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Sample records for prospective randomized evaluations

  1. The risk-stratified osteoporosis strategy evaluation study (ROSE): a randomized prospective population-based study. Design and baseline characteristics.

    PubMed

    Rubin, Katrine Hass; Holmberg, Teresa; Rothmann, Mette Juel; Høiberg, Mikkel; Barkmann, Reinhard; Gram, Jeppe; Hermann, Anne Pernille; Bech, Mickael; Rasmussen, Ole; Glüer, Claus C; Brixen, Kim

    2015-02-01

    The risk-stratified osteoporosis strategy evaluation study (ROSE) is a randomized prospective population-based study investigating the effectiveness of a two-step screening program for osteoporosis in women. This paper reports the study design and baseline characteristics of the study population. 35,000 women aged 65-80 years were selected at random from the population in the Region of Southern Denmark and-before inclusion-randomized to either a screening group or a control group. As first step, a self-administered questionnaire regarding risk factors for osteoporosis based on FRAX(®) was issued to both groups. As second step, subjects in the screening group with a 10-year probability of major osteoporotic fractures ≥15% were offered a DXA scan. Patients diagnosed with osteoporosis from the DXA scan were advised to see their GP and discuss pharmaceutical treatment according to Danish National guidelines. The primary outcome is incident clinical fractures as evaluated through annual follow-up using the Danish National Patient Registry. The secondary outcomes are cost-effectiveness, participation rate, and patient preferences. 20,904 (60%) women participated and included in the baseline analyses (10,411 in screening and 10,949 in control group). The mean age was 71 years. As expected by randomization, the screening and control groups had similar baseline characteristics. Screening for osteoporosis is at present not evidence based according to the WHO screening criteria. The ROSE study is expected to provide knowledge of the effectiveness of a screening strategy that may be implemented in health care systems to prevent fractures. PMID:25578146

  2. A prospective randomized evaluator-blinded trial of two potential wound healing agents for the treatment of venous stasis ulcers.

    PubMed

    Bishop, J B; Phillips, L G; Mustoe, T A; VanderZee, A J; Wiersema, L; Roach, D E; Heggers, J P; Hill, D P; Taylor, E L; Robson, M C

    1992-08-01

    Chronic wounds such as venous stasis ulcers have become a socioeconomic problem. Even with successful initial management, the recurrence rate approaches 70%. With the advent of new wound healing agents, nonoperative attempts to heal these wounds appear indicated. This study reports a prospective randomized evaluator-blinded trial comparing two potential wound healing agents to an inert vehicle placebo. Eighty-six evaluable patients completed the trial. Silver sulfadiazine 1% in a cream proved to statistically reduce the ulcer size compared with a biologically active tripeptide copper complex 0.4% cream formulation or the placebo. There was no difference between the latter two treatments. Silver sulfadiazine has been shown to allow keratinocyte replication and to have antiinflammatory properties. In this trial its antibacterial action was not used since all ulcers had comparable bacterial levels (less than or equal to 10(5)/gm of tissue) before treatment. These results suggest that the silver sulfadiazine cream used in this study may facilitate healing in wounds healing largely by the process of epithelialization. PMID:1495150

  3. A comparative in-vivo evaluation of the alignment efficiency of 5 ligation methods: A prospective randomized clinical trial

    PubMed Central

    Reddy, Vijaya Bhaskara; Kumar, Talapaneni Ashok; Prasad, Mandava; Nuvvula, Sivakumar; Patil, Rajedra Goud; Reddy, Praveen Kumar

    2014-01-01

    Objectives: To conduct a prospective randomized study comparing the efficiency of 5 different ligation systems (ELL; elastomeric ligature, SSL; stainless steel ligature, LL; leone slide ligature, PSL; passive self-ligation and ASL; active self-ligation) over the duration of mandibular crowding alleviation. Materials and Methods: Fifty consecutive patients (54.2% male, 45.8% female; mean age: 16.69 years) satisfying the inclusion criteria were randomly allocated to 5 ligation groups with an equal sample size of 10 per group. The 5 groups received treatment with 0.022-inch MBT pre-adjusted edge-wise technique (ELL: Gemini 3M Unitek, SSL: Gemini 3M Unitek, LL: Gemini 3M Unitek, PSL: SmartClip 3M Unitek and ASL: In-Ovation R Euro GAC International). The models and cephalograms were evaluated for anterior arch alignment, extraction space closure, and lower incisal inclinations at pre-treatment T1 and at the end of initial alignment T2. Analysis of variance (ANOVA) and Post-hoc tests were used for data analysis. Results: Forty-eight participants completed the study, and SL systems showed a significant difference over CL groups in time to alignment, passive space closure, and incisal inclination. Multiple regression showed a reduction of 5.28 days in time to alignment by changing the ligation group in the order of ELL to ASL group and 1 mm increase in initial irregularity index increases time to alignment by 11.68 days. Conclusion: Self-ligation brackets were more efficient than conventional ligation brackets during initial leveling and alignment. PMID:24966742

  4. Evaluation of Endotracheal Intubation with a Flexible Fiberoptic Bronchoscope in Lateral Patient Positioning: A Prospective Randomized Controlled Trial

    PubMed Central

    Li, Hui; Wang, Wu; Lu, Ya-Ping; Wang, Yan; Chen, Li-Hua; Lei, Li-Pei; Fang, Xiang-Ming

    2016-01-01

    Background: There is an unmet need for a reliable method of airway management for patients in the lateral position. This prospective randomized controlled two-center study was designed to evaluate the feasibility of intubation using a flexible fiberoptic bronchoscope in the lateral position during surgery. Methods: Seventy-two patients scheduled for elective nonobstetric surgery in the lateral decubitus position requiring tracheal intubation under general anesthesia at Lishui Central Hospital of Zhejiang Province and Jiaxing First Hospital of Zhejiang Province from April 1, 2015, to September 30, 2015, were enrolled in this study. Patients were randomly assigned to the supine position group (Group S, n = 38) and the lateral position group (Group L, n = 34). Experienced anesthetists performed tracheal intubation with a fiberoptic bronchoscope after general anesthesia. The time required for intubation, intubation success rates, and hemodynamic changes was recorded. Between-group differences were assessed using the Student's t-test, Mann–Whitney U-test, or Chi-square test. Results: The median total time to tracheal intubation was significantly longer in Group S (140.0 [135.8, 150.0] s) compared to Group L (33.0 [24.0, 38.8] s) (P < 0.01). The first-attempt intubation success rate was significantly higher in Group L (97%) compared to Group S (16%). Hemodynamic changes immediately after intubation were more exaggerated in Group S compared to Group L (P = 0.02). Conclusion: Endotracheal intubation with a flexible fiberoptic bronchoscope may be an effective and timesaving technique for patients in the lateral position. Trial Registration: Chinese Clinical Trial Register, ChiCTR-IIR-16007814; http://www.chictr.org.cn/showproj.aspx?proj=13183. PMID:27569229

  5. Results of a prospective randomized trial evaluating surgery versus thrombolysis for ischemia of the lower extremity. The STILE trial.

    PubMed Central

    1994-01-01

    PURPOSE: This study was designed to evaluate intra-arterial thrombolytic therapy as part of a treatment strategy for patients requiring revascularization for lower limb ischemia caused by nonembolic arterial and graft occlusion. MATERIALS AND METHODS: Patients with native arterial or bypass graft occlusion were randomized prospectively to either optimal surgical procedure or intra-arterial, catheter-directed thrombolysis with recombinant tissue plasminogen activator (rt-PA) or urokinase (UK). Thrombolysis patients required successful catheter placement into the occlusion before infusion of either rt-PA at 0.05 mg/kg/hr for up to 12 hours or UK of 250,000 units bolus followed by 4000 units/min x 4 hours, then 2000 units/min for up to 36 hours. A composite clinical outcome of death, ongoing/recurrent ischemia, major amputation, and major morbidity was the primary endpoint. Additional endpoints were reduction in surgical procedure, clinical outcome classification, length of hospitalization, and outcome by duration of ischemia. RESULTS: Randomization was terminated at 393 patients because a significant primary endpoint occurred by the first interim analysis. Failure of catheter placement occurred in 28% of patients who were randomized to lysis, and thus, were considered treatment failures. Thirty-day outcomes demonstrated significant benefit to surgical therapy compared with thrombolysis (p < 0.001), primarily because of a reduction in ongoing/recurrent ischemia (p < 0.001). However, clinical outcome classification at 30 days was similar. Stratification by duration of ischemia indicated that patients with ischemic deterioration of 0 to 14 days had lower amputation rates with thrombolysis (p = 0.052) and shorter hospital stays (p < 0.04). Patients with ischemic deterioration of > 14 days who who were treated surgically had less ongoing/recurrent ischemia (p < 0.001) and trends toward lower morbidity (p = 0.1). At 6-month follow-up, there was improved amputation

  6. Evaluation of minimal dose of atracurium for cataract surgery in children: A prospective randomized double-blind study

    PubMed Central

    Darlong, Vanlal; Garg, Rakesh; Pandey, Ravinder; Khokhar, Sudarshan; Chandralekha; Sinha, Renu; Punj, Jyotsna; Sinha, Rajesh

    2015-01-01

    Background: Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children. Materials and Methods: After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED95; Group 75: Received atracurium at 75% dose of ED95; Group 100: Received atracurium of 100% dose of ED95. Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group. Results: The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001). Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001) with the least satisfaction in Group 0. The laryngeal mask airway (LMA) insertion score was statistically significant in the four groups (P - 0.001). However, number of attempts for LMA placement was comparable among the four groups (P - 0.766). Conclusion: We conclude that a balanced anesthetic technique including atracurium provided better surgical condition for

  7. Lumbar spinal fusion patients' demands to the primary health sector: evaluation of three rehabilitation protocols. A prospective randomized study.

    PubMed

    Soegaard, Rikke; Christensen, Finn B; Lauerberg, Ida; Lauersen, Ida; Bünger, Cody E

    2006-05-01

    Very few studies have investigated the effects or costs of rehabilitation regimens following lumbar spinal fusion. The effectiveness of in-hospital rehabilitation regimens has substantial impact on patients' demands in the primary health care sector. The aim of this study was to investigate patient-articulated demands to the primary health care sector following lumbar spinal fusion and three different in-hospital rehabilitation regimens in a prospective, randomized study with a 2-year follow-up. Ninety patients were randomized 3 months post lumbar spinal fusion to either a 'video' group (one-time oral instruction by a physiotherapist and patients were then issued a video for home exercise), or a 'café' group (video regimen with the addition of three café meetings with other fusion-operated patients) or a 'training' group (exercise therapy; physiotherapist-guided; two times a week for 8 weeks). Register data of service utilization in the primary health care sector were collected from the time of randomization through 24 months postsurgery. Costs of in-hospital protocols were estimated and the service utilization in the primary health care sector and its cost were analyzed. A significant difference (P=0.023) in number of contacts was found among groups at 2-year follow-up. Within the periods of 3-6 months and 7-12 months postoperatively, the experimental groups required less than half the amount of care within the primary health care sector as compared to the video group (P=0.001 and P=0.008). The incremental costs of the café regimen respectively, the training regimen were compensated by cost savings in the primary health care sector, at ratios of 4.70 (95% CI 4.64; 4.77) and 1.70 (95% CI 1.68; 1.72). This study concludes that a low-cost biopsychosocial rehabilitation regimen significantly reduces service utilization in the primary health care sector as compared to the usual regimen and a training exercise regimen. The results stress the importance of a cognitive

  8. [Evaluation of the complementary drug Factor AF2 as a supportive agent in management of advanced urothelial carcinoma. Prospective randomized multicenter study].

    PubMed

    Krege, S; Hinke, A; Otto, T; Rübben, H

    2002-03-01

    This is a prospective randomized multicenter trial for evaluation of the biological response modifier Factor AF2 in advanced urothelial cancer treated with chemotherapy. Main aim of the study was the analysis of supportive effects. Additionally patients were examined with regard to tumor response, time to progression and survival. 106 patients with advanced urothelial cancer received chemotherapy with cisplatin and methotrexate. They were randomized for additional Factor AF2 (500 mg i.v., given at days 0-3, 7-10 and 11-14). Myelotoxicity was more common and severe in the group without Factor AF2 reaching statistical significance. Gastrointestinal side effects occurred in both groups, though grade III to IV toxicity was more common without Factor AF2. Overall remission rate was 38%, median survival 33 weeks, mean time to progression 20 weeks. There was no significant difference between the two groups with or without Factor AF2. PMID:11993095

  9. Comparative Evaluation of Efficacy of Physics Forceps versus Conventional Forceps in Orthodontic Extractions: A Prospective Randomized Split Mouth Study

    PubMed Central

    Managutti, Anil M; Menat, Shailesh; Agarwal, Arvind; Shah, Dishan; Patel, Jigar

    2016-01-01

    Introduction Tooth extraction is one of the most commonly performed procedures in dentistry. It is usually a traumatic procedure often resulting in immediate destruction and loss of alveolar bone and surrounding soft tissues. Various instruments have been described to perform atraumatic extractions which can prevent damage to the paradental structures. Recently developed physics forceps is one of the instruments which is claimed to perform atraumatic extractions. Aim The aim of the present study was to compare the efficacy of physics forceps with conventional forceps in terms of operating time, prevention of marginal bone loss & soft tissue loss, postoperative pain and postoperative complications following bilateral premolar extractions for orthodontic purpose. Materials and Methods In this prospective split-mouth study, outcomes of the 2 groups (n = 42 premolars) requiring extraction of premolars for orthodontic treatment purpose using Physics forceps and Conventional forceps were compared. Clinical outcomes in form of time taken, loss of buccal soft tissue and buccal cortical plate based on extraction defect classification system, postoperative pain and other complication associated with extraction were recorded and compared. Results Statistically significant reduction in the operating time was noted in physics forceps group. Marginal bone loss and soft tissue loss was also significantly lesser in physics forceps group when compared to conventional forceps group. However, there was no statistically significant difference in severity of postoperative pain between both groups. Conclusion The results of the present study suggest that physics forceps was more efficient in reducing operating time and prevention of marginal bone loss & soft tissue loss when compared to conventional forceps in orthodontically indicated premolar extractions.

  10. Evaluation of daclizumab to reduce delayed graft function in non-heart-beating renal transplantation: a prospective, randomized trial.

    PubMed

    Wilson, C; Brook, N R; Gok, M A; Gupta, A; Asher, J F; Nicholson, M L; Talbot, D

    2005-05-01

    Daclizumab (DZB), an interleukin-2 receptor blocker, has been shown to reduce the rate of acute rejection, while non-heart-beating kidney recipients have high rates of delayed graft function that may be prolonged by high levels of calcineurin inhibitors. This study assessed whether DZB could safely replace calcineurin inhibitors in the immediate postoperative period and promote recovery from ischemic acute tubular necrosis. Patients were randomized into one of two groups: DZB induction and daily mycophenolate mofetil (MMF; 2 g) with steroids (20 mg prednisone) or standard triple therapy with tacrolimus, MMF, and prednisone. Patients in the DZB arm were converted to the control arm when either the serum creatinine dropped to <350 micromol/L or there was biopsy evidence of acute rejection. Over 2 years, Leicester and Newcastle non-heart-beating donor (NHBD) centers recruited 51 patients. There was one patient death in the DZB arm, during the study period, after a nonfunctioning graft was removed. A total of two (8%) grafts in the DZB arm and three (11.5%) grafts in the control arm failed to function. The overall rate of immediate function improved from around 5% (pre-2001) to 28%. There were no significant differences in the incidence of acute rejection or graft function (GFR) at 3 months. Machine-perfused kidneys in DZB-treated recipients had the highest rates of immediate function (53%, P = .015). We found that a calcineurin-sparing regime is safe and may be beneficial for recipients of machine-perfused grafts damaged by warm ischemia. PMID:15919462

  11. Evaluation of surgically assisted rapid maxillary expansion with piezosurgery versus oscillating saw and chisel osteotomy - a randomized prospective trial

    PubMed Central

    2013-01-01

    Background 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 piezosurgery medical device allows the efficient cutting of mineralized tissues with minimal trauma to soft tissues. Piezoelectric osteotome has found its role in surgically assisted rapid maxillary expansion (SARME), a procedure well established to correct transverse maxillary discrepancies. The advantages include minimal risk to critical anatomic structures. The purpose of this clinical comparative study (CIS 2007-237-M) was to present the advantages of the piezoelectric cut as a minimally invasive device in surgically assisted, rapid maxillary expansion by protecting the maxillary sinus mucosal lining. Methods Thirty patients (18 females and 12 males) at the age of 18 to 54 underwent a surgically assisted palatal expansion of the maxilla with a combined orthodontic and surgical approach. The patients were randomly divided into two separate treatment groups. While Group 1 received conventional surgery using an oscillating saw, Group 2 was treated with piezosurgery. The following parameters were examined: blood pressure, blood values, required medication, bleeding level in the maxillary sinus, duration of inpatient stay, duration of surgery and height of body temperature. Results The results displayed no statistically significant differences between the two groups regarding laboratory blood values and inpatient stay. The duration of surgery revealed a significant discrepancy. Deploying piezosurgery took the surgeon an average of 10 minutes longer than working with a conventional-saw technique. However, the observation of the bleeding level in the paranasal sinus presented a major and statistically significant advantage of piezosurgery: on average the bleeding level was one category above the one of the remaining patients. Conclusion This method of piezoelectric

  12. A prospective, randomized controlled preclinical trial to evaluate different formulations of biphasic calcium phosphate in combination with a hydroxyapatite collagen membrane to reconstruct deficient alveolar ridges.

    PubMed

    Nevins, Myron; Nevins, Marc L; Schupbach, Peter; Kim, Soo-Woo; Lin, Zhao; Kim, David M

    2013-04-01

    Many patients and clinicians would prefer a synthetic particulate bone replacement graft, but most available alloplastic biomaterials have limited osteogenic potential. An alloplast with increased regenerative capacity would be advantageous for the treatment of localized alveolar ridge defects. This prospective, randomized controlled preclinical trial utilized 6 female foxhounds to analyze the osteogenic impact of different formulations of biphasic calcium phosphate (BCP) in combination with an hydroxyapatite-collagen membrane and their ability to reconstruct deficient alveolar ridges for future implant placement. The grafted sites were allowed to heal 3 months, and then trephine biopsies were obtained to perform light microscopic and histomorphometric analyses. All treated sites healed well with no early membrane exposure or adverse soft tissue responses during the healing period. The grafted sites exhibited greater radiopacity than the surrounding native bone with BCP particles seen as radiopaque granules. The graft particles appeared to be well-integrated and no areas of loose particles were observed. Histologic evaluation demonstrated BCP particles embedded in woven bone with dense connective tissue/marrow space. New bone growth was observed around the graft particles as well as within the structure of the graft particulate. There was intimate contact between the graft particles and newly formed bone, and graft particles were bridged by the newly formed bone in all biopsies from the tested groups. The present study results support the potential of these BCP graft particulates to stimulate new bone formation. Clinical studies are recommended to confirm these preclinical findings. PMID:23611676

  13. PROSPECTIVE RANDOMIZED STUDY COMPARING TWO ANESTHETIC METHODS FOR SHOULDER SURGERY

    PubMed Central

    Ikemoto, Roberto Yukio; Murachovsky, Joel; Prata Nascimento, Luis Gustavo; Bueno, Rogerio Serpone; Oliveira Almeida, Luiz Henrique; Strose, Eric; de Mello, Sérgio Cabral; Saletti, Deise

    2015-01-01

    Objective: To evaluate the efficacy of suprascapular nerve block in combination with infusion of anesthetic into the subacromial space, compared with interscalene block. Methods: Forty-five patients with small or medium-sized isolated supraspinatus tendon lesions who underwent arthroscopic repair were prospectively and comparatively evaluated through random assignation to three groups of 15, each with a different combination of anesthetic methods. The efficacy of postoperative analgesia was measured using the visual analogue scale for pain and the analgesic, anti-inflammatory and opioid drug consumption. Inhalation anesthetic consumption during surgery was also compared between the groups. Results: The statistical analysis did not find any statistically significant differences among the groups regarding anesthetic consumption during surgery or postoperative analgesic efficacy during the first 48 hours. Conclusion: Suprascapular nerve block with infusion of anesthetic into the subacromial space is an excellent alternative to interscalene block, particularly in hospitals in which an electrical nerve stimulating device is unavailable. PMID:27022569

  14. Epidemiological evaluation quality of life in patients suffering from early rheumatoid arthritis: a pragmatic, prospective, randomized, blind allocation controlled of a modular program group intervention

    PubMed Central

    2015-01-01

    OBJECTIVES: Epidemiology has taken on new roles in the management of health care services. In this study, we developed a non-pharmacological self-management modular program group intervention and evaluated its efficacy as an adjunct therapy in patients suffering from early rheumatoid arthritis (RA). METHODS: Patients were randomized to either participate in a non-equivalent intervention group along with the standard of care or only receive standard-of-care treatment at a community rheumatology center. The outcomes measured were a pain visual analog scale (VAS), patient general health (GH) on a VAS, and the Short Form 36 Health Survey version 2 scale measuring quality of life. These parameters were evaluated in the first week to obtain baseline values, and at 20, 32, 48, and 60 weeks to evaluate the efficacy of the intervention group. RESULTS: The patients were randomized, with 100 patients in the intervention group and 106 in the control group. The intervention and control groups were similar with regard to the percentage of women (86% vs. 89.6%), tobacco usage (25% vs. 19.8%), mean age (42.6±13.2 years vs. 46.6±10.9 years), and disease duration (15.3±6.7 months vs. 14.5±6.6 months). The mean outcomes were significantly different between the two groups, and post-hoc pairwise analysis demonstrated significant deterioration in the control group in contrast to improvement in the intervention group at the second, third, fourth, and fifth evaluations. Improvements were often seen as early as the 12-week and 24-week follow-up visits. CONCLUSIONS: Epidemiology contributes to the evaluation of how well specific therapies or other health interventions prevent or control health problems. The modular program group intervention implemented in this study appears to be a suitable and feasible method to facilitate much more comprehensive management of early RA in socioeconomically challenged communities. PMID:26552423

  15. To evaluate the effectiveness of health care ethics consultation based on the goals of health care ethics consultation: a prospective cohort study with randomization

    PubMed Central

    2014-01-01

    Background The growing prevalence of health care ethics consultation (HCEC) services in the U.S. has been accompanied by an increase in calls for accountability and quality assurance, and for the debates surrounding why and how HCEC is evaluated. The objective of this study was to evaluate the effectiveness of HCEC as indicated by several novel outcome measurements in East Asian medical encounters. Methods Patients with medical uncertainty or conflict regarding value-laden issues, and requests made by the attending physicians or nurses for HCEC from December 1, 2009 to April 30, 2012 were randomly assigned to the usual care group (UC group) and the intervention group (HCEC group). The patients in the HCEC group received HCEC conducted by an individual ethics consultant. Data analysis was based on the intention-to-treat principle. Mann–Whitney test and Chi-squared test were used depending on the scale of measurement. Results Thirty-three patients (53.23%) were randomly assigned to the HCEC group and 29 patients were randomly assigned to the UC group. Among the 33 patients in the HCEC group, two (6.06%) of them ultimately did not receive a HCEC service. Among the 29 patients in the UC group, four (13.79%) of them received a HCEC service. The survival rate at hospital discharge did not differ between the two groups. Patients in the HCEC group showed significant reductions in the entire ICU stay and entire hospital stay. HCEC significantly facilitated achieving the goal of medical care (p < .01). Furthermore, patients in the HCEC group had a shorter ICU stay and shorter hospital stay after the occurrence of medical uncertainty or conflict regarding value-laden issues than those in the UC group. Conclusions Our findings demonstrated that HCEC were associated with reduced consumption of medical resources as indicated by shorter entire ICU stay, entire hospital stay, and shorter ICU and hospital stay after the occurrence of the medical uncertainty or conflict

  16. Cefepime versus Imipenem-Cilastatin for Treatment of Nosocomial Pneumonia in Intensive Care Unit Patients: a Multicenter, Evaluator-Blind, Prospective, Randomized Study

    PubMed Central

    Zanetti, G.; Bally, F.; Greub, G.; Garbino, J.; Kinge, T.; Lew, D.; Romand, J.-A.; Bille, J.; Aymon, D.; Stratchounski, L.; Krawczyk, L.; Rubinstein, E.; Schaller, M.-D.; Chiolero, R.; Glauser, M.-P.; Cometta, A.

    2003-01-01

    In a randomized, evaluator-blind, multicenter trial, we compared cefepime (2 g three times a day) with imipenem-cilastatin (500 mg four times a day) for the treatment of nosocomial pneumonia in 281 intensive care unit patients from 13 centers in six European countries. Of 209 patients eligible for per-protocol analysis of efficacy, favorable clinical responses were achieved in 76 of 108 (70%) patients treated with cefepime and 75 of 101 (74%) patients treated with imipenem-cilastatin. The 95% confidence interval (CI) for the difference between these response rates (−16 to 8%) failed to exclude the predefined lower limit for noninferiority of −15%. In addition, therapy of pneumonia caused by an organism producing an extended-spectrum β-lactamase (ESBL) failed in 4 of 13 patients in the cefepime group but in none of 10 patients in the imipenem group. However, the clinical efficacies of both treatments appeared to be similar in a secondary intent-to-treat analysis (95% CI for difference, −9 to 14%) and a multivariate analysis (95% CI for odds ratio, 0.47 to 1.75). Furthermore, the all-cause 30-day mortality rates were 28 of 108 (26%) patients in the cefepime group and 19 of 101 (19%) patients in the imipenem group (P = 0.25). Rates of documented or presumed microbiological eradication of the causative organism were similar with cefepime (61%) and imipenem-cilastatin (54%) (95% CI, −23 to 8%). Primary or secondary resistance of Pseudomonas aeruginosa was detected in 19% of the patients treated with cefepime and 44% of the patients treated with imipenem-cilastatin (P = 0.05). Adverse events were reported in 71 of 138 (51%) and 62 of 141 (44%) patients eligible for safety analysis in the cefepime and imipenem groups, respectively (P = 0.23). Although the primary end point for this study does not exclude the possibility that cefepime was inferior to imipenem, some secondary analyses showed that the two regimens had comparable clinical and microbiological

  17. [Prospective evaluation of antidepressant discontinuation].

    PubMed

    Mourad, I; Lejoyeux, M; Adès, J

    1998-01-01

    The authors prospectively assessed symptoms induced by the interruption of antidepressants in 16 patients (11 women and 5 men), aged from 33 to 85 years (mean = 52.4 +/- 16.4), treated with antidepressants since at least two weeks. All patients were free of alcohol abuse or dependence disorder and of other dependence to psychoactive substances. None of them presented medical illness. Diagnosis were made by separate evaluations by two authors and confirmed with a semistructered assessment instrument: the Schedule for Affective Disorders and Schizophrenia (Lifetime Version). All patients were submitted to a brutal discontinuation of their antidepressant agent. Patients were assessed twice, before the interruption of the antidepressant, and 72 hours later. Effects of antidepressant interruption were assessed by several means. Modification of anxiety and depression were evaluated using the Montgomery Asberg Depression Rating Scale (MADRS) and the Hamilton Anxiety Scale. Symptoms of withdrawal were assessed with Cassano and al.'s scale SESSH including an evaluation of anxiety, agitation, irritability, anergy, difficulty on concentrating, depersonalization, sleep and appetite disorders, muscle pains, nausea, tremor, sweating, altered taste, hyperosmia, paresthesias, photophobia, motor incoordination, dizziness, hyperacousia pain, delirium. Fourteen of the 16 patients (87.5%) presented modifications of their somatic or psychic state 3 days after the interruption of the antidepressant treatment. Most frequent symptoms were: increase in anxiety (31%), increase in irritability (25%), sleep disorders (19%), decrease of anergia and fatigue (19%). Mean scores of anxiety and depression were not significantly modified by the withdrawal. Following TCAs interruption (7 patients) most frequent symptoms were sleep disorders; increase in anxiety, nausea. Among patients withdrawn from SSRIs (6 patients), most frequent symptoms were increase in anxiety, increase in irritability

  18. Evaluation of low-dose dexmedetomidine and neostigmine with bupivacaine for postoperative analgesia in orthopedic surgeries: A prospective randomized double-blind study

    PubMed Central

    Sharma, Ashima; Kumar, Naresh J; Azharuddin, Mohammad; Mohan, Lalith C; Ramachandran, Gopinath

    2016-01-01

    Background and Aims: Neuraxial adjuants to local anesthetics is an effective technique of improving the quality and duration of postoperative analgesia. The safety and efficacy of drugs like dexmedetomidine and neostigmine as epidural medications have been sparsely investigated. Material and Methods: Combined spinal-epidural anesthesia was performed in 60 American Society of Anesthesiologists I and II patients who required lower limb surgeries of ≤3 h duration. The epidural drug was administered at the end of surgery with patients randomized into three groups. Group I, II and III received 6 ml of 0.25% bupivacaine alone, with 1 ug/kg of neostigmine and with 0.5 ug/kg of dexmedetomidine + 1 ug/kg of neostigmine, respectively. The patients were prescribed 50 mg tramadol intravenous as rescue analgesic. Patients were assessed for hemodynamic parameters, pain scores, duration of analgesia, rescue analgesic requirements and the incidence of side-effects over the next 10 h. Data was analyzed using SPSS® version 17.0 (Chicago, IL, USA). P < 0.05 was considered as statistically significant. Results: Patients in Group III had significantly longer mean duration of analgesia (273.5 min) compared to Group II (176.25 min) and Group I (144 min). There was increased requirement of fluids to maintain blood pressures in Group III. Neostigmine did not cause significant incidence of gastrointestinal side effects. Conclusions: Epidurally administered dexmedetomidine and neostigmine exhibit synergism in analgesic action. The incidence of drug-related side-effects was low in our study. PMID:27275047

  19. Evaluation of dual trigger with gonadotropin-releasing hormone agonist and human chorionic gonadotropin in improving oocyte maturity rates: A prospective randomized study

    PubMed Central

    Mahajan, Nalini; Sharma, Shilpa; Arora, Puneet Rana; Gupta, Shalu; Rani, Kumkum; Naidu, Padmaja

    2016-01-01

    BACKGROUND: Mature oocytes are prerequisite for achieving the process of in vitro fertilization. Human chorionic gonadotropin (hCG) is the standard trigger used for stimulating ovulation but is associated with ovarian hyperstimulation syndrome (OHSS). Gonadotropin-releasing hormone agonist trigger achieves oocyte maturation and lowers the incidence of OHSS, but it has limitations of higher pregnancy loss rate and miscarriage rates. Coadministration of both hormones is found to improve the pregnancy rates and the number of mature oocytes retrieved. We aimed to assess if the dual trigger is better than the conventional hCG in triggering oocyte maturation. METHODOLOGY: The study included 76 female patients aged 24–43 years who were randomly divided into two groups with 38 patients in each arm. The study included patients with antimullerian hormone (AMH) <4 ng/ml, antral follicle counts (AFCs)/ovary <12. The study excluded high responders-AMH >4 ng/ml and AFC/ovary >12 to avoid OHSS risk with hCG trigger. RESULTS: The study showed statistically insignificant differences between dual group versus hCG group in terms of the number of oocytes retrieved (10.0 ± 5.6 vs. 8.7 ± 5.0; P = 0.2816), the number of mature oocytes recovered (8.4 ± 5.0 vs. 7.2 ± 4.0; P = 0.2588), fertilization rate (5.9 ± 4.2 vs. 5.6 ± 3.3; P = 0.7390), and the number of usable embryos on day 3 (4.0 ± 3.0 vs. 4.0 ± 2.4; P = 0.8991). CONCLUSION: The dual trigger is equivalent to hCG in triggering oocyte maturation. PMID:27382235

  20. Comparative Evaluation of Dexmedetomidine and Magnesium Sulphate on Propofol Consumption, Haemodynamics and Postoperative Recovery in Spine Surgery: A Prospective, Randomized, Placebo Controlled, Double-blind Study

    PubMed Central

    Srivastava, Vinit K.; Mishra, Abhishek; Agrawal, Sanjay; Kumar, Sanjay; Sharma, Sunil; Kumar, Raj

    2016-01-01

    Purpose: Dexmedetomidine and magnesium sulfate have been used in anesthesia as adjuvant to provide hemodynamic stability and anesthetic agents sparing effect. We compared these effects of dexmedetomidine and magnesium sulfate in spine surgeries. Methods: Ninety patients were randomly assigned to three groups. Group D received dexmedetomidine loading dose 1 µg/kg over a period of 15 minutes and maintenance 0.5 µg/kg/h throughout the surgery. Group M received magnesium sulfate loading dose 50 mg/kg over a period of 15 minutes and maintenance 15 mg/kg/h throughout the surgery. Group C received same volume of normal saline. Heart rate (HR) and blood pressure values were recorded at various intervals. The induction and maintenance doses of anesthetics and recovery parameters were also recorded. Results: Heart rate in group D and group M were significantly decreased (p<0.05) during the whole intraoperative period compared to preoperative values. There was a significant difference in HR values between group C, D and M, during the whole intraoperaive period (p<0.05). Blood pressure values were statistically significantly lower in the group D and group M compared to group C after intubation and all time observations of surgery (p<0.05). Both drugs reduced the anesthetic agent’s requirement during surgery. However, the recovery parameters were statistically significant increase with magnesium sulphate compared to dexmedetomidine and control groups. Conclusion: Dexmedetomidine is more effective than magnesium sulfate for maintaining the hemodynamic stability in spine surgeries. Both these drugs also reduce the requirements of anesthetic agents. Recovery from dexmedetomidine is as rapid as control group compared to magnesium sulfate. PMID:27123421

  1. Three-dimensional evaluation of postoperative swelling in treatment of zygomatic bone fractures using two different cooling therapy methods: a randomized, observer-blind, prospective study

    PubMed Central

    2013-01-01

    Background Surgical treatment and complications in patients with zygomatic bone fractures can lead to a significant degree of tissue trauma resulting in common postoperative symptoms and types of pain, facial swelling and functional impairment. Beneficial effects of local cold treatment on postoperative swelling, edema, pain, inflammation, and hemorrhage, as well as the reduction of metabolism, bleeding and hematomas, have been described. The aim of this study was to compare postoperative cooling therapy applied through the use of cooling compresses with the water-circulating cooling face mask manufactured by Hilotherm in terms of beneficial impact on postoperative facial swelling, pain, eye motility, diplopia, neurological complaints and patient satisfaction. Methods Forty-two patients were selected for treatment of unilateral zygomatic bone fractures and were divided randomly to one of two treatments: either a Hilotherm cooling face mask or conventional cooling compresses. Cooling was initiated as soon as possible after surgery until postoperative day 3 and was applied continuously for 12 hours daily. Facial swelling was quantified through a three-dimensional optical scanning technique. Furthermore, pain, neurological complaints, eye motility, diplopia and patient satisfaction were observed for each patient. Results Patients receiving a cooling therapy by Hilotherm demonstrated significantly less facial swelling, less pain, reduced limitation of eye motility and diplopia, fewer neurological complaints and were more satisfied compared to patients receiving conventional cooling therapy. Conclusions Hilotherapy is more efficient in managing postoperative swelling and pain after treatment of unilateral zygomatic bone fractures than conventional cooling. Trial registration German Clinical Trials Register ID: DRKS00004846 PMID:23895539

  2. Comparative evaluation of dexmedetomidine and clonidine with low dose ropivacaine in cervical epidural anesthesia for modified radical mastectomy: A prospective randomized, double-blind study

    PubMed Central

    Channabasappa, Shivakumar M.; Venkatarao, Gopinath H.; Girish, Shobha; Lahoti, Nandakishore K.

    2016-01-01

    Context: Alpha-2 adrenergic agonists clonidine and dexmedetomidine, are well known to produce analgesia through an opioid independent mechanism. Alpha-2 agonists are used as an adjuvant to local anesthetic agents to extend the duration of spinal, epidural and brachial plexus blocks. Aims: We compared clonidine and dexmedetomidine as an adjuvant to Ropivacaine in cervical epidural anesthesia (CEA) with respect to onset and duration of sensory block, duration of analgesia and adverse effects. Subjects and Methods: A total 150 American Society of Anesthesiologists Class I or II adult female patients who were scheduled to undergo modified radical mastectomy were randomly allocated to the following two groups to receive CEA: Group D receive 15 mL of 0.375% ropivacaine combined with 1 μg/kg of dexmedetomidine; Group C received 15 mL of 0.375% ropivacaine combined with 1.5 μg/kg of clonidine. The onset of sensory block, duration of analgesia, mean arterial pressure (MAP), heart rate (HR), sedation scores, and the incidences of adverse effects, such as hypotension, bradycardia, and oxygen desaturation were recorded. Results: The addition of dexmedetomidine to ropivacaine (Group D) resulted in faster onset of sensory block time compared with the addition of clonidine to ropivacaine (Group C) (95% confidence interval [CI]: 14.53 ± 2.96 vs. 16.72 ± 4.43 P = 0.032). The duration of analgesia block in Group D was significantly longer than that in Group C (95% CI: 234.65 ± 23.76 vs. 286.76 ± 34.65; P = 0.037). The Ramsay sedation score at in Group D were significantly higher between 20 and 60 min as compared to Group C (P < 0.022). MAP level and HR level in Group D and Group C were comparable. Conclusion: The addition of dexmedetomidine to low dose ropivacaine for CEA could shorten the onset of sensory block and extend the duration of analgesia with optimum sedation without episodes of hypoxemia as compared to addition of clonidine to ropivacaine. PMID:26957695

  3. Prospects for Public Library Evaluation.

    ERIC Educational Resources Information Center

    Van House, Nancy A.; Childers, Thomas

    1991-01-01

    Discusses methods of evaluation that can be used to measure public library effectiveness, based on a conference sponsored by the Council on Library Resources. Topics discussed include the Public Library Effectiveness Study (PLES), quantitative and qualitative evaluation, using evaluative information for resource acquisition and resource…

  4. A randomized, prospective, intercontinental evaluation of a bioresorbable polymer sirolimus-eluting coronary stent system: the CENTURY II (Clinical Evaluation of New Terumo Drug-Eluting Coronary Stent System in the Treatment of Patients with Coronary Artery Disease) trial

    PubMed Central

    Saito, Shigeru; Valdes-Chavarri, Mariano; Richardt, Gert; Moreno, Raul; Iniguez Romo, Andrés; Barbato, Emanuele; Carrie, Didier; Ando, Kenji; Merkely, Bela; Kornowski, Ran; Eltchaninoff, Hélène; James, Stefan; Wijns, William

    2014-01-01

    Aim The aim of this study was to establish safety and efficacy of a new sirolimus-eluting stent with bioresorbable polymer, Ultimaster (BP-SES). Sirolimus-eluting stent with bioresorbable polymer was compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in the frame of a CENTURY II clinical trial designed to make global clinical data compliant with regulatory requirements in Europe and Japan. Methods and results The CENTURY II is a prospective, multicentre, randomized (1 : 1), single blind, controlled, non-inferiority clinical trial conducted at 58 study sites in Japan, Europe, and Korea. A total of 1123 patients requiring a percutaneous coronary intervention (PCI) procedure, with implantation of drug-eluting stent (DES), were enrolled [total population (TP)]. Randomization of patients was stratified for the subset of patients matching requirements for DES in Japan (Cohort JR, n = 722). Baseline patient demographic and angiographic characteristics were similar in both study arms, with minimal differences between the TP and Cohort JR. The primary endpoint, freedom from target lesion failure (TLF) at 9 months—TLF [composite of cardiac death, target-vessel-related myocardial infarction (MI) and target lesion revascularization]—was 95.6% with BP-SES and 95.1% with PP-EES (Pnon-inferiority<0.0001). Composite of cardiac death and MI rate was 2.9 and 3.8% (P = 0.40) and target vessel revascularization was 4.5% with BP-SES and 4.2% with PP-EES (P = 0.77). The stent thrombosis rate was 0.9% in both arms. In Cohort JR, freedom from TLF was 95.9 and 94.6% (Pnon-inferiority < 0.0005) with BP-SES and PP-EES, respectively. Conclusion The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting stent at 9-month follow-up. Study registration number UMIN000006940. PMID:24847155

  5. Evaluation of the Efficacy of Methylprednisolone, Etoricoxib and a Combination of the Two Substances to Attenuate Postoperative Pain and PONV in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective, Randomized, Placebo-controlled Trial

    PubMed Central

    Agarwal, Amita; Das, Pravin Kumar; Agarwal, Anil; Kumar, Sanjay; Khuba, Sandeep

    2014-01-01

    Background Establishment of laparoscopic cholecystectomy as an outpatient procedure has accentuated the clinical importance of reducing early postoperative pain, as well as postoperative nausea and vomiting (PONV). We therefore planned to evaluate the role of a multimodal approach in attenuating these problems. Methods One hundred and twenty adult patients of ASA physical status I and II and undergoing elective laparoscopic cholecystectomy were included in this prospective, randomized, placebo-controlled study. Patients were divided into four groups of 30 each to receive methylprednisolone 125 mg intravenously or etoricoxib 120 mg orally or a combination of methylprednisolone 125 mg intravenously and etoricoxib 120 mg orally or a placebo 1 hr prior to surgery. Patients were observed for postoperative pain, fentanyl consumption, PONV, fatigue and sedation, and respiratory depression. Results were analyzed by the ANOVA, a Chi square test, the Mann Whitney U test and by Fisher's exact test. P values of less than 0.05 were considered to be significant. Results Postoperative pain and fentanyl consumption were significantly reduced by methylprednisolone, etoricoxib and their combination when compared with placebo (P<0.05). The methylprednisolone + etoricoxib combination caused a significant reduction in postoperative pain and fentanyl consumption as compared to methylprednisolone or etoricoxib alone (P<0.05); however, there was no significant difference between the methylprednisolone and etoricoxib groups (P>0.05). The methylprednisolone and methylprednisolone + etoricoxib combination significantly reduced the incidence and severity of PONV and fatigue as well as the total number of patients requiring an antiemetic treatment compared to the placebo and etoricoxib (P<0.05). Conclusions A preoperative single-dose administration of a combination of methylprednisolone and etoricoxib reduces postoperative pain along with fentanyl consumption, PONV, antiemetic requirements and

  6. An open, prospective, randomized pilot investigation evaluating pain with the use of a soft silicone wound contact layer vs bridal veil and staples on split thickness skin grafts as a primary dressing.

    PubMed

    Patton, Mary Lou; Mullins, Robert Fred; Smith, David; Korentager, Richard

    2013-01-01

    An open, prospective, randomized, pilot investigation was implemented to evaluate the pain, cost-effectiveness, ease of use, tolerance, efficacy, and safety of a soft silicone wound contact layer (Mepitel One) vs Bridal Veil and staples used on split thickness skin grafts in the treatment of deep partial or full-thickness thermal burns. Individuals aged between 18 and 70 years with deep partial or full-thickness thermal burns (1-25% TBSA) were randomized into two groups and treated for 14 days or until greater than 95% graft take was achieved, whichever occurred first. Data were obtained and analyzed on pain experienced before, during, and after dressing removal. Secondary considerations included the overall cost (direct), graft take and healing, the ease of product use, overall experience of the dressing, and adverse events. A total of 43 subjects were recruited. There were no significant differences in burn area profiles within the groups. The pain level during dressing removal was significant between the groups (P = .0118) with the removal of Mepitel One being less painful. The staff costs were lower in the group of patients treated with Mepitel One (P = .0064) as reflected in the shorter time required for dressing removal (P = .0005), with Mepitel One taking on average less than a quarter of the time to remove. There was no significant difference in healing between the two groups, with 99.0% of the Mepitel One group and 93.1% of the Bridal Veil and staples group showing greater than 95% graft take at post-op day 7 (+/-1) (P = .2373). Clinicians reported that the soft silicone dressing was easier to use, more conformable, and demonstrated better ability to stay in place, compared with the Bridal Veil and staples regime. Both treatments were well tolerated, with no serious adverse events in either treatment group. Mepitel One was at least as effective in the treatment of patients as the standard care (Bridal Veil and staples). In addition, the group of patients

  7. The treatment of soft-tissue sarcomas of the extremities - prospective randomized evaluations of (1) limb-sparing surgery plus radiation therapy compared with amputation and (2) the role of adjuvant chemotherapy

    SciTech Connect

    Rosenberg, S.A.; Tepper, J.; Glatstein, E.

    1982-09-01

    Between May 1975 and April 1981, 43 adult patients with high-grade soft tissue sarcomas of the extremities were prospectively randomized to receive either amputation at or above the joint proximal to the tumor, including all involved muscle groups, or to receive a limb-sparing resection plus adjuvant radiation therapy. The limb-sparing resection group received wide local excision followed by 5000 rads to the entire anatomic area at risk for local spread and 6000 to 7000 rads to the tumor bed. Both randomization groups received postoperative chemotherapy with doxorubicin (maximum cumulative dose 550 mg/m/sup 2/), cyclophosphamide, and high-dose methotrexate. Twenty-seven patients randomized to receive limb-sparing resection and radiotherapy, and 16 received amputation (randomization was 2:1). There were four local recurrences in the limb-sparing group and none in the amputation group (p/sub 1/ = 0.06 generalized Wilcoxon test). However, there were no differences in disease-free survival rates (83% and 88% at five years; p/sub 2/ = 0.99) between the limb-sparing group and the amputation treatment groups. Multivariate analysis indicated that the only correlate of local recurrence was the final margin of resection. Patients with positive margins of resection had a higher likelihood of local recurrence compared with those with negative margins (p/sub 1/ < 0.00001) even when postoperative radiotherapy was used. A simultaneous prospective randomized study of postoperative chemotherapy in 65 patients with high-grade soft-tissue sarcomas of the extremities revealed a marked advantage in patients receiving chemotherapy compared with those without chemotherapy in three-year continuous disease-free (92% vs. 60%; p/sub 1/ = 0.00008) and overall survival (95% vs. 74%; p/sub 1/ = 0.04).

