compared. All patients were followed up for more than 6 months after surgeries, and no ureterostenosis occurred. The study included 189 patients, 41 (21.7 %) females and 148 (78.3 %) males with a medium age of 52 years (range 22-81 years). All surgeries were successfully performed without conversion to open surgery. Stone size in the RPLU group was larger than that of the UHLL group (16.1 ± 1.4 vs. 10.4 ± 1.6 mm, P = 0.012). Operative duration (P = 0.009) and hospitalization time (P < 0.001) in the UHLL group were significantly shorter than those in the RPLU group, whereas stone clearance rate was significantly higher in the RPLU group (100 vs. 88.9 %, P = 0.002). Of note, postoperative fever was more common in patients treated with UHLL (15 cases) versus RPLU (4 cases) (13.9 vs. 4.9 %, P = 0.043). Moreover, in the UHLL group, three patients without a preoperative indwelling ureteral stent were complicated with sepsis, which was not seen in RPLU group. In our study, the safety and stone clearance rate of RPLU are better than those of UHLL in the treatment of unilateral upper ureteric calculi with concurrent UTI. Preoperative antibiotics and indwelling ureteral stent may reduce the risk of postoperative infections.

State of the art of prostatic arterial embolization for benign prostatic hyperplasia.

PubMed

Petrillo, Mario; Pesapane, Filippo; Fumarola, Enrico Maria; Emili, Ilaria; Acquasanta, Marzia; Patella, Francesca; Angileri, Salvatore Alessio; Rossi, Umberto G; Piacentini, Igor; Granata, Antonio Maria; Ierardi, Anna Maria; Carrafiello, Gianpaolo

2018-04-01

Prostatectomy via open surgery or transurethral resection of the prostate (TURP) is the standard treatment for benign prostatic hyperplasia (BPH). Several patients present contraindication for standard approach, individuals older than 60 years with urinary tract infection, strictures, post-operative pain, incontinence or urinary retention, sexual dysfunction, and blood loss are not good candidates for surgery. Prostatic artery embolization (PAE) is emerging as a viable method for patients unsuitable for surgery. In this article, we report results about technical and clinical success and safety of the procedure to define the current status.

Use of the Femtosecond Lasers in Ophthalmology

NASA Astrophysics Data System (ADS)

Roszkowska, Anna M.; Urso, Mario; Signorino, Alberto; Aragona, Pasquale

2018-01-01

Femtosecond laser (FSL) is an infrared laser with a wavelength of 1053 nm. FS laser works producing photodisruption or photoionization of the optically transparent tissue such as cornea. Currently FS lasers have a wide range of applications in ophthalmic surgery. They are used above all in corneal surgery in refractive procedures and keratoplasty, and recently in cataract surgery. The use of the FSL in corneal refractive surgery includes LASIK flap creation, astigmatic keratotomy, Femtosecond Lenticule Extraction (FLEx), Small Incision Lenticule Extraction (SMILE) and channels creation for implantation of the intrastromal corneal rings. As to the corneal grafting, the FS lasers are used in laser-assisted anterior and posterior lamellar keratoplasty and customized trephination in the penetrating keratoplasty. FS Laser Assisted Cataract Surgery (FLACS) includes capsulorrhexis and nuclear fragmentation that enhance safety and efficacy of the procedure.

Laparoscopic entry: a review of Canadian general surgical practice

PubMed Central

Compeau, Christopher; McLeod, Natalie T.; Ternamian, Artin

2011-01-01

Background Laparoscopic surgery has gained popularity over open conventional surgery as it offers benefits to both patients and health care practitioners. Although the overall risk of complications during laparoscopic surgery is recognized to be lower than during laparotomy, inadvertent serious complications still occur. Creation of the pneumoperitoneum and placement of laparoscopic ports remain a critical first step during endoscopic surgery. It is estimated that up to 50% of laparoscopic complications are entry-related, and most injury-related litigations are trocar-related. We sought to evaluate the current practice of laparoscopic entry among Canadian general surgeons. Methods We conducted a national survey to identify general surgeon preferences for laparoscopic entry. Specifically, we sought to survey surgeons using the membership database from the Canadian Association of General Surgeons (CAGS) with regards to entry methods, access instruments, port insertion sites and patient safety profiles. Laparoscopic cholecystectomy was used as a representative general surgical procedure. Results The survey was completed by 248 of 1000 (24.8%) registered members of CAGS. Respondents included both community and academic surgeons, with and without formal laparoscopic fellowship training. The demographic profile of respondents was consistent nationally. A substantial proportion of general surgeons (> 80%) prefer the open primary entry technique, use the Hasson trocar and cannula and favour the periumbilical port site, irrespective of patient weight or history of peritoneal adhesions. One-third of surgeons surveyed use Veress needle insufflation in their surgical practices. More than 50% of respondents witnessed complications related to primary laparoscopic trocar insertion. Conclusion General surgeons in Canada use the open primary entry technique, with the Hasson trocar and cannula applied periumbilically to establish a pneumoperitoneum for laparoscopic surgery. This surgical approach is remarkably consistent nationally, although considerably variant across other surgical subspecialties. Peritoneal entry remains an important patient safety issue that requires ongoing evaluation and study to ensure translation into safe contemporary clinical practice. PMID:21774882

[Factor XIII-guided treatment algorithm reduces blood transfusion in burn surgery].

