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Sule Firinci MD Necmettin Yildiz MD Hakan Alkan MD Zafer Aybek MD 《Neurourology and urodynamics》2020,39(8):2498-2508
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Does fibrin glue sealant decrease the rate of pancreatic fistula after pancreaticoduodenectomy? results of a prospective randomized trial 总被引:9,自引:0,他引:9
Despite substantial improvements in perioperative mortality, complications, and specifically the development of a pancreatic
fistula, remain a common occurrence after pancreaticoduodenectomy. It was the objective of this study to evaluate the role
of fibrin glue sealant as an adjunct to decrease the rate of pancreatic fistula after pancreaticoduodenectomy. One hundred
twenty-five patients were randomized after pancreaticoduodenal resection only if, in the opinion of the surgeon, the pancreaticojejunal
anastomosis was at high risk for development of a pancreatic anastomotic leak. After completion of the pancreaticojejunal
anastomosis, the patients were randomized to topical application of fibrin glue sealant to the surface of the anastomosis
or no such application. The primary postoperative end points in this study were pancreatic fistula, total complications, death,
and length of hospital stay. A total of 59 patients were randomized to the fibrin glue arm, whereas 66 patients were randomized
to the control arm and did not receive fibrin glue application. The pancreatic fistula rate in the fibrin glue arm of the
study was 26% vs. 30% in the control group (p = not significant [NS]). The mean length of postoperative stay for all patients randomized was similar (fibrin glue = 12.2
days, control = 13.6 days) and the mean length of stay for patients in whom pancreatic fistula developed was also not different
(fibrin glue = 18.9 days, control = 21.7 days). There were no differences with respect to total complications or specific
complications such as postoperative bleeding, infection, or delayed gastric emptying. These data demonstrate that the topical
application of fibrin glue sealant to the surface of the pancreatic anastomosis in this patient population undergoing high-risk
pancreaticojejunal anastomosis did not reduce the incidence of pancreatic fistula or total complications after pancreaticodudodenectomy.
There seems to be no benefit regarding the use of this substance in this setting.
Presented at the Forty-Fifth Annual Meeting of the Society for Surgery of the Alimentary Tract, New Orleans, Louisiana, May
15–19, 2004 (oral presentation).
This work was supported in part by the Haemacure Company and Baxter Health Care. 相似文献
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van der Pal F van Balken MR Heesakkers JP Debruyne FM Bemelmans BL 《BJU international》2006,97(3):547-550
OBJECTIVE: To determine the effect of a pause in percutaneous tibial nerve stimulation (PTNS) in successfully treated patients with an overactive bladder (OAB), and the reproducibility of successful treatment when restored. PATIENTS AND METHODS: Eleven patients (mean age 51 years) with refractory OAB (more than seven voids and/or three or more urge incontinence episodes per day) were successfully treated with PTNS, and then discontinued treatment. Patients completed bladder diaries and quality-of-life (QoL) questionnaires (Short Form-36 and I-QoL) before (T1) and after a 6-week pause (T2) of maintenance PTNS, and again after re-treatment (T3). The first objective was defined as a > or = 50% increase in the incontinence episodes and/or voiding frequency in the bladder diary after T2. The second objective was defined as > or = 50% fewer incontinence episodes and/or voiding frequency in bladder diary after T3. RESULTS: At T2, seven of the 11 patients had a > or = 50% increase in incontinence episodes and/or voiding frequency in the bladder diary. The mean voided volume, nocturia, number of incontinence episodes and incontinence severity deteriorated significantly (P < 0.05). At T3, nine patients had > or = 50% fewer incontinence episodes and/or voiding frequency in the bladder diary. Nocturia, the number of incontinence episodes, incontinence severity, mean voided volume and quality of life improved significantly (P < 0.05). CONCLUSIONS: Continuous therapy is necessary in patients with OAB treated successfully by PTNS. The efficacy of PTNS can be reproduced in patients formerly treated successfully. 相似文献
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OBJECTIVE
To determine whether subjects with or with no detrusor overactivity (DO) determined by urodynamic assessment respond differently to treatment with the antimuscarinic agent tolterodine (extended release formulation, ER).SUBJECTS AND METHODS
Adult subjects with urinary frequency (average ≥8 voids/24 h) and urgency with or without urgency urinary incontinence (UUI) underwent urodynamic assessment and were stratified according to whether they had DO (positive urodynamics) or not (negative urodynamics). Subjects in each urodynamic stratum were randomized to receive tolterodine‐ER (4 mg once daily) or placebo for 12 weeks. Diary cards were completed for 7 days before each study visit (at baseline, week 4, and week 12). The volume per void was recorded for 3 of the 7 days.RESULTS
The difference between the positive and negative urodynamic groups in mean change in volume voided between baseline and 12 weeks was 5.38 mL (95% CI, ?93 mL to +15.71 mL). This difference is within the pre‐stipulated range defined for equivalence (±20 mL, P = 0.31). There was also no significant difference in the change from baseline to 12 weeks between the urodynamics groups in mean number of voids per day or UUI episodes. However, there was significant improvement in the treatment group compared with the placebo group, in the number of voids per 24 h (P = 0.003) and in the mean change in volume voided (P = 0.03), from baseline to 12 weeks, but not in UUI episodes (P = 0.35).CONCLUSIONS
Urodynamics status could not predict treatment outcomes between patients treated with tolterodine‐ER or placebo. The results add support to evidence suggesting that urodynamic assessment is not a prerequisite for the treatment of overactive bladder (OAB). Therefore, we recommend that anticholinergic treatment may be initiated to patients with OAB symptoms without the need for urodynamics studies. 相似文献7.