  8. Evaluation of Decompression and Interlaminar Stabilization Compared with Decompression and Fusion for the Treatment of Lumbar Spinal Stenosis: 5-year Follow-up of a Prospective, Randomized, Controlled Trial

    PubMed Central

    Lauryssen, Carl; Davis, Reginald J.; Bae, Hyun W.; Peloza, John H.; Guyer, Richard D.; Zigler, Jack E.; Ohnmeiss, Donna D.; Leary, Scott

    2016-01-01

    Introduction If nonoperative treatment for lumbar stenosis fails, surgery may be considered. This traditionally includes decompression often combined with fusion. Desire for less extensive surgery led to developing new techniques and implants, including an interlaminar device designed with the goal of providing segmental stability without fusion, following decompression. The purpose of this study was to investigate 5-year outcomes associated with an interlaminar device. Methods This prospective, randomized, controlled trial was conducted at 21 centers. Patients with moderate to severe lumbar stenosis at one or two contiguous levels and up to Grade I spondylolisthesis were randomized (2:1 ratio) to decompression and interlaminar stabilization (D+ILS; n=215) using the coflex® Interlaminar Stabilization® device (Paradigm Spine, LLC) or decompression and fusion with pedicle screws (D+PS; n=107). Clinical evaluations were made preoperatively and at 6 weeks and 3, 6, 12, 18, 24, 36, 48, and 60 months postoperatively. Overall Food and Drug Administration success criteria required that a patient meet 4 criteria: 1) >15 point improvement in Oswestry Disability Index (ODI) score; 2) no reoperation, revision, removal, or supplemental fixation; 3) no major device-related complication; and 4) no epidural steroid injection after surgery. Results At 5 years, 50.3% of D+ILS vs. 44% of D+PS patients (p>0.35) met the composite success criteria. Reoperation/revision rates were similar in the two groups (16.3% vs. 17.8%; p >0.90). Both groups had statistically significant improvement through 60 months in ODI scores with 80.6% of D+ILS patients and 73.2% of D+PS patients demonstrating >15 point improvement (p>0.30). VAS, SF-12, and ZCQ scores followed a similar pattern of maintained significant improvement throughout follow-up. On the SF-12 and ZCQ, D+ILS group scores were statistically significantly better during early follow-up compared to D+PS. In the D+ILS group, foraminal height

  9. A prospective, randomized, controlled, clinical study to evaluate the efficacy of high-frequency ultrasound in the treatment of Stage II and Stage III pressure ulcers in geriatric patients.

    PubMed

    Polak, Anna; Franek, Andrzej; Blaszczak, Edward; Nawrat-Szoltysik, Agnieszka; Taradaj, Jakub; Wiercigroch, Lidia; Dolibog, Pawel; Stania, Magdalena; Juras, Grzegorz

    2014-08-01

    International guidelines recommend high-frequency ultrasound (HFUS; MHz) for treating infected pressure ulcers (PUs). A 2-year, prospective, randomized, controlled study was conducted to evaluate how HFUS affects PU healing among 42 geriatric patients treated in four nursing and care centers in Silesia, Poland. Participants (age range 71-95 years,) all with wounds that did not respond to previous treatment for at least 4 weeks, were randomly assigned to the treatment group (TG) (20 with 21 PUs, mean age 83.60 ± 5.04 years) or control group (CG) (22 with 23 PUs, mean age 82.59 ± 6.65 years). All patients received standard wound care (SWC); the TG additionally was provided HFUS (1 MHz, 0.5 W/ cm2, duty cycle of 20%, 1-3 minutes/cm2; one session per day, 5 days a week). Patients were monitored for 6 weeks or until wounds closed. Percent change in wound surface area (WSA), the Gilman's parameter, the weekly rate of change in WSA, and the percentage of PUs that improved (ie, decreased in size by at least 50% or closed) were used to compare differences. Data were analyzed using Fisher's exact test, the Wilcoxon matched pairs test, and the Mann-Whitney U test (P <0.05). Mean baseline WSA and the pretreatment duration of PUs were 15.38 ± 12.92 cm2 and 1.64 ± 0.73 months and 11.08 ± 7.52 cm2 and 2.26 ± 1.42 months in the TG and CG groups, respectively. After 6 weeks of treatment, the WSA of PUs decreased significantly in both groups (P = 0.000069 in the TG and P = 0.0062 in the CG) with significantly greater improvement in the TG (an average of 68.80% ± 37.23% compared with 37.24% ± 57.84%; P = 0.047). The value of the Gilman's parameter was greater in the TG than in the CG (0.88 ± 0.62 and 0.43 ± 0.50, respectively; P = 0.018). The mean weekly change of WSA was greater in the TG than in the CG but only for Stage II PUs (3.09 ± 2.93 cm2/week and 1.08 ± 1.43 cm2/week; P = 0.045). More Stage II PUs in the TG decreased by at least 50% (11 of 14 = 78.57%) than in

  10. Evaluation of the Randomized Multiple Choice Format.

    ERIC Educational Resources Information Center

    Harke, Douglas James

    Each physics problem used in evaluating the effectiveness of Randomized Multiple Choice (RMC) tests was stated in the conventional manner and was followed by several multiple choice items corresponding to the steps in a written solution but presented in random order. Students were instructed to prepare a written answer and to use it to answer the…

  11. A prospective, randomized trial of integrative medicine for women with ovarian cancer☆,☆☆

    PubMed Central

    Judson, Patricia L.; Dickson, Elizabeth L.; Argenta, Peter A.; Xiong, Yin; Geller, Melissa A.; Carson, Linda F.; Ghebre, Rahel; Jonson, Amy L.; Downs, Levi S.

    2012-01-01

    Objectives Despite increased use of integrative medicine in cancer therapy, little data exist on its efficacy. This prospective, randomized, pilot trial sought to evaluate the feasibility of combined modality integrative medicine (CM-IM) in women with ovarian cancer (OvCA) and evaluate its effects on quality of life (QoL), chemotherapy toxicity and immunologic profiles. Methods Women with newly diagnosed OvCA requiring chemotherapy were offered enrollment. Those randomized to the experimental arm received hypnosis, therapeutic massage and healing touch with each cycle of chemotherapy. The control arm received chemotherapy without CM-IM. All patients completed QoL questionnaires prior to cycles 1, 3 and 6, and 6-months after chemotherapy. Immunologic profiles were measured. Statistical analysis was based on intent-to-treat. Student’s t-test and Fischer’s exact-test were used to determine differences. Results Forty-three women enrolled. All women randomized to CM-IM were successfully treated. There were no statistical differences between the groups in age, stage, grade, histologic cell type, CA125 levels, or surgical cytoreductive status. There was no difference in overall QoL measurements. Re-hospitalization rates, treatment delays, anti-emetic use, and infection rates were similar. Immunologic profiles revealed no difference between arms for WBC or salivary IgA levels. Women receiving CM-IM had consistently higher levels of CD4, CD8 and NK cells, although this did not reach statistical significance. Conclusions Prospective clinical evaluation of integrative medicine for women with gynecologic malignancy is feasible. This first, pilot study of CM-IM in gynecologic oncology demonstrated no improvement in QoL or chemotherapy toxicity. Integrative medicine-associated improvements in immunologic profiles warrant further investigation. PMID:21864886

  12. Retrograde Intrarenal Surgery with Combined Spinal-Epidural vs General Anesthesia: A Prospective Randomized Controlled Trial

    PubMed Central

    Zhao, Zhijian; Yang, Fengquan; Zhong, Wen; Wu, Wenqi; Chen, Wenzhong

    2015-01-01

    Abstract Objective: Retrograde intrarenal surgery (RIRS) involves a minimally invasive stone surgery, lending itself potential to combined spinal-epidural anesthesia (CSEA), although it is performed preferably under general anesthesia (GA). This prospective randomized study was undertaken to evaluate the feasibility and efficacy of CSEA for patients undergoing RIRS. Patients and Methods: Seventy consecutive patients who were scheduled for RIRS were randomized to receive CSEA (n=35) or GA (n=35). Operative time, stone clearance rate, visual analog scale (VAS) of pain, complication rate, anesthetic cost, and hospital stay were compared between the two groups. Results: A total of 65 patients randomized to CSEA (31) or GA (34) completed the study. In the CSEA group, each procedure was completed and there was no anesthetic conversion. Although based on the prospective randomized method, the GA group still had a little larger stone size (p=0.059) and more multiple caliceal stones (p=0.037). Overall, there were no statistically significant differences in operative time (p=0.088), stone fragmentation time (p=0.074), postoperative VAS pain score at 6 and 24 hours (p=0.156, 0.146), incidence of complications (p=0.870), stone-free rate (p=0.804), and hospital stays (p=0.907) between the two groups. The patients in the GA group experienced a higher mean hemoglobin drop (6.5±3.2 vs 8.6±2.7 g/L, p=0.012). In addition, the anesthetic cost was much cheaper in the CSEA group (183.8±31.4 vs 391.9±59.1 dollars, p<0.001). Conclusion: RIRS with CSEA can be completed with no anesthetic conversions and with the same efficacy and safety compared with GA. When considering economical aspects, CSEA appears to be a preferable alternative to GA for the patient whose general health status permits it. PMID:25358059

  13. A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

    ClinicalTrials.gov

    2016-07-03

    Prostate Cancer; Local Anesthesia; Prostate-Specific Antigen/Blood; Biopsy/Methods; Image-guided Biopsy/Methods; Prostatic Neoplasms/Diagnosis; Prostate/Pathology; Prospective Studies; Humans; Male; Ultrasonography, Interventional/Methods

  14. Intravenous Versus Oral Antibiotic Prophylaxis Efficacy for Elective Laparoscopic Cholecystectomies: a Prospective Randomized Controlled Trial.

    PubMed

    Karaca, A Serdar; Gündoğdu, Haldun; Özdoğan, Mehmet; Ersoy, Eren

    2015-12-01

    The aim of the present prospective randomized controlled trial is to compare the effectiveness of intravenous and oral antibiotic prophylaxis for cost and surgical site infection in elective laparoscopic cholecystectomy. Three hundred twenty patients were split into two groups as to include 160 patients in each, and they were evaluated in a prospective and randomized fashion. While one group was subjected to 1 g cefazolin via intravenous route during anesthesia induction, other group received 1 g cephalexin monohydrate via oral route 1 h prior to the operation. Demographic findings and operation results of the patients were compared by analyses. Our 320 patients (278 females and 42 males) received elective cholecystectomy and were followed up for a period of 6-26 months. Each group had 160 patients. Both groups were similar with regard to demographic characteristics and inclusion criteria. Among all, only five (1.5 %) cases demonstrated postoperative surgical site infection. Surgical site infection at postoperative period was determined in three (1.8 %) cases of intravenous prophylaxis group and two (1.2 %) cases of oral prophylaxis group. There was no statistically significant difference between the groups in terms of surgical site infection. Oral antibiotic prophylaxis can be used in elective laparoscopic cholecystectomy prophylaxis due to its cost-effective, reliable nature, and low surgical site infection rate. PMID:26730079

  15. Resting heart rate variability after yogic training and swimming: A prospective randomized comparative trial

    PubMed Central

    Sawane, Manish Vinayak; Gupta, Shilpa Sharad

    2015-01-01

    Context: Resting heart rate variability (HRV) is a measure of the modulation of autonomic nervous system (ANS) at rest. Increased HRV achieved by the exercise is good for the cardiovascular health. However, prospective studies with comparison of the effects of yogic exercises and those of other endurance exercises like walking, running, and swimming on resting HRV are conspicuous by their absence. Aims: Study was designed to assess and compare the effects of yogic training and swimming on resting HRV in normal healthy young volunteers. Settings and Design: Study was conducted in Department of Physiology in a medical college. Study design was prospective randomized comparative trial. Subjects and Methods: One hundred sedentary volunteers were randomly ascribed to either yoga or swimming group. Baseline recordings of digital electrocardiogram were done for all the subjects in cohorts of 10. After yoga training and swimming for 12 weeks, evaluation for resting HRV was done again. Statistical Analysis Used: Percentage change for each parameter with yoga and swimming was compared using unpaired t-test for data with normal distribution and using Mann-Whitney U test for data without normal distribution. Results: Most of the HRV parameters improved statistically significantly by both modalities of exercise. However, some of the HRV parameters showed statistically better improvement with yoga as compared to swimming. Conclusion: Practicing yoga seems to be the mode of exercise with better improvement in autonomic functions as suggested by resting HRV. PMID:26170587

  16. Random forest predictive modeling of mineral prospectivity with small number of prospects and data with missing values in Abra (Philippines)

    NASA Astrophysics Data System (ADS)

    Carranza, Emmanuel John M.; Laborte, Alice G.

    2015-01-01

    Machine learning methods that have been used in data-driven predictive modeling of mineral prospectivity (e.g., artificial neural networks) invariably require large number of training prospect/locations and are unable to handle missing values in certain evidential data. The Random Forests (RF) algorithm, which is a machine learning method, has recently been applied to data-driven predictive mapping of mineral prospectivity, and so it is instructive to further study its efficacy in this particular field. This case study, carried out using data from Abra (Philippines), examines (a) if RF modeling can be used for data-driven modeling of mineral prospectivity in areas with a few (i.e., <20) mineral occurrences and (b) if RF modeling can handle evidential data with missing values. We found that RF modeling outperforms weights-of-evidence (WofE) modeling of porphyry-Cu prospectivity in the Abra area, where 12 porphyry-Cu prospects are known to exist. Moreover, just like WofE modeling, RF modeling allows analysis of the spatial associations of known prospects with individual layers of evidential data. Furthermore, RF modeling can handle missing values in evidential data through an RF-based imputation technique whereas in WofE modeling values are simply represented by zero weights. Therefore, the RF algorithm is potentially more useful than existing methods that are currently used for data-driven predictive mapping of mineral prospectivity. In particular, it is not a purely black-box method like artificial neural networks in the context of data-driven predictive modeling of mineral prospectivity. However, further testing of the method in other areas with a few mineral occurrences is needed to fully investigate its usefulness in data-driven predictive modeling of mineral prospectivity.

  17. Prospective randomized double-blind comparison of nephrotoxicity and auditory toxicity of tobramycin and netilmicin.

    PubMed Central

    Gatell, J M; SanMiguel, J G; Araujo, V; Zamora, L; Maña, J; Ferrer, M; Bonet, M; Bohe, M; Jimenez de Anta, M T

    1984-01-01

    Netilmicin or tobramycin was administered to 197 patients in a prospective randomized double-blind trial. Of these patients, 140 recipients of nine or more doses of netilmicin or tobramycin could be evaluated for nephrotoxicity. Fifty-five patients were able to cooperate in the administration of serial audiograms. Nephrotoxicity of similar severity developed in 7 of 73 (9.6%) recipients of tobramycin and in 7 of 67 (10.4%) recipients of netilmicin (P greater than 0.05). Mild or slight auditory toxicity developed in 5 of 28 (17.8%) recipients of tobramycin and in 2 of 27 (7.4%) recipients of netilmicin (P greater than 0.05). PMID:6393868

  18. Needle catheter jejunostomy: a controlled, prospective, randomized trial in patients with gynecologic malignancy.

    PubMed

    Spirtos, N M; Ballon, S C

    1988-06-01

    Sixty patients with gynecologic cancer entered a prospective, randomized study of immediate postoperative feeding. Thirty-three women in the study group received an elemental diet (Vivonex HN) delivered through a needle catheter jejunostomy. Twenty-seven patients in the control group were given standard 5% dextrose and electrolyte solutions. Patients in both groups were stratified according to nutritional status as determined by anthropometric evaluation and levels of serum albumin, total protein, and transferrin. These parameters also were measured at intervals throughout the study. Only one catheter-related complication occurred. Patients in the study group received significantly more calories (p = 0.01) and were better able to maintain serum levels of transferrin (p = 0.05) than those in the control group. An elemental diet administered through the needle catheter jejunostomy effectively maintains postoperative nutrition and is associated with few complications. PMID:3132853

  19. Complications of intravenous therapy: a randomized prospective study--Vialon vs. Teflon.

    PubMed

    McKee, J M; Shell, J A; Warren, T A; Campbell, V P

    1989-01-01

    For the past two decades, the vast majority of vascular-access devices used in I.V. catheterization have been made of Teflon material. More recent developments in material science have produced the Vialon biomaterial currently used in the Insyte I.V. catheter. This prospective, randomized study compared the length of venous dwell time and rate of I.V.-related complications of Teflon peripheral I.V. catheters and Vialon peripheral I.V. catheters. The study population included only the most difficult peripheral I.V. access patients. Conditions of insertion, monitoring, and care were carefully controlled by the investigators. An alternate assignment scheme was used for randomization of eligible patients. Of 247 catheters evaluated over a six-week period in a 550-bed community tertiary care hospital, 191 were evaluable; of these, equivalent numbers were made of Vialon and Teflon. This investigation found that the incidence of phlebitis in the group receiving Vialon I.V. catheters was 36 percent lower than that of the group receiving Teflon I.V. catheters. PMID:2677289

  20. Prospective, Randomized, Multicenter, Controlled Trial of a Bioartificial Liver in Treating Acute Liver Failure

    PubMed Central

    Demetriou, Achilles A.; Brown, Robert S.; Busuttil, Ronald W.; Fair, Jeffrey; McGuire, Brendan M.; Rosenthal, Philip; Am Esch, Jan Schulte; Lerut, Jan; Nyberg, Scott L.; Salizzoni, Mauro; Fagan, Elizabeth A.; de Hemptinne, Bernard; Broelsch, Christoph E.; Muraca, Maurizio; Salmeron, Joan Manuel; Rabkin, John M.; Metselaar, Herold J.; Pratt, Daniel; De La Mata, Manuel; McChesney, Lawrence P.; Everson, Gregory T.; Lavin, Philip T.; Stevens, Anthony C.; Pitkin, Zorina; Solomon, Barry A.

    2004-01-01

    Objective: The HepatAssist liver support system is an extracorporeal porcine hepatocyte-based bioartificial liver (BAL). The safety and efficacy of the BAL were evaluated in a prospective, randomized, controlled, multicenter trial in patients with severe acute liver failure. Summary Background Data: In experimental animals with acute liver failure, we demonstrated beneficial effects of the BAL. Similarly, Phase I trials of the BAL in acute liver failure patients yielded promising results. Methods: A total of 171 patients (86 control and 85 BAL) were enrolled. Patients with fulminant/subfulminant hepatic failure and primary nonfunction following liver transplantation were included. Data were analyzed with and without accounting for the following confounding factors: liver transplantation, time to transplant, disease etiology, disease severity, and treatment site. Results: For the entire patient population, survival at 30 days was 71% for BAL versus 62% for control (P = 0.26). After exclusion of primary nonfunction patients, survival was 73% for BAL versus 59% for control (n = 147; P = 0.12). When survival was analyzed accounting for confounding factors, in the entire patient population, there was no difference between the 2 groups (risk ratio = 0.67; P = 0.13). However, survival in fulminant/subfulminant hepatic failure patients was significantly higher in the BAL compared with the control group (risk ratio = 0.56; P = 0.048). Conclusions: This is the first prospective, randomized, controlled trial of an extracorporeal liver support system, demonstrating safety and improved survival in patients with fulminant/subfulminant hepatic failure. PMID:15082970

  1. MIOTIC study: a prospective, multicenter, randomized study to evaluate the long-term efficacy of mobile phone-based Internet of Things in the management of patients with stable COPD.

    PubMed

    Zhang, Jing; Song, Yuan-Lin; Bai, Chun-Xue

    2013-01-01

    Chronic obstructive pulmonary disease (COPD) is a common disease that leads to huge economic and social burden. Efficient and effective management of stable COPD is essential to improve quality of life and reduce medical expenditure. The Internet of Things (IoT), a recent breakthrough in communication technology, seems promising in improving health care delivery, but its potential strengths in COPD management remain poorly understood. We have developed a mobile phone-based IoT (mIoT) platform and initiated a randomized, multicenter, controlled trial entitled the 'MIOTIC study' to investigate the influence of mIoT among stable COPD patients. In the MIOTIC study, at least 600 patients with stable GOLD group C or D COPD and with a history of at least two moderate-to-severe exacerbations within the previous year will be randomly allocated to the control group, which receives routine follow-up, or the intervention group, which receives mIoT management. Endpoints of the study include (1) frequency and severity of acute exacerbation; (2) symptomatic evaluation; (3) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FVC) measurement; (4) exercise capacity; and (5) direct medical cost per year. Results from this study should provide direct evidence for the suitability of mIoT in stable COPD patient management. PMID:24082784

  2. MIOTIC study: a prospective, multicenter, randomized study to evaluate the long-term efficacy of mobile phone-based Internet of Things in the management of patients with stable COPD

    PubMed Central

    Zhang, Jing; Song, Yuan-lin; Bai, Chun-xue

    2013-01-01

    Chronic obstructive pulmonary disease (COPD) is a common disease that leads to huge economic and social burden. Efficient and effective management of stable COPD is essential to improve quality of life and reduce medical expenditure. The Internet of Things (IoT), a recent breakthrough in communication technology, seems promising in improving health care delivery, but its potential strengths in COPD management remain poorly understood. We have developed a mobile phone-based IoT (mIoT) platform and initiated a randomized, multicenter, controlled trial entitled the ‘MIOTIC study’ to investigate the influence of mIoT among stable COPD patients. In the MIOTIC study, at least 600 patients with stable GOLD group C or D COPD and with a history of at least two moderate-to-severe exacerbations within the previous year will be randomly allocated to the control group, which receives routine follow-up, or the intervention group, which receives mIoT management. Endpoints of the study include (1) frequency and severity of acute exacerbation; (2) symptomatic evaluation; (3) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FVC) measurement; (4) exercise capacity; and (5) direct medical cost per year. Results from this study should provide direct evidence for the suitability of mIoT in stable COPD patient management. PMID:24082784

  3. Silver nitrate versus tetracycline in pleurodesis for malignant pleural effusions; a prospective randomized trial

    PubMed Central

    Tabatabaei, Seyed Abass; Hashemi, Seyed Mozafar; Kamali, Ali

    2015-01-01

    Background: In this study, we aimed to investigate the effectiveness of silver nitrate (SN) versus tetracycline in pleurodesis among patients with malignant pleural effusion (MPE). Methods: In this prospective randomized clinical trial, patients with unilateral MPE candidate for pleurodesis were enrolled. The patients randomly allocated in two groups for receiving 20 mL 0.5% SN or 2.5 g tetracycline diluted in 30 cc normal saline and 0.1% lidocaine, through the chest tube. Patients were followed-up immediately (during 24 h) and 1-month after the procedure for evaluating recurrence of the pleural effusion using chest radiograph. They were clinically evaluated for chest pain and/or dyspnea and fever using a questionnaire that completed by the surgeon. The results were compared with two groups. Results: During this trial, 50 patients with MPE candidate for pleurodesis were selected and randomized into two interventional groups (25 patients in each group). Immediate and late recurrence of pleural effusion after pleurodesis were similar in two groups (P > 0.05). All patients in tetracycline group had fever and chest pain, but in SN group fever and chest pain were reported in 3 (12%) and 12 (48%) of patients, respectively (P < 0.05). Conclusion: SN is at least as effective as tetracycline for MPE treatment. In addition, its side effects were lower than tetracycline. Other advantages of SN are its low cost, availability, and safety. For more accurate results, it is recommended to design further trials with larger sample size and with lower doses of both SN and tetracycline. PMID:26605217

  4. Hyperbaric Oxygen Induces Late Neuroplasticity in Post Stroke Patients - Randomized, Prospective Trial

    PubMed Central

    Efrati, Shai; Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Kliakhandler, Kostantin; Kamiager, Izhak; Gal, Nachum; Friedman, Mony; Ben-Jacob, Eshel; Golan, Haim

    2013-01-01

    Background Recovery after stroke correlates with non-active (stunned) brain regions, which may persist for years. The current study aimed to evaluate whether increasing the level of dissolved oxygen by Hyperbaric Oxygen Therapy (HBOT) could activate neuroplasticity in patients with chronic neurologic deficiencies due to stroke. Methods and Findings A prospective, randomized, controlled trial including 74 patients (15 were excluded). All participants suffered a stroke 6–36 months prior to inclusion and had at least one motor dysfunction. After inclusion, patients were randomly assigned to "treated" or "cross" groups. Brain activity was assessed by SPECT imaging; neurologic functions were evaluated by NIHSS, ADL, and life quality. Patients in the treated group were evaluated twice: at baseline and after 40 HBOT sessions. Patients in the cross group were evaluated three times: at baseline, after a 2-month control period of no treatment, and after subsequent 2-months of 40 HBOT sessions. HBOT protocol: Two months of 40 sessions (5 days/week), 90 minutes each, 100% oxygen at 2 ATA. We found that the neurological functions and life quality of all patients in both groups were significantly improved following the HBOT sessions while no improvement was found during the control period of the patients in the cross group. Results of SPECT imaging were well correlated with clinical improvement. Elevated brain activity was detected mostly in regions of live cells (as confirmed by CT) with low activity (based on SPECT) – regions of noticeable discrepancy between anatomy and physiology. Conclusions The results indicate that HBOT can lead to significant neurological improvements in post stroke patients even at chronic late stages. The observed clinical improvements imply that neuroplasticity can still be activated long after damage onset in regions where there is a brain SPECT/CT (anatomy/physiology) mismatch. Trial Registration ClinicalTrials.gov NCT00715897 PMID:23335971

  5. Prospective safety performance evaluation on construction sites.

    PubMed

    Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

    2015-05-01

    This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. PMID:25746166

  6. Optimizing treatment strategies in myeloma cast nephropathy: rationale for a randomized prospective trial.

    PubMed

    Bridoux, Frank; Fermand, Jean-Paul

    2012-09-01

    Renal failure is a frequent complication of multiple myeloma (MM) that strongly affects patient survival. Although a variety of renal diseases may be observed in MM, myeloma cast nephropathy (MCN), a tubulo-interstitial disorder related to precipitation of a monoclonal light chain (LC) within tubular distal lumens, is the main cause of severe and persistent renal failure. To date, the respective frequency and initial evolution of renal disorders associated with monoclonal LC in MM remain poorly defined. Treatment of MCN relies on urgent symptomatic measures and rapid introduction of chemotherapy to reduce the production of monoclonal LC. The introduction of novel chemotherapy regimens based on the association of bortezomib with dexamethasone is likely to have improved the prognosis of MM patients with renal failure. In addition, the combination of novel agents with efficient removal of circulating LC through high cut-off hemodialysis membrane may further increase renal response rate. However, the impact on patient and renal outcomes of these potential therapeutic advances has not been evaluated in prospective studies. The randomized trials EuLITE in the UK and Germany and MYRE in France should help to answer these issues. MYRE is a randomized controlled phase III trial (NCT01208818) that aims to better define the epidemiology and typology of inaugural renal failure in MM and to optimize therapy of MCN patients with and without dialysis-dependent renal failure. PMID:22920644

  7. Comparison of Rifaximin and Lactulose for the Treatment of Hepatic Encephalopathy: A Prospective Randomized Study

    PubMed Central

    Paik, Yong-Han; Han, Kwang-Hyub; Song, Kun Hoon; Kim, Myoung Hwan; Moon, Byung Soo; Ahn, Sang Hoon; Lee, Se Joon; Park, Hyo Jin; Lee, Dong Ki; Chon, Chae Yoon; Lee, Sang In; Moon, Young Myoung

    2005-01-01

    Rifaximin has been reported to be effective for the treatment of hepatic encephalopathy (HE) in Europe. However, it is unknown whether Rifaximin is effective for the treatment of HE in Koreans, therefore we conducted a open-label prospective randomized study to evaluate the efficacy of rifaximin versus lactulose in Korean patients. Fifty-four patients with liver cirrhosis and hepatic encephalopathy were enrolled. Thirty-two patients were randomized to receive rifaximin and 22 to receive lactulose both over a 7-day periods. Before and at the end of treatment, gradation of blood ammonia, flapping tremor, mental status, number connection test (NCT) were performed and estimation of HE indexes determined. Both rifaximin and lactulose were effective in the majority of patients (84.4% and 95.4%, respectively, p=0.315). Blood NH3, flapping tremor, mental status, and NCT was significantly improved by rifaximin and lactulose, and the posttreatment levels of these measures were similar for the rifaximin and lactulose-treated groups, as was the HE index (rifaximin group (10.0→4.2, p=0.000); lactulose group (11.3→5.0, p=0.000)). One patient treated with rifaximin complained of abdominal pain, which was easily controlled. There was no episode of renal function impairment in either treatment group. Rifaximin proved to be as safe and as effective as lactulose for the treatment of Korean patients with hepatic encephalopathy. PMID:15988813

  8. Effects of platelet-rich plasma on lateral epicondylitis of the elbow: prospective randomized controlled trial☆

    PubMed Central

    Palacio, Evandro Pereira; Schiavetti, Rafael Ramos; Kanematsu, Maiara; Ikeda, Tiago Moreno; Mizobuchi, Roberto Ryuiti; Galbiatti, José Antônio

    2016-01-01

    Objective To evaluate the effects of platelet-rich plasma (PRP) infiltration in patients with lateral epicondylitis of the elbow, through analysis of the Disabilities of the Arm, Shoulder and Hand (DASH) and Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaires. Methods Sixty patients with lateral epicondylitis of the elbow were prospectively randomized and evaluated after receiving infiltration of three milliliters of PRP, or 0.5% neocaine, or dexamethasone. For the scoring process, the patients were asked to fill out the DASH and PRTEE questionnaires on three occasions: on the day of infiltration and 90 and 180 days afterwards. Results Around 81.7% of the patients who underwent the treatment presented some improvement of the symptoms. The statistical tests showed that there was evidence that the cure rate was unrelated to the substance applied (p = 0.62). There was also intersection between the confidence intervals of each group, thus demonstrating that the proportions of patients whose symptoms improved were similar in all the groups. Conclusion At a significance level of 5%, there was no evidence that one treatment was more effective than another, when assessed using the DASH and PRTEE questionnaires. PMID:26962506

  9. Prevention of sternal wound complications after sternotomy: results of a large prospective randomized multicentre trial†

    PubMed Central

    Gorlitzer, Michael; Wagner, Florian; Pfeiffer, Steffen; Folkmann, Sandra; Meinhart, Johann; Fischlein, Theodor; Reichenspurner, Hermann; Grabenwoeger, Martin

    2013-01-01

    OBJECTIVES A prospective randomized multicentre trial was performed to analyse the efficacy of a vest (Posthorax support vest®) to prevent sternal wound infection after cardiac surgery, and to identify risk factors. METHODS From September 2007 to March 2010, 2539 patients undergoing cardiac surgery via median sternotomy were prospectively randomized into those who received a Posthorax® vest and those who did not. Patients were instructed to wear the vest postoperatively for 24 h a day for at least 6 weeks; the duration of follow-up was 90 days. Patients who did not use the vest within a period of 72 h postoperatively were regarded as study dropouts. Statistical calculations were based on an intention-to-treat (ITT) analysis. Further evaluations comprised all subgroups of patients. RESULTS Complete data were available for 2539 patients (age 67 ± 11years, 45% female). Of these, 1351 were randomized to receive a vest, while 1188 received no vest. No significant differences were observed between groups regarding age, gender, diabetes, body mass index, chronic obstructive pulmonary disease (COPD), renal failure, the logistic EuroSCORE and the indication for surgery. The frequency of deep wound complications (dWC: mediastinitis and sternal dehiscence) was significantly lower in vest (n = 14; 1.04%) vs non-vest (n = 27; 2.27%) patients (ITT, P < 0.01), but superficial complications did not differ between groups. Subanalysis of vest patients revealed that only 933 (Group A) wore the vest according to the protocol, while 202 (Group BR) refused to wear the vest (non-compliance) and 216 (Group BN) did not use the vest for other reasons. All dWC occurred in Groups BR (n = 7) and BN (n = 7), although these groups had the same preoperative risk profile as Group A. Postoperatively, Group BN had a prolonged intubation time, a longer stay in the intensive care unit, greater use of intra-aortic balloon pump, higher frequency of COPD and a larger percentage of patients who

  10. Does famotidine enhance tumor infiltrating lymphocytes in breast cancer? Results of a randomized prospective pilot study.

    PubMed

    Parshad, Rajinder; Kapoor, Sorabh; Gupta, Siddhartha Datta; Kumar, Arvind; Chattopadhyaya, Tushar K

    2002-01-01

    Thirty patients with breast cancer were prospectively randomized into case and control groups receiving 40 mg famotidine preoperatively for 10-14 days and routine premedication, respectively. Surgical specimens were evaluated objectively for tumor infiltrating lymphocytes in the center and in the periphery of the tumor along with evaluation of metastatic lymph nodes for reactive changes. Ten famotidine-treated cases (67%) showed significant lymphocytic infiltration in the center compared to 4 controls (27%) (p = 0.03). Eleven cases (77%) had significant lymphocytic infiltration in the periphery (p = 0.03) compared to 5 controls (33%). Considering both sites, lymphocytic response was significant in 9 (60%) cases as opposed to only 3 (20%) controls (p = 0.03). This response did not correlate with the stage, grade of tumor or menopausal status of patients in either group. Seventy-eight percent (78%) of the cases showed significant reactive changes in the metastatic lymph nodes as compared to 22% in controls (p < 0.01). This study suggests that famotidine enhances tumor infiltrating lymphocytes in breast cancer and might have potential as an immunomodulator. A larger confirmatory study is suggested. PMID:12234028

  11. Antiadhesive effect and safety of oxidized regenerated cellulose after thyroidectomy: a prospective, randomized controlled study

    PubMed Central

    Park, Kyoung Sik; Lee, Kyu Eun; Ku, Do Hoon; Kim, Su-Jin; Park, Won Seo; Kim, Hoon Yub; Kwon, Mi Ra

    2013-01-01

    Purpose To evaluate the antiadhesive effects and safety of an oxidized regenerated cellulose (Interceed) after thyroidectomy. Methods Seventy-six thyroidectomized patients were prospectively randomized into two groups with regard to the use of Interceed. We evaluated each group for their adhesive symptoms using four subjective and four objective items at the 2nd week, 3rd and 6th month after thyroidectomy. All patients were examined for vocal cord motility by indirect laryngoscope at each period. Results Total adhesion scores at each postoperative follow-up period decreased with time, but were not significantly different in each group. The median score for swallowing discomfort for liquid was significantly lower in the Interceed group than in the control group 2 weeks after surgery. In addition, the severity of skin adhesion to the trachea was reduced in the Interceed group compared with the control group 6 months after surgery. During the study, there were no adverse effects or significant differences in postoperative complications between the groups. Conclusion Interceed appeared to be safe and effective in improving neck discomfort at early postoperative periods and preventing skin adhesion to the trachea 6 months after thyroidectomy. PMID:23741689

  12. Evaluating the Effectiveness of Developmental Mathematics by Embedding a Randomized Experiment within a Regression Discontinuity Design

    ERIC Educational Resources Information Center

    Moss, Brian G.; Yeaton, William H.; Lloyd, Jane E.

    2014-01-01

    Using a novel design approach, a randomized experiment (RE) was embedded within a regression discontinuity (RD) design (R-RE-D) to evaluate the impact of developmental mathematics at a large midwestern college ("n" = 2,122). Within a region of uncertainty near the cut-score, estimates of benefit from a prospective RE were closely…

  13. Fibrin Sealant Improves Hemostasis in Peripheral Vascular Surgery: A Randomized Prospective Trial

    PubMed Central

    Schenk, Worthington G.; Burks, Sandra G.; Gagne, Paul J.; Kagan, Steven A.; Lawson, Jeffrey H.; Spotnitz, William D.

    2003-01-01

    Objective To evaluate the efficacy and safety of an investigational fibrin sealant (FS) in a randomized prospective, partially blinded, controlled, multicenter trial. Summary Background Data Upper extremity vascular access surgery using polytetrafluorethylene (PTFE) graft placement for dialysis was chosen as a reproducible, clinically relevant model for evaluating the usefulness of FS. The FS consisted of pooled human fibrinogen (60 mg/mL) and thrombin (500 NIH U/mL). Time to hemostasis was measured, and adverse events were monitored. Methods Consenting adult patients (n = 48) undergoing placement of a standard PTFE graft were randomized in a 2:1:1 ratio to the treatment group using FS (ZLB Bioplasma AG, Bern, Switzerland), oxidized regenerated cellulose (Surgicel, Johnson & Johnson, New Brunswick, NJ), or pressure. Patients received heparin (3,000 IU IVP) before placement of vascular clamps. If the treatment was FS, clamps were left in place for 120 seconds after the application of study material to permit polymerization. If treatment was Surgicel, clamps were left in place until the agent had been applied according to manufacturer’s instructions. If the treatment was pressure, clamps were released as soon as the investigator was ready to apply compression. Immediately after release of the last clamp, the arterial and venous suture lines were evaluated for bleeding. The time to hemostasis at both the venous and arterial sites was recorded. Results Significant (P ≤ .005) reduction in time to hemostasis was achieved in the FS group. Thirteen (54.2%) patients randomized to FS experienced immediate hemostasis at both suture lines following clamp removal compared to no patients using Surgicel or pressure. Only one patient (7.1%) in the Surgicel group and no patients in the pressure group experienced hemostasis at 120 seconds from clamp removal, compared to 13 (54.2%) patients for FS. Adverse events were comparable in all groups. There were no seroconversions

  14. Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces

    PubMed Central

    Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

    2015-01-01

    Purpose To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Setting Assil Eye Institute, Beverly Hills, CA, USA. Design Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients and methods Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Results Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (P<0.05 for both). Similarly, mean total balanced salt solution used was significantly less with the transverse system vs torsional (P<0.05). Postoperative safety demonstrated significantly lower endothelial cell loss at 1 day and 1 month (P<0.05) with transverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. Conclusion The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may

  15. Comparison of Simvastatin and Metformin in Treatment of Polycystic Ovary Syndrome: Prospective Randomized Trial

    PubMed Central

    Banaszewska, Beata; Pawelczyk, Leszek; Spaczynski, Robert Z.; Duleba, Antoni J.

    2009-01-01

    Context: Polycystic ovary syndrome (PCOS) is characterized by ovarian dysfunction and hyperandrogenism; it is also associated with increased cardiovascular risks such as adverse lipid profile and endothelial dysfunction. Metformin and, more recently, statins have been shown to improve endocrine and metabolic aspects of PCOS. Objective: The aim of the study was to compare effects of simvastatin and metformin on PCOS. Design: In a prospective trial, women with PCOS (n = 136) were randomized to simvastatin (S), metformin (M), or simvastatin plus metformin (SM) groups. Evaluations were performed at baseline and after 3 months. Setting: The study was conducted at an academic medical center. Primary Outcome: The change of serum total testosterone was measured. Results: The study was completed by 113 subjects. Total testosterone decreased significantly and comparably in all groups: by 17.1, 13.6, and 15.1%, respectively, in the S, M, and SM groups. Significant decreases were also observed in all groups with respect to body mass index, C-reactive protein, and soluble vascular cell adhesion molecule-1. DHEAS declined significantly only in the S group. None of the treatments were associated with significant changes in LH or FSH. Total cholesterol and low-density lipoprotein cholesterol significantly declined only in S and SM groups. Conclusions: Simvastatin treatment was superior to metformin alone, whereas a combination of simvastatin and metformin was not significantly superior to simvastatin alone. PMID:19890022

  16. Superior border versus inferior border fixation in displaced mandibular angle fractures: prospective randomized comparative study.

    PubMed

    Singh, V; Khatana, S; Bhagol, A

    2014-07-01

    A prospective randomized comparative study was conducted to compare open reduction and internal fixation of displaced fractures (>2mm) via intraoral approach with application of a single monocortical miniplate according to Champy's ideal line of osteosynthesis (group A) versus an extraoral approach with application of an inferior border plate with at least two holes (bicortical screws) on either side of the fracture line (group B). Clinical and radiographic assessment was done preoperatively, immediately postoperative, and at 1, 4, and 12 weeks of follow-up. Parametric and non-parametric data were evaluated by independent samples t-test and χ(2) analysis, respectively; P<0.05 was considered statistically significant. There was no significant difference between the two groups with regard to complication rates, although functional outcomes including pain (visual analogue scale score) at the 1-week follow-up and inter-incisal mouth opening at the 12-week follow-up were found to be better in group B. On radiographic assessment, the inferior border was better aligned in group B than in group A, with no superior border distraction in group B. The duration of surgery was shorter in group B, and this was considered to be the easier approach for fixation of the device as assessed by the surgeons. PMID:24636170

  17. Contribution of Geophysical Prospecting to Geohazard Evaluation

    NASA Astrophysics Data System (ADS)

    Nicolich, Rinaldo

    2006-03-01

    The physical properties of the subsoil are studied using geophysical methods. These studies are always indirect, such as gravimetric, magnetometric, magnetotelluric or reflection-refraction seismic surveys and are often combined to obtain more accurate and reliable results. With these tools the oil industry commonly investigates the sedimentary basins to localize structures that may favor the accumulation of hydrocarbons. Above all, seismic prospecting allow the understanding of the underground geology, defining boundaries of the geological formations as well as mechanical and physical properties of the rocks. New cutting-edge techniques allow high quality data to be obtained in almost all geological contexts and make reflection seismic the most powerful tool in subsurface observations. The seismic method was utilized in geothermal resources investigation, research of water strategic resources, volcanic risks assessment, etc. The refraction method was the first to be used in the exploration of oil reservoirs. At present the industry employs mainly refraction seismics to study shallow formations. Conversely, university researchers have applied wide-angle reflection-refraction surveys to localize deep crustal interfaces analyzing the high amplitudes of the wide-angle reflections and the velocities obtained from the refracted signals. Moho discontinuity and velocity distribution within the crust were mapped out, indicating thickness and boundary conditions in different geological settings. The maps have been used in the analysis of geodynamical behavior and of active movements within the crust, useful for seismotectonic investigations. The further addition of the seismic reflection imaging, with deep penetration and long transects, completed multidisciplinary programs to unravel the structure of the crust with clear seismic images and models. High-resolution application of seismic has a central role in the identification and characterization of seismotectonic and

  18. Contribution of Geophysical Prospecting to Geohazard Evaluation

    SciTech Connect

    Nicolich, Rinaldo

    2006-03-23

    The physical properties of the subsoil are studied using geophysical methods. These studies are always indirect, such as gravimetric, magnetometric, magnetotelluric or reflection-refraction seismic surveys and are often combined to obtain more accurate and reliable results. With these tools the oil industry commonly investigates the sedimentary basins to localize structures that may favor the accumulation of hydrocarbons. Above all, seismic prospecting allow the understanding of the underground geology, defining boundaries of the geological formations as well as mechanical and physical properties of the rocks. New cutting-edge techniques allow high quality data to be obtained in almost all geological contexts and make reflection seismic the most powerful tool in subsurface observations. The seismic method was utilized in geothermal resources investigation, research of water strategic resources, volcanic risks assessment, etc. The refraction method was the first to be used in the exploration of oil reservoirs. At present the industry employs mainly refraction seismics to study shallow formations. Conversely, university researchers have applied wide-angle reflection-refraction surveys to localize deep crustal interfaces analyzing the high amplitudes of the wide-angle reflections and the velocities obtained from the refracted signals. Moho discontinuity and velocity distribution within the crust were mapped out, indicating thickness and boundary conditions in different geological settings. The maps have been used in the analysis of geodynamical behavior and of active movements within the crust, useful for seismotectonic investigations. The further addition of the seismic reflection imaging, with deep penetration and long transects, completed multidisciplinary programs to unravel the structure of the crust with clear seismic images and models. High-resolution application of seismic has a central role in the identification and characterization of seismotectonic and

  19. A prospective randomized trial comparing stapler and laser techniques for interlobar fissure completion during pulmonary lobectomy.