PubMed

Carneiro, João Miguel Gonçalves Valadares de Morais; Alves, Joana; Conde, Patrícia; Xambre, Fátima; Almeida, Emanuel; Marques, Céline; Luís, Mariana; Godinho, Ana Maria Mano Garção; Fernandez-Llimos, Fernando

Major burn surgery causes large hemorrhage and coagulation dysfunction. Treatment algorithms guided by ROTEM ® and factor VIIa reduce the need for blood products, but there is no evidence regarding factor XIII. Factor XIII deficiency changes clot stability and decreases wound healing. This study evaluates the efficacy and safety of factor XIII correction and its repercussion on transfusion requirements in burn surgery. Randomized retrospective study with 40 patients undergoing surgery at the Burn Unit, allocated into Group A those with factor XIII assessment (n = 20), and Group B, those without assessment (n = 20). Erythrocyte transfusion was guided by a hemoglobin trigger of 10g.dL -1 and the other blood products by routine coagulation and ROTEM ® tests. Analysis of blood product consumption included units of erythrocytes, fresh frozen plasma, platelets, and fibrinogen. The coagulation biomarker analysis compared the pre- and post-operative values. Group A (with factor XIII study) and Group B had identical total body surface area burned. All patients in Group A had a preoperative factor XIII deficiency, whose correction significantly reduced units of erythrocyte concentrate transfusion (1.95 vs. 4.05, p = 0.001). Pre- and post-operative coagulation biomarkers were similar between groups, revealing that routine coagulation tests did not identify factor XIII deficiency. There were no recorded thromboembolic events. Correction of factor XIII deficiency in burn surgery proved to be safe and effective for reducing perioperative transfusion of erythrocyte units. Copyright © 2017 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

Surgical and conservative treatment of patients with congenital scoliosis: α search for long-term results

PubMed Central

2011-01-01

Background In view of the limited data available on the conservative treatment of patients with congenital scoliosis (CS), early surgery is suggested in mild cases with formation failures. Patients with segmentation failures will not benefit from conservative treatment. The purpose of this review is to identify the mid- or long-term results of spinal fusion surgery in patients with congenital scoliosis. Methods Retrospective and prospective studies were included, reporting on the outcome of surgery in patients with congenital scoliosis. Studies concerning a small numbers of cases treated conservatively were included too. We analyzed mid-term (5 to 7 years) and long-term results (7 years or more), both as regards the maintenance of the correction of scoliosis and the safety of instrumentation, the early and late complications of surgery and their effect on quality of life. Results A small number of studies of surgically treated patients were found, contained follow-up periods of 4-6 years that in the most cases, skeletal maturity was not yet reached, and few with follow-up of 36-44 years. The results of bracing in children with congenital scoliosis, mainly in cases with failure of formation, were also studied. Discussion Spinal surgery in patients with congenital scoliosis is regarded in short as a safe procedure and should be performed. On the other hand, early and late complications are also described, concerning not only intraoperative and immediate postoperative problems, but also the safety and efficacy of the spinal instrumentation and the possibility of developing neurological disorders and the long-term effect these may have on both lung function and the quality of life of children. Conclusions Few cases indicate the long-term results of surgical techniques, in the natural progression of scoliosis. Similarly, few cases have been reported on the influence of conservative treatment. In conclusion, patients with segmentation failures should be treated surgically early, according to the rate of deformity formation and certainly before the pubertal growth spurt to try to avoid cor- pulmonale, even though there is lack of evidence for that in the long-term. Furthermore, in patients with formation failures, further investigation is needed to document where a conservative approach would be necessary. PMID:21639924

Fluorescence-Guided Surgery

PubMed Central

Nagaya, Tadanobu; Nakamura, Yu A.; Choyke, Peter L.; Kobayashi, Hisataka

2017-01-01

Surgical resection of cancer remains an important treatment modality. Despite advances in preoperative imaging, surgery itself is primarily guided by the surgeon’s ability to locate pathology with conventional white light imaging. Fluorescence-guided surgery (FGS) can be used to define tumor location and margins during the procedure. Intraoperative visualization of tumors may not only allow more complete resections but also improve safety by avoiding unnecessary damage to normal tissue which can also reduce operative time and decrease the need for second-look surgeries. A number of new FGS imaging probes have recently been developed, complementing a small but useful number of existing probes. In this review, we describe current and new fluorescent probes that may assist FGS. PMID:29312886

Efficacy and safety of penile girth enhancement by autologous fat injection for patients with thin penises.