    PubMed

    Marulli, Giuseppe; Droghetti, Andrea; Di Chiara, Francesco; Calabrese, Francesca; Rebusso, Alessandro; Perissinotto, Egle; Muriana, Giovanni; Rea, Federico

    2013-02-01

    Alveolar air leaks, often resulting from lung tissue traumatization during dissection of fissures, still remain a challenging problem in lung surgery. Several tools and techniques have been used to reduce air leakage, but none was judged ideal. This prospective, randomized trial was designed to evaluate the feasibility, safety, and effectiveness of completion of fissures during pulmonary lobectomy by using a laser system. A standard stapler technique was used for comparison; the primary goal was to reach at least a comparable result. Forty-four patients were enrolled, 22 were treated with standard technique by using staplers (S) and 22 underwent laser (L) dissection. Randomization to one of the two groups was intraoperative after evaluating the presence of incomplete fissure (grade 3-4 following Craig's classification). A Thulium laser 2010 nm (Cyber TM, Quanta System, Italy) was used at power of 40 W. Outcome primary measures were the evaluation and duration of intra- and postoperative air leaks, the rate of complications, and the hospital stay. Air leaks (2.1 ± 4.2 vs 3.6 ± 7.2 days; p = 0.98) and chest tube duration (6.4 ± 4.2 vs 7.5 ± 6.3 days, p = 0.44) were lower in L compared with S group even if these were not statistically significant. Complications (36.4 vs 77.3 %; p = 0.006), hospital stay (6.9 ± 3.8 vs 9.9 ± 6.9 days; p = 0.03), hospitalization costs (5,650 vs 8,147 euros; p = 0.01), and procedure costs (77 % of difference; p < 0.0001) were significantly lower for L group, while operative time was longer (197 ± 34 vs 158 ± 41 min; p = 0.004). The use of laser dissection to prevent postoperative air leaks is effective and comparable with stapler technique. Aero-haemostatic laser properties (by sealing of small blood vessels and checking air leaks) allow a safe application during pulmonary lobectomy in interlobar fissure completion avoiding stapler use. PMID:22526973

  20. Impact of Epidural Failures on the Results of a Prospective, Randomized Trial.

    PubMed

    Desai, Amita; Alemayehu, Hanna; Weesner, Kathryn A; St Peter, Shawn D

    2016-04-01

    Introduction We conducted a prospective randomized trial to evaluate the merits of two established postoperative pain management strategies: thoracic epidural (EPI) versus patient-controlled analgesia (PCA) with intravenous narcotics after minimally invasive repair of pectus excavatum. Pain scores favored the EPI group for the first two postoperative days only. Critics of the trial suggest that if the epidural failure rate was not so high, results may have favored the EPI group. Therefore, we performed a subset analysis of the EPI group to evaluate the impact of these failures. Methods Patients for whom epidural catheter could not be placed or whose catheters were removed early owing to dysfunction were compared with those with well-functioning catheters. Those with well-functioning catheters were also compared with the PCA group. A two-tailed independent Student t-test and a two-tailed Fisher exact test were used where appropriate. Results Of 55 patients in the EPI group, 12 patients (21.8%) had failed placement or required early removal. Comparing those with failed placements with the rest of the group, there was no difference in daily visual analogue scale pain scores or measures of hospital course. Likewise, comparing those with well-functioning catheters only to those in the PCA group, the results of the trial are replicated in terms of pain scores, hospital course, and length of stay. Conclusion In patients with failed epidural therapy, there is no significant difference in postoperative hospital course. Comparing those with well-functioning catheters to those in the PCA group, trial results are replicated-that is, no significant difference in length of stay, time to regular diet, or time to transition to oral medications. Therefore, failure rate in the EPI group did not influence the results of the trial. PMID:25643246

  1. Comparison of two purification products of shankha bhasma: A prospective randomized control trial

    PubMed Central

    Ranade, Manjiri; Chary, Dingari Laxmana

    2013-01-01

    Background: Shankha bhasma is widely used in the treatment of gastroesophageal reflux disease (GERD) patients. Aim: To compare the efficacy of two purification methods of shankha bhasma in relieving GERD symptoms. In method A, purification was done with lemon juice and method B with sour gruel. Materials and Methods: Patients with heartburn since at least four days/week but who did undergo endoscopy to assess esophageal mucosa could participate. In this single-phase, single-center, prospective, randomized control trial, the patients were randomized to receive either shankha bhasma purified by method A or by method B. The primary efficacy variable was the proportion of patients with resolution of heartburn at week 4 and week 8. Design: Single-phase, single-center, prospective, randomized control trial in a hospital setting. Results: Of the total 70 patients who received samples A and B in a randomized double-blind manner, 65% of the patients showed resolution of symptoms in sample A and 28% in sample B at the end of four weeks, whereas, 71% of the patients showed resolution of symptoms in sample A and 31% in sample B at the end of eight weeks; P value was statistically significant for resolution of symptoms (P <0.005). Conclusion: Purification of shankha bhasma by lemon juice method is better than sour gruel method in terms of clinical outcome in GERD patients and is hence recommended. PMID:23633854

  2. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study

    PubMed Central

    2012-01-01

    Background Total knee arthroplasty (TKA) is often associated with a severe local inflammatory reaction which, unless controlled, leads to persistent pain up to one year after surgery. Standard and accelerated rehabilitation protocols are currently being implemented after TKA, but no consensus exists regarding the long-term effects. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has been demonstrated to exert an anti-inflammatory effect, to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy. The aim of this study was to evaluate whether PEMFs can be used to limit the pain and enhance patient recovery after TKA. Methods A prospective, randomized, controlled study in 30 patients undergoing TKA was conducted. Patients were randomized into experimental PEMFs or a control group. Patients in the experimental group were instructed to use I-ONE stimulator 4hours/day for 60days. Postoperatively, all patients received the same rehabilitation program. Treatment outcome was assessed using the Knee Society Score, SF-36 Health-Survey and VAS. Patients were evaluated pre-operatively and one, two, six and 12 months after TKA. Joint swelling and Non Steroidal Anti Inflammatory Drug (NSAID) consumption were recorded. Comparisons between the two groups were carried out using a two-tail heteroschedastic Student’s t-test. Analysis of variance for each individual subject during the study was performed using ANOVA for multiple comparisons, applied on each group, and a Dunnet post hoc test. A p value < 0.05 was considered statistically significant. Results Pre-operatively, no differences were observed between groups in terms of age, sex, weight, height, Knee-Score, VAS, SF-36 and joint swelling, with the exception of the Functional Score. The Knee-Score, SF-36 and VAS demonstrated significantly positive outcomes in the I-ONE stimulated group compared with the controls at follow-ups. In the I

  3. Prospective Randomized Study of Arthroscopic Proximal vs Open Subpectoral Biceps Tenodesis

    PubMed Central

    Gobezie, Reuben; Shishani, Yousef; Flocken, Janice

    2016-01-01

    Objectives: The biceps tendon is recognized as a significant source of pain in the shoulder for many patients. Operative techniques for tenodesis of the biceps tendon vary widely. No studies have been conducted directly comparing arthroscopic proximal vs. open subpectoral biceps tenodesis using a prospective study. We aim to compare the functional outcomes, pain relief, and complications of proximal vs. subpectoral biceps tenodesis. Methods: A prospective randomized study of 129 consecutive patients requiring biceps tenodesis for treatment of biceps tendon tears, biceps instability or superior labral tears was performed. Clinical outcome measures used to conduct the study included active range of motion, VAS pain score, ASES score and SANE scores. Complications and revisions were also documented. Results: Mean follow-up was 13.2 months (12-24 months) with 50 subpectoral tenodesis and 46 proximal tenodesis patients reaching minimum follow-up of 12 months. In the subpectoral group, the VAS improved from 5.7 to 2.0 (p < 0.001), ASES score improved from 49.8 to 77.7 (p< 0.001), and SANE scores improved from 42.1% to 77.7% (p<0.001). In the arthroscopic proximal tenodesis group, the VAS pain score improved from 5.9 to 1.8 (p<0.001), ASES score improved from 52.0 to 82.5 (p<0.001), and SANE scores improved from 42.8% to 78.6% (p<0.001). The revision rate for the subpectoral group was 4% (2/50 patients). The revision rate for the arthroscopic proximal tenodesis group was 8.6% (4/46). Twelve patients had persistent tenderness over the bicipital groove: 7 following proximal tenodesis and 5 following subpectoral tenodesis. No significant difference was found between methods in any outcome measures evaluated. Conclusion: This study found no difference in the functional outcomes or pain relief between proximal vs subpectoral biceps tenodesis. However, revision rates and occurrence of post-operative persistent bicipital groove pain for arthroscopic proximal tenodesis with

  4. Postprocessing for quantum random-number generators: Entropy evaluation and randomness extraction

    NASA Astrophysics Data System (ADS)

    Ma, Xiongfeng; Xu, Feihu; Xu, He; Tan, Xiaoqing; Qi, Bing; Lo, Hoi-Kwong

    2013-06-01

    Quantum random-number generators (QRNGs) can offer a means to generate information-theoretically provable random numbers, in principle. In practice, unfortunately, the quantum randomness is inevitably mixed with classical randomness due to classical noises. To distill this quantum randomness, one needs to quantify the randomness of the source and apply a randomness extractor. Here, we propose a generic framework for evaluating quantum randomness of real-life QRNGs by min-entropy, and apply it to two different existing quantum random-number systems in the literature. Moreover, we provide a guideline of QRNG data postprocessing for which we implement two information-theoretically provable randomness extractors: Toeplitz-hashing extractor and Trevisan's extractor.

  5. Proof Construction and Evaluation Practices of Prospective Mathematics Educators

    ERIC Educational Resources Information Center

    Imamoglu, Yesim; Togrol, Aysenur Yontar

    2015-01-01

    This study was conducted with 93 freshmen and 82 senior prospective mathematicians and mathematics teachers in order to investigate how they construct and evaluate proofs and whether there are any significant differences in their proof construction (with respect to department and grade) and proof evaluation (with respect to department)…

  6. Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients.

    PubMed

    Ransford, A O; Morley, T; Edgar, M A; Webb, P; Passuti, N; Chopin, D; Morin, C; Michel, F; Garin, C; Pries, D

    1998-01-01

    We have evaluated the use of a synthetic porous ceramic (Triosite) as a substitute for bone graft in posterior spinal fusion for idiopathic scoliosis. In a prospective, randomised study 341 patients at five hospitals in the UK and France were randomly allocated either to autograft from the iliac crest or rib segments (171) or to receive Triosite blocks (170). All patients were assessed after operation and at 3, 6, 12 and 18 months. The two groups were similar with regard to all demographic and baseline variables, but the 184 treated in France (54%) had Cotrel-Dubouset instrumentation and the 157 treated in the UK usually had Harrington-Luque implants. In the Triosite group the average Cobb angle of the upper curve was 56 degrees, corrected to 24 degrees (57%). At 18 months, the average was 26 degrees (3% loss). In the autograft group the average preoperative upper curve of 53 degrees was corrected to 21 degrees (60%). At 18 months the mean curve was 25 degrees (8% loss). Pain levels after operation were similar in the two groups, being mild in most cases. In the Triosite group only three patients had problems of wound healing, but in the autograft group, 14 patients had delayed healing, infection or haematoma in the spinal wound. In addition, 15 autograft patients had pain at the donor site at three months. Seven had infections, two had haematoma and four had delayed healing. The haematological and serum biochemistry results showed no abnormal trends and no significant differences between the groups. There were no adverse events related to the graft material and no evidence of allergenicity. Our results suggest that Triosite synthetic porous ceramic is a safe and effective substitute for autograft in these patients. Histological findings on biopsy indicate that Triosite provides a favourable scaffolding for the formation of new bone and is gradually incorporated into the fusion mass. PMID:9460945

  7. Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study

    PubMed Central

    Asteriou, Christos; Lazopoulos, Achilleas; Rallis, Thomas; Gogakos, Apostolos S; Paliouras, Dimitrios; Barbetakis, Nikolaos

    2016-01-01

    BACKGROUND: Postoperative morbidity and inhospital length of stay are considered major determinants of total health care expenditure associated with thoracic operations. The aim of this study was to prospectively evaluate the role of video-assisted thoracic surgery (VATS) compared to mini-muscle-sparing thoracotomy in facilitating early recovery and hospital discharge after pulmonary sublobar wedge resections. PATIENTS AND METHODS: A total number of 120 patients undergoing elective pulmonary sublobar wedge resection were randomly assigned to VATS (n = 60) or mini-muscle-sparing thoracotomy (n = 60). The primary endpoint was time to hospital discharge. Postoperative complications, cardiopulmonary morbidity and 30-day mortality served as secondary endpoints. RESULTS: Patients' baseline demographic and clinical data did not differ among study arms as well as the number of pulmonary segments resected and the morphology of the nodular lesions. Total hospital stay was significantly shorter in patients assigned to the thoracoscopic technique as opposed to those who were operated using the mini-muscle-sparing thoracotomy approach (4 ± 0.6 versus 4.4 ± 0.6 days respectively, P = 0.006). Multivariate analysis revealed that VATS approach was inversely associated with longer inhospital stay whereas the number of resected segments was positively associated with an increased duration of hospitalization. Patients in the VATS group were less likely to develop atelectasis (≥1 lobe) compared to those who underwent thoracotomy (0% versus 6.7% respectively, P = 0.042). Kaplan-Meier analysis revealed similar 30-day mortality rates in both study arms (Log-rank P = 0.560). CONCLUSION: VATS was associated with shorter duration of hospitalization positively affecting the patients' quality of life and satisfaction. Significant suppression of the total cost of recovery after thoracoscopic pulmonary resections is expected. PMID:27279390

  8. Prospective Randomized Study of Oral Diazepam and Baclofen on Spasticity in Cerebral Palsy

    PubMed Central

    Laisram, Nonica; Wadhwa, Ranjan Kumar; Kothari, Shashank Yashwant

    2016-01-01

    Introduction Spastic cerebral palsy (CP) is the most common form of CP. Diazepam and Baclofen are the most commonly used oral drugs to manage spasticity. Study was designed to evaluate and compare their effects and safety in CP children. Aim Study was aimed to assess and compare outcome of oral Diazepam and Baclofen in spastic cerebral palsy children in terms of extent of reduction of spasticity and side effects profile. Materials and Methods Randomized prospective follow-up study was done for one year after giving Diazepam and Baclofen in weekly incremental doses upto recommended maximum dose to 60 children for three months. Two primary outcome measures were spasticity reduction and adverse effect profile. Spasticity reduction was measured by Modified Ashworth’s Scale (MAS) and Range of Motion improvement (ROM). Results After random allocation, there was no baseline difference between groups. Mean MAS score improved from 1.96±0.4 at baseline to 1.63±0.40 and 1.41± 0.36 at 1 month and 3 months for Diazepam and from 1.84±0.64 to 1.57±0.59 and 1.31± 0.48 respectively for Baclofen. Within the group reduction was significant with p-value = 0.0001. Intergroup comparison showed no statistically significant difference with p-value of 0.48 and 0.22 at 1 and 3 months. Baseline ROM showed significant improvement at 1 and 3 months with p value of 0.004 and 0.001 for Diazepam and 0.01 and 0.000 for Baclofen respectively with no statistically significant difference among two groups. Drowsiness was most common observed side effect in both the groups. Conclusion Patients showed significant improvement in spasticity as measured by Mean MAS score and range of motion in Diazepam as well as Baclofen group. Both drugs were found safe for use in children. Study couldn’t establish any difference between the two drugs. However studies with bigger sample size and longer follow- up assessing functional improvement in patients will be required in near future. PMID:27504360

  9. A Prospective Randomized Controlled Trial of an Interpersonal Violence Prevention Program With a Mexican American Community

    PubMed Central

    Kelly, Patricia J.; Lesser, Janna; Cheng, An-Lin; Osóos-Sánchez, Manuel; Martinez, Elisabeth; Pineda, Daniel; Mancha, Juan

    2014-01-01

    Using methods of community-based participatory research, a prospective randomized controlled trial of a violence prevention program based on Latino cultural values was implemented with elementary school children in a Mexican American community. Community members participated in intervention program selection, implementation, and data collection. High-risk students who participated in the program had greater nonviolent self-efficacy and demonstrated greater endorsement of program values than did high-risk students in the control group. This collaborative partnership was able to combine community-based participatory research with a rigorous study design and provide sustained benefit to community partners. PMID:20531101

  10. Video-assisted thoracic surgery reduces early postoperative stress. A single-institutional prospective randomized study

    PubMed Central

    Asteriou, Christos; Lazopoulos, Achilleas; Rallis, Thomas; Gogakos, Apostolos S; Paliouras, Dimitrios; Tsakiridis, Kosmas; Zissimopoulos, Athanasios; Tsavlis, Drosos; Porpodis, Konstantinos; Hohenforst-Schmidt, Wolfgang; Kioumis, Ioannis; Organtzis, John; Zarogoulidis, Konstantinos; Zarogoulidis, Paul; Barbetakis, Nikolaos

    2016-01-01

    Background Video-assisted thoracic surgery (VATS) has been shown to effectively reduce postoperative pain, enhance mobilization of the patients, shorten in-hospital length of stay, and minimize postoperative morbidity rates. The aim of this prospective study is to evaluate neuroendocrine and respiratory parameters as stress markers in cancer patients who underwent lung wedge resections, using both mini muscle-sparing thoracotomy and VATS approach. Methods The patients were randomly allocated into two groups: Group A (n=30) involved patients who were operated on using the VATS approach, while in group B (n=30), the mini muscle-sparing thoracotomy approach was used. Neuroendocrine and biological variables assessed included blood glucose levels, C-reactive protein (CRP) levels, cortisol, epinephrine, and adrenocorticotropic hormone (ACTH) levels. Arterial oxygen (PaO2) and carbon dioxide (PaCO2) partial pressure were also evaluated. All parameters were measured at the following time points: 24 hours preoperatively (T1), 4 hours (T2), 24 hours (T3), 48 hours (T4), and 72 hours (T5), after the procedure. Results PaO2 levels were significantly higher 4 and 24 hours postoperatively in group A vs group B, respectively (T2: 94.3 vs 77.9 mmHg, P=0.015, T3: 96.4 vs 88.7 mmHg, P=0.034). Blood glucose (T2: 148 vs 163 mg/dL, P=0.045, T3: 133 vs 159 mg/dL, P=0.009) and CRP values (T2: 1.6 vs 2.5 mg/dL, P=0.024, T3: 1.5 vs 2.1 mg/dL, P=0.044) were found increased in both groups 4 and 24 hours after the procedure. However, their levels were significantly lower in the VATS group of patients. ACTH and cortisol values were elevated immediately after the operation and became normal after 48 hours in both groups, without significant difference. Postoperative epinephrine levels measured in group A vs group B, respectively, (T2: 78.9 vs 115.6 ng/L, P=0.007, T3: 83.4 vs 122.5 ng/L, P=0.012, T4: 67.4 vs 102.6 ng/L, P=0.021). The levels were significantly higher in group B. Conclusion This

  11. Prospective randomized study comparing clinical, functional, and aesthetic results of minipterional and classic pterional craniotomies.

    PubMed

    Welling, Leonardo C; Figueiredo, Eberval G; Wen, Hung T; Gomes, Marcos Q T; Bor-Seng-Shu, Edson; Casarolli, Cesar; Guirado, Vinicius M P; Teixeira, Manoel Jacobsen

    2015-05-01

    OBJECT The object of this study was to compare the clinical, functional, and aesthetic results of 2 surgical techniques, pterional (PT) and minipterional (MPT) craniotomies, for microsurgical clipping of anterior circulation aneurysms. METHODS Fifty-eight patients with ruptured and unruptured anterior circulation aneurysms were enrolled into a prospective randomized study. The first group included 28 patients who underwent the MPT technique, and the second group comprised 30 patients who underwent the classic PT craniotomy. To evaluate the aesthetic effects, patients were asked to grade on a rule from 0 to 100 the best and the worst aesthetic result. Photographs were also taken, assessed by 2 independent observers, and classified as showing excellent, good, regular, or poor aesthetic results. Furthermore, quantitative radiological assessment (percentage reduction in thickness and volumetric analysis) of the temporal muscle, subcutaneous tissue, and skin was performed. Functional outcomes were compared using the modified Rankin Scale (mRS). Frontal facial palsy, postoperative hemorrhage, cerebrospinal fistula, hydrocephalus, and mortality were also analyzed. RESULTS Demographic and preoperative characteristics were similar in both groups. Satisfaction in terms of aesthetic result was observed in 19 patients (79%) in the MPT group and 13 (52%) in the PT group (p = 0.07). The mean score on the aesthetic rule was 27 in the MPT group and 45.8 in the PT group (p = 0.03). Two independent observers analyzed the patient photos, and the kappa coefficient for the aesthetic results was 0.73. According to these observers, excellent and good results were seen in 21 patients (87%) in the MPT and 12 (48%) in the PT groups. The degree of temporal muscle, subcutaneous tissue, and skin atrophy was 14.9% in the MPT group and 24.3% in the PT group (p = 0.01). Measurements of the temporal muscle revealed 12.7% atrophy in the MPT group and 22% atrophy in the PT group (p = 0.005). The

  12. Using Vascular Quality Initiative as a Platform for Organizing Multicenter, Prospective, Randomized Clinical Trials: OVERPAR Trial

    PubMed Central

    Eslami, Mohammad H.; Doros, Gheorghe; Goodney, Philip P.; Elderup-Jorgenson, Jens; Cronenwett, Jack L.; Malikova, Marina; Farber, Alik

    2014-01-01

    Background We describe the organization of a prospective, randomized, multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair (OPAR) and endovascular popliteal artery aneurysm repair (EPAR) of asymptomatic popliteal artery aneurysms (PAAs) as an example for how to use the Vascular Quality Initiative (VQI) framework. Given that many centers participate in the VQI, this model can be used to perform multicenters’ prospective trials on very modest budget. Methods VQI prospectively collects data on many vascular procedures. These data include many important perioperative, intraoperative, and postoperative details regarding both patients and their procedures. We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question. Data will be collected using modified VQI forms within the existing VQI data reporting structure. We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts. Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years. Our primary hypothesis is that major adverse limb event–free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions, improved quality of life, and decreased length of stay. The budget for this trial is fixed at $10,000/year for the course of the study, and the trial is judged to be feasible because of the functionality of the VQI platform. Conclusions Using the existing VQI infrastructure, Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget. The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates. PMID:25311746

  13. Statistical Evaluation of a Superconductive Physical Random Number Generator

    NASA Astrophysics Data System (ADS)

    Sugiura, Tatsuro; Yamanashi, Yuki; Yoshikawa, Nobuyuki

    A physical random number generator, which generates truly random number trains by using the randomness of physical phenomena, is widely used in the field of cryptographic applications. We have developed an ultra high-speed superconductive physical random number generator that can generate random numbers at a frequency of more than 10GHz by utilizing the high-speed operation and high-sensitivity of superconductive integrated circuits. In this study, we have statistically evaluated the quality of the random number trains generated by the superconductive physical random number generator. The performances of the statistical tests were based on a test method provided by National Institute of Standards and Technology (NIST). These statistical tests comprised several fundamental tests that were performed to evaluate the random number trains for their utilization in practical cryptographic applications. We have generated 230 random number trains consisting of 20, 000-bits by using the superconductive physical random number generator fabricated by the SRL 2.5kA/cm2 Nb standard process. The generated random number trains passed all the fundamental statistical tests. This result indicates that the superconductive random number generator can be sufficiently utilized in practical applications.

  14. Is hypothermia in the victim of major trauma protective or harmful? A randomized, prospective study.

    PubMed Central

    Gentilello, L M; Jurkovich, G J; Stark, M S; Hassantash, S A; O'Keefe, G E

    1997-01-01

    OBJECTIVE: The purpose of this randomized, prospective clinical trial was to determine whether hypothermia during resuscitation is protective or harmful to critically injured trauma patients. SUMMARY BACKGROUND DATA: Hypothermia has both protective and harmful clinical effects. Retrospective studies show higher mortality in patients with hypothermia; however, hypothermia is more common in more severely injured patients, which makes it difficult to determine whether hypothermia contributes to mortality independently of injury severity. There are no randomized, prospective treatment studies to assess hypothermia's impact as an independent variable. METHODS: Fifty-seven hypothermic (T < or = 34.5 C), critically injured patients requiring a pulmonary artery catheter were randomized to a rapid rewarming protocol using continuous arteriovenous rewarming (CAVR) or to a standard rewarming (SR) control group. The primary outcome of interest was first 24-hour blood product and fluid resuscitation requirements. Other comparative analyses included coagulation assays, hemodynamic and oxygen transport measurements, length of stay, and mortality. RESULTS: The two groups were well matched for demographic and injury severity characteristics. CAVR rewarmed significantly faster than did SR (p < 0.01), producing two groups with different amounts of hypothermia exposure. The patients who underwent CAVR required less fluid during resuscitation to the same hemodynamic goals (24,702 mL vs. 32,540 mL, p = 0.05) and were significantly more likely to rewarm (p = 0.002). Only 2 (7%) of 29 patients who underwent CAVR failed to warm to 36 C and both died, whereas 12 (43%) of 28 patients who underwent SR failed to reach 36 C, and all 12 died. Patients who underwent CAVR had significantly less early mortality (p = 0.047). CONCLUSION: Hypothermia increases fluid requirements and independently increases acute mortality after major trauma. PMID:9351712

  15. Intraoperative monitoring of stroke volume variation versus central venous pressure in laparoscopic liver surgery: a randomized prospective comparative trial☆

    PubMed Central

    Ratti, Francesca; Cipriani, Federica; Reineke, Raffaella; Catena, Marco; Paganelli, Michele; Comotti, Laura; Beretta, Luigi; Aldrighetti, Luca

    2015-01-01

    Background Central venous pressure (CVP) is used as a marker of cardiac preload to control intraoperative blood loss in open hepatectomies, while its reliability in laparoscopy is less certain. The aim of this randomized prospective trial was to evaluate the outcome of laparoscopic resections performed with stroke volume variation (SVV) or CVP monitoring. Methods All candidates for laparoscopic liver resection were assigned randomly to SVV or to CVP groups. Outcome was evaluated included conversion rate, cause of conversion, intraoperative blood loss, need for transfusions, length of surgery and postoperative results. Results Ninety consecutive patients were enrolled: both SVV and CVP groups included 45 patients each and were comparable in terms of patient and disease characteristics. A reduced rate of conversion was recorded in the SVV compared to the CVP group (6.7% and 17.8% respectively, p = 0.02). Blood loss was lower in the SVV group (150 mL), compared to the CVP group (300 mL, p = 0.04). Morbidity, mortality, length of stay and functional recovery were comparable. On multivariate analysis, lesion location, extent of hepatectomy and type of cardiac preload monitoring were associated significantly to risk of conversion. Conclusion SVV monitoring in laparoscopic liver surgery improves intraoperative outcome, thus enhancing the benefits of the minimally-invasive approach and fast-track protocols. PMID:26902132

  16. Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial

    PubMed Central

    2016-01-01

    Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid. PMID:27478346

  17. Comparative Effectivenesses of Pulsed Radiofrequency and Transforaminal Steroid Injection for Radicular Pain due to Disc Herniation: a Prospective Randomized Trial.

    PubMed

    Lee, Dong Gyu; Ahn, Sang-Ho; Lee, Jungwon

    2016-08-01

    Transforaminal Epidural steroid injections (TFESI) have been widely adopted to alleviate and control radicular pain in accord with current guidelines. However, sometimes repeated steroid injections have adverse effects, and thus, this prospective randomized trial was undertaken to compare the effectivenesses of pulsed radiofrequency (PRF) administered to a targeted dorsal root ganglion (DRG) and TFESI for the treatment of radicular pain due to disc herniation. Subjects were recruited when first proved unsuccessful (defined as a score of > 4 on a visual analogue scale (VAS; 0-10 mm) and of > 30% according to the Oswestry Disability Index (ODI) or the Neck Disability Index (NDI)). Forty-four patients that met the inclusion criteria were enrolled. The 38 subjects were randomly assigned to receive either PRF (PRF group; n = 19) or additional TFESI (TFESI group; n = 19) and were then followed for 2, 4, 8, and 12 weeks. To evaluate pain intensity were assessed by VAS. ODI and NDI were applied to evaluate functional disability. Mean VAS scores for cervical and lumbar radicular pain were significantly lower 12 weeks after treatment in both study groups. NDI and ODI scores also declined after treatment. However, no statistically significant difference was observed between the PRF and TFESI groups in terms of VAS, ODI, or NDI scores at any time during follow-up. PRF administered to a DRG might be as effective as TFESI in terms of attenuating radicular pain caused by disc herniation, and its use would avoid the adverse effects of steroid. PMID:27478346

  18. Testing the prospective evaluation of a new healthcare system.

    PubMed

    Planitz, Birgit; Sanderson, Penelope; Freeman, Clinton; Xiao, Tania; Botea, Adi; Orihuela, Cristina Beltran

    2012-01-01

    Research into health ICT adoption suggests that the failure to understand the clinical workplace has been a major contributing factor to the failure of many computer-based clinical systems. We suggest that clinicians and administrators need methods for envisioning future use when adopting new ICT. This paper presents and evaluates a six-stage "prospective evaluation" model that clinicians can use when assessing the impact of a new electronic patient information system on a Specialist Outpatients Department (SOPD). The prospective evaluation model encompasses normative, descriptive, formative and projective approaches. We show that this combination helped health informaticians to make reasonably accurate predictions for technology adoption at the SOPD. We suggest some refinements, however, to improve the scope and accuracy of predictions. PMID:23304347

  19. Hyperbaric Oxygen Therapy Can Improve Post Concussion Syndrome Years after Mild Traumatic Brain Injury - Randomized Prospective Trial

    PubMed Central

    Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Friedman, Mony; Hoofien, Dan; Shlamkovitch, Nathan; Ben-Jacob, Eshel; Efrati, Shai

    2013-01-01

    Background Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. Methods and Findings The trial population included 56 mTBI patients 1–5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. “Mindstreams” was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. Conclusions HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. Trial Registration ClinicalTrials.gov NCT00715052 PMID:24260334

  20. A Randomized Prospective Study on Outcomes of an Empathy Intervention among Second-year Student Pharmacists

    PubMed Central

    Truong, Julie T; Ip, Eric J; Barnett, Mitchell J

    2015-01-01

    Objective. To determine the impact of a single, 3-day intervention on empathy levels as measured by the validated Jefferson Scale of Empathy-Health Profession Students version (JSE-HPS). Methods. Forty second-year student pharmacists were recruited to participate in a non-blinded prospective study. Subjects were randomized to an intervention group (n=20) or control group (n=20) and completed the JSE-HPS at baseline, 7 days postintervention, and 90 days postintervention. The intervention group consisted of a 3-day simulation, each day including a designated activity with loss of dominant hand usage, vision, and speech. Results. The 3-day simulation increased empathy levels in the intervention group compared to the control group 7 days postintervention (p=0.035). However, there were no effects on empathy levels 90 days postintervention (p=0.38). Conclusion. Empathy scores increased but were not sustained in the long-term with a 3-day empathy intervention. PMID:25861099

  1. [Homeopathic treatment of adenoid vegetations. Results of a prospective, randomized double-blind study].

    PubMed

    Friese, K H; Feuchter, U; Moeller, H

    1997-08-01

    In a monocenter prospective randomized double-blind clinical trial the efficacy of homeopathic treatment was investigated on children with adenoid vegetations justifying an operation. Patients were treated with either homeopathic remedies such as Nux vomica D200, Okoubaka D3, Tuberculinum D200, Barium jodatum D4 and Barium jodatum D6 or with placebo. The duration of the study for each patient was 3 months. Examination of the ears using a microscope, rhinoscopy, stomatoscopy and pharyngoscopy, as well as tympanometry and audiometry were performed after 4, 8 and 12 weeks. Out of a total of 97 children studied between the ages of 4 to 10 years 82 could be analyzed. At the end of the study no operation was required in 70.7% of the placebo-treated children and in 78.1% of the children treated with homeopathic preparations. These results show no statistical significance. PMID:9378668

  2. Prospective randomized comparison of cefepime and cefotaxime for treatment of bacterial meningitis in infants and children.

    PubMed Central

    Sáez-Llorens, X; Castaño, E; García, R; Báez, C; Pérez, M; Tejeira, F; McCracken, G H

    1995-01-01

    Ninety infants and children were prospectively randomized to receive cefepime (n = 43) or cefotaxime (n = 47) for therapy of bacterial meningitis. The two treatment groups were comparable in terms of age, duration of illness before enrollment, history of seizures, clinical status on admission, and etiology. Six (7%) patients died--two treated with cefepime and four treated with cefotaxime. Clinical response, cerebrospinal fluid sterilization, development of complications, antibiotic toxicity, and hospital stay were similar for the two treatment regimens. Concentrations of cefepime in cerebrospinal fluid varied from 55 to 95 times greater than the maximal MIC required by the causative pathogens. Audiologic and/or neurologic sequelae were found in 16% of the cefepime-treated patients and 15% of the cefotaxime-treated patients examined 2 to 6 months after discharge. We conclude that cefepime is safe and therapeutically equivalent to cefotaxime for management of bacterial meningitis in infants and children. PMID:7785999

  3. Preoperative hair removal: a random prospective study of shaving versus clipping.

    PubMed

    Balthazar, E R; Colt, J D; Nichols, R L

    1982-07-01

    We report the results of a random, prospective study of electrical clipping versus routine razor shaving in the removal of hair immediately before operation. Two hundred patients having elective inguinal herniorrhaphy according to strict protocol were included in this study. Unsatisfactory skin preparation, as evidenced by gross cuts made in the skin during hair removal, was noted in 7% of those shaved and 4% of those clipped. Two subcutaneous wound infections occurred in the shaved group (2%) and one in the clipped group (1%). This study indicates that preoperative clipping of hair with electric barber's clippers immediately before operation is a safe, well tolerated procedure that does not increase the risk of postoperative wound infection. PMID:7089645

  4. [Traveler's diarrhea in Turkey. Prospective randomized therapeutic comparison of charcoal versus tannin albuminate/ethacridine lactate].

    PubMed

    Ziegenhagen, D J; Raedsch, R; Kruis, W

    1992-12-15

    In most cases traveler's diarrhea is a self-limiting disease not requiring professional assistance. As data on self-treatment are very limited, a prospective randomized trial was performed in 620 German tourists spending a two week-holiday in Turkey. 31.6% of these travelers developed diarrhea and 186 were assigned to two treatment groups, receiving either medical coal or a combination of tannalbuminate and ethacridinlactate (TA/EL). In the TA/EL group stool frequencies significantly earlier returned to normal and complaints of moderate to severe abdominal pain were recorded less frequently (50 vs. 82.2%) than in patients receiving charcoal preparations. Both medications were well tolerated and TA/EL appeared more efficient for self medication of uncomplicated traveler's diarrhea. PMID:1287425

  5. A prospective randomized controlled trial of Wallace and Rocket embryo transfer catheters.

    PubMed

    El-Shawarby, Salem A; Ravhon, Amir; Skull, Jonathan; Ellenbogen, Adrian; Trew, Geoffrey; Lavery, Stuart

    2008-10-01

    The aim of this study was to compare the efficacy of two embryo transfer catheters: Wallace and Rocket Embryon in an IVF programme of a tertiary referral university centre. A total of 308 patients undergoing embryo transfer were prospectively randomized to either a transfer with the Wallace catheter or a transfer with the Rocket catheter. The main outcome measure in this study was the clinical pregnancy rate, and secondary outcome measures included implantation rate, visibility of the catheter under ultrasound, number of retained embryos post transfer, and whether change of catheter was required. In addition, patient discomfort during the procedure was recorded. Pregnancy and implantation rates were similar when Wallace or Rocket catheters were used. However, for the Rocket catheter, the tip was more often clearly seen on ultrasound and it had a lower rate of retained embryos in the catheter after transfer (P < 0.05). Experience with different transfer catheters is recommended for difficult cases. PMID:18854110

  6. Intensified Adjuvant IFADIC Chemotherapy for Adult Soft Tissue Sarcoma: A Prospective Randomized Feasibility Trial

    PubMed Central

    Brodowicz, Thomas; Schwameis, Eva; Widder, Joachim; Amann, Gabriele; Wiltschke, Christoph; Dominkus, Martin; Windhager, Reinhard; Ritschl, Peter; Pötter, Richard; Kotz, Rainer

    2000-01-01

    Purpose. The present prospective randomized adjuvant trial was carried out to compare the toxicity, feasibility and efficacy of augmented chemotherapy added to hyperfractionated accelerated radiotherapy after wide or marginal resection of grade 2 and grade 3 soft tissue sarcoma (STS). Patients and methods. Fifty-nine patients underwent primary surgery by wide or marginal excision and were subsequently randomized to receive radiotherapy alone or under the addition of six courses of ifosfamide (1500 mg/m2 , days 1–4), dacarbazine (DTIC) (200 mg/m2 , days 1–4) and doxorubicin (25 mg/m2 , days 1–2) administered in 14-day-intervals supported by granulocyte-colony stimulating factor (30 × 106 IU/day, s.c.) on days 5–13. According to the randomization protocol, 28 patients received radiotherapy only, whereas 31 patients were treated with additional chemotherapy. Results. The relative ifosfamide–doxorubicin–DTIC (IFADIC) dose intensity achieved was 93%. After a mean observation period of 41±19.7 months (range, 8.1–84 months), 16 patients (57%) in the control group versus 24 patients (77%) in the chemotherapy group were free of disease (p>0.05).Within the control group, tumor relapses occurred in 12 patients (43%;six patients with distant metastases, two with local relapse, four with both) versus seven patients (23%; five patients with distant metastases, one with local recurrence, one with both) from the chemotherapy group. Relapse-free survival (RFS) (p=0.1), time to local failure (TLF) (p=0.09), time to distant failure (TDF) (p=0.17) as well as overall survival (OS) (p=0.4) did not differ significantly between the two treatment groups. Treatment-related toxicity was generally mild in both treatment arms. Conclusion. We conclude that the safety profile of intensified IFADIC added to radiotherapy was manageable and tolerable in the current setting. Inclusion of intensified IFADIC was not translated into a significant benefit concerning OS, RFS, TLF and

  7. Prospective Randomized Comparison Between Transperitoneal Laparoscopic Pyeloplasty and Retroperitoneoscopic Pyeloplasty for Primary Ureteropelvic Junction Obstruction

    PubMed Central

    Singh, Vishwajeet; Gupta, Dheeraj Kumar; Kumar, Vikas; Pandey, Mohit; Akhtar, Asif

    2014-01-01

    Background and Objectives: To compare laparoscopic transperitoneal versus retroperitoneoscopic pyeloplasty for primary ureteropelvic junction obstruction in a prospective randomized manner and assess overall results with long-term follow-up. Methods: In this prospective study, from 2008 to 2012, 112 cases of primary ureteropelvic junction obstruction were randomized in a 1:1 ratio into 2 groups. Group I included patients who underwent transperitoneal laparoscopic pyeloplasty, and group II consisted of patients who underwent retroperitoneoscopic laparoscopic pyeloplasty. Demographic and clinical characteristics and postoperative and operative data were collected and analyzed. The statistical analysis was performed with the Fisher exact test, χ2 test, and Mann-Whitney U test for independent groups, and P < .05 was considered statistically significant. Results: The total operative time and intracorporeal suturing time were significantly higher in group II than in group I (P < .001). The visual analog scale score for pain on postoperative day 1 and the requirement for tramadol were significantly higher in group I than in group II (P = .004). The hospital stay and the rate of temporary ileus were significantly greater (P < .036 and P < .02, respectively) in group I than in group II. The success rate of transperitoneal laparoscopic pyeloplasty versus retroperitoneoscopic laparoscopic pyeloplasty was 96.4% versus 96.6% with a mean follow-up period of 30.75 ± 4.85 months versus 30.99 ± 5.59 months (P < .88). Conclusion: Transperitoneal laparoscopic pyeloplasty is associated with significantly greater postoperative pain, a higher tramadol dose, a higher rate of ileus, and a longer hospital stay in comparison with retroperitoneoscopic laparoscopic pyeloplasty. Although the operative time for retroperitoneoscopic laparoscopic pyeloplasty is significantly longer, the success rate remains the same for both procedures. PMID:25392671

  8. Aprotinin and classic wound drainage are unnecessary in total hip replacement a prospective randomized trial

    PubMed Central

    2011-01-01

    Background Classic wound drainage is still common in hip replacement but its benefit is doubtful. The role of systemic administration of proteinase inhibitors like aprotinin to avoid perioperative blood loss is still unclear. Patients and Methods In a prospective randomized trial, the perioperative blood loss in alloplastic hip replacement under the influence of proteinase inhibitor (aprotinin, Trasylol®) using wound drainage as well as compression treatment alone were compared. 80 patients were prospectively randomized in 4 arms. Patients received either aprotinin or placebo during surgery as well as drainage or targeted external wound compression. Results Observing the "drug therapy" aprotinin had no effect on the intraor postoperative blood loss (p > 0.05), a trend to lower postoperative hemoglobin decline was found, but without significance. thrombosis occurred in neither the aprotinin nor in the placebo group. Two patients had a severe allergic drug reaction and were excluded from the study. Under "non drug therapy" with compression therapy and wound drainage a significant difference in blood loss was found (p < 0.001). The blood loss was higher under the wound drainage. There was no influence on the infection rate. Yet we could observe increased bruising under the sole external compression treatment. Conclusion The administration of aprotinin did not achieve the desired reduction of perioperative blood loss. Hence, costs and two severe allergic drug reactions in our study represent arguments against its use in regular treatment. Furthermore, it seems that wound drainage is neglectable in hip replacement and can be substituted by a sole compression treatment. PMID:21345766

  9. Azithromycin therapy of papillomatosis in dogs: a prospective, randomized, double-blinded, placebo-controlled clinical trial.

    PubMed

    Yağci, Buğrahan Bekir; Ural, Kerem; Ocal, Naci; Haydardedeoğlu, Ali Evren

    2008-08-01

    Azithromycin, an azalide subclass macrolide antibiotic, is an effective, well-tolerated and safe therapeutic option for treatment of papillomatosis in humans. This study reports the clinical and histopathological results from a prospective, randomized, double-blinded, placebo-controlled trial of 17 dogs of various breeds with diagnosis of oral (n = 12) and cutaneous papillomatosis (n = 5) treated with azithromycin. Papillomas appeared as whitish, verrucous, hyperkeratotic papules 1-2.7 mm in size. The cases were randomly assigned to azithromycin (n = 10) and placebo treatment groups (n = 7). Both owners and investigators were blinded to the allocation to the groups. Azithromycin (10 mg/kg) was administered per os every 24 h for 10 days. Clinical evaluations were done by the same investigator throughout the trial. Azithromycin treatment significantly decreased clinical scores (P < 0.001), whereas there was no change seen in the placebo group. In the azithromycin treatment group, skin lesions disappeared in 10-15 days. One case in the placebo had spontaneous regression of its papillomas by day 41, but lesions were still evident at day 50 in the remaining six cases. There was no recurrence of papillomatosis in the azithromycin treated dogs (follow up 8 months). No adverse effects were seen in either group. In conclusion, azithromycin appears to be a safe and effective treatment for canine papillomatosis. PMID:18494759

  10. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study

    PubMed Central

    2010-01-01

    Background Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients and methods Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Results Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. Conclusion IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy. PMID:20152024

  11. Comparison between dexmedetomidine and fentanyl on intubation conditions during awake fiberoptic bronchoscopy: A randomized double-blind prospective study

    PubMed Central

    Mondal, Sudeshna; Ghosh, Sarmila; Bhattacharya, Susmita; Choudhury, Brojen; Mallick, Suchismita; Prasad, Anu

    2015-01-01

    Background and Aims: Various drugs are used for providing favorable intubation conditions during awake fiberoptic intubation (AFOI). However, most of them cause respiratory depression and airway obstruction leading to hypoxemia. The aim of this study was to compare intubation conditions, and incidence of desaturation between dexmedetomidine and fentanyl group during AFOI. Material and Methods: This randomized double-blind prospective study was conducted on a total of 60 patients scheduled for elective laparotomies who were randomly allocated into two groups: Group A received dexmedetomidine 1 mcg/kg and Group B received fentanyl 2 mcg/kg over 10 min. Patients in both groups received glycopyrrolate 0.2 mg intravenous, nebulization with 2% lidocaine 4 ml over 20 min and 10% lidocaine spray before undergoing AFOI. Adequacy of intubation condition was evaluated by cough score and post-intubation score. Incidence of desaturation, hemodynamic changes and sedation using Ramsay sedation scale (RSS) were noted and compared between two groups. Results: Cough Score (1-4), post-intubation Score (1-3) and RSS (1-6) were significantly favorable (P < 0.0001) along with minimum hemodynamic responses to intubation (P < 0.05) and less oxygen desaturation (P < 0.0001) in Group A than Group B. Conclusion: Dexmedetomidine is more effective than fentanyl in producing better intubation conditions, sedation along with hemodynamic stability and less desaturation during AFOI. PMID:25948903

  12. Preparation of nose for nasal endoscopy: cotton pledget packing versus topical spray. A prospective randomized blinded study.

    PubMed

    Mishra, Prasun; Kaushik, Maitri; Dehadaray, Arun; Qadri, Haris; Raichurkar, Annapurna; Seth, Tanvi

    2013-01-01

    During nasal endoscopy it is essential to have proper visualization of structures with minimal discomfort to patient and surgeon. For this it is essential that the nose is well prepared before the procedure. The main objective of the study is to compare and evaluate the efficacy of cotton pledget packing versus topical sprays in preparation of nose for nasal endoscopy. The method includes prospective randomized blinded study on 100 patients. Patients were randomly divided in two groups. In first group the nose was packed with 4% lignocaine with xylometazoline nasal drops and in the other group it was prepared with 10% lignocaine topical spray and xylometazoline nose drops. Following the procedure, patient and the surgeon were asked a pre-formed questionnaire to know their experience during endoscopy. It was observed the packing group required more preparatory time as compared to the spray group. The group which was packed had less discomfort, less pain while endoscopy. The visualization of structures was significantly better in the packed group. Eight patients in the packed group did have some mucosal bleed during the process of packing which was not seen in the spray group. Both methods of preparation have merits and demerits but in terms of discomfort, pain during procedure and visualization of structure, packing of nasal cavity with 4% lignocaine and xylometazoline drops is better than spraying of nose with 10% lignocaine and xylometazoline drops. PMID:22427029

  13. Evaluation of a Geothermal Prospect Using a Stochastic Joint Inversion Algorithm

    NASA Astrophysics Data System (ADS)

    Tompson, A. F.; Mellors, R. J.; Ramirez, A.; Dyer, K.; Yang, X.; Trainor-Guitton, W.; Wagoner, J. L.

    2013-12-01

    A stochastic joint inverse algorithm to analyze diverse geophysical and hydrologic data for a geothermal prospect is developed. The purpose is to improve prospect evaluation by finding an ensemble of hydrothermal flow models that are most consistent with multiple types of data sets. The staged approach combines Bayesian inference within a Markov Chain Monte Carlo (MCMC) global search algorithm. The method is highly flexible and capable of accommodating multiple and diverse datasets as a means to maximize the utility of all available data to understand system behavior. An initial application is made at a geothermal prospect located near Superstition Mountain in the western Salton Trough in California. Readily available data include three thermal gradient exploration boreholes, borehole resistivity logs, magnetotelluric and gravity geophysical surveys, surface heat flux measurements, and other nearby hydrologic and geologic information. Initial estimates of uncertainty in structural or parametric characteristics of the prospect are used to drive large numbers of simulations of hydrothermal fluid flow and related geophysical processes using random realizations of the conceptual geothermal system. Uncertainty in the results is represented within a ranked subset of model realizations that best match all available data within a specified norm or tolerance. Statistical (posterior) characteristics of these solutions reflect reductions in the perceived (prior) uncertainties. This work was performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344. LLNL-ABS-641792.

  14. Dienogest as preoperative treatment of submucous myomas for hysteroscopic surgery: a prospective, randomized study.

    PubMed

    Laganà, Antonio Simone; Giacobbe, Valentina; Triolo, Onofrio; Granese, Roberta; Ban Frangež, Helena; Vrtačnik-Bokal, Eda; Ietto, Chiara; Palmara, Vittorio Italo

    2016-05-01

    The aim of this single-center, prospective, randomized, parallel-group study was to compare Dienogest and Danazol as endometrial preparation in patients who have to undergo hysteroscopic surgery for submucous myomas. We enrolled 80 consecutive eligible patients, in reproductive age, affected by submucous myomas. Pre- and posttreatment characterization of endometrium was performed by hysteroscopic visual observation and histologic confirmation. The enrolled patients were randomly assigned to two groups: 40 were treated with 2 mg of Dienogest/die, 40 with 100 mg of Danazol/die, both orally for 5 weeks, starting on day 1 of menstruation. Posttreatment comparison of endometrial patterns showed a significant more marked effect of Dienogest, respect to Danazol, in atrophying endometrium ("normotrophic non-responders" versus "hypotrophic"-"atrophic", p = 0.028). Intraoperative data showed no significant difference between the two groups for cervical dilatation time (p = 0.326), while in the Dienogest group, we found a significant reduction of operative time (p = 0.001), infusion volume (p = 0.001), and severity of bleeding (p = 0.042). Moreover, Dienogest caused less side effects (p = 0.008). According to our data analysis, Dienogest, respect to Danazol, is more effective for the preparation of the endometrium in patients who have to undergo hysteroscopic surgery for submucous myomas, and causes less side effects. PMID:26743136

  15. Teaching cognitive skills improves learning in surgical skills courses: a blinded, prospective, randomized study

    PubMed Central

    Kohls-Gatzoulis, Julie A.; Regehr, Glenn; Hutchison, Carol

    2004-01-01

    Objective To investigate the teaching of cognitive skills within a technical skills course, we carried out a blinded, randomized prospective study. Methods Twenty-one junior residents (postgraduate years 1– 3) from a single program at a surgical-skills training centre were randomized to 2 surgical skills courses teaching total knee arthroplasty. One course taught only technical skill and had more repetitions of the task (5 or 6). The other focused more on developing cognitive skills and had fewer task repetitions (3 or 4). All were tested with the Objective Structured Assessment of Technical Skill (OSATS) both before and after the course, as well as a pre- and postcourse error-detection exam and a postcourse exam with multiple-choice questions (MCQs) to test their cognitive skills. Results Both groups' technical skills as assessed by OSATS were equivalent, both pre- and postcourse. Taking their courses improved the technical skills of both groups (OSATS, p < 0.01) over their pre-course scores. Both groups demonstrated equivalent levels of knowledge on the MCQ exam, but the cognitive group scored better on the error-detection test (p = 0.02). Conclusions Cognitive skills training enhances the ability to correctly execute a surgical skill. Furthermore, specific training and practice are required to develop procedural knowledge into appropriate cognitive skills. Surgeons need to be trained to judge the correctness of their actions. PMID:15362330

  16. Malignant astrocytoma: hyperfractionated and standard radiotherapy with chemotherapy in a randomized prospective clinical trial

    SciTech Connect

    Payne, D.G.; Simpson, W.J.; Keen, C.; Platts, M.E.

    1982-12-01

    A prospective randomized trial of 157 patients with malignant astrocytomas (Grade III or IV) was carried out at a single institution. The minimization technique ensured balanced distribution of prognostic factors between the treatment groups. All received oral lomustine (CCNU, 80 mg/m/sup 2/) six weekly and hydroxyurea (HU, 3.5 gm/m/sup 2/ over 5 days) three weekly, for one year or until recurrence, with doses adjusted for myelosuppression. Patients were randomized to daily (5000 rad in 25 fractions (fr) in 5 weeks) or Q3h (every 3 hours) Cobalt 60 irradiation (3600-4000 rad in 36-40 fr of 100 rad each, given 4 fr per day at 3-hour intervals over two weeks). Steroid therapy (up to 16 mg day dexamethasone) was permitted. Complications were moderate and equivalent in the two groups. No significant survival or toxicity differences were seen between the two groups. Age, initial performance status, and extent of surgical resection were found to be significant (P<0.01) prognostic factors for survival. Median survival of the whole group was 48 weeks with a minimum follow-up of one year. There was no advantage to large radiation fields. The hyperfractionation and daily regimes had similar efficacy and toxicity. Hyperfractionation with chemotherapy offers a useful alternative approach in the management of this disease.

  17. Is alcohol required for effective pancreatic cyst ablation? The prospective randomized CHARM trial pilot study

    PubMed Central

    Moyer, Matthew T.; Dye, Charles E.; Sharzehi, Setareh; Ancrile, Brooke; Mathew, Abraham; McGarrity, Thomas J.; Gusani, Niraj; Yee, Nelson; Wong, Joyce; Levenick, John; Dougherty-Hamod, Brandy; Mathers, Bradley

    2016-01-01

    Background and study aims: In this study, we aim to determine the safety and feasibility of an alcohol-free approach to pancreatic cyst ablation using a chemotherapeutic ablation cocktail. Patients and methods: In this prospective, randomized, double-blinded pilot study, 10 patients with known mucinous type pancreatic cysts underwent endoscopic ultrasound (EUS)-guided fine needle aspiration and then lavage with either 80 % ethanol or normal saline. Both groups were then treated with a cocktail of paclitaxel and gemcitabine. Primary outcomes were reduction in cyst volume and rates of complications. Results: At 6 months, patients randomized to the alcohol arm had an 89 % average volume reduction, with a 91 % reduction noted in the alcohol-free arm. Complete ablation was achieved in 67 % of patients in the alcohol-free arm at both 6 and 12 months, whereas the alcohol group recorded complete ablation rates of 50 % and 75 % at 6 and 12 months, respectively. One patient in the alcohol arm developed acute pancreatitis (20 %) with no adverse events in the alcohol-free arm. Conclusions: This study revealed similar ablation rates between the alcohol ablation group and the alcohol-free arm and demonstrates the safety and feasibility of an alcohol-free ablation protocol. This pilot study suggests that alcohol may not be required for effective cyst ablation. PMID:27227122

  18. OPEN DRAINAGE VERSUS PERCUTANEOUS DRAINAGE IN THE TREATMENT OF TROPICAL PYOMYOSITIS. PROSPECTIVE AND RANDOMIZED STUDY

    PubMed Central

    Palacio, Evandro Pereira; Rizzi, Nívea Gitahy; Reinas, Gustavo Serra; Júnior, Melvis Michiuti; Júnior, Alcides Durigan; Mizobuchi, Roberto Ryuiti; Yanasse, Ricardo Hideki; da Silva, Marcos Vinícius Muriano; Branco, Rodrigo Borsatto; Galbiatti, José Antônio

    2015-01-01

    Objective: To compare the results from treating tropical pyomyositis through percutaneous drainage of abscesses versus open surgical drainage of abscesses, by means of a randomized prospective study. Methods: Twenty-five patients with tropical pyomyositis (Chiedozi grade II) were included in this study. They were randomized into two groups: group A (n = 13), treated with antibiotics and open drainage of the abscesses; and group B (n = 12), treated with antibiotics and percutaneous drainage of the abscesses. Results: The mean age was 35.3 years (± 19.2) in group A and 30.1 years (± 9) in group B (p = 0.41). There were eight female patients (61.5%) and five male patients (38.5%) in group A; in group B, three were female (25%) and nine were male (75%) (p = 0.11). Staphylococcus aureus was the microorganism most frequently found (72%). The mean hospital stay in group A was 12.7 days (± 2.3), and in group B, 10.6 days (± 1.6) (p = 0.01). The mean duration of antibiotic use in group A was 12.2 days (± 2.3), and in group B, 10.1 days (± 1.5) (p = 0.02). Conclusion: Percutaneous drainage of the abscesses, in association with antibiotic therapy, is an efficient treatment method for tropical pyomyositis grade II, with shorter antibiotic use and hospital stay for patients. PMID:27022550

  19. Effect of Preoperative Nerve Block on Postthyroidectomy Headache and Cervical Pain: A Randomized Prospective Study

    PubMed Central

    Barua, Sunil Malla Bujar; Kishore, Kamal; Mishra, Saroj Kanta; Agarwal, Gaurav; Agarwal, Amit; Verma, Ashok Kumar

    2016-01-01

    The aim of the current study was to investigate the efficacy of greater occipital nerve (GON) block and bilateral superficial cervical plexuses (BSCP) blocks in alleviating postoperative occipital headache and posterior neck pain after thyroidectomy. This randomized prospective study consisted of 75 women undergoing total thyroidectomy. Patients were randomized into three groups: Group I (n = 25): patients receiving GON, Group II (n = 25): patients receiving bilateral (BSCP) blocks, and Group III (n = 25): patients receiving no block. Assessment of occipital headache, posterior neck, and incision site pains was made at 12 hours and 24 hours after extubation by Visual Analogue Scale (VAS). In comparison to Group III significantly fewer patients in Groups I and II experienced occipital headache at 12 (p = 0.006) and 24 hours (p = 0.005) and also posterior neck pain at 24 hours (p = 0.003). Mean VAS scores at 12 and 24 hours for occipital headache (p = 0.003 and p = 0.041) and posterior neck pain (p = 0.015 and p = 0.008) were significantly lower in Group I. The differences between Groups II and III were not significant except for the occipital headache at 12 hours. The efficacy of GON block is superior to BSCP blocks in alleviating postthyroidectomy occipital headache and posterior cervical pain. PMID:27034886

  20. A prospective, randomized, double-blind trial of the use of fibrin sealant for face lifts.

    PubMed

    Oliver, D W; Hamilton, S A; Figle, A A; Wood, S H; Lamberty, B G

    2001-12-01

    Fibrin sealant imitates the final phase of the blood coagulation process. Fibrinogen is converted into fibrin on a tissue surface by the action of thrombin, which is then cross-linked by factor XIIIa, creating a mechanically stable fibrin network. This fibrin network is thought to reduce the amount of postoperative bleeding by sealing capillary vessels and allowing raw operative surfaces to adhere. The authors conducted a prospective, double-blind, randomized, controlled trial on the use of fibrin sealant in 20 consecutive patients undergoing bilateral face lifts by the same surgeon. Each patient was randomized for the use of fibrin sealant on either the right or the left side with the contralateral side acting as the control. Total drainage was recorded on each side for 24 hours before drains were removed. The age range of the patients in the trial (all of whom were women) was 44 to 70 years (mean, 55). The side treated with fibrin glue had a median drainage of 10 ml and the control side 30 ml. The Wilcoxon signed rank test shows a significant difference in drainage between sides (p = 0.002). The reduction in postoperative drainage could also reduce pain and bruising, increasing patient satisfaction with this procedure. The need for drains may also be obviated. PMID:11743409

  1. Oral clonidine and gabapentin suppress pressor response: A prospective, randomized, double blind study

    PubMed Central

    Kapse, Upendra Kumar S.; Bhalerao, Pradnya Milind

    2016-01-01

    Background: Pressor response is a part of stress response caused by reflex sympathetic discharge due to direct laryngoscopy and tracheal intubation resulting in tachycardia, hypertension and arrhythmias. Both clonidine, and gabapentin administered orally can effectively blunt this detrimental hemodynamic response. Aim: To study the effect of oral clonidine to blunt the pressor response to direct laryngoscopy and to compare it with oral gabapentin. To observe for postoperative sedation and side effects if any. Settings and Design: Sixty patients of American Society of Anaesthesiologist Grade I and II scheduled for surgery under general anesthesia were considered in this prospective randomized double-blind study. They were randomly allocated into two groups of 30 each using computerized randomization. Materials and Methods: Group A was given oral clonidine 5 μg/kg and Group B was given oral gabapentin 800 mg. Both the drugs were given 90 min prior to surgery. Heart rate (HR) and blood pressure were monitored at baseline, 0, 1, 3, 5, 10, 15, and 30th min of laryngoscopy. Sedation was monitored by Ramsay Sedation Scale score and side effects were noted. Results: HR decreased in both groups at 0 and 1 min, increased at 3rd min and gradually decreased by 30th min. Statistically, significant difference was found between two groups at 1, 3, 5, 10, and 15th min (P < 0.05). Though there was no significant difference in systolic blood pressure, diastolic blood pressure and mean arterial pressure between the two groups, there was no rise in these parameters. Gabapentin produced more sedation than clonidine postoperatively, and few side effects were noted. Conclusion: Both oral clonidine and gabapentin are effective in obtunding pressor response to direct laryngoscopy, clonidine being better in terms of controlling HR. Gabapentin produces more postoperative sedation than clonidine. PMID:26957684

  2. Prospective randomized trial of early postoperative intraperitoneal chemotherapy as an adjuvant to resectable gastric cancer.

    PubMed Central

    Yu, W; Whang, I; Suh, I; Averbach, A; Chang, D; Sugarbaker, P H

    1998-01-01

    OBJECTIVE: Surgeons have postulated on numerous occasions that cancer resection may participate in the dissemination of a malignancy. This randomized trial sought to determine whether a large volume of chemotherapy solution used perioperatively to flood the peritoneal cavity could eliminate microscopic residual disease and thereby improve survival of patients with gastric cancer. SUMMARY BACKGROUND DATA: Surgical treatment failures in patients with gastric cancer are confined to the abdomen in most patients. Resection site and peritoneal surface spread, along with liver metastases, are the most common areas of recurrence. Survival and quality of life of patients with gastric cancer would be improved if disease progression at these anatomic sites was reduced. METHODS: In a prospective randomized trial of 248 patients, intraperitoneal mitomycin C on day 1 and intraperitoneal 5-fluorouracil on days 2 through 5 were administered after gastric cancer resection. Patients who were thought to have stage II or stage III disease were randomized after resection to surgery alone versus surgery plus early postoperative intraperitoneal chemotherapy. After final pathologic examinations, there were 39 patients with stage I, 50 with stage II 95 with stage III, and 64 with resected stage IV cancer. RESULTS: The 5-year survival of the surgery-only group was 29.3%, and the surgery-plus-intraperitoneal chemotherapy group was 38.7% (p = 0.219). In a subset analysis, the patients with stage I, stage II, and stage IV disease showed no statistically significant difference in survival. The 5-year survival rate of patients with stage III disease who underwent surgery only was 18.4% versus a survival rate of 49.1% for patients who underwent surgery plus intraperitoneal chemotherapy (p = 0.011). CONCLUSIONS: In a subset analysis, patients with stage III gastric cancer have shown a statistically significant improvement in survival when treated with perioperative intraperitoneal chemotherapy

  3. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial.

    PubMed

    Wu, Yung-Tsan; Ke, Ming-Jen; Chou, Yu-Ching; Chang, Chih-Ya; Lin, Ching-Yueh; Li, Tsung-Ying; Shih, Feng-Mei; Chen, Liang-Cheng

    2016-06-01

    Three recent studies demonstrated the positive effect of extracorporeal shock wave therapy (ESWT) for treating carpal tunnel syndrome (CTS). However, none have entirely proved the effects of ESWT on CTS because all studies had a small sample size and lacked a placebo-controlled design. Moreover, radial ESWT (rESWT) has not been used to treat CTS. We conducted a prospective randomized, controlled, double-blinded study to assess the effect of rESWT for treating CTS. Thirty-four enrolled patients (40 wrists) were randomized into intervention and control groups (20 wrists in each). Participants in the intervention group underwent three sessions of rESWT with nightly splinting, whereas those in the control group underwent sham rESWT with nightly splinting. The primary outcome was visual analog scale (VAS), whereas the secondary outcomes included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. Evaluations were performed before treatment and at 1, 4, 8, and 12 weeks after the third rESWT session. A significantly greater improvement in the VAS, BCTQ scores, and CSA of the median nerve was noted in the intervention group throughout the study as compared to the control group (except for BCTQ severity at week 12 and CSA at weeks 1 and 4) (p < 0.05). This is the first study to assess rESWT in a randomized placebo-controlled trial and demonstrate that rESWT is a safe and effective method for relieving pain and disability in patients with CTS. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:977-984, 2016. PMID:26610183

  4. A Randomized, Prospective, Double-Blind, Placebo-Controlled Trial of Terlipressin for Type 1 Hepatorenal Syndrome

    PubMed Central

    SANYAL, ARUN J.; BOYER, THOMAS; GARCIA–TSAO, GUADALUPE; REGENSTEIN, FREDERICK; ROSSARO, LORENZO; APPENRODT, BEATE; BLEI, ANDRES; GÜLBERG, VEIT; SIGAL, SAMUEL; TEUBER, PETER

    2013-01-01

    Background & Aims Hepatorenal syndrome (HRS) type 1 is a progressive functional renal failure in subjects with advanced liver disease. The aim of this study was to evaluate the efficacy and safety of terlipressin, a systemic arterial vasoconstrictor, for cirrhosis type 1 HRS. Methods A prospective, randomized, double-blind, placebo-controlled clinical trial of terlipressin was performed. Subjects with type 1 HRS were randomized to terlipressin (1 mg intravenously every 6 hours) or placebo plus albumin in both groups. The dose was doubled on day 4 if the serum creatinine (SCr) level did not decrease by 30% of baseline. Treatment was continued to day 14 unless treatment success, death, dialysis, or transplantation occurred. Treatment success was defined by a decrease in SCr level to ≤1.5 mg/dL for at least 48 hours by day 14 without dialysis, death, or relapse of HRS type 1. Results Fifty-six subjects were randomized to each arm. Treatment success with terlipressin was double that with placebo (25% vs 12.5%, P = .093). SCr level improved from baseline to day 14 on terlipressin (−0.7 mg/dL) as compared with placebo (0 mg/dL), P < .009. Terlipressin was superior to placebo for HRS reversal (34% vs 13%, P= .008), defined by decrease in SCr level ≤1.5 mg/dL. Overall and transplantation-free survival was similar between study groups; HRS reversal significantly improved survival at day 180. One nonfatal myocardial infarction occurred with terlipressin, but the total adverse event rate was similar to placebo. Conclusions Terlipressin is an effective treatment to improve renal function in HRS type 1. PMID:18471513

  5. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study

    PubMed Central

    Zhang, Yu; Zhu, Hao-Ping; Fan, Jian-Xia; Yu, Hong; Sun, Li-Zhou; Chen, Lian; Chang, Qing; Zhao, Nai-Qing; Di, Wen

    2015-01-01

    Background: In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. Methods: This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2. Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h. Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes. Results: A total of 173 women for misoprostol group and 49 women for placebo were analyzed. The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs. 22.5%, relative risk [RR]: 2.9, 95% confidence interval [CI]: 1.4–6.0). The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs. 18.4%, RR: 2.6, 95% CI: 1.2–5.7); and the induction-onset of labor interval was significantly shorter in the misoprostol group (P = 0.0003). However, there were no significant differences in the median process time of vaginal labor (6.4 vs. 6.8 h; P = 0.695), incidence (39.3% vs. 49.0%, RR: 0.8, 95% CI: 0.4–1.5) and indications (P = 0.683) of cesarean section deliveries, and frequencies of maternal, fetal/neonatal adverse events between the groups. Conclusion: Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening. PMID:26481739

  6. Core Decompression and Autologous Bone Marrow Concentrate for Treatment of Femoral Head Osteonecrosis: A Randomized Prospective Study

    PubMed Central

    Pepke, Wojciech; Kasten, Philip; Beckmann, Nicholas A.; Janicki, Patricia; Egermann, Marcus

    2016-01-01

    The aim of this study was to investigate the safety of injection of bone marrow aspirate concentrate during core decompression and to study its clinical (visual analogue scale; Harris-Hip-score) and radiological outcomes (magnetic resonance imaging). In this prospective and randomized clinical trial we evaluated 24 consecutive patients with non-traumatic femoral head necrosis (FHN) during a period of two years after intervention. In vitro analysis of mesenchymal stem cells was performed by evaluating the fibroblast colony forming units (CFU-Fs). Postoperatively, significant decrease in pain associated with a functional benefit lasting was observed. However, there was no difference in the clinical outcome between the two study groups. Over the period of two years there was no significant difference between the head survival rate between both groups. In contrast to that, we could not perceive any significant change in the volume of FHN in both treatment groups related to the longitudinal course after treating. The number of CFU showed a significant increase after centrifugation. This trial could not detect a benefit from the additional injection of bone marrow concentrate with regard to bone regeneration and clinical outcome in the short term. PMID:27114808

  7. Core Decompression and Autologous Bone Marrow Concentrate for Treatment of Femoral Head Osteonecrosis: A Randomized Prospective Study.

    PubMed

    Pepke, Wojciech; Kasten, Philip; Beckmann, Nicholas A; Janicki, Patricia; Egermann, Marcus

    2016-03-21

    The aim of this study was to investigate the safety of injection of bone marrow aspirate concentrate during core decompression and to study its clinical (visual analogue scale; Harris-Hip-score) and radiological outcomes (magnetic resonance imaging). In this prospective and randomized clinical trial we evaluated 24 consecutive patients with non-traumatic femoral head necrosis (FHN) during a period of two years after intervention. In vitro analysis of mesenchymal stem cells was performed by evaluating the fibroblast colony forming units (CFU-Fs). Postoperatively, significant decrease in pain associated with a functional benefit lasting was observed. However, there was no difference in the clinical outcome between the two study groups. Over the period of two years there was no significant difference between the head survival rate between both groups. In contrast to that, we could not perceive any significant change in the volume of FHN in both treatment groups related to the longitudinal course after treating. The number of CFU showed a significant increase after centrifugation. This trial could not detect a benefit from the additional injection of bone marrow concentrate with regard to bone regeneration and clinical outcome in the short term. PMID:27114808

  8. Prospective Randomized Comparison of Chemoembolization with Doxorubicin-Eluting Beads and Bland Embolization with BeadBlock for Hepatocellular Carcinoma

    SciTech Connect

    Malagari, Katerina; Pomoni, Mary; Kelekis, Alexis; Pomoni, Anastasia; Dourakis, Spyros; Spyridopoulos, Themis; Moschouris, Hippokratis; Emmanouil, Emmanouil; Rizos, Spyros; Kelekis, Dimitrios

    2010-06-15

    The purpose of this study was to evaluate the added role of a chemotherapeutic in transarterial chemoembolization (TACE) of intermediate-stage hepatocellular carcinoma (HCC). The issue is of major importance since, as suggested by recent evidence, hypoxia or incomplete devascularization of the tumor is a potent stimulator of angiogenesis, and there are not many papers supplying level one evidence confirming the value of a chemotherapeutic. The hypothesis was that since drug-eluting bead (DEB)-TACE is standardized and reproducible, a comparison with bland TACE can readily reveal the potential value of the chemotherapeutic. Two groups were randomized in this prospective study: group A (n = 41) was treated with doxorubicin DEB-TACE, and group B (n = 43) with bland embolization. Patients were randomized for tumor diameter. Patients were embolized at set time intervals (2 months), with a maximum of three embolizations. Tumor response was evaluated using the EASL criteria and {alpha}-fetoprotein levels. At 6 months a complete response was seen in 11 patients (26.8%) in the DEB-TACE group and in 6 patients (14%) in the bland embolization group; a partial response was achieved in 19 patients (46.3%) and 18 (41.9%) patients in the DEB-TACE and bland embolization groups, respectively. Recurrences at 9 and 12 months were higher for bland embolization (78.3% vs. 45.7%) at 12 months. Time to progression (TTP) was longer for the DEB-TACE group (42.4 {+-} 9.5 and 36.2 {+-} 9.0 weeks), at a statistically significant level (p = 0.008). In conclusion, DEB-TACE presents a better local response, fewer recurrences, and a longer TTP than bland embolization with BeadBlock. However, survival benefit and bland embolization with smaller particles must be addressed in future papers to better assess the clinical value.

  9. Restrictive versus Standard Fluid Regimen in Elective Minilaparotomy Abdominal Aortic Repair-Prospective Randomized Controlled Trial.

    PubMed

    Piljic, Dragan; Petricevic, Mate; Piljic, Dilista; Ksela, Jus; Robic, Boris; Klokocovnik, Tomislav

    2016-06-01

    Objective Elective minilaparotomy abdominal aortic aneurysm (AAA) repair is associated with a significant number of complications involving respiratory, cardiovascular, gastrointestinal, and central nervous systems, with mortality ranging up to 5%. In our study, we tested the hypothesis that intra- and postoperative intravenous restrictive fluid regimen reduces postoperative morbidity and mortality, and improves the outcome of minilaparotomy AAA repair. Methods From March 2009 to July 2013, 60 patients operated due to AAA were included in a prospective randomized controlled trial (RCT). About the administration of fluid during the operation and in the early postoperative period, all the patients were randomized into two groups: the group of standard fluid administration (S-group, 30 patients) and the group of reduced fluid administration (R-group, 30 patients). The verification of the treatment success was measured by the length of intensive care unit (ICU) stay, duration of hospitalization after the procedure, as well as the number and type of postoperative complications and mortality. This prospective RCT was registered in a publicly accessible database ClinicalTrials.gov with unique Identifier ID: NTC01939652. Results Total fluid administration and administration of blood products were significantly lower in R-group as compared with S-group (2,445.5 mL vs. 3308.7 mL, p = 0.004). Though the number of nonlethal complications was significantly lower in R-group (2 vs. 9 patients, p = 0.042), the difference in lethal complications remained nonsignificant (0 vs. 1 patient, p = ns). The average ICU stay (1.2 vs. 1.97 days, p = 0.003) and duration of postoperative hospital stay (4.33 vs. 6.20 days, p = 0.035 for R-group and S-group, respectively) were found to be significantly shorter in R-group. Conclusion Intra- and postoperative restrictive intravenous fluid regimen in patients undergoing minilaparotomy AAA repair significantly reduces

  10. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    ERIC Educational Resources Information Center

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  11. Tamsulosin versus tadalafil as a medical expulsive therapy for distal ureteral stones: A prospective randomized study

    PubMed Central

    Shrestha, Anil; Acharya, Ganesh Bhakta; Basnet, Robin Bahadur; Shah, Arvind Kumar; Shrestha, Parash Mani

    2016-01-01

    Purpose This study aimed to compare the safety and efficacy of tamsulosin and tadalafil as medical expulsive therapy for distal ureteral stones. Materials and Methods This prospective randomized study was conducted at the Department of Urology of Bir Hospital over a period of 12 months in patients with distal ureteral stones sized 5 to 10 mm. Patients were randomly divided into 2 groups: group A received tamsulosin 0.4 mg and group B received tadalafil 10 mg at bedtime for 2 weeks. Stone expulsion rate, number of ureteric colic episodes and pain score, analgesic requirements, and adverse drug effects were noted in both groups. Statistical analyses were performed by using Student t-test and chi-square test. Results Altogether 85 patients, 41 in group A and 44 in group B, were enrolled in the study. The patients' average age was 31.72±12.63 years, and the male-to-female ratio was 1.5:1. Demographic profiles, stone size, and baseline investigations were comparable between the 2 groups. The stone expulsion rate was significantly higher in the tadalafil group than in the tamsulosin group (84.1% vs. 61.0%, p=0.017). Although the occurrence of side effects was higher with tadalafil, this difference was not significant (p=0.099). There were no serious adverse effects. Conclusions Tadalafil has a significantly higher stone expulsion rate than tamsulosin when used as a medical expulsive therapy for distal ureteral stones sized 5–10 mm. Both drugs are safe, effective, and well tolerated with minor side effects. PMID:27617317

  12. A prospective, randomized trial of BiPAP in severe acute congestive heart failure.

    PubMed

    Levitt, M A

    2001-11-01

    Noninvasive positive pressure ventilation has been found to be efficacious in the setting of acute respiratory failure, specifically in chronic obstructive pulmonary disease exacerbations. Its use in congestive heart failure (CHF) is less well established. Additionally, it has been reported that there is an increase in acute myocardial infarction (AMI) rate with the use of bilevel positive pressure ventilation (BiPAP) in CHF patients. This study examined whether BiPAP decreases the intubation rate or improves cardiopulmonary parameters in severe CHF patients compared to high flow O(2) by mask (MASK), and whether there is an increase in AMI rate with the use of BiPAP. A prospective, randomized clinical trial at a county hospital teaching Emergency Department was conducted by enrolling 38 patients who were in severe CHF. Patients were randomized to receive either BiPAP or MASK in addition to adjunct therapy. Age and gender were not different between the groups. Heart rate, systolic blood pressure, diastolic blood pressure, respiratory rate, and pulse oximetry all showed no significant difference in change over time between groups, but there was a significant change over time within groups. Arterial pH, pCO(2), and pO(2) also showed no significant difference in change over time between groups, but there was a significant change over time within groups. The intubation rate for BiPAP was 23.8% (5) vs. MASK at 41.2% (7). The AMI rate was 19% (4) in the BiPAP group and 29.4% (5) in the MASK group. No true differences were detected between groups for increased oxygenation or a reduction in intubation rate. An increase in AMI rate with BiPAP was not found in this study as previously reported. This study provides support for a larger clinical trial assessing the safety and efficacy of BiPAP in acute CHF. PMID:11728761

  13. Hypertonic fluid administration in patients with septic shock: a prospective randomized controlled pilot study.

    PubMed

    van Haren, Frank M P; Sleigh, James; Boerma, E Christiaan; La Pine, Mary; Bahr, Mohamed; Pickkers, Peter; van der Hoeven, Johannes G

    2012-03-01

    We assessed the short-term effects of hypertonic fluid versus isotonic fluid administration in patients with septic shock. This was a double-blind, prospective randomized controlled trial in a 15-bed intensive care unit. Twenty-four patients with septic shock were randomized to receive 250 mL 7.2% NaCl/6% hydroxyethyl starch (HT group) or 500 mL 6% hydroxyethyl starch (IT group). Hemodynamic measurements included mean arterial blood pressure (MAP), central venous pressure, stroke volume index, stroke volume variation, intrathoracic blood volume index, gastric tonometry, and sublingual microcirculatory flow as assessed by sidestream dark field imaging. Systolic tissue Doppler imaging velocities of the medial mitral annulus were measured using echocardiography to assess left ventricular contractility. Log transformation of the ratio MAP divided by the norepinephrine infusion rate (log MAP/NE) quantified the combined effect on both parameters. Compared with the IT group, hypertonic solution treatment resulted in an improvement in log MAP/NE (P = 0.008), as well as an increase in systolic tissue Doppler imaging velocities (P = 0.03) and stroke volume index (P = 0.017). No differences between the groups were found for preload parameters (central venous pressure, stroke volume variation, intrathoracic blood volume index) or for afterload parameters (systemic vascular resistance index, MAP). Hypertonic solution treatment decreased the need for ongoing fluid resuscitation (P = 0.046). No differences between groups were observed regarding tonometry or the sublingual microvascular variables. In patients with septic shock, hypertonic fluid administration did not promote gastrointestinal mucosal perfusion or sublingual microcirculatory blood flow in comparison to isotonic fluid. Independent of changes in preload or afterload, hypertonic fluid administration improved the cardiac contractility and vascular tone compared with isotonic fluid. The need for ongoing fluid

  14. Effect of Pressurized Cement Insertion on Cardiopulmonary Parameters during Cemented Hip Hemiarthroplasty: A Randomized Prospective Study

    PubMed Central

    Song, Woo Suk; Kim, Tae Hyun; Oh, Sang Hoon; Park, Sub Ri; Park, Byoung Hark

    2014-01-01

    Purpose We aimed to investigate the cardiopulmonary effects of pressurized cement insertion in elderly patients undergoing cemented hip hemiarthroplasty. Materials and Methods We conducted a randomized prospective study on elderly patients undergoing cemented hip hemiarthroplasty. Patients were divided into pressurized and non-pressurized groups based on the pressure application during cement insertion. We measured mean arterial blood pressure (MAP), systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), arterial blood gases and serotonin concentration in blood. These variables were measured before bone cement insertion, and 3 and 5 minute after insertion. They were also measured immediately and 15 minutes after reduction. Results In cemented hip hemiarthroplasty, there were no significant change in MAP (P=0.92), SBP (P=0.85), DBP (P=0.98), HR (P=0.97) and serotonin concentration over time. There were no statistically significant difference between the two groups in MAP, SBP, DBP, HR, PO2, PaCO2, SaO2 and serotonin concentration, though three minutes after cement insertion, both groups showed decreases in SBP, DBP and MBP. Conclusion The pressurization method in cemented hip hemiarthroplasty was not found to be related with development of bone cement syndromes in elderly patients.

  15. A prospective, randomized comparison of interpleural and paravertebral analgesia in thoracic surgery.

    PubMed

    Richardson, J; Sabanathan, S; Mearns, A J; Shah, R D; Goulden, C

    1995-10-01

    We have undertaken a prospective, randomized comparison of the superficially similar techniques of interpleural and paravertebral (extrapleural) analgesia in 53 patients undergoing posterolateral thoracotomy. Local anaesthetic placed anterior to the superior costotransverse ligament and posterior to the parietal pleura produces a paravertebral block and instilled between the parietal and visceral pleurae produces an interpleural block. Patients received preoperative and postoperative continuous bupivacaine paravertebral blocks in group 1 and interpleural blocks in group 2. Premedication comprised diclofenac and morphine, and after operation all patients had regular diclofenac and patient-controlled morphine (PCM). Analgesia was assessed by visual analogue pain scores (VAS), PCM requirements, ratio of preoperative to postoperative spirometric values (PFT), rates of postoperative respiratory morbidity (PORM) and hospital stay, all recorded by blinded observers. Eight patients were withdrawn and data from 45 patients were analysed. Patient characteristics, surgery, VAS scores and PCM use were similar in both groups. PFT were significantly better (P = 0.03-0.0001) in group 1, and PORM was lower and hospital stay approximately 1 day less in this group. Five patients in group 2 became temporarily confused, probably because of bupivacaine toxicity (P = 0.02). We conclude that bupivacaine deposited paravertebrally produced greater preservation of lung function and fewer side effects than bupivacaine administered interpleurally. PMID:7488477

  16. Prospective randomized comparison of progressive dilational vs forceps dilational percutaneous tracheostomy.

    PubMed

    Kaiser, E; Cantais, E; Goutorbe, P; Salinier, L; Palmier, B

    2006-02-01

    This trial prospectively compares two methods of percutaneous tracheostomy, both routinely used in ICU: the Ciaglia progressive dilational tracheostomy and the Griggs forceps dilational tracheostomy. One hundred patients were randomized using a single-blinded envelope method to receive progressive or forceps percutaneous tracheostomy performed at the bedside. Operative time, the occurrence of hypoxaemia or hypercapnia and complications were recorded. The progressive technique took longer than the forceps technique (median 7 (range 2-26) vs. 4 (1-16) minutes, P = 0.0005). Hypercapnia occurred in both groups but was more marked with the progressive technique (56 (16) vs. 49 (13) mmHg, P = 0.0082). Minor complications (minor bleeding, transient hypoxaemia, damage to posterior tracheal wall without emphysema) were also more frequent with the progressive technique (31 vs. 9 complications, P < 0.0001). Six major complications occurred with the progressive technique, none with the forceps technique (P = 0.0085): tension pneumothorax, posterior tracheal wall injury with subcutaneous emphysema, loss of airway with hypoxaemia, loss of stoma with impossible re-catheterization, and two conversions to another technique. In conclusion, progressive dilational tracheostomy took longer, caused more hypercapnia and more minor and major difficulties than forceps dilational tracheostomy. PMID:16494150

  17. Total costs of laparoscopic and lichtenstein inguinal hernia repairs: a randomized prospective study.

    PubMed

    Heikkinen, T; Haukipuro, K; Leppälä, J; Hulkko, A

    1997-02-01

    In a prospective, randomized study, laparoscopic (n = 20) and Lichtenstein (n = 18) inguinal hernia repairs were compared in relation to operative time, operative costs, hospital stay, postoperative pain, return to work, patient satisfaction, complications, and total costs. All the operations were performed with the patient under general anesthesia. The median operative times in the laparoscopic and Lichtenstein groups were 71.5 (range, 43-140) and 45 (16-83) min, respectively (p < 0.001). Postoperative pain and use of analgesics was less in the laparoscopic group. The median time to return to work was 14 (8-26) days in the laparoscopic group and 19 (5-40) days in the Lichtenstein group. More complications occurred in the Lichtenstein group. The median of the operative costs, in U.S. dollars, was $1,395 and $878, respectively, and the median total costs (including community expenses resulting from lost workdays) were $4,796 in the laparoscopic and $5,320 in the Lichtenstein groups. PMID:9116938

  18. Effect of prophylactic antibiotics in acute nonperforated appendicitis: a prospective, randomized, double-blind clinical study.

    PubMed Central

    Busuttil, R W; Davidson, R K; Fine, M; Tompkins, R K

    1981-01-01

    A prospective, randomized, double-blind clinical study was performed to determined the efficacy of short-term (24 hr) perioperative antibiotics in preventing septic complications after emergency appendectomy for nonperforated appendicitis. The patients were stratified into three clinical arms: Group I (placebo, n = 45), Group II (cefamandole, n = 46) and Group III (cefamandole plus carbenicillin, n = 45). The three groups of patients were similar in regard to age, sex, duration of operation and pathologic classification of the appendix. The overall incidence of infection in the study was 5.1%. The infection rates in Groups II (2.2%) and III (0%) were significantly lower than Group I (placebo) (13.3%), (p less than 0.05). No difference was observed between cefamandole alone and cefamandole plus carbenicillin. Average postoperative hospital days per patient for each group was: Group I - 3.8 days; Group II - 2.9 days; Group III - 3.1 days. Cost analysis of hospitalization including cost of prophylactic antibiotics revealed a $247.99 per patient saving for Group II versus Group I and $95.53 for Group III versus Group I. Systemic prophylactic antibiotics can successfully reduce septic complications after appendectomy for nonperforated appendicitis, and a single drug (cefamandole) directed at the facultative pathogens is as effective as double drug therapy, which includes specific anaerobic coverage. PMID:7025769

  19. RANDOMIZED PROSPECTIVE STUDY COMPARING TRANSVERSE AND EXTRACORTICAL FIXATION IN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION

    PubMed Central

    da Silva Guarilha, Eduardo; de Andrade Fígaro Caldeira, Paulo Roberto; de Almeida Lira Neto, Ozorio; Navarro, Marcelo Schmidt; Milani, Antonio; Filho, Mario Carneiro

    2015-01-01

    Objective: This study had the objective of prospectively comparing transverse fixation (Cross-Pin™) with extracortical fixation (EZLoc™) for the femur, in surgical reconstruction of the anterior cruciate ligament, from a clinical, biomechanical and functional point of view. Methods: Between April 2007 and November 2009, 50 patients with acute or chronic anterior cruciate ligament injuries underwent arthroscopic reconstruction using the homologous flexor tendons (gracilis and semitendinosus). Randomization of the femoral fixation method was done by means of a draw at the time of the procedure. Patients were excluded if they presented multiple ligament lesions, fractures, previous surgery, autoimmune disease and impairment of the contralateral knee. The Lysholm scale, SF36 quality-of-life questionnaire and KT1000™ arthrometer were used. Results: After a mean follow-up of 18.1 months, there were no statistically significant differences between the groups regarding the Lysholm scale and KT1000™ measurements. However, the SF36 questionnaire showed a statistical difference such that transverse fixation was superior regarding pain and vitality. Conclusion: Both techniques were shown to be efficient for transfemoral fixation, but with almost no statistically significant difference between them. We believe that new studies will be necessary for better understanding of these differences. PMID:27042646

  20. A prospective, randomized, controlled study of a suspension positioning system used with elderly bedridden patients with neurogenic fecal incontinence.

    PubMed

    Su, Mei-Yin; Lin, Shi-Quan; zhou, Ye-Wen; Zhou, Ye-Wen; Liu, Si-Ya; Lin, Ai; Lin, Xi-Rong

    2015-01-01

    Elderly patients with acute neurological impairment are prone to severe disability, fecal incontinence (FI), and resultant complications. A suspension positioning system (SPS), based on the orthopedic suspension traction system commonly used for conservative treatment of pediatric femoral fracture and uncomplicated adult pelvic fracture, was developed to facilitate FI management in patients immobilized secondary to an acute neurological condition. To evaluate the effectiveness and safety of the system, a prospective, randomized, controlled study was conducted between October 2009 and July 2012. Two hundred (200) elderly, bedridden, hospitalized patients with acute, nonchronic neurological impairment were randomly assigned to receive routine FI nursing care (ie, individualized dietary modification, psychological support, health education, and social support for caregivers and family members [control group]) or routine incontinence care plus the SPS (experimental group) during the day. Rates of perianal fecal contamination, skin breakdown, incontinence associated dermatitis, pressure ulcer development, and lower urinary tract infection (LUTI) were significantly lower in the SPS than in the control group (P <0.05). Length of hospitalization and costs of care were also lower in the SPS group (P <0.05). Patient quality-of-life (QoL) and FI QoL scores were similar at baseline but significantly higher (better) at the 6-month follow-up interview in the SPS than in the control group (P <0.05). In this study, the rate of FI-associated morbidities was lower and 6-month patient QoL scores were higher in the SPS than in the control group. No adverse events were observed, and all patients completed the study. Further clinical studies are needed to examine the long-term effects of SPS use among neurologically impaired FI patients. PMID:25581605

  1. A randomized controlled prospective study to assess the role of subconjunctival bevacizumab in primary pterygium surgery in Indian patients

    PubMed Central

    Singh, Priyanka; Sarkar, Lopa; Sethi, H S; Gupta, V S

    2015-01-01

    Background: Pterygium is an ocular surface disorder with prevalence rates ranges from 0.3% to 29% in different parts of the world. Vascular endothelial growth factor (VEGF) has been detected in increased amounts in pterygium epithelium, compared with normal conjunctiva. Bevacizumab is a recombinant, humanized anti-VEGF antibody suggested as a possible adjunctive therapy for pterygium excision that appears to have a role in prevention of recurrence. We conducted this study to evaluate the role of subconjunctival bevacizumab in primary pterygium surgery in Indian patients. Methods: In this randomized prospective clinical study, the patients were randomized into two groups of 30 patients each. Study group received 1.25 mg/0.05 ml subconjunctival bevacizumab 1 week before pterygium surgery with conjunctival autograft. Control group received 1.25 mg (0.05 ml) subconjunctival normal saline 1 week prior to pterygium surgery with conjunctival autograft. Patients were followed up at day 1, day 7, 1 month and 3 months. The main outcome measures were morphology of pterygium after injection, intra-operative ease, recurrence of pterygia, and any complications. Results: After giving bevacizumab, there was statistically significant improvement in grade, color intensity, size of pterygium, and symptoms of patients. Intra-operatively, less bleeding was observed by the surgeon. No statistically significant difference regarding reduction in astigmatism, improvement of visual acuity, and complications were observed in two groups. Recurrence was noted in five patients (8.33%) in total study population at the end of 3 months. It was present in two patients (6.67%) in Group A and three patients (10%) in Group B. Conclusion: Single preoperative administration of subconjunctival injection bevacizumab given 1 week before the pterygium excision with conjunctival autograft decreases the vascularity of newly formed blood vessels, hence may decrease recurrence rate though not in our study. PMID

  2. Comparison of Incidence of hypoxia during modified rapid sequence induction and an alternative technique: a prospective randomized controlled trial

    PubMed Central

    Sun, Ji; Li, Xing-Huan; Zuo, Yun-Xia

    2015-01-01

    Background: We evaluated the effects and safety of an alternative technique for rapid sequence intubation in children predicting to have high risk of pulmonary aspiration in this prospective, randomized, placebo-controlled study. Methods: One hundred sixty-five children predicting to have high risk of pulmonary aspiration were randomly allocated to spontaneous breathing maintained induction and intubation group (Group S) and the modified rapid sequence group (Group C). The primary outcome was the incidence of hypoxemia around the intubation period, which was defined as SpO2<90% at any time during the induction and 10 min after the endotracheal intubation. Secondary outcomes included the incidence of pulmonary aspiration, gastroesophageal reflux and other major adverse events associated with the induction and intubation. Results: There were no differences in the incidence of hypoxemia around the intubation period between Group C and Group S; 25.9% vs. 14.8% (P=0.079). The incidence of severe hypoxemia appeared higher in Group C than Group S but not statistical significance, 6.2% vs. 2.5% (P=0.246). Simultaneously, gastroesophageal reflux (upper esophageal pH≤4) was detected in 4.93% children in Group C and 2.47% in group S, which was not significantly different between the two groups (P=0.552). There were no witnessed aspirations in all subjects. Conclusion: Sevoflurane based deep sedation with spontaneous respiration maintained technique is not superior to modified rapid sequence induction but can be an alternative technique for anesthesia induction for those predicting to have high risk of aspiration in children. PMID:26629138

  3. Comparative efficacy of tadalafil versus tamsulosin as the medical expulsive therapy in lower ureteric stone: a prospective randomized trial

    PubMed Central

    Mylarappa, Prasad; Aggarwal, Kuldeep; Patil, Avinash; Joshi, Prarthan; Desigowda, Ramesh

    2016-01-01

    Introduction In recent years, medical expulsive therapy has been used in the management of distal ureteric stones as a supplement to conservative treatment. Therefore, we conducted a prospective randomized study to evaluate the possible role of tadalafil individually in comparison with proven tamsulosin therapy in ureteric stone expulsion. The aim of this study is to compare the safety and efficacy of a phosphodiesterase-5 inhibitor (tadalafil) and an α-1 blocker (tamsulosin) as medical expulsive therapy for distal ureteric calculi. Material and methods Between August 2014 and October 2015, 207 patients who presented with distal ureteric stones of size 5–10 mm were randomly divided into two groups: tadalafil (Group A) and tamsulosin (Group B). Therapy was given for a maximum of 4 weeks. Stone expulsion rate, time to stone expulsion, analgesic use, number of hospital visits for pain, follow-up, endoscopic treatment and adverse effects of drugs were noted. Both groups were compared for normally distributed data by percentage, analysis of variance, and T-test. All the classified and categorical data were analyzed for both groups using the chi-square test. Results A statistically significant expulsion rate of 84.0% in Group A compared with 68.0% in Group B (P value = 0.0130), and shorter stone expulsion time in Group A (14.7±3.8) in comparison to Group B (16.8 ±4.5) was observed. Statistically significant differences were noted in renal colic episodes and analgesic requirement in Group A than Group B. No serious adverse effects were noted. Conclusions Tadalafil is safe, efficacious, and well tolerated as medical expulsive therapy for distal ureteric stones. This study showed that tadalafil increases ureteric stone expulsion quite significantly along with better control of pain and significantly lower analgesic requirement. PMID:27551555

  4. EDUC’AVK: Reduction of Oral Anticoagulant-related Adverse Events After Patient Education: A Prospective Multicenter Open Randomized Study

    PubMed Central

    Labarère, José; Yver, Jacqueline; Satger, Bernadette; Allenet, Benoit; Berremili, Touffek; Fontaine, Michèle; Franco, Guy; Bosson, Jean Luc

    2008-01-01

    Background Long-term oral anticoagulation treatment is associated with potential morbidity. Insufficient patient education is linked to poorly controlled anticoagulation. However the impact of a specific educational program on anticoagulation related morbidity remains unknown. Objective To evaluate the effect of an oral anticoagulation patient education program in reducing both hemorrhagic and recurrent thrombotic complications. Design/Participants We conducted a prospective, multicenter open randomized study, comparing an interventional group who received a specific oral anticoagulation treatment educational program with a control group. Eligible patients were older than 18 and diagnosed as having deep vein thrombosis or pulmonary embolism requiring therapy with a vitamin K antagonist for 3 months or more. Our primary outcome was the occurrence of hemorrhagic or thromboembolic events. Results During the 3-month follow-up the main outcome criteria were observed 20 times (6.6% of patients), 5 (3.1%) in the experimental and 15 (10.6%) in the control group. Consequently, in multivariate analysis, the cumulative risk reduction in the experimental group was statistically significant (OR 0.25, 95% CI 0.1 – 0.7,  < 0.01). Conclusions Patient education using an educational program reduced VKA-related adverse event rates. PMID:18566863

  5. Longtime soaking of high concentration tranexamic acid in total hip arthroplasty: A prospective randomized controlled trial in 224 patients

    PubMed Central

    Xu, Xingming; Li, Xiaofeng; Liu, Wei; Wang, Zhenyu

    2015-01-01

    Objectives: To evaluate the efficacy and safety of intra-articular Soaking of high concentration Tranexamic Acid (TXA) in total hip arthroplasty. Methods: From March 2013 to March 2014, 224 patients who underwent unilateral primary THA in our hospital was enrolled in this randomized, prospective double-blinded study. The patients were allocated into two groups according to intra-articular solution received: Intra-articular soaking of TXA group, Control group (physiologic saline). The solution was injected from intermuscular space following fixation of the implants and closure of articular capsule, short external rotators. Total blood loss, total volume of drainage and transfusion were recorded. Postoperative deep vein thrombosis and other complications was also measured. Results: The mean total blood loss was 730±296 ml in intra-articular soaking of TXA group compared with 1048±295ml in control group (P<0.05). The postoperative mean total volume of drainage was 93±50 mL in intra-articular soaking of TXA group versus 312±136 mL in control group.22 patients (19.8%, control) and 6 patients (5.3%, Intra-articular soaking of TXA) required transfusion (P=0.001). Postoperative deep vein thrombosis and other complications were no statistical significance between the two groups. Conclusions: Intra-articular soaking of high concentration TXA with 2-hour clamping drain can reduce the total blood loss and transfusion rates in primary THA without significant increase in postoperative thrombotic complications. PMID:26870087

  6. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

    PubMed Central

    2011-01-01

    Background The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences. Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. Methods/Design This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning). Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory. Study parameters are clinical consolidation, radiological consolidation

  7. Is early oral feeding safe after elective colorectal surgery? A prospective randomized trial.

    PubMed Central

    Reissman, P; Teoh, T A; Cohen, S M; Weiss, E G; Nogueras, J J; Wexner, S D

    1995-01-01

    INTRODUCTION: The routine use of a nasogastric tube after elective colorectal surgery is no longer mandatory. More recently, early feeding after laparoscopic colectomy has been shown to be safe and well tolerated. Therefore, the aim of our study was to prospectively assess the safety and tolerability of early oral feeding after elective "open" abdominal colorectal operations. MATERIALS AND METHODS: All patients who underwent elective laparotomy with either colon or small bowel resection between November 1992 and April 1994 were prospectively randomized to one of the following two groups: group 1: early oral feeding--all patients received a clear liquid diet on the first postoperative day followed by a regular diet as tolerated; group 2: regular feeding--all patients were treated in the "traditional" way, with feeding only after the resolution of their postoperative ileus. The nasogastric tube was removed from all patients in both groups immediately after surgery. The patients were monitored for vomiting, bowel movements, nasogastric tube reinsertion, time of regular diet consumption, complications, and length of hospitalization. The nasogastric tube was reinserted if two or more episodes of vomiting of more than 100 mL occurred in the absence of bowel movement. Ileus was considered resolved after a bowel movement in the absence of abdominal distention or vomiting. RESULTS: One hundred sixty-one consecutive patients were studied, 80 patients in group 1 (34 males and 46 females, mean age 51 years [range 16-82 years]), and 81 patients in group 2 (43 males and 38 females, mean age 56 years [range 20-90 years]). Sixty-three patients (79%) in the early feeding group tolerated the early feeding schedule and were advanced to regular diet within the next 24 to 48 hours. There were no significant differences between the early and regular feeding groups in the rate of vomiting (21% vs. 14%), nasogastric tube reinsertion (11% vs. 10%), length of ileus (3.8 +/- 0.1 days vs. 4

  8. Reliability Evaluation Based on Different Distributions of Random Load

    PubMed Central

    Gao, Peng; Xie, Liyang

    2013-01-01

    The reliability models of the components under the nonstationary random load are developed in this paper. Through the definition of the distribution of the random load, it can be seen that the conventional load-strength interference model is suitable for the calculation of the static reliability of the components, which does not reflect the dynamic change in the reliability and cannot be used to evaluate the dynamic reliability. Therefore, by developing an approach to converting the nonstationary random load into the random load whose pdf is the same at each moment when the random load applies, the reliability model based on the longitudinal distribution is derived. Moreover, through the definition of the transverse standard load and the transverse standard load coefficient, the reliability model based on the transverse distribution is derived. When the occurrence of the random load follows the Poisson process, the dynamic reliability models considering the strength degradation are derived. These models take the correlation between the random load and the strength into consideration. The result shows that the dispersion of the initial strength and that of the transverse standard load coefficient have great influences on the reliability and the hazard rate of the components. PMID:24223504

  9. Use of Axillary Deodorant and Effect on Acute Skin Toxicity During Radiotherapy for Breast Cancer: A Prospective Randomized Noninferiority Trial

    SciTech Connect

    Theberge, Valerie; Harel, Francois; Dagnault, Anne

    2009-11-15

    Purpose: To prospectively determine the effect of deodorant use on acute skin toxicity and quality of life during breast radiotherapy (RT). Methods and Materials: Before breast RT, 84 patients were randomly assigned to the deodorant group (n = 40) or the no-deodorant group (n = 44). The patients were stratified by axillary RT and previous chemotherapy. Toxicity evaluations were always performed by the principal investigator, who was unaware of the group assignment, at the end of RT and 2 weeks after completion using the Radiation Therapy Oncology Group acute skin toxicity criteria. Symptoms of acute skin toxicity (i.e., discomfort, pain, pruritus, sweating) and quality of life were self-evaluated. For each criterion, the point estimate of rate difference with the 95% one-sided upper confidence limit was computed. To claim noninferiority owing to deodorant use, the 95% one-sided upper confidence limit had to be lower than the noninferiority margin, fixed to 12.8%. Results: In the deodorant vs. no-deodorant groups, Grade 2 axillary radiodermatitis occurred in 23% vs. 30%, respectively, satisfying the statistical criteria for noninferiority (p = .019). Grade 2 breast radiodermatitis occurred in 30% vs. 34% of the deodorant vs. no-deodorant groups, respectively, also satisfying the statistical criteria for noninferiority (p = .049). Similar results were observed for the self-reported evaluations. The deodorant group reported less sweating (18% vs. 39%, p = .032). No Grade 3 or 4 radiodermatitis was observed. Conclusion: According to our noninferiority margin definition, the occurrence of skin toxicity and its related symptoms were statistically equivalent in both groups. No evidence was found to prohibit deodorant use (notwithstanding the use of an antiperspirant with aluminum) during RT for breast cancer.