PubMed

Kang, Dong Hyuk; Chung, Jae Hoon; Kim, Yong Jin; Lee, Haeng Nam; Cho, Seung Hoon; Chang, Taek Hee; Lee, Seung Wook

2012-08-01

This study aimed to investigate the efficacy and safety of autologous fat injection (AFI) for penile girth enhancement (PGE) in patients with thin penises. This study investigated 52 patients with a small penile circumference who underwent AFI for PGE and were followed up for more than 6 months. The patients whose proximal one third (G1) and distal one third of their penis (G2) had a mean thickness of 7.4 cm or less were selected as subjects. After fat suction using a liposuction device, fat was evenly injected into the superficial, middle, and deep layers of the Colles' fascia. Patient age and operative time were analyzed. The G1, G2, flaccid (L1), stretched length (L2), and five-item version of the International Index of Erectile Function-5 (IIEF-5) before and 6 months after the surgery were compared. Postoperative complications were surveyed. The patient mean age was 42.15 years (range, 22-56) years, and the operative time was 44.44 min (range, 37-49 min). The injected fat volume was 38.54 ml (range, 25-49 ml). Preoperatively, G1 was 7.01±0.39 cm, and G2 was 7.06±0.37 cm. Postoperatively, G1 was 9.29±0.82 cm (P<0.001), and G2 was 9.34±0.86 (P<0.001) cm 6 months after the surgery. The difference between L1 and L2 before and after the surgery was not significant. The IIEF-5 was 19.10±3.22 before the surgery and 19.90±3.05 after the surgery (P=0.001). The only complication was nodular fat observed in one case (1.92%). The use of AFI for PGE in men with thin penises was effective and safe without major complications. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors at www.springer.com/00266.

Enhanced Recovery after Emergency Surgery: A Systematic Review.

PubMed

Paduraru, Mihai; Ponchietti, Luca; Casas, Isidro Martinez; Svenningsen, Peter; Zago, Mauro

2017-04-01

To evaluate the current scientific evidence for the applicability, safety and effectiveness of pathways of enhanced recovery after emergency surgery (ERAS). We undertook a search using PubMed and Cochrane databases for ERAS protocols in emergency cases. The search generated 65 titles; after eliminating the papers not meeting search criteria, we selected 4 cohort studies and 1 randomized clinical trial (RCT). Data extracted for analysis consisted of: patient age, type of surgery performed, ERAS elements implemented, surgical outcomes in terms of postoperative complications, mortality, length of stay (LOS) and readmission rate. The number of ERAS items applied was good, ranging from 11 to 18 of the 20 recommended by the ERAS Society. The implementation resulted in fewer postoperative complications. LOS for ES patients was shorter when compared to conventional care. Mortality, specifically reported in three studies, was equal or lower with ERAS. Readmission rates varied widely and were generally higher for the intervention group but without statistical significance. The studies reviewed agreed that ERAS in emergency surgery (ES) was feasible and safe with generally better outcomes. Lower compliance with some of the ERAS items shows the need for the protocol to be adapted to ES patients. More evidence is clearly required as to what can improve outcomes and how this can be formulated into an effective care pathway for the heterogeneous ES patient.

Minimally Invasive Surgery in Gastrointestinal Cancer: Benefits, Challenges, and Solutions for Underutilization

PubMed Central

Gusani, Niraj J.; Kimchi, Eric T.; Kavic, Stephen M.

2014-01-01

Background and Objectives: After the widespread application of minimally invasive surgery for benign diseases and given its proven safety and efficacy, minimally invasive surgery for gastrointestinal cancer has gained substantial attention in the past several years. Despite the large number of publications on the topic and level I evidence to support its use in colon cancer, minimally invasive surgery for most gastrointestinal malignancies is still underused. Methods: We explore some of the challenges that face the fusion of minimally invasive surgery technology in the management of gastrointestinal malignancies and propose solutions that may help increase the utilization in the future. These solutions are based on extensive literature review, observation of current trends and practices in this field, and discussion made with experts in the field. Results: We propose 4 different solutions to increase the use of minimally invasive surgery in the treatment of gastrointestinal malignancies: collaboration between surgical oncologists/hepatopancreatobiliary surgeons and minimally invasive surgeons at the same institution; a single surgeon performing 2 fellowships in surgical oncology/hepatopancreatobiliary surgery and minimally invasive surgery; establishing centers of excellence in minimally invasive gastrointestinal cancer management; and finally, using robotic technology to help with complex laparoscopic skills. Conclusions: Multiple studies have confirmed the utility of minimally invasive surgery techniques in dealing with patients with gastrointestinal malignancies. However, training continues to be the most important challenge that faces the use of minimally invasive surgery in the management of gastrointestinal malignancy; implementation of our proposed solutions may help increase the rate of adoption in the future. PMID:25489209