  10. A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors

    PubMed Central

    Peters, Melissa; Boeldt, Debra L.; Ariniello, Lauren; Kim, Ju Young; Sheard, Judith; Komatireddy, Ravi; Barrett, Paddy

    2016-01-01

    Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers–some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s) (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG) and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program–making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large short-term increases

  11. Prospective Randomized Trial of ACUSEAL Versus Vascu-Guard Patching in Carotid Endarterectomy

    PubMed Central

    Stone, Patrick A.; AbuRahma, Ali F.; Mousa, Albeir Y.; Phang, David; Hass, Stephen M.; Modak, Asmita; Dearing, David

    2015-01-01

    Background Multiple studies have been conducted that demonstrate the superiority of patch angioplasty over primary closure for carotid endarterectomy (CEA). Patch angioplasty with poly-tetrafluorethylene patches (ACUSEAL) have shown results comparable to patch angioplasty with saphenous vein and polyester patches. This is a prospective randomized study to compare the clinical outcomes of CEA using ACUSEAL versus bovine pericardium patching (Vascu-Guard). Methods Two hundred patients were randomized (1:1) to either ACUSEAL or Vascu-Guard patching. Demographic data/clinical characteristics were collected. Intraoperative hemostasis times and the frequency of reexploration for neck hematoma were recorded. All patients received immediate and 1-month postoperative duplex ultrasound studies, which were repeated at 6-month intervals. A Kaplan–Meier analysis was used to estimate the risk of restenosis and the stroke-free survival rates. Results The demographics were similar in both groups, except for a higher incidence of current smokers in the ACUSEAL group and more patients with congestive heart failure in the Vascu-Guard group (P = 0.02 and 0.03, respectively). The mean operative internal carotid artery diameter and the mean arteriotomy length were similar in both groups. The mean hemostasis time was 4.90 min for ACUSEAL patching vs. 3.09 min for Vascu-Guard (P = 0.027); however, the mean operative times were similar for both groups (ACUSEAL 2.09 hr vs. Vascu-Guard 2.16 hr, P = 0.669). The incidence of reexploration for neck hematoma was higher in the Vascu-Guard group; 6.12% vs. 1.03% (P = 0.1183). The incidence of perioperative ipsilateral neurologic events was 3.09% for ACUSEAL patching vs. 1.02% for Vascu-Guard patching (P = 0.368). The mean follow-up period was 15 months. The respective freedom from ≥70% carotid restenosis at 1, 2, and 3 years were 100%, 100%, and 100% for ACUSEAL patching vs. 100%, 98%, and 98% for Vascu-Guard patching (P = 0.2478). The

  12. A prospective randomized trial examining health care utilization in individuals using multiple smartphone-enabled biosensors.

    PubMed

    Bloss, Cinnamon S; Wineinger, Nathan E; Peters, Melissa; Boeldt, Debra L; Ariniello, Lauren; Kim, Ju Young; Sheard, Judith; Komatireddy, Ravi; Barrett, Paddy; Topol, Eric J

    2016-01-01

    Background. Mobile health and digital medicine technologies are becoming increasingly used by individuals with common, chronic diseases to monitor their health. Numerous devices, sensors, and apps are available to patients and consumers-some of which have been shown to lead to improved health management and health outcomes. However, no randomized controlled trials have been conducted which examine health care costs, and most have failed to provide study participants with a truly comprehensive monitoring system. Methods. We conducted a prospective randomized controlled trial of adults who had submitted a 2012 health insurance claim associated with hypertension, diabetes, and/or cardiac arrhythmia. The intervention involved receipt of one or more mobile devices that corresponded to their condition(s) (hypertension: Withings Blood Pressure Monitor; diabetes: Sanofi iBGStar Blood Glucose Meter; arrhythmia: AliveCor Mobile ECG) and an iPhone with linked tracking applications for a period of 6 months; the control group received a standard disease management program. Moreover, intervention study participants received access to an online health management system which provided participants detailed device tracking information over the course of the study. This was a monitoring system designed by leveraging collaborations with device manufacturers, a connected health leader, health care provider, and employee wellness program-making it both unique and inclusive. We hypothesized that health resource utilization with respect to health insurance claims may be influenced by the monitoring intervention. We also examined health-self management. Results & Conclusions. There was little evidence of differences in health care costs or utilization as a result of the intervention. Furthermore, we found evidence that the control and intervention groups were equivalent with respect to most health care utilization outcomes. This result suggests there are not large short-term increases or

  13. Prospective Randomized Trial Comparing Hepatic Venous Outflow and Renal Function after Conventional versus Piggyback Liver Transplantation

    PubMed Central

    Brescia, Marília D’Elboux Guimarães; Massarollo, Paulo Celso Bosco; Imakuma, Ernesto Sasaki; Mies, Sérgio

    2015-01-01

    Background This randomized prospective clinical trial compared the hepatic venous outflow drainage and renal function after conventional with venovenous bypass (n = 15) or piggyback (n = 17) liver transplantation. Methods Free hepatic vein pressure (FHVP) and central venous pressure (CVP) measurements were performed after graft reperfusion. Postoperative serum creatinine (Cr) was measured daily on the first week and on the 14th, 21st and 28th postoperative days (PO). The prevalence of acute renal failure (ARF) up to the 28th PO was analyzed by RIFLE-AKIN criteria. A Generalized Estimating Equation (GEE) approach was used for comparison of longitudinal measurements of renal function. Results FHVP-CVP gradient > 3 mm Hg was observed in 26.7% (4/15) of the patients in the conventional group and in 17.6% (3/17) in the piggyback group (p = 0.68). Median FHVP-CVP gradient was 2 mm Hg (0–8 mmHg) vs. 3 mm Hg (0–7 mm Hg) in conventional and piggyback groups, respectively (p = 0.73). There is no statistically significant difference between the conventional (1/15) and the piggyback (2/17) groups regarding massive ascites development (p = 1.00). GEE estimated marginal mean for Cr was significantly higher in conventional than in piggyback group (2.14 ± 0.26 vs. 1.47 ± 0.15 mg/dL; p = 0.02). The conventional method presented a higher prevalence of severe ARF during the first 28 PO days (OR = 3.207; 95% CI, 1.010 to 10.179; p = 0.048). Conclusion Patients submitted to liver transplantation using conventional or piggyback methods present similar results regarding venous outflow drainage of the graft. Conventional with venovenous bypass technique significantly increases the harm of postoperative renal dysfunction. Trial Registration ClinicalTrials.gov https://clinicaltrials.gov/ct2/show/NCT01707810 PMID:26115520

  14. Benefit of Left Atrial Roof Linear Ablation in Paroxysmal Atrial Fibrillation: A Prospective, Randomized Study

    PubMed Central

    Arbelo, Elena; Guiu, Esther; Bisbal, Felipe; Ramos, Pablo; Borras, Roger; Andreu, David; Tolosana, José María; Berruezo, Antonio; Brugada, Josep; Mont, Lluís

    2014-01-01

    Background Isolation of the pulmonary veins (PVs) for the treatment of atrial fibrillation (AF) is often supplemented with linear lesions within the left atrium (LA). However, there are conflicting data on the effects of creating a roof line (RL) joining the superior PVs in paroxysmal atrial fibrillation (PAF). Methods and Results A cohort of 120 patients with drug‐refractory PAF referred for ablation were prospectively randomized into 2 strategies: (1) PV isolation in combination with RL ablation (LA roof ablation [LARA]‐1: 59 patients) or (2) PV isolation (LARA‐2: 61 patients). Follow‐up was performed at 1, 3, and 6 months after the procedure and every 6 months thereafter. After a 3‐month blanking period, recurrence was defined as the ocurrence of any atrial tachyarrhythmia lasting ≥30 seconds. PV isolation was achieved in 89% and complete RL block in 81%. RF duration, fluoroscopy, and procedural times were slightly, but not significantly, longer in the LARA‐1 group. After 15±10 months, there was no difference in the arrhythmia‐free survival after a single AF ablation procedure (LARA‐1: 59% vs. LARA‐2: 56% at 12 months; log rank P=0.77). The achievement of complete RL block did not influence the results. The incidence of LA macroreentrant tachycardias was 5.1% in the LARA‐1 group (n=3) versus 8.2% in the LARA‐2 (n=5) (P=ns). Univariate analysis only identified AF duration as a covariate associated with arrhythmia recurrence (hazard ratio, 1.01 [95% confidence interval, 1.002 to 1.012]; P<0.01). Conclusion The linear block at the LA roof is not associated with an improved clinical outcome compared with PV isolation alone. Clinical Trial Registration URL: ClinicalTrials.gov. Unique identifier: NCT01203241. PMID:25193295

  15. Comparison between Ultrasound Guided Transperineal and Transrectal Prostate Biopsy: A Prospective, Randomized, and Controlled Trial

    PubMed Central

    Guo, Le-Hang; Wu, Rong; Xu, Hui-Xiong; Xu, Jun-Mei; Wu, Jian; Wang, Shuai; Bo, Xiao-Wan; Liu, Bo-Ji

    2015-01-01

    This prospective study of comparing transperineal prostate biopsy (TPBx) with transrectal prostate biopsy (TRBx) was aimed to provide evidence for clinicians to select the appropriate biopsy approach under different conditions. TPBx (n = 173) and TRBx (n = 166) were performed randomly for 339 patients who were suspicious of prostate cancer (PCa). The cancer detection rate (CDR), complication rate, visual analogue scale (VAS) score, most painful procedure, number of repeated biopsy and additional anesthesia, and operating time (starting from lying down on the operating table to getting up) were recorded. The results showed that TPBx and TRBx were equivalent in CDR (35.3% vs. 31.9%) and minor complication rate (44.9% vs. 41.0%) (both P > 0.05). The major complication rate was lower in TPBx than in TRBx (0.6% vs. 4.3%, P < 0.05). TPBx was more time-consuming (17.51 ± 3.33 min vs. 14.73 ± 3.25 min) and painful (VAS score: 4.0 vs. 2.0); and it had higher rates of repeated biopsy (3.2% vs. 1.1%) and additional anesthesia (15.0% vs. 1.2%) (all P < 0.05). In summary, both TPBx and TRBx are effective to detect PCa. The major complication rate for TRBx is higher, whereas TPBx procedure is more complex and painful. PMID:26526558

  16. Benefits of immediate jejunostomy feeding after major abdominal trauma--a prospective, randomized study.

    PubMed

    Moore, E E; Jones, T N

    1986-10-01

    Benefits of immediate postinjury nutritional support remain ill defined. Seventy-five consecutive patients undergoing emergent celiotomy with an abdominal trauma index (A.T.I.) greater than 15 were randomized prospectively to a control group (no supplemental nutrition during first 5 days) or enteral-fed group. The enteral patients had a needle catheter jejunostomy (N.C.J.) placed at laparotomy with the constant infusion of an elemental diet (Vivonex HN) begun at 18 hours and advanced to 3,000 ml/day (3,000 kcal, 20 gm N2) within 72 hours. Control and enteral-fed groups were comparable with respect to demographic features, trauma mechanism, shock, colon injury, splenectomy, A.T.I., and initial nutritional assessment. Twenty (63%) of the enteral patients were maintained on the elemental diet greater than 5 days; four (12%) needed total parenteral nutrition (T.P.N.). Nine (29%) of the control patients required T.P.N. Nitrogen balance was markedly improved (p less than 0.001) in the enteral-fed group. Although visceral protein markers and overall complication rate were not significantly different, septic morbidity was greater (p less than 0.025) in the control group (abdominal infection in seven and pneumonia in two) compared to the enteral-fed patients (abdominal abscess in three). Analysis of patients with A.T.I. 15-40 disclosed sepsis in seven (26%) of the control versus one (4%) of the enteral-fed group (p less than 0.01). Our clinical experience demonstrates the feasibility of immediate postoperative enteral feeding via N.C.J. after major abdominal trauma, and suggests this early nutrition reduces septic complications in critically injured patients. PMID:3095557

  17. Comparison of Modified Limberg Flap and Karydakis Flap Operations in Pilonidal Sinus Surgery: Prospective Randomized Study

    PubMed Central

    Tokac, Mehmet; Dumlu, Ersin Gurkan; Aydin, Murat Seyit; Yalcın, Abdussamed; Kilic, Mehmet

    2015-01-01

    The best surgical technique for pilonidal sinus disease (PSD) is still disputed. The objective of this prospective randomized study is to compare the short and long-term results of modified Limberg flap and Karydakis flap surgeries that have been widely used in recent years. Ninety one patients were included in the study. The patients were divided into two groups: modified Limberg flap (MLF; n = 46) and Karydakis flap (KF; n = 45). Preoperative findings of the patients, their surgical findings, and short and long-term postoperative findings were recorded and statistically compared. While no significant difference was discovered between the groups in terms of postoperative analgesic need, hospital stay, postoperative infection rate, drain stay time, painless sitting time, painless toilet-sitting time, and painless walking time, return to work or school time was shorter in the MLF group compared with the KF group (20.61 ± 7.89 days, 23.29 ± 6.42, respectively; P < 0.05). Cosmetically, the visual analog scale (VAS) of the KF group was significantly higher than that of the MLF group (VAS score 7.12 ± 1.28, 5.45 ± 1.77, respectively; P < 0.05). Considering recurrence rates, no statistically significant difference was found between the groups. Our study found out that short and long-term results of the MLF and KF procedures are similar. We believe both methods can be safely used in surgical PSD treatment given that in the MLF procedure, shorter return-to-work time is achieved, while the procedure provides better cosmetic results. PMID:26011208

  18. EFFECTS OF ZOLEDRONIC ACID ON OOFORECTOMIZED RATS' TIBIAE: A PROSPECTIVE AND RANDOMIZED STUDY

    PubMed Central

    Alves Pereira, Fernando Roberto; Dutra, Ricardo César; Reis Olímpio, Thiago César; Müller, Sérgio Swain; Palacio, Evandro Pereira

    2015-01-01

    To investigate clinical, biomechanic and histomorphometric effects of zoledronic acid on osteoporotic rats’ tibiae after bilateral ooforectomy. Methods: 40 female Wistar (Rattus novergicus albinus) rats were prospectively studied. On the 60th day of life, the animals were randomized into two groups according to the surgical procedure: bilateral ooforectomy (O) (n=20) and sham surgery (“sham”) (P) (n=20). After 30 days, the animals were divided into four groups, according to the administration of zoledronic acid (ZA) 0.1mg/kg or distilled water (DW): OZA (n=10), ODW (n=10), PZA (n=10) and PDW (n=10). After 12 months, the animals were sacrificed, and had their tibiae assessed. In the clinical study, animals’ weight was considered; in the biomechanical study, compressive assays were applied and, in the histomorphometric analysis, the bone trabecular area was determined. Results: “O” groups showed a significantly greater weight gain than “P” groups (p=0.005). Groups OZA and PZA showed an insignificant weight gain when compared to ODW (p=0.47) and PDW (p=0.68). The groups receiving zoledronic acid and distilled water were able to bear maximum load, similar (p=0.2), at the moment of fracture. In the groups receiving zoledronic acid, an insignificant increase of the bone trabecular area was found when compared to the groups receiving distilled water (p=0.21). There was a positive correlation between trabecular area and maximum load (p=0.04; r=0.95). Conclusion: Zoledronic acid did not significantly influence animals’ weight. The results showed an insignificant increase both of the tibial shaft bone resistance and the bone trabecular area. PMID:26998455

  19. Efficacy of Clopidogrel and Clinical Outcome When Clopidogrel Is Coadministered With Atorvastatin and Lansoprazole: A Prospective, Randomized, Controlled Trial.

    PubMed

    Zhang, Jian-rong; Wang, Di-qing; Du, Jun; Qu, Guang-su; Du, Jian-lin; Deng, Song-bai; Liu, Ya-jie; Cai, Jin-xi; She, Qiang

    2015-12-01

    This prospective, randomized, nonblind, controlled trial evaluated the effects of clopidogrel on platelet function upon coadministration with atorvastatin and lansoprazole. One hundred four adult patients with non-ST-segment elevated acute coronary syndrome (NSTE-ACS) who underwent percutaneous coronary intervention (PCI) with drug-eluting stent implantation were included. All patients were treated with standard dual antiplatelet therapy (DAPT) plus rosuvastatin 10  mg daily after the operation. On the sixth day after PCI, patients were randomly divided into 4 groups, Group A: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin) + lansoprazole 30  mg daily, Group B: DAPT + atorvastatin 20  mg daily (a change from rosuvastatin to atorvastatin), Group C: DAPT + lansoprazole 30  mg daily (continuing to take rosuvastatin), Group D is the control group. Additional drugs were used according to the situation of patients. Platelet function and concentrations of platelet activation markers (granular membrane protein 140 (P-selectin), thromboxane B2 (TXB2), and human soluble cluster of differentiation 40 ligand (sCD40L)) were assessed before randomization and at 15- and 30-day follow-up visits. All patients were maintained on treatment for 6 months and observed for bleeding and ischemic events. A total of 104 patients were enrolled, 27 patients in group A, 26 patients in Group B/C, 25 patients in Group D separately, and all the patients were analyzed. There were no differences in platelet function and the levels of platelet activation markers (P-selectin, TXB2, and sCD40L) among or within the 4 groups at the 3 time points of interest (P > 0.05). In the subsequent 6 months, no significant bleeding events occurred, and 12 patients experienced ischemic events, these results were also not significantly different among the groups (P > 0.05). In patients diagnosed with NSTE-ACS who have had drug-eluting stent implantation

  20. Risk reduction of brain infarction during carotid endarterectomy or stenting using sonolysis - Prospective randomized study pilot data

    NASA Astrophysics Data System (ADS)

    Kuliha, Martin; Školoudík, David; Martin Roubec, Martin; Herzig, Roman; Procházka, Václav; Jonszta, Tomáš; Krajča, Jan; Czerný, Dan; Hrbáč, Tomáš; Otáhal, David; Langová, Kateřina

    2012-11-01

    Sonolysis is a new therapeutic option for the acceleration of arterial recanalization. The aim of this study was to confirm risk reduction of brain infarction during endarterectomy (CEA) and stenting (CAS) of the internal carotid artery (ICA) using sonolysis with continuous transcranial Doppler (TCD) monitoring by diagnostic 2 MHz probe, additional interest was to assess impact of new brain ischemic lesions on cognitive functions. Methods: All consecutive patients 1/ with ICA stenosis >70%, 2/ indicated to CEA or CAS, 3/ with signed informed consent, were enrolled to the prospective study during 17 months. Patients were randomized into 2 groups: Group 1 with sonolysis during intervention and Group 2 without sonolysis. Neurological examination, assessment of cognitive functions and brain magnetic resonance imaging (MRI) were performed before and 24 hours after intervention in all patients. Occurrence of new brain infarctions (including infarctions >0.5 cm3), and the results of Mini-Mental State Examination, Clock Drawing and Verbal Fluency tests were statistically evaluated using T-test. Results: 97 patients were included into the study. Out of the 47 patients randomized to sonolysis group (Group 1) 25 underwent CEA (Group 1a) and 22 CAS (Group 1b). Out of the 50 patients randomized to control group (Group 2), 22 underwent CEA (Group 2a) and 28 CAS (Group 2b). New ischemic brain infarctions on follow up MRI were found in 14 (29.8%) patients in Group 1-4 (16.0%) in Group 1a and 10 (45.5%) in Group 1b. In Group 2, new ischemic brain infarctions were found in 18 (36.0%) patients-6 (27.3%) in Group 2a and 12 (42.9%) in Group 2b (p>0.05 in all cases). New ischemic brain infarctions >0.5 cm3 were found in 4 (8.5 %) patients in Group 1 and in 11 (22.0 %) patients in Group 2 (p= 0.017). No significant differences were found in cognitive tests results between subgroups (p>0.05 in all tests). Conclusion: Sonolysis seems to be effective in the prevention of large ischemic

  1. Vaginal Versus Sublingual Misoprostol for Labor Induction at Term and Post Term: a Randomized Prospective Study

    PubMed Central

    Ayati, Sedigheh; Vahidroodsari, Fatemeh; Farshidi, Farnoosh; Shahabian, Masoud; Afzal Aghaee, Monavar

    2014-01-01

    We want to compare the efficacy and safety of vaginal versus sublingual misoprostol for cervical ripening and induction of labor. This randomized clinical trial was performed on 140 women with medical or obstetric indications for labor induction. The patients were randomly divided into two groups: vaginal and sublingual administration of misoprostol. In first group, 25 µg misoprostol was placed in the posterior fornix of the vagina and second group received 25 µg misoprostol sublingually, every 6 hours for 24 h. Maternal and neonatal outcomes were analyzed. There was no significant difference in the demographic characteristics between two groups. The main indication for cesarean section in both groups was fetal distress, followed by absence of active labor progress. Evaluation of cesarean indication was not significantly different in two groups; including fetal distress, absence of active labor, uterine over activity and failure to progress. The maternal complication in sublingual group included residual placenta (2%), tachysystole (2%), vomiting (12%), atoni (3.3%) and abdominal pain (5.5%), although there was no significant difference between two groups. Sublingual misoprostol is as effective as vaginal misoprostol for induction of labor at term. However, sublingual misoprostol has the advantage of easy administration and may be more suitable than vaginal misoprostol. PMID:24734084

  2. Clinical effects of lateral wedge arch support insoles in knee osteoarthritis: A prospective double-blind randomized study.

    PubMed

    Hsieh, Ru-Lan; Lee, Wen-Chung

    2016-07-01

    We compared the short-term efficacy of rigid versus soft lateral wedge arch support (LWAS) insoles for patients with knee osteoarthritis (OA), as assessed using the International Classification of Functioning, Disability and Health (ICF) system, through a prospective, double-blind, randomized controlled trial.Participants who fulfilled the combined radiographic and clinical criteria for knee OA, as defined by the American College of Rheumatology, were randomly prescribed 1 pair of rigid or soft LWAS insoles. Body functions and structures were evaluated according to Kellgren-Lawrence scores, the Foot Posture Index, Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, postural stability, dynamic balance, and fall risk; activities and participation were assessed according to 10-m fast speed walking, stair climbing and chair rising times, and Chronic Pain Grade questionnaire responses; and knee OA-related health status was evaluated using the Knee Injury and Osteoarthritis Outcome Score (KOOS). Hospital Anxiety and Depression Scale scores, the pain-pressure threshold, physical activity, balance, Chronic Pain Grade questionnaire responses, and the KOOS were recorded before treatment and at 1-, 2-, and 3-month follow-ups.We enrolled 90 participants, 70 women and 20 men, with mean ages of 60.6 ± 10.8 and 63.1 ± 10.8 years in the rigid and soft LWAS insole groups, respectively. Repeated-measures analysis of covariance revealed significant time × group effect improvements in pain (P = 0.008 for the KOOS), stair ascent time (P = 0.003), daily living function (P = 0.003 for the KOOS), sports and recreation function (P = 0.012 for the KOOS), and quality of life (P = 0.021 for the KOOS) in the soft LWAS insole group.Patients with knee OA who used soft LWAS insoles for a short term showed more significant improvement than did those who used rigid LWAS insoles in pain, physical activity, daily living function, sports and recreation function

  3. Sleep quality in patients with xerostomia: a prospective and randomized case-control study.

    PubMed

    Lopez-Jornet, Pia; Lucero Berdugo, Maira; Fernandez-Pujante, Alba; C, Castillo Felipe; Lavella C, Zamora; A, Pons-Fuster; J, Silvestre Rangil; Silvestre, Francisco Javier

    2016-01-01

    Objectives To investigate sleep quality, anxiety/depression and quality-of-life in patients with xerostomia. Materials and methods This prospective, observational, cross-sectional study was conducted among a group of xerostomia patients (n = 30) compared with 30 matched control subjects. The following evaluation scales were used to assess the psychological profile of each patient: the Hospital Anxiety and Depression Scale, the Oral Health Impact Profile-14 (OHIP-14), the Xerostomia Inventory, the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Results The PSQI obtained 5.3 3 ± 1.78 for patients with xerostomia compared with 4.26 ± 1.01 for control subjects (p = 0.006); ESS obtained 5.7 ± 2.1 for test patients vs 4.4 0 ± 1 for control subjects (p = 0.010). Statistical regression analysis showed that xerostomia was significantly associated with depression (p = 0.027). Conclusions Patients with xerostomia exhibited significant decreases in sleep quality compared with control subjects. PMID:26473793

  4. Comparison of vaginal and abdominal hysterectomy:A prospective non-randomized trial

    PubMed Central

    Chen, Bing; Ren, Dong-Ping; Li, Jing-Xuan; Li, Chun-Dong

    2014-01-01

    Objective: To compare outcomes of vaginal and abdominal hysterectomy procedures in women with benign gynaecological diseases. Methods: This was a prospective study of outcomes of consecutive patients who underwent total vaginal hysterectomy (VH) or abdominal hysterectomy (AH) for benign gynaecological diseases. Patient characteristics before, during, and after the operations were reviewed. Patients were followed up for three months to evaluate postoperative complications. Results: This study included a total of 313 patients. 143 patients underwent AH and 170 patients underwent VH. Baseline characteristics were similar between the two groups. There were no intraoperative complications in either group. Operation time, intraoperative blood loss, first postoperative flatus time, time to out-of-bed activity, mean maximum postoperative body temperature, and duration of fever were all significantly shorter and less severe in the VH group compared with the AH group. In addition, vaginal length in the VH group was significantly shorter than in the AH group. Conclusions: Vaginal hysterectomy has advantages over AH in the treatment of benign gynaecological diseases, providing greater efficacy and safety with minimal invasiveness. PMID:25097536

  5. Prospective evaluation of syndesmotic ankle sprains without diastasis.

    PubMed

    Nussbaum, E D; Hosea, T M; Sieler, S D; Incremona, B R; Kessler, D E

    2001-01-01

    Sixty consecutive collegiate athletes with "high" ankle symptoms were prospectively evaluated over a 3-year period in an effort to better define this debilitating ankle injury. All athletes included in this study had tenderness over the distal anterior tibiofibular ligament, tenderness proximally along the interosseous membrane, and functional disability. No study subject had a fracture or frank tibia-fibula diastasis. The severity of the sprain was quantified using the interosseous "tenderness length." A standard rehabilitation protocol was followed by all patients. Athletes returned to competition when they could perform all functional testing without difficulty. Time to return to full competitive activity averaged 13.4 days. The number of days missed from competition was statistically related to the interosseous tenderness length (P = 0.0001) and to positive results on the squeeze test (P = 0.03). Fifty-three of the 60 injured athletes were evaluated at least 6 months after injury. Patients rated their outcomes as good or excellent. Six of the patients experienced occasional ankle pain and stiffness, four patients reported recurrent ankle sprains, and one patient had heterotopic ossification formation. PMID:11206253

  6. A prospective evaluation of outcomes of two tapered implant systems.

    PubMed

    Andreasi Bassi, M; Lopez, M A; Confalone, L; Gaudio, R M; Lombardo, L; Lauritano, D

    2016-01-01

    The purpose of this prospective clinical study was to evaluate survival rate (SVR - i.e. fixtures still in place at the end of the observation period) and success rate (SCR - i.e. bone resorption around the implant neck) of two tapered implant systems. Both systems were equipped with a tapered connection, one requiring bone-level (BL) placement, while the other required soft-tissue-level (STL) placement. In the period between January 1996 and October 2011, 133 fixtures were inserted, 90 in females and 43 in males, with a mean age of 60±11 years. The mean post-surgical follow-up was 64±38 months. Several clinical parameters were evaluated as potential outcome conditioners. An SPSS program was used for statistical analysis and a Cox analysis was performed. The SVR was 100% since no fixtures were lost. SCR, expressed through the mean marginal bone loss, was 88%. No significant differences were found, for most of the variables investigated with the exception of bone grafting and implant type: STL implants showed a better clinical outcome than BL implants when bone grafting was performed simultaneously with implant placement. Tapered implants are reliable devices for oral rehabilitation of jaws. PMID:27469541

  7. Total thyroidectomy performed with the Starion vessel sealing system versus the conventional technique: a prospective randomized trial.

    PubMed

    Scerrino, Gregorio; Paladino, Nunzia Cinzia; Di Paola, Valentina; Morfino, Giuditta; Matranga, Domenica; Gulotta, Gaspare; Bonventre, Sebastiano

    2010-09-01

    Meticulous dissection and accurate hemostasis are required in thyroid surgery. The authors recently performed a number of thyroidectomies using a new device that combines heat and pressure for sealing and cutting tissue. A prospective randomized trial was conducted on 98 patients subjected to total thyroidectomy for benign disease: 49 patients (group A) with the Starion tissue welding system and 49 (group B) with the clamp-and-tie technique. The 2 groups were comparable in mean age, gender, thyroidal volume (20-60 mL), incision length (<35 mm), and pathology. The authors evaluated operative time, postoperative serum calcemia, dosage and length of postoperative calcium and vitamin D treatment, drainage volume, hospital stay, and complications. Student's t test was used for quantitative variables; for categorical variables, the chi(2) test or Fisher's exact test, as appropriate, was used. The mean operative time was 53.8 +/- 6.1 minutes in group A and 63.2 +/- 8 minutes in group B (P < .0001). The difference in terms of postoperative calcemia was significant (group A: 8.35 +/- 0.39 mg/dL; group B: 8.08 +/- 0.39 mg/dL; P < .001). The duration of postoperative treatment with calcium and vitamin D was significantly different (group A: 4 days; group B: 5 days; P < .039). No significant difference in terms of postoperative complications was found. The new system reduced operative time and the duration of postoperative hypocalcemia, and there was minimal tissue necrosis and thermal spread. The reduction in duration of postoperative calcium and vitamin D treatment is also an indication of improvement in quality of the treatment. PMID:20670960

  8. Treatment of severe, nonfulminant acute hepatitis B with lamivudine vs placebo: a prospective randomized double-blinded multicentre trial.

    PubMed

    Wiegand, J; Wedemeyer, H; Franke, A; Rößler, S; Zeuzem, S; Teuber, G; Wächtler, M; Römmele, U; Ruf, B; Spengler, U; Trautwein, C; Bock, C T; Fiedler, G M; Thiery, J; Manns, M P; Brosteanu, O; Tillmann, H L

    2014-10-01

    Acute hepatitis B virus (aHBV) infection can lead to fulminant liver failure, which likely is prevented by early lamivudine therapy. Even nonfulminant but severe acute hepatitis B can lead to significant morbidity and impaired quality of life. Therefore, lamivudine was evaluated in patients with severe aHBV in a placebo-controlled trial. Patients with severe aHBV infection (ALT >10× ULN, bilirubin >85 μm, prothrombin time >50%) were prospectively treated with lamivudine 100 mg/day or with placebo within 8 days after the diagnosis. The primary end point was time to bilirubin <34.2 μm. Secondary end points were time to clear HBsAg and HBV-DNA, development of anti-HBs and normalization of ALT. Eighteen cases were randomized to lamivudine, 17 to placebo. 94% of patients were hospitalized. No individual progressed to hepatic failure; all but one patient achieved the primary end point. Due to smaller than expected patient numbers, all study end points did not become statistically significant between treatment arms. Median time end points [in days] were bilirubin <34.2 μm (26.5 vs 32), ALT normalization (35 vs 48) and HBsAg clearance (48 vs 67) referring to earlier recovery under lamivudine, in contrast to loss of HBV-DNA (62 vs 54) and development of anti-HBs (119 vs 109). In all but two patients (one in every group), HBsAg clearance was reached in the study. Adverse events occurred more frequently during lamivudine therapy, but did not reach statistical significance. Lamivudine may ameliorate severe aHBV infection, but limited patient numbers prevented definite conclusions. PMID:24329913

  9. Juvéderm Volbella with Lidocaine for Lip and Perioral Enhancement: A Prospective, Randomized, Controlled Trial

    PubMed Central

    Chantrey, Jonquille; Belhaouari, Lakdhar; Saleh, Roy; Murphy, Diane K.

    2015-01-01

    Background: Juvéderm Volbella with Lidocaine is a new hyaluronic acid dermal filler. Methods: In this prospective, randomized, multicenter study, 280 subjects desiring lip volume enhancement were treated with Juvéderm Volbella with Lidocaine or Restylane-L. Investigators rated treatment outcomes on Allergan’s Lip Fullness Scale, Perioral Lines Scale, and Oral Commissures Severity Scale. A blinded independent central reviewer (ICR) assessed 3-dimensional digital photographs using these scales. Subjects evaluated outcomes using the FACE-Q Recovery Early Life Impact and Recovery Early Symptoms modules. The primary endpoint was noninferiority of Juvéderm Volbella with Lidocaine to Restylane-L based on responder rate (percentage of subjects with ≥1-point Lip Fullness Scale improvement at month 3 ICR assessment vs baseline). Results: Juvéderm Volbella with Lidocaine was noninferior to Restylane-L. Although responder rates based on ICR assessments of lip fullness, perioral lines, and oral commissures did not differ between treatments, investigator assessments showed significant improvements in perioral lines and oral commissures with Juvéderm Volbella with Lidocaine vs Restylane-L (P ≤ 0.029). Subjects treated with Juvéderm Volbella with Lidocaine had higher mean FACE-Q scores on day 1 (P ≤ 0.001), indicating less disruption of daily activities. Mean change in lip volume from baseline to day 1 was smaller in the Juvéderm Volbella with Lidocaine group (but similar between treatments on day 14), indicating less acute swelling. Severe injection site responses occurred less frequently with Juvéderm Volbella with Lidocaine. Conclusions: Juvéderm Volbella with Lidocaine is effective for lip enhancement, improves perioral lines and oral commissures, and results in less short-term swelling and disruption in daily activities than Restylane-L. PMID:25878932

  10. A prospective randomized controlled trial assessing the efficacy of adjunctive hyperbaric oxygen therapy in the treatment of hidradenitis suppurativa.

    PubMed

    Yildiz, Hamza; Senol, Levent; Ercan, Erdinc; Bilgili, Memet Ersan; Karabudak Abuaf, Ozlem

    2016-02-01

    Hyperbaric oxygen therapy (HBOT) appears to enhance wound healing, increase bactericidal activity, and act synergistically with a number of antibiotics. The aim of this study was to evaluate the efficacy of HBOT as an adjunctive therapy in patients with hidradenitis suppurativa (HS) treated with a combination of systemic rifampicin and clindamycin. The study was a prospective, single-center, single-dose, open-label, randomized controlled clinical study of HBOT in patients with moderate to severe HS. Efficacy was measured by modified Sartorius score (SS), HS Severity Index (HSSI), Dermatology Life Quality Index (DLQI), and a visual analog scale (VAS) before treatment and after the completion of 4 and 10 weeks of treatment. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were also measured. Forty-three patients were enrolled in the study. More patients in the HBOT than in the control group showed a decrease of ≥50% from baseline parameters at week 10 for SS (100%), HSSI (100%), DLQI (95.5%), VAS (100%), ESR (100%), and CRP (72.7%). Clinically and statistically significant improvements from baseline were observed at 4 and 10 weeks in HSSI (P = 0.009 at both), SS (P = 0.021 at both), and DLQI (P = 0.044 at week 4, P = 0.009 at week 10). Adjunctive HBOT was considered to be effective in significantly improving antibiotic treatment of HS. The treatment was well tolerated, and no unexpected safety issues were identified. PMID:26267600

  11. Safety and Tolerability of Cyclosporin A in Severe Traumatic Brain Injury Patients: Results from a Prospective Randomized Trial

    PubMed Central

    Mazzeo, Anna Teresa; Brophy, Gretchen M.; Gilman, Charlotte B.; Alves, Óscar Luís; Robles, Jaime R.; Hayes, Ronald L.; Povlishock, John T.

    2009-01-01

    Abstract Cyclosporin A (CsA) has recently been proposed for use in the early phase after traumatic brain injury (TBI), for its ability to preserve mitochondrial integrity in experimental brain injury models, and thereby provide improved behavioral outcomes as well as significant histological protection. The aim of this prospective, randomized, double-blind, dual-center, placebo-controlled trial was to evaluate the safety, tolerability, and pharmacokinetics of a single intravenous infusion of CsA in patients with severe TBI. Fifty adult severe TBI patients were enrolled over a 22-month period. Within 12 h of the injury patients received 5 mg/kg of CsA infused over 24 h, or placebo. Blood urea nitrogen (BUN), creatinine, hemoglobin, platelets, white blood cell count (WBC), and a hepatic panel were monitored on admission, and at 12, 24, 36, and 48 h, and on days 4 and 7. Potential adverse events (AEs) were also recorded. Neurological outcome was recorded at 3 and 6 months after injury. This study revealed only transient differences in BUN levels at 24 and 48 h and for WBC counts at 24 h between the CsA and placebo patients. These modest differences were not clinically significant in that they did not negatively impact on patient course. Both BUN and creatinine values, markers of renal function, remained within their normal limits over the entire monitoring period. There were no significant differences in other mean laboratory values, or in the incidence of AEs at any other measured time point. Also, no significant difference was demonstrated for neurological outcome. Based on these results, we report a good safety profile of CsA infusion when given at the chosen dose of 5 mg/kg, infused over 24 h, during the early phase after severe head injury in humans, with the aim of neuroprotection. PMID:19621985

  12. Photoselective vaporization of prostate vs. transurethral resection of prostate: A prospective, randomized study with one year follow-up

    PubMed Central

    Mohanty, Nayan K.; Vasudeva, Pawan; Kumar, Anup; Prakash, Sanjay; Jain, Manoj; Arora, Rajender P.

    2012-01-01

    Objectives: To evaluate in a prospective, randomized study, the efficacy and safety profile of photoselective vaporization of prostate (PVP) using a 80W potassium titanyl phosphate (KTP) laser when compared to standard transurethral resection of prostate (TURP) in patients with lower urinary tract symptoms (LUTS) due to benign prostatic enlargement (BPE). Materials and Methods: Between February 2009 and August 2009, 117 patients satisfying the eligibility criteria underwent surgery [60 PVP{Group A}; 57 TURP{Group B}]. The groups were compared for functional outcome (both subjective and objective parameters), perioperative parameters and complications, with a follow up of one year. P value<0.05 was considered statistically significant. Results: The baseline characteristics of the two groups were comparable. Mean age was 66.68 years and 65.74 years, mean IPSS score was 19.98 and 20.88, mean prostate volume was 44.77 cc and 49.02 cc in Group A and B, respectively. Improvements in IPSS, QOL, prostate volume, Q max and PVRU at 12 months were similar in both groups. PVP patients had longer operating time, lesser perioperative blood loss, shorter catheterization time and a higher dysuria rate when compared to TURP patients. The overall complication rate was similar in the two groups. Conclusions: In patients with LUTS due to BPE, KTP-PVP is an equally efficacious alternative to TURP with durable results at one year follow up with additional benefits of lesser perioperative blood loss, lesser transfusion requirements and a shorter catheterization time. Long term comparative data is awaited to clearly define the role of KTP-PVP in such patients. PMID:23204660

  13. The effect of hydroxyapatite coated screw in the lateral fragility fractures of the femur. A prospective randomized clinical study.

    PubMed

    Pesce, V; Maccagnano, G; Vicenti, G; Notarnicola, A; Moretti, L; Tafuri, S; Vanni, D; Salini, V; Moretti, B

    2014-01-01

    Due to a growing numbers of lateral fragility fractures of the femur and their high social costs the need to work out an effective strategy in order to find a better solution for these patients is warranted. From January 2010 to July 2011, we carried out a prospective randomized clinical study comparing the results of patients with femoral lateral fractures treated by nail and cephalic hydroxyapatite coated screws (study group including 27 patients) compared to the patients with the same fractures treated with nail and head standard screws (control group including 27 patients). We defined the two parts of the femoral neck as ROI 1 (under the head screw) and ROI 2 (above the femoral screw) on the AP view. The bone density of the two areas was calculated using DEXA at T0 (1st day post-surgery), at T1 (40th day post-surgery), at T2 (3 months later), at T3 (1 year later). The clinical-radiography evaluations were based on the Harris Hip Score (HHS), ADL test and x-ray views of the hip. As far as the bone mineral density average of ROI 1 and ROI 2 is concerned, we found a significant statistical increase at T1 and T3 in the study group, while it was not significant in the control group. We could account for this data through the higher mechanical stability of hydroxyapatite coated screws than standard screws. In fact, this material was responsible for improved implant osteointegration. Thanks to a 1 year follow-up we were able to demonstrate the implant utility associated with augmentation and the importance of densitometry exams such as easily repeatable and low cost diagnostics to prevent the onset of complications linked to screw loosening. PMID:24750798

  14. Effect of a clown’s presence at botulinum toxin injections in children: a randomized, prospective study

    PubMed Central

    Hansen, Lars Kjaersgaard; Kibaek, Maria; Martinussen, Torben; Kragh, Lene; Hejl, Mogens

    2011-01-01

    Background The effect of the presence of a hospital clown during pediatric procedures has rarely been evaluated. In a pediatric ward, botulinum toxin injection is a painful procedure and a stressful experience for the child. We undertook a study of the effect of the presence of a hospital clown on children treated with botulinum toxin in an outpatient setting. Methods In total, 60 children, the majority of whom had spastic cerebral palsy, were subjected to a total of 121 botulinum toxin treatment sessions. Thirty-two children were being treated for the first time. During a 2-year period, we enrolled 121 treatment sessions prospectively, and the children were randomized to either the presence of a female clown during treatment or to no presence of a clown. The duration of the child’s crying during the procedure was used as an indicator of the effect of the presence of a clown. Results The effect of the clown was significantly related to patient gender. Girls were found to have a significantly shorter period of crying when the clown was present. For children younger than 8 years, the effect on boys was negative. Children treated for the first time did not appear to benefit from the presence of the clown, and showed no difference in effect between genders. Conclusion No effect of the clown was documented for children being treated for the first time. At repeat treatments, we saw a positive effect of the female clown in relation to girls, and a negative effect on boys younger than 8 years of age. PMID:22003302

  15. Topical Biafine and Lipiderm for the prevention of radiation dermatitis: a randomized prospective trial.

    PubMed

    Fenig, E; Brenner, B; Katz, A; Sulkes, J; Lapidot, M; Schachter, J; Malik, H; Sulkes, A; Gutman, H

    2001-01-01

    We evaluated the effects of Biafine and Lipiderm ointments in preventing radiation dermatitis. The study population included 74 patients after conservative surgery for early breast carcinoma who were referred for adjuvant external beam irradiation. Patients were randomized to receive Biafine or Lipiderm or no treatment. Both study preparations were applied twice daily, starting 10 days before onset of radiotherapy and continuing until 10 days after its completion. The skin treatment was upgraded, if clinically necessary, to steroids (grade 3), antibiotics (grade 4), or pause in therapy (grade 5). Success of treatment was evaluated according to the maximal level of skin treatment, the number of gaps in radiation therapy, the impression of the patients and the subjective skin reaction, and scores of the study nurse and radiotherapist. The three groups were comparable for all clinical features, except for a lower mean age of the Biafine group. Comparative analysis of the results showed no advantage for either preparation compared to the control arm other than maximal treatment level required for a skin reaction (mean 1.7 and 1.6 vs. 2.2), which did not reach statistical significance (p=0.145). Nevertheless, 86% of the patients in both the Biafine and Lipiderm arms expressed satisfaction with the respective ointments. In conclusion, neither Biafine nor Lipiderm seems to have a radioprotective effect. PMID:11182045

  16. A prospective double-blind, randomized clinical trial of levocarnitine to treat autism spectrum disorders

    PubMed Central

    Geier, David A.; Kern, Janet K.; Davis, Georgia; King, Paul G.; Adams, James B.; Young, John L.; Geier, Mark R.

    2011-01-01

    Summary Background L-carnitine was proposed as a potential treatment for patients diagnosed with an autism spectrum disorder to improve mitochondrial dysfunction, but no prior randomized controlled trials have been conducted. Material/Methods Thirty subjects diagnosed with an ASD were randomly assigned to receive a standardized regimen (50 mg L-carnitine/kg bodyweight/day) of liquid L-carnitine (n=19) or placebo (n=11) for 3-months. Measures included changes in professionally completed Childhood Autism Rating Scale (CARS), hand muscle testing, and modified clinical global impression (CGI) forms; parent completed Autism Treatment Evaluation Checklist (ATEC), treatment adherence measurement (TAM), frequency and intensity of side effect rating (FISER)/global rating of side effect burden (GRSEB)/patient report of incidence of side effects (PRISE) forms; and lab testing. Results Significant improvements were observed in CARS (−2.03, 95% CI=−3.7 to −0.31), CGI (−0.69, 95% CI=−1.1 to −0.06), and ATEC scores. Significant correlations between changes in serum free-carnitine levels and positive clinical changes were observed for hand muscle strength (R2=0.23, P=0.046), cognitive scores (R2=0.27, P=0.019), and CARS scores (R2=0.20, P=0.047). Study subjects were protocol-compliant (average adherence was >85%) and generally well-tolerated the L-carnitine therapy given. Conclusions L-carnitine therapy (50 mg/kilogram-bodyweight/day) administered for 3-months significantly improved several clinical measurements of ASD severity, but subsequent studies are recommended. PMID:21629200

  17. Femtosecond laser versus mechanical microkeratome-assisted flap creation for LASIK: a prospective, randomized, paired-eye study

    PubMed Central

    Pajic, Bojan; Vastardis, Iraklis; Pajic-Eggspuehler, Brigitte; Gatzioufas, Zisis; Hafezi, Farhad

    2014-01-01

    Purpose To compare a femtosecond laser with a microkeratome for flap creation during laser in situ keratomileusis (LASIK) in terms of flap thickness predictability and visual outcomes. Patients and methods This was a prospective, randomized, masked, paired-eye study. Forty-four patients (34 females) who received bilateral LASIK were included. Patients were stratified by ocular dominance, and they then underwent randomization of flap creation using the femtosecond laser on one eye and undergoing the microkeratome procedure on the other one. The visual outcome differences between the corrected distance visual acuity (CDVA) at baseline and the uncorrected distance visual acuity (UDVA) on the first day postoperatively were set as the efficiency index for both groups. All visual acuity outcome results and the deviation of flap thickness were evaluated. P-values <0.05 were considered statistically significant. Results The index of efficiency regarding the postoperative visual outcomes in the microkeratome group was lower (P<0.0001). This result was correlated with the difference between intended and achieved flap thickness (P=0.038; r=0.28), and a negative relationship in the regression analysis was confirmed (P<0.04; R2=0.1428). The UDVA in the microkeratome group improved significantly by the end of the first month (P<0.0271) in comparison to the baseline CDVA. The deviation between intended and postoperative flap thickness using either optical coherence pachymetry or Heidelberg Retinal Tomography II confocal microscopy was statistically significant (paired t-test; P<0.001) between the groups. The flap thickness deviation in the microkeratome group was higher. In the femtosecond laser group, the efficiency index was stable postoperatively (P=0.64) The UDVA improved significantly by the end of the first postoperative week (P=0.0043) in comparison to the baseline CDVA. Six months after surgery, improvement in the UDVA was significant in both groups (all P<0.001; one way

  18. Prospective Randomized Study Comparing Robotic-Assisted Surgery with Traditional Laparotomy for Rectal Cancer-Indian Study.

    PubMed

    Somashekhar, S P; Ashwin, K R; Rajashekhar, Jaka; Zaveri, Shabber

    2015-12-01

    Rectal cancer is one of the common cancers in India. Surgical management is the mainstay of initial treatment for majority of patients. Minimally invasive surgery has gained acceptance for the surgical treatment of rectal cancer because, compared with laparotomy, it is associated with fewer complications, shorter hospitalization, and faster recovery. The aim of this study is to evaluate the safety, feasibility, technique, and outcomes (postoperative, oncological, and functional) of robotic-assisted rectal surgery in comparison with open surgery in the Indian population. A prospective randomized study was undertaken from August 2011 to December 2012. Fifty patients who presented with rectal carcinoma were randomized to either robotic arm (RA) or open arm (OA) group. Both groups were matched for clinical stage and operation type. Technique and feasibility of robotic-assisted surgery in terms of operating time, estimated blood loss, margins status, total number of lymph nodes retrieved, hospital stay, conversion to open procedure, complications, and functional outcomes were analyzed. The mean operative time was significantly longer in the RA than in the OA group (310 vs 246 min, P < 0.001) but was significantly reduced in the latter part of the robotic-assisted patients compared with the initial patients. The mean estimated blood loss was significantly less in the RA compared with the OA group (165.14 vs 406.04 ml, P < 0.001). None of the patients had margin positivity. The mean distal resection margin was significantly longer in the RA than in the OA group (3.6 vs 2.4 cm, P < 0.001). A total of 100 % of patients in the RA group had complete mesorectal excision while two patients in the OA group had incomplete mesorectal excision. The average number of retrieved lymph nodes was adequate for accurate staging. The number of lymph nodes removed by robotic method is slightly higher than the open method (16.88 vs 15.20) but with no statistical significance

  19. Cardiopulmonary Safety of Propofol Versus Midazolam/Meperidine Sedation for Colonoscopy: A Prospective, Randomized, Double-Blinded Study

    PubMed Central

    Gurbulak, Bunyamin; Uzman, Sinan; Kabul Gurbulak, Esin; Gul, Yasar Gokhan; Toptas, Mehmet; Baltali, Sevim; Anil Savas, Osman

    2014-01-01

    Background: Different levels of pharmacological sedation ranging from minimal to general anesthesia are often used to increase patient tolerance for a successful colonoscopy. However, sedation increases the risk of respiratory depression and cardiovascular complications during colonoscopy. Objectives: We aimed to compare the propofol and midazolam/meperidine sedation methods for colonoscopy procedures with respect to cardiopulmonary safety, procedure-related times, and patient satisfaction. Patients and Methods: This was a prospective, randomized, double-blinded study, in which 124 consecutive patients undergoing elective outpatient diagnostic colonoscopies were divided into propofol and midazolam/meperidine sedation groups (n: 62, m/f ratio: 26/36, mean age: 46 ± 15 for the propofol group; n: 62, m/f ratio: 28/34, mean age: 49 ± 15 for the midazolam/meperidine group) by computer-generated randomization. The frequency of cardiopulmonary events (hypotension, bradycardia, hypoxemia), procedure-related times (duration of colonoscopy, time to cecal intubation, time to ileal intubation, awakening time, and time to hospital discharge) and patients’ evaluation results (pain assessment, quality of sedation, and recollection of procedure) were compared between the groups. Results: There were no statistically significant differences between the two groups with respect to demographic and clinical characteristics of the patients, the frequency of hypotension, hypoxemia or bradycardia, cecal and ileal intubation times, and the duration of colonoscopy. The logistic regression analysis indicated that the development of cardiopulmonary events was not associated with the sedative agent used or the characteristics of the patients. The time required for the patient to be fully awake and the time to hospital discharge was significantly longer in the propofol group (11 ± 8 and 37 ± 11 minutes, respectively) than the midazolam/meperidine group (8 ± 6 and 29 ± 12 minutes

  20. A randomized double-blind prospective study of the efficacy of pulsed electromagnetic fields for interbody lumbar fusions

    SciTech Connect

    Mooney, V. )

    1990-07-01

    A randomized double-blind prospective study of pulsed electromagnetic fields for lumbar interbody fusions was performed on 195 subjects. There were 98 subjects in the active group and 97 subjects in the placebo group. A brace containing equipment to induce an electromagnetic field was applied to patients undergoing interbody fusion in the active group, and a sham brace was used in the control group. In the active group there was a 92% success rate, while the control group had a 65% success rate (P greater than 0.005). The effectiveness of bone graft stimulation with the device is thus established.

  1. Total Hip Arthroplasty Performed Through Direct Anterior Approach Provides Superior Early Outcome: Results of a Randomized, Prospective Study.

    PubMed

    Parvizi, Javad; Restrepo, Camilo; Maltenfort, Mitchell G

    2016-07-01

    Studies suggest that total hip arthroplasty (THA) performed through direct anterior (DA) approach has better functional outcomes than other surgical approaches. The immediate to very early outcomes of DA THA are not known. A prospective, randomized study examined the very early outcome of THA performed through DA versus direct lateral approach. The functional outcomes on day 1, day 2, week 6, week 12, 6 months, and 1 year were measured. Patients receiving DA THA had significantly higher functional scores during the early period following surgery. The difference in functional scores leveled out at 6 months. PMID:27241374

  2. Effects on the hemostatic system and liver function in relation to Implanon and Norplant. A prospective randomized clinical trial.

    PubMed

    Egberg, N; van Beek, A; Gunnervik, C; Hulkko, S; Hirvonen, E; Larsson-Cohn, U; Bennink, H C

    1998-08-01

    In this prospective randomized clinical trial, two long-term contraceptive implants were studied with respect to hemostasis and liver function in 86 healthy young women. The two implants used were Implanon, containing the progestagen etonogestrel (the biologically active metabolite of desogestrel) and Norplant, the implant containing the progestagen levonorgestrel. The results of the trial showed that both implants had similar small effects on the hemostatic system that are not suggestive of a tendency towards thrombosis. The effect on liver function was characterized by increases in total bilirubin and gamma-glutamyl transferase and decreases in alanine aminotransferase and aspartate aminotransferase. PMID:9773263

  3. Does High Thoracic Epidural Analgesia with Levobupivacaine Preserve Myocardium? A Prospective Randomized Study

    PubMed Central

    Bektas, Serife Gokbulut; Karadeniz, Umit; Ozturk, Burcin; Yavas, Soner; Biricik, Dilan; Saydam, Gul Sevim; Erdemli, Ozcan

    2015-01-01

    Background. Our study aimed to compare HTEA and intravenous patient-controlled analgesia (PCA) in patients undergoing coronary bypass graft surgery (CABG), based on haemodynamic parameters and myocardial functions. Materials and Methods. The study included 34 patients that were scheduled for elective CABG, who were randomly divided into 2 groups. Anesthesia was induced and maintained with total intravenous anesthesia in both groups while intravenous PCA with morphine was administered in Group 1 and infusion of levobupivacaine was administered from the beginning of the anesthesia in Group 2 by thoracic epidural catheter. Blood samples were obtained presurgically, at 6 and 24 hours after surgery for troponin I, creatinine kinase-MB (CK-MB), total antioxidant capacity, and malondialdehyde. Postoperative pain was evaluated every 4 hours until 24 hours via VAS. Results. There were significant differences in troponin I or CK-MB values between the groups at postsurgery 6 h and 24 h. Heart rate and mean arterial pressure in Group 1 were significantly higher than in Group 2 at all measurements. Cardiac index in Group 2 was significantly higher than in Group 1 at all measurements. Conclusion. Patients that underwent CABG and received HTEA had better myocardial function and perioperative haemodynamic parameters than those who did not receive HTEA. PMID:25918718

  4. Prospective randomized trial comparing alumina ceramic-on-ceramic with ceramic-on-conventional polyethylene bearings in total hip arthroplasty.

    PubMed

    Lewis, Peter M; Al-Belooshi, Ali; Olsen, Michael; Schemitch, Emil H; Waddell, James P

    2010-04-01

    This prospective randomized study aims to compare the outcome between an alumina ceramic-on-ceramic (CC) articulation with a ceramic on ultra-high-molecular-weight polyethylene articulation (CP). Fifty-six hips in 55 patients with mean age 42.2 (range, 19-56) each received uncemented components, a 28-mm alumina head with randomization of acetabular liner. Mean St Michael's outcome score for each group with up to 10 years follow-up (median, 8 years; range, 1-10) was 22.8 and 22.9, respectively (P = .819). Wear was identified in all but 1 CP replacement, but only 12 of the 23 CC. Mean wear in the CP group was 0.11 mm/y and 0.02 mm/yr in the CC group (P < .001). Other than significantly greater wear in the polyethylene group, there was no significant difference in midterm outcome between the 2 groups. PMID:19195824

  5. The Prospective and Retrospective Memory Questionnaire: a population-based random sampling study.

    PubMed

    Piauilino, D C; Bueno, O F A; Tufik, S; Bittencourt, L R; Santos-Silva, R; Hachul, H; Gorenstein, C; Pompéia, S

    2010-05-01

    The Prospective and Retrospective Memory Questionnaire (PRMQ) has been shown to have acceptable reliability and factorial, predictive, and concurrent validity. However, the PRMQ has never been administered to a probability sample survey representative of all ages in adulthood, nor have previous studies controlled for factors that are known to influence metamemory, such as affective status. Here, the PRMQ was applied in a survey adopting a probabilistic three-stage cluster sample representative of the population of Sao Paulo, Brazil, according to gender, age (20-80 years), and economic status (n=1042). After excluding participants who had conditions that impair memory (depression, anxiety, used psychotropics, and/or had neurological/psychiatric disorders), in the remaining 664 individuals we (a) used confirmatory factor analyses to test competing models of the latent structure of the PRMQ, and (b) studied effects of gender, age, schooling, and economic status on prospective and retrospective memory complaints. The model with the best fit confirmed the same tripartite structure (general memory factor and two orthogonal prospective and retrospective memory factors) previously reported. Women complained more of general memory slips, especially those in the first 5 years after menopause, and there were more complaints of prospective than retrospective memory, except in participants with lower family income. PMID:20408038

  6. Conservative management of cesarean scar pregnancies: a prospective randomized controlled trial at a single center

    PubMed Central

    Wang, Mingyi; Yang, Zhiling; Li, Yunming; Chen, Biliang; Wang, Jian; Ma, Xiangdong; Wang, Yu

    2015-01-01

    Purpose: To assess clinical outcomes related to conservative management of women with cesarean scar pregnancies (CSPs), specifically through uterine artery embolization (UAE) with local and systemic methotrexate (MTX) treatment (UAE-MTX), or ultrasound-guided local and systemic MTX treatment (USG-MTX). Methods: Forty-five patients with CSP were randomly allocated to receive UAE-MTX (n = 24) or USG-MTX (n = 21). Participants’ clinical outcomes were compared, and clinical characteristics of failed cases were evaluated relative to successful cases. Results: The 2 groups were similar in clinical characteristics, success rate (83.3% cf. 80.9%), time to normalization of serum beta (β) human chorionic gonadotropin (β-hCG), and percentage of patients receiving multiple doses of systemic MTX. However, within the failed cases, the percentages of patients with gestational sac > 5 cm (87.5%), or type II CSP (75.0%) was significantly higher than in the successful cases (13.5% and 18.9%, respectively; P < 0.001, both), without regard to treatment group. According to the logistic regression model, a gestational sac diameter > 5 cm or type II CSP were independent risk factors for failed CSP management (gestational sac > 5 cm: OR 51.87, 95% CI 3.48-775.91, P < 0.01; type II CSP: OR 15.54, 95% CI 1.25-193.36, P < 0.05). Conclusion: The conservative treatments UAE-MTX and USG-MTX were similarly effective in treating CSP patients. Either treatment was likely to fail for CSP patients with gestational sac > 5 cm or type II CSP. PMID:26770522

  7. Tamsulosin versus Alfuzosin in the Treatment of Patients with Distal Ureteral Stones: Prospective, Randomized, Comparative Study

    PubMed Central

    Al-sayed, Abul-yazid Saad

    2010-01-01

    Purpose We evaluated and compared the efficacy of tamsulosin and alfuzosin in the medical treatment of symptomatic, uncomplicated distal ureteral stones. Materials and Methods A total of 87 patients with distal ureteral stones of ≤10 mm were randomly divided into 3 groups. Group I patients (n=29) received 0.4 mg tamsulosin daily, group II patients (n=30) received 10 mg alfuzosin daily, and group III patients (n=28) were not given tamsulosin or alfuzosin. Patients in all groups received Diclofenac sodium regularly for 1 week and then on demand. Follow-up was done on a weekly basis for 30 days. Results The mean stone size was comparable in the 3 groups (4.97±2.24, 5.47±2.13, and 5.39±1.81 mm, respectively). The stone expulsion rate was 86.2%, 76.6%, and 50% in groups I, II, and III, respectively. The difference in groups I and II with respect to group III was significant (p=0.0028 and 0.035). The mean expulsion time for groups I to III was 7.52±7.06, 8.26±7.34, and 13.90±6.99 days, respectively. The expulsion time was significantly shorter in groups I and II than in group III (p=0.0097 and 0.026). Patients taking tamsulosin and alfuzosin had fewer pain attacks than did group III patients (1.24±0.57 vs. 1.43±0.67 vs. 1.75±1.17). Only 3 cases of drug side effects, 2 in group I and 1 in group II, were recorded. Conclusions The use of tamsulosin or alfuzosin for the medical treatment of lower ureteric stones proved to be safe and effective. Moreover, tamsulosin did not have any significant benefits over alfuzosin. PMID:20414396

  8. Randomized, prospective double-blind trial of metoclopramide and placebo for gastroesophageal reflux in infants.

    PubMed

    Tolia, V; Calhoun, J; Kuhns, L; Kauffman, R E

    1989-07-01

    The effect of metoclopramide on gastroesophageal reflux was studied in 30 infants less than 1 year of age. Gastroesophageal reflux was documented in all infants by extended pH monitoring before enrollment in the study. Patients were randomly assigned to receive metoclopramide 0.1 mg/kg or placebo four times a day, 1/2 hour before feeding for 1 week, followed by the alternate regimen for 1 week. The infants were reevaluated with extended pH monitoring and scintigraphy after 4 to 7 days of each treatment. A symptom score was derived by determining the average number of occurrences of all symptoms recorded daily by parents on a symptom checklist during pretreatment, placebo, and metoclopramide treatment periods. There was a difference between pretreatment evaluation and placebo periods with respect to daily symptom scores (p less than 0.005), reflecting a significant placebo response. However, no difference in scintigraphic study was found between placebo and metoclopramide periods. A significant difference between placebo and metoclopramide periods was noted in the percentage of time esophageal pH was less than 4.0 (p less than 0.001). However, although metoclopramide decreased the proportion of time esophageal pH was less than 4.0, pH remained less than 4.0 for more than 5% of the time in most patients. Substratification of the total group into infants younger and older than 3 months revealed that older infants had greater average daily weight gain during the metoclopramide treatment period (34.3 gm/day) than in the placebo treatment period (6.6 gm/day, p = 0.05). We conclude that metoclopramide in the dosage 0.1 mg/kg four times daily reduces reflux in infants and may be useful for infants with poor weight gain and other serious complications of gastroesophageal reflux. PMID:2661788

  9. Prospective Randomized Comparison of Open versus Transperitoneal Laparoscopic Ureterolithotomy: Experience of a Single Center from Northern India

    PubMed Central

    Garg, Manish; Singh, Vishwajeet; Sinha, Rahul J.; Sankhwar, Satya N.; Kumar, Manoj; Kumar, Amit; Prakash, Jai; Kumar, Pradeep; Pandey, Mohit

    2013-01-01

    Aim Prospective randomized study on transperitoneal laparoscopic ureterolithotomy (TPLU) versus open ureterolithotomy (OU) for treatment of large impacted ureteric stones (≥ 1.5 cm) and assessment of overall results. Material & Methods In a prospective study between 2010 to 2012, 30 patients underwent TPLU and 30 OU based on 1:1 randomization. The operation was indicated primarily in 44 cases or after failed shock-wave lithotripsy/ureteroscopy in 16 cases. Two groups were compared for operative time, success rate, visual pain score, analgesic requirement, hospital stay, and postoperative complications. Statistical analysis was performed with SPSS® version 16.0 using Fisher exact or Mann-Whitney U tests with p < 0.05 considered statistically significant. Results The difference in visual pain score (6.2 in TPLU group vs 3.1 in OU group on day 1; 4.8 vs. 2.4 on day 2) and tramadol requirements (184.32 mg in TPLU group vs. 150.87 mg in OU group on day 1; 97.34 mg vs. 65.56 mg on day 2) were statistically significant and more in OU. Hospital stay and convalescence were significantly lower in the TPLU. However, stone removal in one attempt was similar in both the groups. Conclusion Although successful stone removal rates are equal in both groups, TPLU is associated significantly with less postoperative pain, less analgesic requirement, shorter hospital stay and short convalescence in comparison to OU. PMID:24917764

  10. RScore: a peptide randomicity score for evaluating tandem mass spectra.

    PubMed

    Li, Fuxin; Sun, Wei; Gao, Youhe; Wang, Jue

    2004-01-01

    RScore, a new criterion of randomicity for evaluating tandem mass (MS/MS) spectra, is described. RScore is defined as the relative quality in cross-correlation and matched intensity percentage of a potentially positive peptide to those of other possible candidates for the same spectrum. By utilizing RScore combined with less stringent SEQUEST score filters, the number of true positive peptides can be increased and the number of false positives in datasets from a known protein mixture can be reduced compared with current SEQUEST parameters used alone. This algorithm is simple and adds little overheads to SEQUEST computation. PMID:15282793

  11. Specialized Pediatric Palliative Home Care: A Prospective Evaluation

    PubMed Central

    Borasio, Gian Domenico; Nickolay, Carla; Bender, Hans-Ulrich; von Lüttichau, Irene; Führer, Monika

    2013-01-01

    Abstract Objectives: In Germany since 2007 children with advanced life-limiting diseases are eligible for Pediatric Palliative Home Care (PPHC), which is provided by newly established specialized PPHC teams. The objective of this study was to evaluate the acceptance and effectiveness of PPHC as perceived by the parents. Methods: Parents of children treated by the PPHC team based at the Munich University Hospital were eligible for this prospective nonrandomized study. The main topics of the two surveys (before and after involvement of the PPHC team) were the assessment of symptom control and quality of life (QoL) in children; and the parents' satisfaction with care, burden of patient care (Häusliche Pflegeskala, home care scale, HPS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS), and QoL (Quality of Life in Life-Threatening Illness–Family Carer Version, QOLLTI-F). Results: Of 43 families newly admitted to PPHC between April 2011 and June 2012, 40 were included in the study. The median interval between the first and second interview was 8.0 weeks. The involvement of the PPHC team led to a significant improvement of children's symptoms and QoL (P<0.001) as perceived by the parents; and the parents' own QoL and burden relief significantly increased (QOLLTI-F, P<0.001; 7-point change on a 10-point scale), while their psychological distress and burden significantly decreased (HADS, P<0.001; HPS, P<0.001). Conclusions: The involvement of specialized PPHC appears to lead to a substantial improvement in QoL of children and their parents, as experienced by the parents, and to lower the burden of home care for the parents of severely ill children. PMID:24168349

  12. Evaluation and outcome of antenatal hydronephrosis: a prospective study.

    PubMed

    Gökaslan, Filiz; Yalçınkaya, Fatoş; Fitöz, Suat; Özçakar, Z Birsin

    2012-01-01

    Antenatal hydronephrosis (AHN), defined as dilatation of renal pelvis and/or calyces, is the most frequently detected antenatal abnormality. However, postnatal management of AHN is controversial. The purpose of this study was to describe the clinical outcomes of infants with AHN and to contribute to the definition of the postnatal evaluation of these patients. One hundred and thirty-six infants with AHN were prospectively followed up to 18 months. Patients were divided into two groups according to the degree of sonographic hydronephrosis (HN) on days 5-7: group I (n = 87, 64%) included patients who had grades 1 and 2 (64%) and group II (n = 49, 36%) included patients who had grade 3 and above HN. The grade of HN was found to be correlated with the increased risk of urologic pathologies. Frequency of vesicoureteral reflux was found to be significantly lower in patients with mild HN (6%) as compared to patients with severe AHN (29%) (p = 0.005). In addition, the risk of urinary tract infection increases with increasing grades of HN (10% vs. 29%, p = 0.006). The frequency of spontaneous resolution in patients with mild AHN (64%) was also significantly higher than in patients with severe HN (29%) (p < 0.001). The degree of AHN can be used for making decision about further diagnostic imaging and treatment. Our results strongly suggest that low-grade HN is a relatively self-limited condition and needs minimal investigation. In contrast, the outcome of more severe degrees of AHN needs clarification. PMID:22506510

  13. SECONDARILY INFECTED NON-STRUVITE UROLITHIASIS: A PROSPECTIVE EVALUATION

    PubMed Central

    de Cógáin, Mitra R.; Lieske, John C.; Vrtiska, Terri J.; Tosh, Pritish K.; Krambeck, Amy E.

    2014-01-01

    Purpose To characterize patients who form non-struvite stones associated with infection (secondarily infected calculi) and to define the bacteria associated with these. Materials and Methods Patients undergoing percutaneous nephrolithotomy were prospectively recruited. Medical records were reviewed and stones were analyzed using microCT and infrared spectroscopy. A fragment of each stone was sent for bacterial culture. Patients were categorized by stone culture results (SC+/−) and the presence of struvite (ST+/−). Fisher’s exact test was used for comparison of proportion. Sterility of intraoperative SC was established with independently collected controls. Results In total, 125 patients were enrolled: 24 SC+/ST−, 19 SC+/ST+ and 82 SC−/ST−. Proportions of patients with prior urologic surgery, diabetes, and immunodeficiency were similar between groups. Patients with neurogenic bladder were more likely to have SC+/ST+ stones or SC+/ST− stones than SC−/ST− stones (26% vs. 8% vs. 0%, respectively, p<0.01). Among patients with metabolic evaluations, hypocitraturia was found in 31.6% (6/19) SC+/ST− patients, 46.7% (7/15) SC+/ST+ patients, and 26.0% (19/73) of SC−/ST− patients (p=0.28). Approximately 40% of cultured organisms in the secondarily infected calculi possessed urease and another 40% citrate lyase activity. Conclusions Secondarily infected stones were detected in approximately 20% of this surgical cohort and may be more common than previously appreciated. Neurogenic bladder appeared to predispose patients to either struvite or secondarily infected stones. The role of bacterial infection in stone formation is unclear, but may include alteration of urinary components, acting as a nidus for crystallization, or inducing inflammation. PMID:25306481

  14. A Randomized Prospective Study Of The Use Of Ipads In Reducing Anxiety During Cast Room Procedures

    PubMed Central

    Ko, Justine S.; Whiting, Zachariah; Nguyen, Cynthia; Liu, Raymond W; Gilmore, Allison

    2016-01-01

    Background Cast room procedures can be a source of anxiety for children. Various techniques, including music therapy, have been evaluated as a way to ease this anxiety. The use of iPads as a form of distraction during cast room procedures has not previously been evaluated and was the purpose of the current study. Methods 146 children and adolescents who underwent cast room procedures during June- August 2015 were randomly assigned to one of three groups: no-iPad, iPad with video, or iPad with game. Patient heart rates were measured using a pulse oximeter in the waiting room, before the procedure, during the procedure, and after the procedure. Mean values for each group were calculated at each time interval and compared both between groups and within groups over time. Results There were no significant differences in baseline (waiting room) heart rate between the no-iPad and iPad groups. When compared with the no-iPad group, there was a trend toward decreased heart rate in the video group (p=0.13) and a significant increase in heart rate in the game group (p=0.026) before the procedure. There were no significant decreases in heart rate within any of the groups when comparing the waiting room heart rates with the during procedure heart rates. There was a significant difference between the no-iPad and video groups (p=0.047) when comparing the change in heart rate from baseline to before the procedure, with a decreased heart rate observed in the video group. Conclusions The results of this study show a significant decrease in heart rate when transitioning from the waiting room to the cast room while watching videos on the iPad. iPad-based video delivery appears to decrease anxiety prior to cast room procedures. iPad-based game play is difficult to assess as elevations in heart rate prior to the procedure are presumed to be related to game play and confound the observed effect it may have on anxiety related to the procedure. PMID:27528849

  15. An Education- and Telephone-Based Intervention to Improve Follow-up to Vision Care in Patients With Diabetes: A Prospective, Single-Blinded, Randomized Trial.

    PubMed

    Zangalli, Camila S; Murchison, Ann P; Hale, Nicole; Hark, Lisa A; Pizzi, Laura T; Dai, Yang; Leiby, Benjamin E; Haller, Julia A

    2016-01-01

    The aim was to evaluate the effectiveness of a multipronged intervention on diabetic dilated fundus examination (DFE) adherence. In a prospective trial, 521 patients with diabetes who were due for follow-up DFEs were randomized to usual care or the intervention group. Usual care received a form letter reminder to schedule and an automated reminder phone call prior to their appointment. Intervention participants received an educational brochure about diabetic eye disease and a personalized letter reminder to schedule. A research assistant called intervention participants to help schedule the appointment, and they received a reminder letter and an automated phone call prior to the scheduled visit. Patients in the intervention group were significantly more likely to schedule (63% vs 40%; P < .0001) and complete their appointment (48% vs 30%; P < .0001) compared with usual care. A multipronged intervention, including an educational mailing and telephone assistance with scheduling an appointment, significantly improved diabetic DFE adherence. PMID:25270737

  16. The effect of laser epilation on recurrence and satisfaction in patients with sacrococcygeal pilonidal disease: a prospective randomized controlled trial

    PubMed Central

    Demircan, Firat; Akbulut, Sami; Yavuz, Ridvan; Agtas, Huseyin; Karabulut, Koray; Yagmur, Yusuf

    2015-01-01

    Background: The primary aim of this prospective study was to investigate the effects of laser epilation on patient satisfaction and recurrence in patients who underwent pilonidal sinus surgery. Method: Sixty patients scheduled for pilonidal sinus surgery in our clinic between 2011 and 2012 were enrolled in this prospective randomized controlled study. Patients were divided in two groups of 30 patients each. Only the Karydakis flap reconstruction technique was performed in the first group. Two sessions of laser epilation were applied in the second group in addition to Karydakis flap reconstruction. The patients in the second group underwent laser epilation 2 weeks before and 3 weeks after the surgery for a total of 2 times in a private office. Results: There were no statistically significant differences between the groups in terms of age, gender, smoking usage, ASA Score, duration of patient’s complaints, BMI and hospital stay. There were no statistically significant differences between the groups in terms of surgical site infection, wound separation, abscess formation at the any time postoperatively. There were statistically significant differences between the two groups in the first week post operation considering the VAS pain score (P<0.03) and VAS satisfaction score (P<0.01). While there were statistically significant differences between the two groups in the first month post operation considering the VAS pain score (P<0.0001), there were no statistically significant differences between the groups in terms of VAS satisfaction score in the first and three month postoperatively. In the telephone interviews done 1 year after the surgery, recurrence were detected in 4% of first group and in 20% of second group. Recurrence rates were significantly higher in the second group (P=0.045). Conclusion: Our results show that laser epilation does not reduce the relapse rates in pilonidal sinus surgery, as expected. It is obvious that prospective randomized studies need to

  17. The deception and fallacies of sponsored randomized prospective double-blinded clinical trials: the bisphosphonate research example.

    PubMed

    Marx, Robert E

    2014-01-01

    The randomized prospective double-blinded clinical trial (RCT) is accepted as Level I evidence and is highly regarded. However, RCTs that gained FDA approval of drugs such as Vioxx, Fen-Phen, and oral and intravenous bisphosphonates have proven to generate misleading results and have not adequately identified serious adverse reactions. The development, research, and clinical marketing of the oral and intravenous bisphosphonates can serve as a representative example for the deteriorated value of many of today's RCTs. The expected high value of RCTs is jeopardized by: (1) sponsorship that incorporates bias; (2) randomization that can select out an expected improved result or eliminate higher-risk individuals; (3) experimental design that can avoid recognition of serious adverse reactions; (4) blinding that can easily become unblinded by the color, shape, odor, or administration requirements of a drug; (5) definitions that can define an observation as something other than what it actually represents, or fail to define it as an adverse reaction; (6) labeling of retrospective data as a prospective trial by using adjudicators prospectively to look at retrospective data; (7) change of the length of study to avoid the longer-term adverse reaction from accumulation of drug or treatment effects; (8) ghost writing, as when drug company physicians or a hired corporation either edit or write the entire protocol and/or manuscript for publication. Such corruption of the well-intended properly conducted RCT should be viewed with a sense of outrage by practitioners and requires a restructuring of the levels of evidence accepted today. PMID:24451886

  18. Prospect evaluation of shallow I-35 reservoir of NE Malay Basin offshore, Terengganu, Malaysia

    NASA Astrophysics Data System (ADS)

    Janjua, Osama Akhtar; Wahid, Ali; Salim, Ahmed Mohamed Ahmed; Rahman, M. Nasir B. A.

    2016-02-01

    A potential accumulation of hydrocarbon that describes significant and conceivable drilling target is related to prospect. Possibility of success estimation, assuming discovery of hydrocarbons and the potential recoverable quantities range under a commercial development program are the basis of Prospect evaluation activities. The objective was to find the new shallow prospects in reservoir sandstone of I -Formation in Malay basin. The prospects in the study area are mostly consisting of faulted structures and stratigraphic channels. The methodology follows seismic interpretation and mapping, attribute analysis, evaluation of nearby well data i.e., based on well - log correlation. The petrophysical parameters analogue to nearby wells was used as an input parameter for volumetric assessment. Based on analysis of presence and effectiveness, the prospect has a complete petroleum system. Two wells have been proposed to be drilled near the major fault and stratigraphic channel in I-35 reservoir that is O-1 and O-2 prospects respectively. The probability of geological success of prospect O-1 is at 35% while for O-2 is 24%. Finally, for hydrocarbon in place volumes were calculated which concluded the best estimate volume for oil in O-1 prospect is 4.99 MMSTB and O-2 prospect is 28.70 MMSTB while for gas is 29.27 BSCF and 25.59 BSCF respectively.

  19. DRIVE it home: making the case for prospective economic data collection in randomized clinical trials.

    PubMed

    Eisenstein, Eric L

    2008-12-01

    Although the results of Pizzi et al. point to the potential economic attractiveness of a ferric gluconate treatment strategy, they may not be sufficient to change public policy and reimbursement practices. What is required is a large, simple trial that will replicate the results of the DRIVE trial in a broader population with longer follow-up and a prospectively defined economic and quality-of-life study conducted from the societal perspective. PMID:19034299

  20. Comparison of clinical and radiological outcomes after automated open lumbar discectomy and conventional microdiscectomy: a prospective randomized trial

    PubMed Central

    Lee, Sang-Ho; Bae, Jun Seok

    2015-01-01

    Objective: Microdiscectomy (MD) is the gold standard for surgical discectomy. As a minimally invasive discectomy, automated open lumbar discectomy (AOLD) is designed to preserve annular integrity and disc height as well as effectively remove herniated disc and degenerated disc material. However, there have been no prospective clinical studies comparing their effectiveness. The study was designed to compare clinical and radiological outcomes after AOLD with those of MD. Methods: Seventy-eight patients were evaluated for unilateral leg pain with the presence of disc herniation on magnetic resonance imaging (MRI) scans at a single attributable level. Sixty-two patients were enrolled; 33 patients (53%) were randomly assigned to the AOLD group and the remaining 29 patients (47%) were assigned to the MD group. Follow-up assessment was performed for 19 of the AOLD patients and 17 of the MD patients. The average follow-up period was 20 months. Clinical and functional outcomes were assessed using VAS and ODI scores. Change of disc height (DH), instability, and disc degeneration were assessed from radiographs, while Modic change and reherniation were assessed using MRI scans. Results: Postoperative VAS scores for leg pain and ODI scores for function were significantly improved in both groups. Postoperative VAS for back pain tended to decrease in the MD group but the decrease was statistically insignificant (P = 0.081). The postoperative VAS for back pain was significantly reduced in the AOLD group (P = 0.012). Patients from the MD group showed greater DH reduction than the AOLD group (P = 0.049). The MD group experienced greater disc degeneration and Modic change than the AOLD group. Follow-up MRI revealed 2 cases of reherniation in the AOLD group; 1 case was symptomatic, the other was asymptomatic. Conclusions: AOLD showed comparable clinical and radiological outcomes to conventional MD. AOLD preserves the central disc and removes only the loose degenerative disc fragments

  1. Prospective randomized study comparing concomitant chemoradiotherapy using weekly cisplatin & paclitaxel versus weekly cisplatin in locally advanced carcinoma cervix

    PubMed Central

    Seam, Rajeev; Gupta, Manoj; Gupta, Manish

    2016-01-01

    Background To evaluate the benefit with the addition of paclitaxel to cisplatin-based concurrent chemoradiotherapy (C-CRT) for the treatment of locally advanced carcinoma of the uterine cervix in terms of local control, disease free survival (DFS) and overall survival (OS). Methods From 1/7/2011 to 31/5/2012, 81 women (median age of 50 years) with newly diagnosed, histopathologically proven carcinoma cervix with FIGO stages IIA to IIIB were randomized to two arms—cisplatin 40 mg/m2/week for 5 weeks was given in single agent cisplatin (control arm), while cisplatin 30 mg/m2/week and paclitaxel 50 mg/m2/week for 5 weeks were given in cisplatin and paclitaxel (study arm). External beam radiotherapy (EBRT) was delivered to a total dose of 50 Gray (Gy) in 25 fractions (#) followed by intracavitary (I/C) brachytherapy or supplement EBRT at 20 Gy/10# with 2 cycles of respective chemotherapy. This prospective trial was registered with clinicaltrials.gov (NCT01593306). Results Patients (n=81) had a maximum follow up of 36 months with a median follow up of 29 months. At first follow up study arm showed complete response in 84% vs. 75.6% in control arm (P=0.4095). An increase in toxicities was observed in the study arm in comparison to the control arm in terms of haematological grade II (35% vs. 12.2%), gastrointestinal (GI) grade III (20% vs. 7.4%) and GI grade IV (12.5% vs. 2.4%) toxicities. At median follow-up, the study arm demonstrated enhanced outcomes over the control arm in terms of DFS (79.5% vs. 64.3%; P=0.07) and OS (87.2% vs. 78.6%; P=0.27). Conclusions Despite the expected increase in manageable toxicities, these early results reveal promise with the inclusion of paclitaxel into the standard cisplatin based chemoradiation regime. Larger multi-institutional studies are justified to confirm a potential for the enhancement of response rates and survival. PMID:26904570

  2. Outcome of Burns Treated With Autologous Cultured Proliferating Epidermal Cells: A Prospective Randomized Multicenter Intrapatient Comparative Trial.

    PubMed

    Gardien, Kim L M; Marck, Roos E; Bloemen, Monica C T; Waaijman, Taco; Gibbs, Sue; Ulrich, Magda M W; Middelkoop, Esther

    2016-01-01

    Standard treatment for large burns is transplantation with meshed split skin autografts (SSGs). A disadvantage of this treatment is that healing is accompanied by scar formation. Application of autologous epidermal cells (keratinocytes and melanocytes) may be a suitable therapeutic alternative, since this may enhance wound closure and improve scar quality. A prospective, multicenter randomized clinical trial was performed in 40 adult patients with acute full thickness burns. On two comparable wound areas, conventional treatment with SSGs was compared to an experimental treatment consisting of SSGs in combination with cultured autologous epidermal cells (ECs) seeded in a collagen carrier. The primary outcome measure was wound closure after 5-7 days. Secondary outcomes were safety aspects and scar quality measured by graft take, scar score (POSAS), skin colorimeter (DermaSpectrometer) and elasticity (Cutometer). Wound epithelialization after 5-7 days was significantly better for the experimental treatment (71%) compared to the standard treatment (67%) (p = 0.034, Wilcoxon), whereas the take rates of the grafts were similar. No related adverse events were recorded. Scar quality was evaluated at 3 (n = 33) and 12 (n = 28) months. The POSAS of the observer after 3 and 12 months and of the patient after 12 months were significantly better for the experimental area. Improvements between 12% and 23% (p ≤ 0.010, Wilcoxon) were detected for redness, pigmentation, thickness, relief, and pliability. Melanin index at 3 and 12 months and erythema index at 12 months were closer to normal skin for the experimental treatment than for conventional treatment (p ≤ 0.025 paired samples t-test). Skin elasticity showed significantly higher elasticity (p = 0.030) in the experimental area at 3 months follow-up. We showed a safe application and significant improvements of wound healing and scar quality in burn patients after treatment with ECs versus SSGs only

  3. Blood loss associated with radical cystectomy: A prospective, randomized study comparing impact LigaSure vs. stapling device☆

    PubMed Central

    Thompson, Ian M.; Kappa, Stephen F.; Morgan, Todd M.; Barocas, Daniel A.; Bischoff, Carl J.; Keegan, Kirk A.; Stratton, Kelly L.; Clark, Peter E.; Resnick, Matthew J.; Smith, Joseph A.; Cookson, Michael S.; Chang, Sam S.

    2014-01-01

    Objectives Radical cystectomy (RC) is associated with significant blood loss and transfusion requirement. We performed a prospective, randomized trial to compare blood loss, operative time, and cost using 2 different and commonly employed approaches to tissue ligation and division during RC: mechanical (stapler device) and electrosurgical (heat-sealing device). Methods and materials Eighty patients undergoing RC for urothelial bladder carcinoma were randomized to use of either an Endo GIA Stapler or Impact LigaSure device for tissue ligation and division. Primary outcomes were blood loss, operative time, and device costs. Data were analyzed with Wilcoxon rank sum test and Welch 2-sample t test. Results There were no significant demographic or preoperative differences between the cohorts. Mean estimated blood loss was similar between the electrosurgical (687 ml) and stapler (708 ml) arms (P = 0.850). There were no significant differences between cohorts when comparing operative times or transfusion requirement. There was a significant increase in the mean number of adjunctive suture ligatures used in the stapling device arm (3.0 vs. 1.5, P = 0.047). Total device costs were significantly lower with the LigaSure compared with the GIA Stapler ($625.00 vs. $1490.10, P < 0.001). There were no complications attributable to either device. Conclusions This prospective, randomized study demonstrates no significant difference in blood loss, transfusion requirement, or safety between mechanical vs. electrosurgical control of the vascular pedicles. The LigaSure device, however, is significantly less costly than the GIA Stapler and required fewer additional measures for hemostasis. PMID:24054870

  4. Ceramic on Ceramic or Ceramic-on-polyethylene for Total Hip Arthroplasty: A Systemic Review and Meta-analysis of Prospective Randomized Studies

    PubMed Central

    Dong, Yu-Lei; Li, Tao; Xiao, Ke; Bian, Yan-Yan; Weng, Xi-Sheng

    2015-01-01

    Background: Wear debris of polyethylene has become a restraining factor of the durability for total hip arthroplasty (THA). Ceramic on ceramic (COC) has better wear resistance while the squeaking sound and prosthesis fracture are of concern. It is still a controversy that bearing couples are better for THA. Methods: We performed a systematic review of all English articles identified from PubMed (1966-), Embase (1980-) and the Cochrane Library. Clinical outcomes, complications, revision rates, and radiographic outcomes of COC-THA and ceramic on polyethylene (COP)-THA were compared and evaluated. Results: Eight prospective randomized trials enrolling a total of 1508 patients and 1702 THA surgeries were identified. Our results demonstrated the prosthesis fracture and the squeaking sound is significantly higher in COC group and higher wear rate of the COP. Hip function, loosening rate, dislocation rate, revision rate, and the osteolysis rate were comparable between two groups. According to Grading of Recommendations Assessment, Development and Evaluation system assessment, the strength of evidence was high for prosthesis fracture, dislocation, osteolysis, and moderate for radiolucent line or loosening, hip noise, and revision. Conclusions: Up to now, there is insufficient evidence to identify any clinical advantage of COC compared with COP. Longer follow-up of larger randomized trial is needed to clarify the outcomes. PMID:25947407

  5. Hypospadias repair using laser tissue soldering (LTS): preliminary results of a prospective randomized study

    NASA Astrophysics Data System (ADS)

    Kirsch, Andrew J.; Cooper, Christopher S.; Canning, Douglas A.; Snyder, Howard M., III; Zderic, Stephen A.