Safety and Efficacy of Single Incision Laparoscopic Surgery for Total Extraperitoneal Inguinal Hernia Repair

PubMed Central

2011-01-01

Almost 20 years after the first laparoscopic inguinal hernia repair was performed, single incision laparoscopic surgery (SILS™) is set to revolutionize minimally invasive surgery. However, the loss of triangulation must be overcome before the technique can be popularized. This study reports the first 100 laparoscopic total extraperitoneal hernia repairs using a single incision. The study cohort comprised 68 patients with a mean age of 44 (range, 18 to 83): 36 unilateral and 32 bilateral hernias. Twelve patients also underwent umbilical hernia repair with the Ventralex patch requiring no additional incisions. A 2.5-cm to 3-cm crescentic incision within the confines of the umbilicus was performed. Standard dissecting instruments and 52-cm/5.5-mm/300 laparoscope were used. Operation times were 50 minutes for unilateral and 80 minutes for bilateral. There was one conversion to conventional 3-port laparoscopic repair and none to open surgery. Outpatient surgery was achieved in all (except one). Analgesic requirements were minimal: 8 Dextropropoxyphene tablets (range, 0 to 20). There were no intraoperative or postoperative complications with a high patient satisfaction score. Single-incision laparoscopic hernia repair is safe and efficient simply by modifying dissection techniques (so-called “inline” and “vertical”). Comparable success can be obtained while negating the risks of bowel and vascular injuries from sharp trocars and achieving improved cosmetic results. PMID:21902942

Pulse pressure variation-guided fluid therapy after cardiac surgery: a pilot before-and-after trial.

PubMed

Suzuki, Satoshi; Woinarski, Nicholas C Z; Lipcsey, Miklos; Candal, Cristina Lluch; Schneider, Antoine G; Glassford, Neil J; Eastwood, Glenn M; Bellomo, Rinaldo

2014-12-01

The aim of this study is to study the feasibility, safety, and physiological effects of pulse pressure variation (PPV)-guided fluid therapy in patients after cardiac surgery. We conducted a pilot prospective before-and-after study during mandatory ventilation after cardiac surgery in a tertiary intensive care unit. We introduced a protocol to deliver a fluid bolus for a PPV≥13% for at least >10 minutes during the intervention period. We studied 45 control patients and 53 intervention patients. During the intervention period, clinicians administered a fluid bolus on 79% of the defined PPV trigger episodes. Median total fluid intake was similar between 2 groups during mandatory ventilation (1297 mL [interquartile range 549-1968] vs 1481 mL [807-2563]; P=.17) and the first 24 hours (3046 mL [interquartile range 2317-3982] vs 3017 mL [2192-4028]; P=.73). After adjusting for several baseline factors, PPV-guided fluid management significantly increased fluid intake during mandatory ventilation (P=.004) but not during the first 24 hours (P=.47). Pulse pressure variation-guided fluid therapy, however, did not significantly affect hemodynamic, renal, and metabolic variables. No serious adverse events were noted. Pulse pressure variation-guided fluid management was feasible and safe during mandatory ventilation after cardiac surgery. However, its advantages may be clinically small. Copyright © 2014 Elsevier Inc. All rights reserved.

No-patch 23-gauge vitrectomy under topical anesthesia: a pilot study.

PubMed

Deka, Satyen; Bhattacharjee, Harsha; Barman, M J; Kalita, Kruto; Singh, Sunil Kumar

2011-01-01

A pilot study was designed to evaluate the safety and efficacy of 23-gauge vitrectomy under topical anesthesia. Five eyes of five patients underwent 23-gauge sutureless vitrectomy under topical anesthesia with a pledget soaked in 0.5% proparacaine hydrochloride anesthetic, for vitreous hemorrhage (four eyes), epiretinal membrane (one eye). Subjective pain and discomfort were graded using a visual analogue chart from 0 (no pain or discomfort) to 4 (severe pain and discomfort). At the end of surgery no patch was applied and patients were given dark glasses. Patients underwent an immediate postoperative assessment, followed by next day and one week postoperative evaluation. Four patients had Grade 0 pain during the surgery. One patient had Grade 1 pain during the placement and withdrawal of the micro cannulas. The surgical outcomes were favorable. 23-gauge vitrectomy under topical anesthesia is safe and effective in selected cases. Further study is recommended to validate the outcome of this study.