    1998-07-01

    Purpose: The purpose of this study was to evaluate laser tissue soldering using an 808 nm diode laser and wavelength- matched human albumin solder for urethral surgery in children. Methods: Currently, 30 boys, ages 3 months to 8 years were randomized to standard suturing (n equals 22) or 'sutureless' laser hypospadias repair (n equals 18). Laser soldering was performed with a human albumin solder doped with indocyanine green dye (2.5 mg/ml) using a laser power output of 0.5 W, pulse duration of 0.5 sec, and interval of 0.1 sec. Power density was approximately 16 W/cm2. In the laser group, sutures were used for tissue alignment only. At the time of surgery, neourethral and penile lengths, operative time for urethral repair, and number of sutures/throws were measured. Postoperatively, patients were examined for complications of wound healing, stricture, or fistula formation. Results: Mean age, severity of urethral defect, type of repair, and neourethra length were equivalent between the two groups. Operative time was significantly faster for laser soldering in both simple (1.6 plus or minus 0.21 min, p less than 0.001) and complex (5.4 plus or minus 0.28 min, p less than 0.0001) hypospadias repairs compared to controls (10.6 plus or minus 1.4 min and 27.8 plus or minus 2.9 min, respectively). The mean number of sutures used in the laser group for simple and complex repairs (3.3 plus or minus 0.3 and 8.1 plus or minus 0.64, respectively) were significantly (p less than 0.0001) less than for controls (8.2 plus or minus 0.84 and 20 plus or minus 2.3, respectively). Followup was between 3 months and 14 months. The overall complication rate in the laser group (11%) was lower than the controls (23%). However, statistical significance (p less than 0.05) was achieved only for the subgroup of patients undergoing simple repairs (LTS, 100% success versus suturing, 69% success). Conclusions: These preliminary results indicate that laser tissue soldering for hypospadias repair

  6. Niger Delta basin oil and gas prospects evaluated

    SciTech Connect

    Not Available

    1992-09-28

    This paper reports that an ambitious project to map African oil and gas prospects has produced its first findings in a report on the Niger Delta basin. In Nigeria, 73% of discoveries are smaller than 50 million bbl, with a 42% success rate for wildcats. There are 'out of round prospects off Nigeria, too, with a number of companies currently in discussions. Petroconsultants the there are further opportunities for exploration in the Northern Onshore Fringe Belt, which has an estimated potential of 500 million bbl of reserves. Three OPLs are open.

  7. Quantized Step-up Model for Evaluation of Internship in Teaching of Prospective Science Teachers.

    ERIC Educational Resources Information Center

    Sindhu, R. S.

    2002-01-01

    Describes the quantized step-up model developed for the evaluation purposes of internship in teaching which is an analogous model of the atomic structure. Assesses prospective teachers' abilities in lesson delivery. (YDS)

  8. A Randomized, Prospective, Parallel Group Study of Laparoscopic vs. Laparoendoscopic Single Site Donor Nephrectomy for Kidney Donation

    PubMed Central

    Aull, Meredith J.; Afaneh, Cheguevara; Charlton, Marian; Serur, David; Douglas, Melissa; Christos, Paul J.; Kapur, Sandip; Del Pizzo, Joseph J.

    2014-01-01

    Few prospective, randomized studies have assessed benefits of laparoendoscopic single site donor nephrectomy (LESS-DN) over laparoscopic donor nephrectomy (LDN). Our center initiated such a trial in January 2011, following subjects randomized to LESS-DN vs. LDN from surgery through 5 years post-donation. Subjects complete recovery/satisfaction questionnaires at 2, 6, and 12 months post-donation; transplant recipient outcomes are also recorded. 100 subjects (49 LESS-DN, 51 LDN) underwent surgery; donor demographics were similar between groups, and included a predominance of female, living unrelated donors, mean age of 47 years who underwent left donor nephrectomy. Operative parameters (overall time, time to extraction, warm ischemia time, blood loss) were similar between groups. Conversion to hand-assist laparoscopy was required in 3 LESS-DN (6.1%) vs. 2 LDN (3.9%; P=0.67). Questionnaires revealed 97.2% of LESS-DN vs. 79.5% of LDN (P=0.03) were 100% recovered by two months after donation. No significant difference was seen in satisfaction scores between the groups. Recipient outcomes were similar between groups. Our randomized trial comparing LESS donor nephrectomy to LDN confirms that LESS-DN offers a safe alternative to conventional LDN in terms of intra- and post-operative complications. LDN and LESS-DN offer similar recovery and satisfaction after donation. PMID:24934732

  9. Comfort, satisfaction, and anxiolysis in surgical patients using a patient-adjustable comfort warming system: a prospective randomized clinical trial.

    PubMed

    O'Brien, Denise; Greenfield, Mary Lou V H; Anderson, Jane E; Smith, Beverly A; Morris, Michelle

    2010-04-01

    Comfort warming systems aim to produce a comfortable local environment over which the individual patient has control. We studied a patient-adjustable comfort warming system using the Bair PAWS (Patient Adjustable Warming System) (Arizant Healthcare, Inc, Eden Prairie, MN), specifically to study comfort warming rather than therapeutic warming. One-hundred thirty patients were enrolled in this prospective randomized clinical trial, with 58 patients randomized to the patient warming gown, and 72 randomized to the warm blanket group. Groups were similar for gender, age, height, weight, surgical time, body surface area, and body mass index. The patient-adjustable warming system group had perceived greater control and satisfaction at 30 minutes after treatment was initiated compared with the warmed blanket control group. However, there were no differences in satisfaction levels with thermal comfort among those patients contacted one day postoperatively. Additional research is needed to improve external validity of study findings. Further refinement of a nursing definition of thermal comfort should be explored. PMID:20359643

  10. Credit Risk Evaluation of Power Market Players with Random Forest

    NASA Astrophysics Data System (ADS)

    Umezawa, Yasushi; Mori, Hiroyuki

    A new method is proposed for credit risk evaluation in a power market. The credit risk evaluation is to measure the bankruptcy risk of the company. The power system liberalization results in new environment that puts emphasis on the profit maximization and the risk minimization. There is a high probability that the electricity transaction causes a risk between companies. So, power market players are concerned with the risk minimization. As a management strategy, a risk index is requested to evaluate the worth of the business partner. This paper proposes a new method for evaluating the credit risk with Random Forest (RF) that makes ensemble learning for the decision tree. RF is one of efficient data mining technique in clustering data and extracting relationship between input and output data. In addition, the method of generating pseudo-measurements is proposed to improve the performance of RF. The proposed method is successfully applied to real financial data of energy utilities in the power market. A comparison is made between the proposed and the conventional methods.

  11. Evaluating Prospects: The Criteria Used to Hire New Teachers

    ERIC Educational Resources Information Center

    Cranston, Jerome

    2012-01-01

    Teacher hiring decisions have far-reaching effects. Accordingly, it is important that prospective teachers be scrutinized carefully. The process that yields new teacher hires also deserves careful analysis. This article reports on key findings derived from a larger study that examined the overall organization of the hiring process and how criteria…

  12. Exit-Site Infection of Peritoneal Catheter is Reduced by the Use of Polyhexanide. Results of a Prospective Randomized Trial

    PubMed Central

    Núñez-Moral, M.; Sánchez-Álvarez, E.; González-Díaz, I.; Peláez-Requejo, B.; Fernández-Viña, A.; Quintana-Fernández, A.; Rodríguez-Suárez, C.

    2014-01-01

    ♦ Background: One of the most common and severe complications affecting peritoneal dialysis (PD) patients is exit-site infection of the peritoneal catheter; it is therefore of vital importance to prevent it. This complication has a negative impact on the success of the technique. In spite of this, there are no clear guidelines concerning how to take care of the exit site. The objective of this study was to assess the efficacy of polyhexanide in preventing exit-site infection over a 12-month period. ♦ Methods: We designed a single-center, prospective, open-labeled, randomized controlled clinical trial with parallel groups. Requirements for participation in the study included implantation of the peritoneal catheter at least six weeks before entering the study and no infectious complications requiring either hospital admission or antibiotic treatment for at least three months before entering into the study. Patients were randomized to be daily cured as follows: Group A: traditional care with saline serum and povidone-iodine; and Group B: polyhexanide solution. Exit sites were evaluated at baseline and every four to six weeks or if any event occurred, according to the Twardowski criteria. ♦ Results: Of the 60 included patients, 46 completed the 12-month follow-up period. Six underwent transplantation, five died and three were transferred to hemodialysis (HD). The treatment was well tolerated, with no side effects nor abandonments due to such effects. Throughout the study period, six patients (20%) undergoing traditional care and only two (6,7%) receiving polyhexanide developed an exit-site infection (p = 0.032). There were a total number of 12 infections; nine occurred in patients following the traditional approach and only three in patients treated with polyhexanide (p = 0.037). The germs responsible for the infections were: S. aureus (six cases), Corynebacterium jeikeium (two cases) and P. aeruginosa (one case) in the saline serum and povidone-iodine group and

  13. A multifaceted prospective memory intervention to improve medication adherence: design of a randomized control trial.

    PubMed

    Insel, Kathleen C; Einstein, Gilles O; Morrow, Daniel G; Hepworth, Joseph T

    2013-01-01

    Adherence to prescribed antihypertensive agents is critical because control of elevated blood pressure is the single most important way to prevent stroke and other end organ damage. Unfortunately, nonadherence remains a significant problem. Previous interventions designed to improve adherence have demonstrated only small benefits of strategies that target single facets such as understanding medication directions. The intervention described here is informed by prospective memory theory and performance of older adults in laboratory-based paradigms and uses a comprehensive, multifaceted approach to improve adherence. It incorporates multiple strategies designed to support key components of prospective remembering involved in taking medication. The intervention is delivered by nurses in the home with an education control group for comparison. Differences between groups in overall adherence following the intervention and 6 months later will be tested. Systolic and diastolic blood pressure levels also will be examined between groups and as they relate to adherence. Intra-individual regression is planned to examine change in adherence over time and its predictors. Finally, we will examine the association between executive function/working memory and adherence, predicting that adherence will be related to executive/working memory in the control group but not in the intervention group. PMID:23010608

  14. Prospective Multicenter Trial Evaluating Balloon-Catheter Partial-Breast Irradiation for Ductal Carcinoma in Situ

    SciTech Connect

    Abbott, Andrea M.; Portschy, Pamela R.; Lee, Chung; Le, Chap T.; Han, Linda K.; Washington, Tara; Kinney, Michael; Bretzke, Margit; Tuttle, Todd M.

    2013-11-01

    Purpose: To determine outcomes of accelerated partial-breast irradiation (APBI) with MammoSite in the treatment of ductal carcinoma in situ (DCIS) after breast-conserving surgery. Methods and Materials: We conducted a prospective, multicenter trial between 2003 and 2009. Inclusion criteria included age >18 years, core needle biopsy diagnosis of DCIS, and no prior breast cancer history. Patients underwent breast-conserving surgery plus MammoSite placement. Radiation was given twice daily for 5 days for a total of 34 Gy. Patients were evaluated for development of toxicities, cosmetic outcome, and ipsilateral breast tumor recurrence (IBTR). Results: A total of 41 patients (42 breasts) completed treatment in the study, with a median follow up of 5.3 years. Overall, 28 patients (68.3%) experienced an adverse event. Skin changes and pain were the most common adverse events. Cosmetic outcome at 6 months was judged excellent/good by 100% of physicians and by 96.8% of patients. At 12 months, 86.7% of physicians and 92.3% of patients rated the cosmetic outcome as excellent/good. Overall, 4 patients (9.8%) developed an IBTR (all DCIS), with a 5-year actuarial rate of 11.3%. All IBTRs were outside the treatment field. Among patients with IBTRs, the mean time to recurrence was 3.2 years. Conclusions: Accelerated partial-breast irradiation using MammoSite seems to provide a safe and cosmetically acceptable outcome; however, the 9.8% IBTR rate with median follow-up of 5.3 years is concerning. Prospective randomized trials are necessary before routine use of APBI for DCIS can be recommended.

  15. A randomized prospective study to assess the efficacy of two cold-therapy treatments following carpal tunnel release.

    PubMed

    Hochberg, J

    2001-01-01

    A prospective randomized study was performed comparing the efficacy of controlled cold therapy (CCT) with the efficacy of ice therapy in the postoperative treatment of 72 patients with carpal tunnel syndrome. Immediately after surgery, patients applied either a temperature-controlled cooling blanket (CCT) or a standard ice pack over their surgical dressings. Pain was assessed by visual analog scale and swelling by wrist circumference preoperatively, immediately after surgery, and on postoperative day 3. Patients kept log books of daily treatment times. Narcotic use (of Vicodin ES) was determined by pill count at day 3 and by daily log book recordings. Patients who used CCT showed significantly greater reduction in pain, edema (wrist circumference), and narcotic use at postoperative day 3 than did those using ice therapy. This study indicates that after carpal tunnel surgery, the use of CCT, compared with traditional ice therapy, provides patients with greater comfort and lessens the need for narcotics. PMID:11511016

  16. Is Electrocautery of Patella Useful in Patella Non-Resurfacing Total Knee Arthroplasty?: A Prospective Randomized Controlled Study.

    PubMed

    Kwon, Sae Kwang; Nguku, Levis; Han, Chang Dong; Koh, Yong-Gon; Kim, Dong-Wook; Park, Kwan Kyu

    2015-12-01

    There is controversy over the need for electrocauterization of the patella in non-resurfacing total knee arthroplasty (TKA). We investigated whether this procedure is beneficial through a prospective randomized controlled trial. Fifty patients who underwent electrocautery were compared with 50 patients who did not undergo this procedure. We determined cartilage status, preoperative and postoperative American Knee Society (AKS) score, the Western Ontario and McMaster Universities score (WOMAC) and the Patellofemoral (PF) scores for a minimum of 5 years. The two groups did not differ significantly in demographics, intraoperative cartilage status, or preoperative or postoperative outcomes. No complications were detected in either group. We found no benefits of electrocautery of the patella in patellar non-resurfacing TKA up to 5 years. PMID:26100474

  17. Acetaminophen and diphenhydramine as premedication for platelet transfusions: a prospective randomized double-blind placebo-controlled trial.

    PubMed

    Wang, Stephen E; Lara, Primo N; Lee-Ow, Angie; Reed, Jeanne; Wang, Lori R; Palmer, Patti; Tuscano, Joseph M; Richman, Carol M; Beckett, Laurel; Wun, Ted

    2002-07-01

    Non-hemolytic transfusion reactions (NHTR) occur in up to 30% of patients receiving platelet transfusions. Premedication with acetaminophen and diphenhydramine is a common strategy to prevent NHTR, but its efficacy has not been studied. In this prospective trial, transfusions in patients receiving pre-storage leukocyte-reduced single-donor apheresis platelets (SDP) were randomized to premedication with either acetaminophen 650 mg PO and diphenhydramine 25 mg IV, or placebo. Fifty-one patients received 98 transfusions. Thirteen patients had 15 NHTR: 15.4% (8/52) in the treatment arm and 15.2% (7/46) in the placebo arm. Premedication prior to transfusion of pre-storage leukocyte reduced SDP does not significantly lower the incidence of NHTR as compared to placebo. PMID:12111764

  18. Preoperative CT angiography versus Doppler ultrasound mapping of abdominal perforator in DIEP breast reconstructions: A randomized prospective study.

    PubMed

    Klasson, S; Svensson, H; Malm, K; Wassélius, J; Velander, P

    2015-06-01

    Is there a difference in surgery time and complication rate when Doppler ultrasound (US) is used for the preoperative mapping of perforators in comparison with computer tomography angiography (CTA)? Women who were candidates for breast reconstruction using the deep inferior epigastric perforator (DIEP) free flap were enrolled in a prospective randomized study. The operating time was 249 ± 62 min (mean ± SD) in the CTA group (n = 32) and 255 min ± 75 in the US group (n = 31)--hence a difference of 6 min on average. No flaps were lost. Sixteen complications occurred in 15 patients: seven in the CTA group and nine in the US group. Complications were remedied without delay and all patients came through with a favorable reconstruction. Preoperative mapping of perforators with US is satisfactory enough provided the microsurgery team has proper experience in breast reconstruction with the DIEP flap. PMID:25824193

  19. Randomized, prospective, and double-blind trial of new beta-lactams in the treatment of appendicitis.

    PubMed Central

    Lau, W Y; Fan, S T; Chu, K W; Suen, H C; Yiu, T F; Wong, K K

    1985-01-01

    A prospective, randomized, and double-blind study was conducted with 864 patients operated on for appendicitis. In early cases, including normal and acute appendicitis, one dose of antibiotic was given. The rate of postappendectomy septic complications in patients who received cefotaxime, cefoperazone, or moxalactam was very low (about 3%), and there was no statistical difference between the drugs. For late cases, including gangrenous and perforated appendicitis, the antibiotics were continued for 5 days. Moxalactam decreased significantly the septic complications in these patients when compared with the other two drugs. It is safe, free from serious toxic side effects, and more convenient and easier to administer than combination antibiotic therapy. The main disadvantage of moxalactam is its high cost, but this has to be balanced against the savings in nursing time, the cost of monitoring renal function and serum level when aminoglycosides are used, and the reduced usage and manipulation of infusion sets. PMID:3911877

  20. Low-calorie sweeteners and body weight and composition: a meta-analysis of randomized controlled trials and prospective cohort studies123

    PubMed Central

    Miller, Paige E; Perez, Vanessa

    2014-01-01

    Background: Replacement of caloric sweeteners with lower- or no-calorie alternatives may facilitate weight loss or weight maintenance by helping to reduce energy intake; however, past research examining low-calorie sweeteners (LCSs) and body weight has produced mixed results. Objective: The objective was to systematically review and quantitatively evaluate randomized controlled trials (RCTs) and prospective cohort studies, separately, that examined the relation between LCSs and body weight and composition. Design: A systematic literature search identified 15 RCTs and 9 prospective cohort studies that examined LCSs from foods or beverages or LCSs consumed as tabletop sweeteners. Meta-analyses generated weighted mean differences in body weight and composition values between the LCS and control groups among RCTs and weighted mean correlations for LCS intake and these parameters among prospective cohort studies. Results: In RCTs, LCSs modestly but significantly reduced all outcomes examined, including body weight (−0.80 kg; 95% CI: −1.17, −0.43), body mass index [BMI (in kg/m2): −0.24; 95% CI: −0.41, −0.07], fat mass (−1.10 kg; 95% CI: −1.77, −0.44), and waist circumference (−0.83 cm; 95% CI: −1.29, −0.37). Among prospective cohort studies, LCS intake was not associated with body weight or fat mass, but was significantly associated with slightly higher BMI (0.03; 95% CI: 0.01, 0.06). Conclusions: The current meta-analysis provides a rigorous evaluation of the scientific evidence on LCSs and body weight and composition. Findings from observational studies showed no association between LCS intake and body weight or fat mass and a small positive association with BMI; however, data from RCTs, which provide the highest quality of evidence for examining the potentially causal effects of LCS intake, indicate that substituting LCS options for their regular-calorie versions results in a modest weight loss and may be a useful dietary tool to improve

  1. Early ambulation following 6 French diagnostic left heart catheterization: a prospective randomized trial.

    PubMed

    Wood, R A; Lewis, B K; Harber, D R; Kovack, P J; Bates, E R; Stomel, R J

    1997-09-01

    Outpatient cardiac catheterization is frequently performed, but the optimal recovery time after sheath removal has not been defined. Left heart catheterization was performed via the femoral artery utilizing 6 French catheters on 323 outpatients. One hundred thirty-five patients were randomized to ambulate at a mean of 2.5 hr (group 1) after puncture site compression, whereas 188 patients were randomized to ambulate at a mean of 4.1 hr (group 2). Telephone follow-up occurred within 48 hr. A small hematoma (< 5 cm) occurred in 2 (1.6%) patients in group 1 and in 4 (2.4%) patients in group 2. These results indicate that it is safe to ambulate patients 2.5 hr following 6 French diagnostic heart catheterization. PMID:9286529

  2. Retroperitoneoscopic versus open mini-incision ureterolithotomy for upper- and mid-ureteric stones: a prospective randomized study.

    PubMed

    Prakash, Jai; Singh, Vishwajeet; Kumar, Manoj; Kumar, Manoj; Sinha, Rahul Janak; Sankhwar, Satyanarayan

    2014-04-01

    To compare the retroperitoneoscopic ureterolithotomy (RPLU) versus open mini-incision ureterolithotomy (MIOU) for large and impacted proximal or mid-ureteric stones in prospective randomized manner and to assess the outcome results. In a prospective randomized study between January 2009 and December 2012, 35 RPLU and 35 MIOU were included in the study. The indications for ureterolithotomy were as primary treatment of large and impacted stones more than 1.5 cm in the proximal and mid-ureter and as salvage treatment of failed ureteroscopy (URS)/extracorporeal shock wave lithotripsy (SWL). The two groups were compared for visual pain score on the first and second postoperative day, analgesic requirement, stone removal in one attempt, operative time, blood loss, postoperative complications, hospital stays and the period of convalescence. The difference in the visual pain score and the tramadol requirement was significantly higher in MIOU group. The hospital stay (RPLU 2.86 ± 0.43, MIOU 5.71 ± 0.67, P ≤ 0.001) and period of convalescence (RPLU 12.29 ± 4.06, MIOU 24.11 ± 5.55, P ≤ 0.001) were also significantly higher in MIOU group. The complications were 11.4 % (P ≤ 0.02) in RPLU versus 17.4 % in MIOU group. However, the stone removal in one attempt was similar in both groups. In condition of failed URS/SWL, unavailability of the full endoscopic armamentarium and limitation of costs, RPLU and MIOU both are safe and effective treatment options for large impacted upper- and mid-ureteric stones and RPLU has better tolerability, lesser hospital time and equal stone clearance rate. PMID:24272062

  3. Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data

    PubMed Central

    Kotela, Andrzej; Lorkowski, Jacek; Kucharzewski, Marek; Wilk-Frańczuk, Magdalena; Śliwiński, Zbigniew; Frańczuk, Bogusław; Łęgosz, Paweł  ; Kotela, Ireneusz

    2015-01-01

    Total knee arthroplasty (TKA) is a frequently performed procedure in orthopaedic surgery. Recently, patient-specific instrumentation was introduced to facilitate correct positioning of implants. The aim of this study was to compare the early clinical results of TKA performed with patient-specific CT-based instrumentation and conventional technique. A prospective, randomized controlled trial on 112 patients was performed between January 2011 and December 2011. A group of 112 patients who met the inclusion and exclusion criteria were enrolled in this study and randomly assigned to an experimental or control group. The experimental group comprised 52 patients who received the Signature CT-based implant positioning system, and the control group consisted of 60 patients with conventional instrumentation. Clinical outcomes were evaluated with the KSS scale, WOMAC scale, and VAS scales to assess knee pain severity and patient satisfaction with the surgery. Specified in-hospital data were recorded. Patients were followed up for 12 months. At one year after surgery, there were no statistically significant differences between groups with respect to clinical outcomes and in-hospital data, including operative time, blood loss, hospital length of stay, intraoperative observations, and postoperative complications. Further high-quality investigations of various patient-specific systems and longer follow-up may be helpful in assessing their utility for TKA. PMID:26301241

  4. The Efficacy and Safety of Jaungo, a Traditional Medicinal Ointment, in Preventing Radiation Dermatitis in Patients with Breast Cancer: A Prospective, Single-Blinded, Randomized Pilot Study

    PubMed Central

    Kong, Moonkyoo; Hwang, Deok-Sang; Lee, Jee Young; Yoon, Seong Woo

    2016-01-01

    Purpose. This study was performed to evaluate the efficacy and safety of Jaungo in preventing radiation dermatitis in patients with breast cancer. Methods. Thirty patients were prospectively enrolled and randomly assigned to receive Jaungo or general supportive skin care. Radiation dermatitis and pain were examined at daily intervals from the start of radiotherapy until 4 weeks after its completion. The primary endpoint of this study was the incidence of radiation dermatitis. The secondary endpoints were time to onset of radiation dermatitis, duration of radiation dermatitis, and maximum pain score. Results. Jaungo reduced the incidence of grade ≥2 (46.7% versus 78.6%) and grade 3 radiation dermatitis (20.0% versus 50.0%) in comparison with general supportive skin care. Jaungo also delayed the onset of grade 2 dermatitis (35 days versus 30 days). In terms of time to onset of grade 3 dermatitis, duration of dermatitis, and maximum pain score, Jaungo showed results comparable to those achieved with general supportive skin care. No patients experienced adverse effects caused by Jaungo administration. Conclusions. Jaungo minimized radiation dermatitis in patients with breast cancer without causing adverse effects. Further randomized studies with a larger sample size are required to assess clinical use of Jaungo. PMID:27066103

  5. Reflections and Future Prospects for Evaluation in Human Resource Development

    ERIC Educational Resources Information Center

    Han, Heeyoung; Boulay, David

    2013-01-01

    Human resource development (HRD) evaluation has often been criticized for its limited function in organizational decision making. This article reviews evaluation studies to uncover the current status of HRD evaluation literature. The authors further discuss general evaluation theories in terms of value, use, and evaluator role to extend the…

  6. TOURNIQUET VERSUS NO TOURNIQUET USE IN KNEE VIDEOARTHROSCOPY: A MULTICENTRIC, PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED CLINICAL TRIAL

    PubMed Central

    Júnior, Lúcio Honório de Carvalho; Soares, Luiz Fernando Machado; Gonçalves, Matheus Braga Jacques; Gomes, Tiago Pinto de Oliveira; Oliveira, Juraci Rosa de; Coelho, Mauro Gualberto; Santos, Rogério Luciano dos; Andrade, Marco Antônio Percope de; Silva, Guilherme de Lima e; Novais, Eduardo Nilo Vasconcelos

    2015-01-01

    To evaluate whether, by using an arthropump (irrigation equipment with pressure sensor), pneumatic tourniquet use could interfere with the duration of surgery, recovery of movement and joint volume in patients who underwent knee videoarthroscopy for partial meniscectomy. Methods: 103 patients divided randomly into two groups regarding use or nonuse of a pneumatic tourniquet were evaluated in five different centers by seven different surgeons. The variables were evaluated during the surgery and seven days after the operation. Results: No statistically significant differences were found among any of the variables studied. Conclusion: There are no reasons that would either justify or discredit tourniquet use in this specific situation. PMID:27022588

  7. Unilateral versus bilateral ultrasound-guided transversus abdominis plane blocks during ureteric shock wave lithotripsy: A prospective randomized trial

    PubMed Central

    Elnabtity, Ali Mohamed Ali; Shabana, Waleed Mansour

    2016-01-01

    Background: Ultrasound-guided transversus abdominis plane (TAP) block has been used for intra- and post-operative analgesia during abdominal operations and for ureteric shock wave lithotripsy (SWL) as well. Aim: This study aimed at comparing ultrasound-guided unilateral versus bilateral TAP blocks as analgesic techniques for unilateral ureteric SWL. Settings and Design: Prospective randomized comparative study. Patients and Methods: Sixty patients scheduled for unilateral ureteric SWL were randomly allocated into two groups: Group (U) received unilateral TAP block in the form of 25 ml of bupivacaine 0.25% (i.e., 62.5 mg), and Group (B) received bilateral TAP blocks in the form of 25 ml of bupivacaine 0.25% (i.e., 62.5 mg) on each side. Statistical Analysis: This was performed using SPSS program version 19 ((IBM Corp., Armonk, NY, USA) and EP 16 program. Results: The mean values of intra- and post-procedural visual analog scale at different time intervals were around (30), which was statistically insignificant between groups (P > 0.05). There were no significant differences between groups regarding cardiopulmonary stability, postanesthesia care unit time, the total amount of rescue fentanyl and patient satisfaction scores (P > 0.05). There were no significant side effects in both groups. Conclusion: Ultrasound-guided unilateral TAP block is as safe and effective analgesic technique as bilateral TAP blocks during unilateral ureteric SWL. It can be used as the sole analgesic technique during ureteric SWL. PMID:27453645

  8. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

    PubMed Central

    Banerjee, Debasis; Das, Anjan; Majumdar, Saikat; Mandal, Rahul Deb; Dutta, Soumyadip; Mukherjee, Anindya; Chakraborty, Aparna; Chattopadhyay, Sandip

    2014-01-01

    Background: postoperative nausea and vomiting (PONV) frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62) receiving (IV) Ondansetron (4 mg)] and Group B [(n=62) receiving IV Ramosetron (0.3 mg)] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6, 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05) was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg) has better efficacy than single dose IV Ondansetron (4 mg) in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia. PMID:24665236

  9. A Prospective Randomized Study to Assess the Optimal Duration of Intravenous Antimicrobial Prophylaxis in Elective Gastric Cancer Surgery

    PubMed Central

    Haga, Norihiro; Ishida, Hideyuki; Ishiguro, Toru; Kumamoto, Kensuke; Ishibashi, Keiichiro; Tsuji, Yoshitaka; Miyazaki, Tatsuya

    2012-01-01

    The duration of antimicrobial prophylaxis in gastric cancer surgery is not yet established. This prospective randomized study was performed to confirm the noninferiority of single-dose versus multiple-dose antimicrobial prophylaxis in terms of the incidence of surgical-site infection in gastric cancer surgery. Three hundred twenty-five patients undergoing elective resection for gastric cancer were randomized to receive only single-dose cefazolin (1 g) during surgery (single-dose group) or an additional 5 doses every 12 hours postoperatively (multiple-dose group). The overall incidence of surgical-site infections was 9.1% in the single-dose group and 6.2% in the multiple-dose group [difference (95% confidence interval): −2.9% (−5.9%–0.0%)]. Multivariate logistic regression analysis identified blood loss, being overweight, and advanced age as significant independent risk factors for surgical-site infection. Single-dose antimicrobial prophylaxis seemed to be acceptable, and choosing multiple-dose prophylaxis may have little impact on the prevention of surgical-site infections in elective gastric cancer surgery. PMID:23102084

  10. Blood loss in elective cesarean section: is there a difference related to the type of anesthesia? A randomized prospective study

    PubMed Central

    Aksoy, Hüseyin; Aksoy, Ülkü; Yücel, Burak; Özyurt, Sezin Saygı; Açmaz, Gökhan; Babayiğit, Mustafa Alparslan; Gökahmetoğlu, Günhan; Aydın, Turgut

    2015-01-01

    Objective We aimed to compare the effect of general and spinal anesthesia on maternal blood loss in elective cesarean section (CS). Material and Methods This was a prospective randomized study and included 418 healthy pregnant women with a term uncomplicated singleton pregnancy between 37 and 41 weeks of gestation. The study participants were randomly divided into two groups: the general anesthesia group and spinal anesthesia group. CSs were all performed using the same surgical technique, and within the groups, the same anesthetic procedures were used (either general or spinal). The primary outcome for this study was operative blood loss. Hemoglobin and hematocrit concentrations were compared between the two groups. Results The preoperative hemoglobin and hematocrit levels were similar in the both groups (p=0.08 and p=0.239, respectively). Significantly lower operative blood loss was achieved using spinal anesthesia versus general anesthesia during elective CS. The differences between preoperative and postoperative blood values for both the study groups were statistically significant (p<0.001). Conclusion This study demonstrates that spinal anesthesia is associated with a lower risk of operative blood loss than general anesthesia in low risk patients undergoing elective CS. PMID:26401109

  11. Human islet isolation--a prospective randomized comparison of pancreatic vascular perfusion with hyperosmolar citrate or University of Wisconsin solution.

    PubMed

    Robertson, G S; Chadwick, D; Thirdborough, S; Swift, S; Davies, J; James, R; Bell, P R; London, N J

    1993-09-01

    University of Wisconsin solution has become the most commonly used vascular perfusate during multiorgan donation world-wide. In the UK however, hyperosmolar citrate remains in common use. The purpose of this prospective randomized study was to compare the effect of systemic perfusion with UW or HOC on subsequent islet yield and purification for pancreata with short cold ischemic times. Seven pancreata were randomized to each group, with the donor age, pancreas weight, and period of cold ischemia being similar in both. Perfusion with UW was shown to inhibit collagenase digestion, and a higher concentration of this enzyme was needed to achieve comparable numbers of islets with good separation of exocrine and islet tissue after a similar period of digestion. There were no differences in the number, size, purity, or viability of islets between the two groups. In conclusion, UW solution offers no benefits over HOC for pancreata with short cold ischemic times, and because of its expense and need to use greater amounts of collagenase enzyme, we continue to use HOC. PMID:8212148

  12. Comparison of 7 and 8 French guiding catheters for elective PTCA: results of a prospective randomized trial.

    PubMed

    Talley, J D; Wilkins, C; Ciccone, J; Hattel, L J

    1994-11-01

    A prospective randomized trial was performed to detect technical and clinical differences of 7F compared to 8F guiding catheters (GC) used in elective coronary angioplasty (PTCA). One hundred and fifteen patients undergoing elective PTCA with standard balloon dilatation catheters were randomized to 7F (55 pts) or 8F (58 pts) guiding catheters. The endpoints were primarily coronary artery and peripheral vascular complications; and secondarily, technical details and quantitative and qualitative angiographic quality. There was no difference between 7F or 8F GC for development of coronary or peripheral vascular complications. With 7F GC there was less blood loss (Hct, 3.5 +/- 3.4% vs. 6.5 +/- 9.6%, P = .033), and less contrast medium (160 +/- 88 mL vs. 200 +/- 119 mL, P = .049) used. Angiographic quality was similar, although visualization of lesions in the left anterior descending coronary artery in the left anterior oblique projection was improved with the 8F GC. There is no advantage of 7F GC for the prevention of coronary or peripheral vascular complications, although there was less blood loss and contrast medium used with the 7F systems. PMID:7874712

  13. Combination therapy with methotrexate and 5-fluorouracil: a prospective randomized clinical trial of order of administration.

    PubMed

    Coates, A S; Tattersall, M H; Swanson, C; Hedley, D; Fox, R M; Raghavan, D

    1984-07-01

    Because of biochemical and tissue culture evidence casting doubt on the physiologic relevance of reported synergy afforded by sequential administration of methotrexate (MTX) followed by 5-fluorouracil (5-FU), a randomized controlled clinical trial was conducted in 108 patients with advanced cancer, including 70 with squamous cell carcinoma (SCC) of the head and neck, nine with SCC of other primary sites, 24 with colorectal, and five with gastric adenocarcinomas. Patients were randomized to receive weekly therapy consisting of MTX followed one hour later by 5-FU, or 5-FU followed one hour later by MTX. There was a trend to higher tumor response rates in patients treated with MTX before 5-FU (45% v 33% overall; 65% v 39% in patients with previously untreated head and neck cancer), but these differences were not significant, either by chi-square test or by multivariate stepwise logistic regression. The trend in survival favoring the reverse sequence of 5-FU before MTX was not significant in univariate analyses. Stepwise multivariate Cox model analysis showed that Eastern Cooperative Oncology Group performance status at study entry was the major prognostic factor for survival (P less than 0.001), but among the 70 patients with head and neck cancer, the sequence of drug administration was the only other significant prognostic factor for survival, and favored the sequence of 5-FU followed by MTX (P less than 0.025). PMID:6376719

  14. Angioplasty or Primary Stenting for Infrapopliteal Lesions: Results of a Prospective Randomized Trial

    SciTech Connect

    Randon, C. Jacobs, B.; De Ryck, F.; Vermassen, F.

    2010-04-15

    Excellent results with small stents in coronary arteries have led endovascular therapists to their use in infrapopliteal vessels. However, to date no level I evidence exists to recommend primary stenting over infrapopliteal angioplasty alone. The aim of this randomized single-center trial was to compare their 1-year outcome. A total of 38 limbs in 35 patients with critical limb ischemia were randomized to angioplasty (22 pts) or primary stenting (16 pts). Target lesions were infrapopliteal occluded (36) or stenotic (20) lesions ranging from <2 to >15 cm in length. The mean age was 72 years. At 12 months, there was no statistical difference in survival (angioplasty, 69.3%; primary stenting, 74.7%), in limb salvage (angioplasty, 90%; primary stenting, 91.7%), or in primary and secondary patency (angioplasty, 66 and 79.5%; primary stenting, 56 and 64%) between the groups Renal insufficiency was the only significant negative predicting factor for limb salvage in both groups. In conclusion, the 1-year results for both groups were broadly similar. Stenting has its place in infrapopliteal angioplasty if the procedure is jeopardized by a dissection or recoil, but our results do not support primary stenting in all cases.

  15. A randomized, prospective study of total hip wound closure with resorbable subcuticular staples.

    PubMed

    Fisher, David A; Bengero, Lowell L; Clapp, Brenda C; Burgess, Mary

    2010-09-01

    Resorbable subcuticular staples are a new way to close surgical wounds and have not been reported in the orthopedic literature. This randomized, controlled study compared a resorbable subcuticular staple system with stainless steel wound stapling in patients undergoing unilateral primary total hip arthroplasty (THA). Institutional Review Board approval and patient consent was obtained for all patients. Sixty patients (30 each group) were randomized to receive either resorbable subcuticular staples or stainless steel staples after primary THA. Incision length, number of staples used, and any staple insertion problems were recorded. Subjective reports of pain levels or incision complaints were solicited, and wound photographs were obtained on days 1 and 14 and 6 weeks postoperatively. The presence of wound drainage, erythema, wound separation, or echymosis was recorded at each visit, as well as all postoperative complications. The average incision length in the resorbable group was 13.2 cm and required 16 staples for closure, compared to 15 cm and 20 staples for the metal staple group. No infections occurred in either group, although the incidence of erythema and wound drainage at 2 weeks was higher for patients in the stainless steel group. One patient with metal staples had a postoperative hematoma requiring secondary irrigation and debridement. Patient satisfaction was higher with the resorbable staples. A resorbable subcuticular staple system can provide comparable wound closure to stainless steel staples following THA and may do so with less local discomfort, wound drainage, or erythematous reaction. PMID:20839703

  16. China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS): A new, prospective, multicenter, randomized controlled trial in China

    PubMed Central

    Gao, Peng; Zhao, Zhenwei; Wang, Daming; Wu, Jian; Cai, Yiling; Li, Tianxiao; Wu, Wei; Shi, Huaizhang; He, Weiwen; Zhu, Fengshui; Ling, Feng

    2015-01-01

    Background Patients with symptomatic stenosis of intradural arteries are at high risk for subsequent stroke. Since the SAMMPRIS trial, stenting is no longer recommended as primary treatment; however, the results of this trial, its inclusion criteria and its center selection received significant criticism and did not appear to reflect our experience regarding natural history nor treatment complications rate. As intracranial atherosclerosis (ICAS) is the most common cause for stroke in Asian countries, we are hereby proposing a refined prospective, randomized, multicenter study in an Asian population with strictly defined patient and participating center inclusion criteria. Methods The China Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis (CASSISS) trial is an ongoing, government-funded, prospective, multicenter, randomized trial. It recruits patients with recent TIA or stroke caused by 70%–99% stenosis of a major intracranial artery. Patients with previous stroke related to perforator ischemia will not be included. Only high-volume centers with a proven track record will enroll patients as determined by a lead-in phase. Patients will be randomized (1:1) to best medical therapy alone or medical therapy plus stenting. Primary endpoints are any stroke or death within 30 days after enrollment or after any revascularization procedure of the qualifying lesion during follow-up, or stroke in the territory of the symptomatic intracranial artery beyond 30 days. The CASSISS trial will be conducted in eight sites in China with core imaging lab review at a North American site and aims to have a sample size of 380 participants (stenting, 190; medical therapy, 190). Recruitment is expected to be finished by December 2016. Patients will be followed for at least three years. The trial is scheduled to complete in 2019. Conclusion In the proposed trial, certain shortcomings of SAMMPRIS including patient and participating center selection will be addressed. The

  17. Repair versus shaving of partial-thickness articular-sided tears of the upper subscapularis tendon. A prospective randomized controlled trial

    PubMed Central

    RANDELLI, PIETRO; ARRIGONI, PAOLO; ALIPRANDI, ALBERTO; SDAO, SILVANA; RAGONE, VINCENZA; D’AMBROSI, RICCARDO; RANDELLI, FILIPPO; CABITZA, PAOLO; BANFI, GIUSEPPE

    2015-01-01

    Purpose the purpose of this study was to evaluate whether treating partial-thickness articular-sided tears of the upper subscapularis (SSC) tendon with a dedicated suture anchor would result in an internal rotation strength improvement compared with simple shaving of the SSC tendon and footprint. Methods twenty-six patients with a limited SSC tendon tear (equal or inferior to the most superior centimeter) in association with a posterosuperior cuff lesion were prospectively randomized to two treatments: repair with a dedicated suture anchor versus shaving of the tendon and footprint. The patients also underwent long head of the biceps (LHB) treatment and posterosuperior cuff tear repair. In each patient the following parameters were measured both preoperatively and at a minimum follow-up of 2.5 years: strength in internal rotation in the bear-hug testing position (using a digital tensiometer), DASH score and Constant scores. MRI assessment of tendon healing was performed at the final follow-up. Results twenty of the 26 patients (76%) were reviewed after a mean follow-up time of 42 months: 11 patients had undergone SSC tendon repair and nine simple shaving. At final follow-up no significant differences were found between the repaired and shaving group in strength in internal rotation (9.5 ± 3.8 kg versus 10.3±5.4 kg; p=0.7). The DASH score and Constant score also failed to show significant differences between the two groups. Furthermore, no significant difference in SSC tendon healing rate was observed on MRI evaluation. Conclusions partial-thickness articular-sided tear of the upper SSC tendon in association with a posterosuperior rotator cuff repair and LHB treatment, when limited to the superior centimeter of the SSC tendon, shows a comparable performance in terms of strength in internal rotation either after simple shaving or a tendon-to-bone repair. Level of evidence Level II, prospective comparative study. PMID:26889466

  18. Deep Brain Stimulation in Early Stage Parkinson’s Disease: Operative Experience from a Prospective, Randomized Clinical Trial

    PubMed Central

    Kahn, Elyne; D'Haese, Pierre-Francois; Dawant, Benoit; Allen, Laura; Kao, Chris; Charles, P. David; Konrad, Peter

    2013-01-01

    Background Recent evidence suggests that STN-DBS may have a disease-modifying effect in early PD. A randomized, prospective study is underway to determine whether STN-DBS in early PD is safe and tolerable. Objectives / Methods Fifteen of thirty early PD patients were randomized to receive STN-DBS implants in an IRB-approved protocol. Operative technique, location of DBS leads, and perioperative adverse events are reported. Active contact used for stimulation in these patients were compared with 47 advanced PD patients undergoing an identical procedure by the same surgeon. Results Fourteen of the 15 patients did not sustain any long-term (> 3 months) complications from the surgery. One subject suffered a stroke resulting in mild cognitive changes and slight right arm and face weakness. The average optimal contact used in symptomatic treatment of early PD patients was: anterior −1.1±1.7mm, lateral 10.7±1.7mm, superior −3.3±2.5mm (AC-PC coordinates). This location is statistically no different (0.77mm, p> 0.05) than the optimal contact used in treatment of 47 advanced PD patients. Conclusions The perioperative adverse events in this trial of subjects with early stage PD are comparable to that reported for STN-DBS in advanced PD. The active contact position used in early PD is not significantly different from that used in late stage disease. This is the first report of the operative experience from a randomized, surgical-versus-best-medical-therapy trial for the early treatment of Parkinson’s disease. PMID:21890575

  19. Comparative study between computed tomography guided superior hypogastric plexus block and the classic posterior approach: A prospective randomized study

    PubMed Central

    Ghoneim, Ayman A.; Mansour, Sahar M.

    2014-01-01

    Context: The classic posterior approach to superior hypogastric plexus block (SHPB) is sometimes hindered by the iliac crest or a prominent transverse process of L5. The computed tomography (CT) – guided anterior approach might overcome these difficulties. Aims: This prospective, comparative, randomized study was aimed to compare the CT guided anterior approach versus the classic posterior approach. Settings and Design: Controlled randomized study. Materials and Methods: A total of 30 patients with chronic pelvic cancer pain were randomized into either classic or CT groups where classic posterior approach or CT guided anterior approach were done, respectively. Visual analog score, daily analgesic morphine consumed and patient satisfaction were assessed just before the procedure, then, after 24 h, 1 week and monthly for 2 months after the procedure. Duration of the procedure was also recorded. Adverse effects associated with the procedure were closely observed and recorded. Statistical Analysis Used: Student's t-test was used for comparison between groups. Results: Visual analog scale and morphine consumption decreased significantly in both groups at the measured times after the block compared with the baseline in the same group with no significant difference between both groups. The procedure was carried out in significantly shorter duration in the CT group than that in the classic group. The mean patient satisfaction scale increased significantly in both groups at the measured times after the block compared with the baseline in the same group. The patients in the CT groups were significantly more satisfied than those in classic group from day one after the procedure until the end of the study. Conclusions: The CT guided approach for SHPB is easier, faster, safer and more effective, with less side-effects than the classic approach. PMID:25191191

  20. Onyalai--therapeutic effects of vincristine sulphate. A prospective randomized trial.

    PubMed

    Hesseling, P B; Girdle-Brown, B; Smit, J

    1986-08-16

    Twenty out of 40 patients with onyalai admitted to Rundu State Hospital, Kavango, SWA/Namibia, were randomized to receive a vincristine sulphate bolus of 1.5 mg/m2 or an equivalent volume of normal saline intravenously on days 8 and 15 when haemorrhage or a platelet count of less than 50 X 10(9)/l persisted for more than 1 week after admission. All patients were observed in hospital for at least 21 days. Five out of 10 patients who received vincristine achieved a platelet count in excess of 100 X 10(9)/l on day 21 and only 2 out of 10 patients who received placebo achieved a similar rise in the platelet count. Two patients, neither of whom was treated with vincristine, died of cerebral haemorrhage. PMID:3738655

  1. Prediction of gestational diabetes mellitus in the first trimester, comparison of fasting plasma glucose, two-step and one-step methods: a prospective randomized controlled trial.

    PubMed

    Yeral, M Ilkin; Ozgu-Erdinc, A Seval; Uygur, Dilek; Seckin, K Doga; Karsli, M Fatih; Danisman, A Nuri

    2014-08-01

    Our aim was to evaluate and compare the diagnostic performance of three methods commonly used for GDM screening: fasting plasma glucose (FPG), two-step 50 g glucose challenge test (GCT), and 75 g glucose tolerance test (GTT) in a randomized study design to predict GDM in the first trimester and determine the best approach in predicting GDM. In a non-blind, parallel-group prospective randomized controlled study; 736 singleton pregnant women underwent FPG testing in the first trimester and randomly assigned to two groups; two-step 50 g GCT and 75 g GTT. GDM diagnosis was made according to Carpenter-Coustan or ADA (American Diabetes Association) criteria in two-step 50 g GCT and 75 g GTT groups, respectively. Subsequent testing was performed by two-step 50 g GCT at 24-28 weeks for screen negatives. After excluding the women who were lost to follow-up or withdrawn as a result of pregnancy loss, 486 pregnant women were recruited in the study. The FPG, two-step GCT, and one-step GTT methods identified GDM in 25/486 (5.1 %), 15/248 (6.0 %), and 27/238 (11.3 %) women, respectively. Area under ROC curves were 0.623, 0.708, and 0.792, respectively. Sensitivities were 47.17, 68.18, and 87.1 %, respectively. Specificities were 77.37, 100, and 100 %, respectively. Positive predictive values were 20.33, 100, and 100 %, respectively. Negative predictive values were 92.29, 97, and 98.1 %, respectively. Until superior screening alternatives become available, the 75 g GTT may be preferred for GDM screening in the first trimester. PMID:24282036

  2. Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

    ERIC Educational Resources Information Center

    Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

    2011-01-01

    We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

  3. Laboratory evaluation of the COBAS MIRA S random access analyser.

    PubMed

    Kanluan, T; Intaramanee, S; Tangvarasittichai, S; Tangvarasittichai, O; Suwanton, L; Manochiopinij, S; Tantrarongroj, S; Leangphibul, P

    1991-01-01

    The random access analyser COBAS MIRA S (Roche Diagnostics) was evaluated for two months. The instrument is a computer-controlled discrete analyser which can be run in a combination profile and single test mode. This instrument has special features, including an automatic cuvette segment changer, a reagent rack cooling system, an external keyboard and monitor, as well as a bar-code facility for the entry of test parameters, worklists and sample identification numbers. Study of within-run and between-run precision gave values of % CV 0.54-3.37 and 0.61-3.65, respectively, for a variety of assays. Linearity testing to the upper limit of each test was also studied and were found to cover the necessary pathological range. Within the two-month period, no major problems were encountered. The instrument required minimum operator attention during operation. Correlation studies with the Hitachi 705 using six clinical chemistry tests (glucose, cholesterol, triglyceride, ALP, AST, ALT) gave correlation coefficients ranging from 0.95-0.99 and slopes of 0.91-1.17. PMID:18924890

  4. A blinded, prospective, randomized controlled trial of topical negative pressure wound closure in India.

    PubMed

    Mody, Gita N; Nirmal, Ida Anita; Duraisamy, Sulochana; Perakath, Benjamin

    2008-12-01

    Wound closure using topical negative pressure (TNP) has been reported to be effective, but equipment costs can be prohibitive in resource-challenged countries. Because nonhealing wounds are exceedingly common in developing countries such as India, the ability to optimize wound care with limited resources is very important. To investigate the feasibility and efficacy of providing TNP in an Indian medical referral center, a randomized controlled trial comparing a locally constructed TNP device (treatment) to wet-to-dry gauze dressings (control) was conducted. Eligible study participants (N = 48) were recruited from the inpatient wards. Wound etiologies included diabetic foot ulcers (15), pressure ulcers (11), cellulitis/fasciitis (11), and "other" (11). Following enrollment, wound size was assessed using computer-aided measurements of digital photographs and block-randomized to the study arms using a concealed allocation table. Wounds in both treatment groups were débrided before dressing application and patients were followed until wound closure or being lost to follow-up for an average of 26.3 days (+/- 18.5) in the control and 33.1 days (+/- 37.3) in the treatment group. No statistically significant differences in time to closure between the two treatment groups were observed except in a subset analysis of pressure ulcers (mean 10 +/- 7.11 days for treatment and 27 +/- 10.6 days in control group, P = 0.05). Direct costs to close a pressure ulcer also were lower in the TNP than in the control group. A review of the literature suggests the outcomes obtained using a locally constructed TNP device are similar to those obtained using commercially available devices. As a result of this study, a dedicated tissue viability team has been established to identify wounds suitable for TNP, oversee treatment, monitor the need for surgical débridement, and employ wound healing principles and technology appropriately. These results suggest that inexpensive materials can be

  5. Alignment of the tibial component in total knee arthroplasty procedures using an intramedullary or extramedullary guide: double-blind randomized prospective study☆

    PubMed Central

    da Rocha Moreira Rezende, Bruno; Fuchs, Thiago; Nishi, Rodrigo Nishimoto; Hatem, Munif Ahmad; da Silva, Luciana Mendes Ferreira; Fuchs, Rogério; de Alencar, Paulo Gilberto Cimbalista

    2015-01-01

    Objectives To evaluate the results obtained through using an intramedullary or extramedullary guide for sectioning the tibia in total knee arthroplasty procedures, with a view to identifying the accuracy of these guides and whether one might be superior to the other. Methods This was a randomized double-blind prospective study on 41 total knee arthroplasty procedures performed between August 2011 and March 2012. The angle between the base of the tibial component and the mechanical axis of the tibia was measured during the immediate postoperative period by means of radiography in anteroposterior view on the tibia that encompassed the knee and ankle. Results There was no demographic difference between the two groups evaluated. The mean alignment of the tibial component in the patients of group A (intramedullary) was 90.3° (range: 84–97°). In group B (extramedullary), it was 88.5° (range: 83–94°). Conclusion In our study, we did not find any difference regarding the precision or accuracy of either of the guides. Some patients present an absolute or relative contraindication against using one or other of the guides. However, for the other cases, neither of the guides was superior to the other one. PMID:26229912

  6. Sirolimus conversion in liver transplant recipients with renal dysfunction: a prospective, randomized, single-center trial.

    PubMed

    Shenoy, Surendra; Hardinger, Karen L; Crippin, Jeffrey; Desai, Niraj; Korenblat, Kevin; Lisker-Melman, Mauricio; Lowell, Jeffrey A; Chapman, William

    2007-05-27

    This pilot trial was designed to assess the safety and efficacy of SRL in liver transplant recipients with renal dysfunction. Forty patients with renal dysfunction (24-hr CrCl 40-80 mL/min) were randomized to be withdrawn from the calcineurin inhibitor (CNI) and receive sirolimus (SRL) or to continue CNI (control arm). Improvement in 24-hour CrCl was seen in the SRL arm at 3 months (75 mL/min SRL vs. 56 mL/min control, P=0.012), whereas at 12 months there was a trend toward improvement in the SRL arm (72 mL/min SRL vs. 58 mL/min control, P=0.09). Two patients, one in each arm, developed steroid-sensitive rejection. Side effects of SRL were limited and included hyperlipidemia requiring treatment (15%), pruritus (5%), and mouth sores (25%). In this trial, SRL-based immunosuppression was a safe alternative to CNI. Although early improvements were observed, withdrawing CNI and replacing it with SRL did not result in a statistically significant improvement in renal function at 12 months of follow-up. PMID:17519792

  7. A prospective, randomized, triple-blind comparison of articaine and bupivacaine for maxillary infiltrations

    PubMed Central

    Vílchez-Pérez, Miguel A.; Sancho-Puchades, Manuel; Valmaseda-Castellón, Eduard; Paredes-García, Jordi; Berini-Aytés, Leonardo

    2012-01-01

    Objectives: To compare the clinical anesthetic efficacy of 0.5% bupivacaine and 4% articaine (both with 1:200.000 adrenaline) for anterior maxillary infiltration in healthy volunteers. Material and methods: A triple-blind split-mouth randomized clinical trial was carried out in 20 volunteers. A supraperiosteal buccal injection of 0.9 ml of either solution at the apex of the lateral incisor was done in 2 appointments separated 2 weeks apart. The following outcome variables were measured: latency time, anesthetic efficacy (dental pulp, keratinized gingiva, alveolar mucosa and upper lip mucosa and tissue) and the duration of anesthetic effect. Hemodynamic parameters were monitored during the procedure. Results: Latency time recorded was similar for both anesthetic solutions (p>0.05). No statistically significant differences were found in terms of anesthetic efficacy for dental pulp, keratinized gingiva or alveolar mucosa. Articaine had a significant higher proportion of successful anesthesia at 10 minutes after infiltration in lip mucosa and lip skin (p=0.039). The duration of anesthesia was 336 minutes for bupivacaine and 167 minutes for articaine. (p<0.001). No significant hemodynamic alterations were noted during the procedure. Conclusions: Articaine and bupivacaine exhibited similar anesthetic efficacy for maxillary infiltrations. The duration of anesthesia was longer with the bupivacaine solution, but lip anesthesia was better with articaine. Key words:Articaine, bupivacaine, maxillary, infiltrative anesthesia, long-acting anesthetics. PMID:22143708

  8. A prospective randomized trial of ofloxacin vs. doxycycline in the treatment of uncomplicated male urethritis.

    PubMed

    Boslego, J W; Hicks, C B; Greenup, R; Thomas, R J; Wiener, H A; Ciak, J; Tramont, E C

    1988-01-01

    One hundred fourteen men with uncomplicated urethritis were randomized to receive 1 week of therapy with either doxycycline (100 mg twice daily) or ofloxacin (300 mg twice daily). Of the 109 men completing the post-treatment visit, 56 received ofloxacin and 52 (93%) were clinically cured. Forty four (83%) of the 53 men treated with doxycycline were cured. All 30 patients with gonorrhea (including three with penicillinase-producing Neisseria gonorrhoeae [PPNG] isolates) who were treated with ofloxacin became culture-negative, as compared with 32 of 34 patients receiving doxycycline. In contrast, three of 18 patients with Chlamydia trachomatis were microbiologic failures after ofloxacin therapy, while all ten treated with doxycycline were cured. Adverse effects of both treatment regimens were generally mild, and compliance was excellent except for one patient receiving doxycycline. These results show that ofloxacin, in a dosage of 300 mg taken orally twice daily for seven days, is an effective treatment for uncomplicated urethritis in men but may not reliably cure chlamydial infections. PMID:3147522

  9. Prospective Comparison of CAPR MRA with CTA for Evaluation of Below the Knee Runoff

    PubMed Central

    Young, Phillip M.; Mostardi, Petrice M.; Glockner, James F.; Vrtiska, Terri R.; Macedo, Thanila; Haider, Clifton R.; Riederer, Stephen J.

    2013-01-01

    Purpose To prospectively compare the assessment of stenosis and radiologist confidence in the evaluation of below the knee lower extremity runoff vessels between computed tomographic angiography (CTA) and contrast enhanced magnetic resonance angiography (MRA) in a cohort of 19 clinical patients. Materials and Methods Our study was HIPAA compliant and IRB-approved. 19 consecutive patients with known or suspected peripheral arterial disease were imaged with both CTA and a recently developed MRA technique performed within 24 hours of each other and prior to any therapeutic intervention. Resulting images were randomized and interpreted in blinded fashion by four board certified radiologists with expertise in CTA and MRA. Vasculature of the lower leg was apportioned into 22 segments, 11 for each leg. For each segment, degree of stenosis and confidence of diagnosis were each determined using a three-point scale. Differences between CTA and MRA were assessed for significance using pooled histograms which were analyzed using the Wilcoxon signed rank test. Results For assessment of stenosis, there was no difference in CTA vs. MRA for 20/22 segments. For confidence of diagnosis, assessment of popliteal arteries was superior on CTA compared to MRA (p<0.05). Confidence in assessment of both tibioperoneal trunks and the left proximal anterior tibial artery was not significantly different between CTA and MRA. Confidence in assessment of all other 17 segments was superior with MRA than CTA (p<0.02). Conclusion MRA using the method described here is a promising technique for evaluating lower extremity arterial runoff. MRA had an overall superior performance in radiologist confidence when compared to CTA for imaging runoff vessels below the knee. PMID:23433414

  10. One-site versus two-site phacotrabeculectomy: a prospective randomized study

    PubMed Central

    Moschos, Marilita M; Chatziralli, Irini P; Tsatsos, Michael

    2015-01-01

    Purpose The purpose of this study is to compare the efficacy and safety of one-site and two-site combined phacotrabeculectomy with foldable posterior chamber intraocular lens implantation. Methods Thirty-four patients (41 eyes) with glaucoma and cataract were randomly assigned to undergo either a one-site (22 eyes) or a two-site (19 eyes) combined procedure. One-site approach consisted of a standard superior phacotrabeculectomy with a limbus-based conjunctival flap, while two-site approach consisted of a clear cornea phacoemulsification and a separate superior trabeculectomy with a limbus-based conjunctival flap. Results Mean follow-up period was 54 months (standard deviation [SD] 2.3). Mean preoperative intraocular pressure (IOP) in the one-site group was 21.3 mmHg (SD 2.8) and in the two-site group was 21.8 mmHg (SD 3.0) (P>0.1). Mean postoperative IOP significantly decreased in both groups compared to the preoperative level and was 15.6 mmHg (SD 3.5) in the one-site group and 14.9 mmHg (SD 2.7) in the two-site group. Three months later, the difference between the two groups was not statistically significant (P=0.058). The one-site group required significantly more medications than the two-site group (P=0.03). Best-corrected visual acuity (BCVA) improved similarly in both groups, but there was less postoperative (induced) astigmatism in the two-site group in a marginal statistical level (P=0.058). Intra- and postoperative complications were comparable in the two groups. Conclusion Both techniques yielded similar results concerning final BCVA and IOP reduction. However, the two-site group had less induced astigmatism and a better postoperative IOP control with less required postoperative antiglaucoma medications compared to the one-site group. PMID:26347460

  11. Sedation with etomidate-fentanyl versus propofol-fentanyl in colonoscopies: A prospective randomized study

    PubMed Central

    Banihashem, Nadia; Alijanpour, Ebrahim; Basirat, Majid; Shokri Shirvany, Javad; Kashifard, Mehrdad; Taheri, Hasan; Savadkohi, Shahriyar; Hosseini, Vahid; Solimanian, Seyed Sedigheh

    2015-01-01

    Background: The combination of propofol-fentanyl for sedation during colonoscopy is characterized by high prevalence of side effects. Etomidate-fentanyl provides fewer hemodynamic and respiratory complications. The aim of our study was to compare the safety and efficacy of propofol-fentanyl and etomidate-fentanyl for conscious sedation in elective colonoscopy. Methods: This double-blind clinical trial was conducted on 90 patients aged between 18- 55 years old who were candidates for elective colonoscopy. Patients were randomized to receive sedation with fentanyl plus propofol or etomidate. Two minutes after injecting 1 micro/kg of fentanyl, the patients received 0.5mg/kg propofol by infusion (25 µ/kg/min) or 0.1 mg/kg etmoidate (15 µ/kg/min). Pulse rate, mean arterial blood pressure, respiratory rate, and saturation of peripheral oxygen (SPO2) were monitored. In addition, the patient and colonoscopist satisfaction, the recovery time, sedation and pain score in both groups were assessed. Results: Sedation score in propofol group was higher. Pain score as well as the physician and patient satisfaction showed no significant difference between the two study groups. Hemodynamic changes and arterial saturation were the same in both groups. The duration of recovery was 1.27±0.82 minutes in the etomidate group; versus 2.57±2.46 minutes in the propofol group (P=0.001). Recovery time in the etmoid group was 2.68±3.14 minutes and in the propofol group was 5.53±4.67 minutes (p=0.001). Conclusion: The combination of fentanyl and etomidate provides an acceptable alternative to sedation with fentanyl and propofol with the advantage of significantly faster recovery time, in the outpatient setting. PMID:26221491

  12. Allogenic versus autologous cancellous bone in lumbar segmental spondylodesis: a randomized prospective study

    PubMed Central

    Strube, Patrick; Funk, Julia F.; Gross, Christian; Mönig, Hans-Joachim; Perka, Carsten; Pruss, Axel

    2009-01-01

    The current gold standard in lumbar fusion consists of transpedicular fixation in combination with an interbody interponate of autologous bone from iliac crest. Because of the limited availability of autologous bone as well as the still relevant donor site morbidity after iliac crest grafting the need exists for alternative grafts with a comparable outcome. Forty patients with degenerative spinal disease were treated with a monosegmental spondylodesis (ventrally, 1 PEEK-cage; dorsally, a screw and rod system), and randomly placed in two groups. In group 1, autogenous iliac crest cancellous bone was used as a cage filling. In group 2 the cages were filled with an allogenic cancellous bone graft. Following 3, 6, 9 and 12 months, the clinical outcome was determined on the basis of: the Oswestry Low Back Pain Disability Questionnaire; patient satisfaction; patient willingness to undergo the operation again; and a visual analog scale for pain. The radiological outcome was based on both fusion rate (radiographs, computed tomography), and on the bone mineral density of the grafts. After 6 months, the X-rays of the patients in group 2 had a significantly lower rate of fusion. Aside from this, there were no further significant differences. After 12 months, radiological results showed a similar fusion rate in both groups. Donor site complications consisted of five patients with hematoma, and three patients with persistent pain in group 1. No implant complications were observed. If a bone bank is available for support and accepting the low risk of possible transmission of infectious diseases, freeze–dried allogenic cancellous bone can be used for monosegmental spondylodeses. The results demonstrated an equivalent clinical outcome, as well as similar fusion rates following a 12-month period. This is in despite of a delayed consolidation process. PMID:19148687

  13. Brinzolamide/timolol versus dorzolamide/timolol fixed combinations: A hospital-based, prospective, randomized study

    PubMed Central

    Galose, Mary S; Elsaied, Heba M; Macky, Tamer A; Fouad, Pakinam H

    2016-01-01

    Purpose: To compare the efficacy and tolerability of brinzolamide/timolol (BT) and dorzolamide/timolol (DT) fixed combinations on intraocular pressure (IOP) reduction. Methods: Patients with primary open angle glaucoma or normal tension glaucoma were randomized to receive either BT or DT. IOPs were measured at baseline, 2 weeks, and 1, 2, and 3 months. The primary outcome measures were the mean change in IOP from baseline at each visit. Secondary outcome measures included the tolerability of each fixed combination. Results: Seventy-three patients (73 eyes) were included; 37 eyes in BT group and 36 eyes in DT group. Baseline mean IOP were 24.14 ± 4.5 and 29.53 ± 6 mmHg for BT and DT, respectively (P < 0.001). Both BT and DT provided statistically significant mean IOP reductions from baseline values within each group at all study visits (P < 0.001). DT provided greater mean IOP reductions from baseline than BT at each visit which was statistically significant at 2 weeks (P = 0.037). Mean percentage of IOP reduction was 24.35% and 46.33% at 2 weeks (P < 0.001), and 24.65% and 47% at 3 months (P < 0.001) for BT and DT, respectively. Patients' tolerability appeared to be better for DT than for BT with complete ocular comfort without any ocular adverse effects in 31 patients (81.1%) in DT group and 11 patients (29.7%) in BT group (P < 0.001). Conclusion: Both drops provide effective IOP reduction which was greater, and patients were more likely to achieve lower target pressures with DT than with BT. PMID:27050347

  14. A prospective, randomized study on hepatotoxicity of anastrozole compared with tamoxifen in women with breast cancer

    PubMed Central

    Lin, Ying; Liu, Jianlun; Zhang, Xiaohua; Li, Li; Hu, Rui; Liu, Jian; Deng, Yongchuan; Chen, Dedian; Zhao, Yangbing; Sun, Shengrong; Ma, Rong; Zhao, Ying; Liu, Jinping; Zhang, Yang; Wang, Xijing; Li, Yafen; He, Pingqing; Li, Enxiao; Xu, Zheli; Wu, Yaqun; Tong, Zhongsheng; Wang, Xiaojia; Huang, Tao; Liang, Zhongxiao; Wang, Shui; Su, Fengxi; Lu, Yunfei; Zhang, Helong; Feng, Guosheng; Wang, Shenming

    2014-01-01

    Tamoxifen and anastrozole are widely used as adjuvant treatment for early stage breast cancer, but their hepatotoxicity is not fully defined. We aimed to compare hepatotoxicity of anastrozole with tamoxifen in the adjuvant setting in postmenopausal breast cancer patients. Three hundred and fifty-three Chinese postmenopausal women with hormone receptor-positive early breast cancer were randomized to anastrozole or tamoxifen after optimal primary therapy. The primary end-point was fatty liver disease, defined as a liver–spleen ratio <0.9 as determined using a computed tomography scan. The secondary end-points included abnormal liver function and treatment failure during the 3-year follow up. The cumulative incidence of fatty liver disease after 3 years was lower in the anastrozole arm than that of tamoxifen (14.6% vs 41.1%, P < 0.0001; relative risk, 0.30; 95% CI, 0.21–0.45). However, there was no difference in the cumulative incidence of abnormal liver function (24.6% vs 24.7%, P = 0.61). Interestingly, a higher treatment failure rate was observed in the tamoxifen arm compared with anastrozole and median times to treatment failure were 15.1 months and 37.1 months, respectively (P < 0.0001; HR, 0.27; 95% CI, 0.20–0.37). The most commonly reported adverse events were ‘reproductive system disorders’ in the tamoxifen group (17.1%), and ‘musculoskeletal disorders’ in the anastrozole group (14.6%). Postmenopausal women with hormone receptor-positive breast cancer receiving adjuvant anastrozole displayed less fatty liver disease, suggesting that this drug had a more favorable hepatic safety profile than tamoxifen and may be preferred for patients with potential hepatic dysfunction. PMID:24975596

  15. Laparoscopic Sleeve Gastrectomy versus Laparoscopic Banded Sleeve Gastrectomy: First Prospective Pilot Randomized Study

    PubMed Central

    Ippoliti, Simona; Gaspari, Achille; Gentileschi, Paolo

    2016-01-01

    Introduction. The placement of ring or band around the gastric tube might prevent the dilation after Laparoscopic Sleeve Gastrectomy (LSG). We describe the first randomized study comparing LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG). Material and Method. Fifty obese patients were enrolled in the study between January 2014 and January 2015. We analysed differences in operative time, complication rate, mortality, and BMI between the two groups over a period of 12 months. Results. Twenty-five patients received LSG (group A) and 25 LBSG (group B). The mean preoperative BMI was 47.3 ± 6.58 kg/m2 and 44.95 ± 5.85 kg/m2, respectively, in the two groups. There was no statistical relevant difference in operative time. No intraoperative complications occurred. Mean BMI registered after 3, 6, and 12 months in groups A and B, respectively, were 37.86 ± 5.72 kg/m2 and 37.58 ± 6.21 kg/m2 (p = 0.869), 33.64 ± 6.08 kg/m2 and 32.03 ± 5.24 kg/m2 (p = 0.325), and 29.72 ± 4.40 kg/m2 and 27.42 ± 4.47 kg/m2 (p = 0.186); no statistical relevant difference was registered between the two groups. Conclusion. LBSG is a safe and feasible procedure. The time required for the device positioning did not influence significantly the surgical time. The results of bodyweight loss did not document any statistically significant differences among the two groups, even though LBSG group showed a mean BMI slightly lower than that of the control group. PMID:27143964

  16. Ketamine as an Adjunct to Postoperative Pain Management in Opioid Tolerant Patients After Spinal Fusions: A Prospective Randomized Trial

    PubMed Central

    Ya Deau, Jacques T.; Wukovits, Barbara; Lipnitsky, Jane Y.

    2007-01-01

    Management of acute postoperative pain is challenging, particularly in patients with preexisting narcotic dependency. Ketamine has been used at subanesthetic doses as a N-methyl d-aspartate (NMDA) receptor antagonist to block the processing of nociceptive input in chronic pain syndromes. This prospective randomized study was designed to assess the use of ketamine as an adjunct to acute pain management in narcotic tolerant patients after spinal fusions. Twenty-six patients for 1–2 level posterior lumbar fusions with segmental instrumentation were randomly assigned to receive ketamine or act as a control. Patients in the ketamine group received 0.2 mg/kg on induction of general anesthesia and then 2 mcg kg−1 hour−1 for the next 24 hours. Patients were extubated in the operating room and within 15 minutes of arriving in the Post Anesthesia Care Unit (PACU) were started on intravenous patient-controlled analgesia (PCA) hydromorphone without a basal infusion. Patients were assessed for pain (numerical rating scale [NRS]), narcotic use, level of sedation, delirium, and physical therapy milestones until discharge. The ketamine group had significantly less pain during their first postoperative hour in the PACU (NRS 4.8 vs 8.7) and continued to have less pain during the first postoperative day at rest (3.6 vs 5.5) and with physical therapy (5.6 vs 8.0). Three patients in the control group failed PCA pain management and were converted to intravenous ketamine infusions when their pain scores improved. Patients in the ketamine group required less hydromorphone than the control group, but the differences were not significant. Subanesthetic doses of ketamine reduced postoperative pain in narcotic tolerant patients undergoing posterior spine fusions. PMID:18751864

  17. A Prospective Randomized Controlled Study of Endoscopic Sphincterotomy With the Endocut Mode or Conventional Blended Cut Mode

    PubMed Central

    Tanaka, Yoshiki; Tsuchida, Hiroyuki; Mizuide, Masafumi; Yasuoka, Hidetoshi; Ishida, Katsutoshi; Mori, Masatomo; Kusano, Motoyasu; Yamada, Masanobu

    2015-01-01

    Background: Although the potential advantages of the Endocut mode (E-mode) of endoscopic sphincterotomy (EST) over the conventional blended cut mode (C-mode) have been reported, the problems, including the small sample size and retrospective analysis, that occurred in previous studies make it difficult to conclude the advantage of the E-mode regarding the safety and efficacy. We performed a prospective randomized controlled study to compare these modes. Methods: A total of 360 patients with choledocholithiasis or stenosis of the bile duct were randomly assigned to one of the modes. To avoid the technical bias due to multiple operators or institutions, the main operator and the institution were restricted to only one experienced doctor and 3 institutions at his place of employment, respectively. We defined pancreatitis, bleeding, and perforation as complications of EST. Besides, bleeding includes endoscopically evident bleeding that was defined as visible during the procedure of sphincterotomy and temporary slight oozing. Results: The complications occurred in 20 (11.2%) patients from the E-mode group: pancreatitis in 6 (3.4%) and endoscopically evident bleeding in 14 (7.8%). In contrast, the complications occurred in 25 (13.8%) patients from the C-mode group: pancreatitis in 7 (3.9%) and endoscopically evident bleeding in 18 (9.9%), although these findings were not statistically significant. Overall, there were no severe complications. There were no significant differences in completion ratio of EST and the time taken for the sphincterotomy between both groups. Conclusions: The E-mode could not surpass the C-mode in safety and efficacy under the operation by a single endoscopist. PMID:24583745

  18. Autologous platelet-rich gel for treatment of diabetic chronic refractory cutaneous ulcers: A prospective, randomized clinical trial.

    PubMed

    Li, Lan; Chen, Dawei; Wang, Chun; Yuan, Nanbing; Wang, Yan; He, Liping; Yang, Yanzhi; Chen, Lihong; Liu, Guanjian; Li, Xiujun; Ran, Xingwu

    2015-01-01

    The purpose of the study is to examine the safety and effectiveness of topical autologous platelet-rich gel (APG) application on facilitating the healing of diabetic chronic refractory cutaneous ulcers. The study was designed as a prospective, randomized controlled trial between January 1, 2007 and December 31, 2011. Eligible inpatients at the Diabetic Foot Care Center of West China Hospital, Sichuan University (China) were randomly prescribed with a 12-week standard treatment of ulcers (the control group) or standard treatment plus topical application APG (the APG group). The wound healing grades (primary endpoint), time to complete healing, and healing velocity within 12 weeks were monitored as short-term effectiveness measurements, while side effects were documented safety endpoints. The rates of survival and recurrence within the follow up were recorded as long-term effectiveness endpoints. Analysis on total diabetic ulcers (DUs) (n = 117) and subgroup analysis on diabetic foot ulcers (DFUs) (n = 103) were both conducted. Standard treatment plus APG treatment was statistically more effective than standard treatment (p < 0.05 in both total DUs and subgroup of DFUs). The subjects defined as healing grade 1 were 50/59 (84.8%) in total DUs and 41/48 (85.4%) in DFUs in the APG group compared with 40/58 (69.0%) and 37/55 (67.3%) in the control group from intent to treat population. The Kaplan-Meier time-to-healing were significantly different between the two groups (p < 0.05 in both total DUs and subgroup of DFUs). No side effects were identified after topical APG application. The long-term survival and recurrence rates were comparative between groups (p > 0.05). This study shows that topical APG application plus standard treatment is safe and quite effective on diabetic chronic refractory cutaneous ulcers, compared with standard treatment. PMID:25847503

  19. Anesthesiologic Effects of Transperitoneal Versus Extraperitoneal Approach During Robot-Assisted Radical Prostatectomy: Results of a Prospective Randomized Study

    PubMed Central

    Moro, Fabrizio Dal; Crestani, Alessandro; Valotto, Claudio; Guttilla, Andrea; Soncin, Rodolfo; Mangano, Angelo; Zattoni, Filiberto

    2015-01-01

    ABSTRACT Objectives: To compare the effects of CO2 insufflation on hemodynamics and oxygen levels and on acid-base level during Robot-Assisted Radical Prostatectomy (RARP) with transperitoneal (TP) versus extra-peritoneal (EP) accesses. Materials and Methods: Sixty-two patients were randomly assigned to TP (32) and EP (30) to RARP. Pre-operation data were collected for all patients. Hemodynamic, respiratory and blood acid-base parameters were measured at the moment of induction of anesthesia (T0), after starting CO2 insuffation (T1), and at 60 (T2) and 120 minutes (T3) after insufflation. In all cases, the abdominal pressure was set at 15 mmHg. Complications were reported according to the Clavien-Dindo classification. Student's two–t-test, with a significance level set at p<0.05, was used to compare categorical values between groups. The Mann-Whitney U-test was used to compare the median values of two nonparametric continuous variables. Results: The demographic characteristics of the patients in both groups were statistically comparable. Analysis of intra-operative anesthesiologic parameters showed that partial CO2 pressure during EP was significantly higher than during TP, with a consequent decrease in arterial pH. Other parameters analysed were similar in the two groups. Postoperative complications were comparable between groups. The most important limitations of this study were the small size of the patient groups and the impossibility of maintaining standard abdominal pressure throughout the operational phases, despite attempts to regulate it. Conclusions: This prospective randomized study demonstrates that, from the anesthesiologic viewpoint, during RARP the TP approach is preferable to EP, because of lower CO2 reabsorption and risk of acidosis. PMID:26200539

  20. Improving acne keloidalis nuchae with targeted ultraviolet B treatment: a prospective, randomized, split-scalp comparison study

    PubMed Central

    Okoye, G.A.; Rainer, B.M.; Leung, S.G.; Suh, H.S.; Kim, J.H.; Nelson, A.M.; Garza, L.A.; Chien, A.L.; Kang, S.

    2014-01-01

    Background Acne keloidalis nuchae (AKN) is a chronic scarring folliculitis with fibrotic papules on the occipital scalp. Its treatment is limited and unsatisfactory. Objectives To determine if targeted ultraviolet B (tUVB) phototherapy will (1) improve the clinical appearance of AKN and (2) induce extracellular matrix remodeling in affected lesions. Methods Eleven patients with AKN were enrolled in a prospective, randomized, split-scalp comparison study. One randomly selected side of the scalp was treated with tUVB up to three times weekly for eight weeks. After week 8, both sides were treated for eight additional weeks. Assessment included lesion counts in two 3×3 cm regions of interest (ROI), one on each side of the scalp (ROI-1: tUVB week 0–16, ROI-2: tUVB week 9–16), patient self-assessment, and analysis of MMP-1, MMP-9, TGF-β1, and Col1a1 mRNA expression by qRT-PCR. Results Before treatment, the mean lesion count was similar between tUVB-treated and untreated sides (14.8 vs. 15.0). After eight weeks of tUVB, the mean lesion count decreased significantly to 9.4±1.2 (P=0.03), with no change on the untreated side. With continued treatment, the mean lesion count in ROI-1 decreased further to 7±1.5 (P=0.04) after 16 weeks of tUVB. Conclusion Targeted UVB significantly improved clinical appearance of AKN, led to patient satisfaction, and was well tolerated. PMID:24863570

  1. Rapid pleurodesis is an outpatient alternative in patients with malignant pleural effusions: a prospective randomized controlled trial

    PubMed Central

    Özkul, Serkan; Demirkaya, Ahmet; Aksoy, Burcu; Kaynak, Kamil

    2014-01-01

    Background Chemical pleurodesis can be palliative for recurrent, symptomatic pleural effusions in patients who are not candidate for a thoracic surgical procedure. We hypothesized that effective pleurodesis could be accomplished with a rapid method of pleurodesis as effective as the standard method. Methods A prospective randomized ‘non-inferiority’ trial was conducted in 96 patients with malignant pleural effusion (MPE) who are not potentially curable and/or not amenable to any other surgical intervention. They were randomly allocated to group 1 (rapid pleurodesis) and to group 2 (standard protocol). In group 1, following complete fluid evacuation, talc slurry was instilled into the pleural space. This was accomplished within 2 h of thoracic catheter insertion, unless the drained fluid was more than 1,500 mL. After clamping the tube for 30 min, the pleural space was drained for 1 h, after which the thoracic catheter was removed. In group 2, talc-slurry was administered when the daily drainage was lower than 300 mL/day. Results No-complication developed due to talc-slurry in two groups. Complete or partial response was achieved in 35 (87.5%) and 33 (84.6%) patients in group 1 and group 2 respectively (P=0.670). The mean drainage time was 40.7 and 165.2 h in group 1 and group 2 respectively (P<0.001). Conclusions Rapid pleurodesis with talc slurry is safe and effective and it can be performed in an outpatient basis. PMID:25589966

  2. Prospective Randomized Comparison of Imipenem-Cilastatin and Piperacillin-Tazobactam in Nosocomial Pneumonia or Peritonitis

    PubMed Central

    Jaccard, C.; Troillet, N.; Harbarth, S.; Zanetti, G.; Aymon, D.; Schneider, R.; Chiolero, R.; Ricou, B.; Romand, J.; Huber, O.; Ambrosetti, P.; Praz, G.; Lew, D.; Bille, J.; Glauser, M. P.; Cometta, A.

    1998-01-01

    Nosocomial pneumonia and acute peritonitis may be caused by a wide array of pathogens, and combination therapy is often recommended. We have previously shown that imipenem-cilastatin monotherapy was as efficacious as the combination of imipenem-cilastatin plus netilmicin in these two settings. The efficacy of imipenem-cilastatin is now compared to that of piperacillin-tazobactam as monotherapy in patients with nosocomial pneumonia or acute peritonitis. Three hundred seventy one patients with nosocomial pneumonia or peritonitis were randomly assigned to receive either imipenem-cilastatin (0.5 g four times a day) or piperacillin-tazobactam (4.5 g three times a day). Three hundred thirteen were assessable (154 with nosocomial pneumonia and 159 with peritonitis). For nosocomial pneumonia, clinical-failure rates in the piperacillin-tazobactam group (13 of 75 [17%]) and in the imipenem-cilastatin group (23 of 79 [29%]) were similar (P = 0.09), as were the numbers of deaths due to infection (6 in the imipenem-cilastatin group [8%], 7 in the piperacillin-tazobactam group [9%]) (P = 0.78). For acute peritonitis, clinical success rates were comparable (piperacillin-tazobactam, 72 of 76 [95%]; imipenem-cilastatin, 77 of 83 [93%]). For infections due to Pseudomonas aeruginosa, 45 patients had nosocomial pneumonia (21 in the piperacillin-tazobactam group and 24 in the imipenem-cilastatin group) and 10 had peritonitis (5 in each group). In the patients with nosocomial pneumonia, clinical failure was less frequent in the piperacillin-tazobactam group (2 of 21 [10%]) than in the piperacillin-cilastatin group (12 of 24 [50%]) (P = 0.004). Bacterial resistance to allocated regimen was the main cause of clinical failure (1 in the piperacillin-tazobactam group and 12 in the imipenem-cilastatin group). For the patients with peritonitis, no difference in clinical outcome was observed (five of five cured in each group). The overall frequencies of adverse events related to treatment in

  3. Prospective evaluation of outcome measures in free-flap surgery.

    PubMed

    Kelly, John L; Eadie, Patricia A; Orr, David; Al-Rawi, Mogdad; O'Donnell, Margaret; Lawlor, Denis

    2004-08-01

    Free-flap failure is usually caused by venous or arterial thrombosis. In many cases, lack of experience and surgical delay also contribute to flap loss. The authors prospectively analyzed the outcome of 57 free flaps over a 28-month period (January, 1999 to April, 2001). The setting was a university hospital tertiary referral center. Anastomotic technique, ischemia time, choice of anticoagulant, and the grade of surgeon were recorded. The type of flap, medications, and co-morbidities, including preoperative radiotherapy, were also documented. Ten flaps were re-explored (17 percent). There were four cases of complete flap failure (6.7 percent) and five cases of partial failure (8.5 percent). In patients who received perioperative systemic heparin or dextran, there was no evidence of flap failure (p = .08). The mean ischemia time was similar in flaps that failed (95 +/- 29 min) and in those that survived (92 +/- 34 min). Also, the number of anastomoses performed by trainees in flaps that failed (22 percent), was similar to the number in flaps that survived (28 percent). Nine patients received preoperative radiotherapy, and there was complete flap survival in each case. This study reveals that closely supervised anastomoses performed by trainees may have a similar outcome to those performed by more senior surgeons. There was no adverse effect from radiotherapy or increased ischemia time on flap survival. PMID:15356760

  4. Intraoperative music reduces perceived pain after total knee arthroplasty: a blinded, prospective, randomized, placebo-controlled clinical trial.

    PubMed

    Simcock, Xavier C; Yoon, Richard S; Chalmers, Peter; Geller, Jeffrey A; Kiernan, Howard A; Macaulay, William

    2008-10-01

    Patients undergoing total knee arthroplasty (TKA) often experience a difficult recovery due to severe postoperative pain. Using a multimodal pain management protocol, a blinded, randomized, placebo-controlled study was designed to evaluate the efficacy of patient-selected music on reducing perceived pain. Thirty patients undergoing primary unilateral TKA were enrolled and randomized into the music group (15 patients) or the control group (15 patients). Postoperative pain scores, assessed with the visual analog scale, indicated the music group experienced less pain at 3 and 24 hours postoperatively than did the nonmusic group (at 3 hours: 1.47+/-1.39 versus 3.87+/-3.44, P=.01; at 24 hours: 2.41+/-1.67 versus 4.03+/-2.89, P=.04). Intraoperative music provides an inexpensive nonpharmacological option to further reduce postoperative pain. PMID:18979928

  5. Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate

    SciTech Connect

    Kochhar, R.; Patel, F.; Dhar, A.; Sharma, S.C.; Ayyagari, S.; Aggarwal, R.; Goenka, M.K.; Gupta, B.D.; Mehta, S.K. )

    1991-01-01

    In a prospective study, 37 consecutive patients with radiation-induced proctosigmoiditis were randomized to receive a four-week course of either 3.0 g oral sulfasalazine plus 20 mg twice daily rectal prednisolone enemas (group I, N = 18) or 2.0 g twice daily rectal sucralfate enemas plus oral placebo (group II, N = 19). The two groups were comparable with respect to demographic features, duration of symptoms, and clinical and endoscopic staging of the disease. Fifteen patients in group I and 17 in group II completed the trial. At four weeks, both groups showed significant clinical improvement (P less than 0.01 for group I and P less than 0.001 for group II) and endoscopic healing (P less than 0.01 for group I and P less than 0.001 for group II). When the two groups were compared, sucralfate enemas showed a significantly better response as assessed clinically (P less than 0.05), although endoscopically the response was not statistically different (P greater than 0.05). We conclude that both treatment regimens are effective in the management of radiation proctitis. Sucralfate enemas give a better clinical response, are tolerated better, and because of the lower cost should be the preferred mode of short-term treatment.

  6. Does Visceral Osteopathic Treatment Accelerate Meconium Passage in Very Low Birth Weight Infants?- A Prospective Randomized Controlled Trial

    PubMed Central

    Haiden, Nadja; Pimpel, Birgit; Kreissl, Alexandra; Jilma, Bernd; Berger, Angelika

    2015-01-01

    Background To determine whether the complementary approach of visceral manipulative osteopathic treatment accelerates complete meconium excretion and improves feeding tolerance in very low birth weight infants. Methods This study was a prospective, randomized, controlled trial in premature infants with a birth weight <1500 g and a gestational age <32 weeks who received a visceral osteopathic treatment 3 times during their first week of life or no treatment. Results Passage of the last meconium occurred after a median of 7.5 days (95% confidence interval: 6–9 days, n = 21) in the intervention group and after 6 days (95% confidence interval: 5-9 days, n = 20,) in the control group (p = 0.11). However, osteopathic treatment was associated with a 8 day longer time to full enteral feedings (p = 0.02), and a 34 day longer hospital stay (Median = 66 vs. 100 days i.e.; p=0.14). Osteopathic treatment was tolerated well and no adverse events were observed. Conclusions Visceral osteopathic treatment of the abdomen did not accelerate meconium excretion in VLBW (very low birth weight)-infants. However infants in the osteopathic group had a longer time to full enteral feedings and a longer hospital stay, which could represent adverse effects. Based on our trial results, we cannot recommend visceral osteopathic techniques in VLBW-infants. Trial registration Clinical trials.gov: NCT02140710 PMID:25875011

  7. A prospective randomized trial of either famotidine or pantoprazole for the prevention of bleeding after endoscopic submucosal dissection.

    PubMed

    Jeong, Hye Kyong; Park, Chang Hwan; Jun, Chung Hwan; Lee, Gi Hoon; Kim, Hyung Il; Kim, Hyun Soo; Choi, Sung Kyu; Rew, Jong Sun

    2007-12-01

    Endoscopic submucosal dissection (ESD) has been reported to have a higher bleeding rate than conventional methods. However, there are few reports on whether a proton pump inhibitor or a histamine2-receptor antagonist is the more effective treatment for preventing bleeding after ESD. In a prospective trial, patients undergoing ESD due to gastric adenoma or adenocarcinoma were randomly assigned to pantoprazole or famotidine. Both drugs were given intravenously for the first 2 days, thereafter by mouth. Eighty-five in the pantoprazole group and 79 in the famotidine group were included for analysis. Primary outcome measure was the delayed bleeding rate. Clinical characteristics were not different between the two groups. The delayed bleeding rate was significantly lower in the pantoprazole group compared with the famotidine group (3.5% vs. 12.7%, p=0.031). On multivariate analysis, the preventive use of pantoprazole (relative hazard: 0.220, 95% CI: 0.051- 0.827, p=0.026) and the specimen size (> or =34 mm, relative hazard: 4.178, 95% CI: 1.229-14.197, p=0.022) were two independent factors predictive of delayed bleeding. There were no significant differences in en bloc and complete resection rate between the two groups. In conclusion, pantoprazole is more effective than famotidine for the prevention of delayed bleeding after ESD. PMID:18162722

  8. Gut barrier function and systemic endotoxemia after laparotomy or laparoscopic resection for colon cancer: A prospective randomized study

    PubMed Central

    Schietroma, Mario; Pessia, Beatrice; Carlei, Francesco; Cecilia, Emanuela Marina; Amicucci, Gianfranco

    2016-01-01

    PURPOSE: The gut barrier is altered in certain pathologic conditions (shock, trauma, or surgical stress), resulting in bacterial and/or endotoxin translocation from the gut lumen into the systemic circulation. In this prospective randomized study, we investigated the effect of surgery on intestinal permeability (IP) and endotoxemia in patients undergoing elective colectomy for colon cancer by comparing the laparoscopic with the open approach. PATIENTS AND METHODS: A hundred twenty-three consecutive patients underwent colectomy for colon cancer: 61 cases were open resection (OR) and 62 cases were laparoscopic resection (LR). IP was measured preoperatively and at days 1 and 3 after surgery. Serial venous blood sample were taken at 0, 30, 60, 90, 120, and 180 min, and at 12, 24, and 48 h after surgery for endotoxin measurement. RESULTS: IP was significantly increased in the open and closed group at day 1 compared with the preoperative level (P < 0.05), but no difference was found between laparoscopic and open surgery group. The concentration endotoxin systemic increased significantly in the both groups during the course of surgery and returned to baseline levels at the second day. No difference was found between laparoscopic and open surgery. A significant correlation was observed between the maximum systemic endotoxin concentration and IP measured at day 1 in the open group and in the laparoscopic group. CONCLUSION: An increase in IP, and systemic endotoxemia were observed during the open and laparoscopic resection for colon cancer, without significant statistically difference between the two groups. PMID:27279398

  9. High- versus low-top shoes for the prevention of ankle sprains in basketball players. A prospective randomized study.

    PubMed

    Barrett, J R; Tanji, J L; Drake, C; Fuller, D; Kawasaki, R I; Fenton, R M

    1993-01-01

    Using a prospective, randomized experimental design, 622 college intramural basketball players were stratified by a previous history of ankle sprains to wear a new pair of either high-top, high-top with inflatable air chambers, or low-top basketball shoes during all games for a complete season. Subjects were asked to complete a history questionnaire and were given a complete ankle examination. They were allowed to wear these shoes only during basketball competition. Followed over the course of a 2-month intramural season, 15 ankle injuries occurred during 39,302 minutes of player-time: 7 in high-top shoes, 4 in low-top shoes, and 4 in high-top shoes with inflatable air chambers. The injury rates (injuries per player-minute) were 4.80 x 10(-4) in high-top shoes, 4.06 x 10(-4) in low-top shoes, and 2.69 x 10(-4) in high-top shoes with inflatable air chambers. There was no significant difference among these 3 groups, leading to the conclusion that there is no strong relationship between shoe type and ankle sprains. PMID:8368420

  10. Benefits of maltodextrin intake 2 hours before cholecystectomy by laparotomy in respiratory function and functional capacity: a prospective randomized clinical trial

    PubMed Central

    Zani, Fabiana Vieira Breijão; Aguilar-Nascimento, José Eduardo; Nascimento, Diana Borges Dock; da Silva, Ageo Mário Cândido; Caporossi, Fernanda Stephan; Caporossi, Cervantes

    2015-01-01

    ABSTRACT Objective: To evaluate the change in respiratory function and functional capacity according to the type of preoperative fasting. Methods: Randomized prospective clinical trial, with 92 female patients undergoing cholecystectomy by laparotomy with conventional or 2 hours shortened fasting. The variables measured were the peak expiratory flow, forced expiratory volume in the first second, forced vital capacity, dominant handgrip strength, and non-dominant handgrip strength. Evaluations were performed 2 hours before induction of anesthesia and 24 hours after the operation. Results: The two groups were similar in preoperative evaluations regarding demographic and clinical characteristics, as well as for all variables. However, postoperatively the group with shortened fasting had higher values than the group with conventional fasting for lung function tests peak expiratory flow (128.7±62.5 versus 115.7±59.9; p=0.040), forced expiratory volume in the first second (1.5±0.6 versus 1.2±0.5; p=0.040), forced vital capacity (2.3±1.1 versus 1.8±0.9; p=0.021), and for muscle function tests dominant handgrip strength (24.9±6.8 versus 18.4±7.7; p=0.001) and non-dominant handgrip strength (22.9±6.3 versus 17.0±7.8; p=0.0002). In the intragroup evaluation, there was a decrease in preoperative compared with postoperative values, except for dominant handgrip strength (25.2±6.7 versus 24.9±6.8; p=0.692), in the shortened fasting group. Conclusion: Abbreviation of preoperative fasting time with ingestion of maltodextrin solution is beneficial to pulmonary function and preserves dominant handgrip strength. PMID:26154547