The role of prospective randomized clinical trials in pediatric surgery: state of the art? 总被引:5,自引:0,他引:5
Moss RL Henry MC Dimmitt RA Rangel S Geraghty N Skarsgard ED 《Journal of pediatric surgery》2001,36(8):1182-1186
PURPOSE: This study sought to determine the role of randomized controlled trials (RCT) in the evolution of pediatric surgical practice. METHODS: The authors used a computer-assisted literature search to identify all clinical trials related to pediatric surgery published in the English-language literature from 1966 through 1999. Each article was reviewed in detail for purpose, content, conduct, and quality of the trial. The authors assessed quality with a previously validated instrument (Chalmers Qualitative Assessment). RESULTS: The authors identified 134 RCTs related to pediatric surgery over the past 33 years. This accounts for 0.17% of 80,377 articles published in the field. The areas of surgery studied were analgesia 65 (49%), antibiotics 17 (13%), extracorporeal membrane oxygenation (ECMO) 9 (7%), gastrointestinal, burns, oncology, minimally invasive surgery, vascular access, congenital anomalies, and trauma (each <5%). Only 16 (12%) trials compared 2 surgical therapies, 9 (7%) compared a medical versus a surgical therapy, and 109 (81%) compared 2 medical therapies in surgical patients. Fourteen (10%) RCTs were funded by peer-reviewed agencies. Only 17 (13%) RCTs included a biostatistician as an author or a consultant. Trial design included calculation of sample size and statistical power in 21 (16%) RCTs. Method of randomization was reported in only 51 (38%). The test statistic and observed probability value was reported in 15 (11%). CONCLUSIONS: Clinical trials are used infrequently to answer questions related to pediatric surgery. When RCTs are utilized, they often suffer from poor trial design, inadequate statistical analysis, and incomplete reporting. Pediatric surgery could benefit from increased expertise, funding, and participation in clinical trials. 相似文献
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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. 相似文献
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Maiorca R Brunori G Viola BF Zubani R Cancarini G Parrinello G De Carli A 《Journal of nephrology》2000,13(4):267-270
There are no solid data on the real advantage of an early start of dialysis, as suggested by the DOQI guidelines. Uremic patients frequently have a poor nutritional status. However, we cannot distinguish between the detrimental effect on nutrition of too low a residual renal function or too long a period of low protein-diet, per se. However, it appears that a very-low-protein diet (VLPD) supplemented with essential amino acids and keto-analogs of amino acids, and with an adequate quantity of calories, can prevent hypoalbuminemia at the start of dialysis and can slow the progression of chronic renal failure. EDTA and USRDS data suggest that most patients starting dialysis nowadays are elderly, who also have the highest incidence of morbidity and mortality. Moreover, hospitalization rate becomes higher after the start of dialysis compared to the pre-dialysis period. Can an aminoacid-supplemented VLPD, prolonged beyond the GFR limits suggested by DOQI, offer elderly patients better survival and better quality of life than dialysis? The answer can only come from a prospective, randomized trial, in elderly patients, starting at the GFR values suggested by the NKF-DOQI for starting dialysis, comparing outcomes with a vegetarian VLPD supplemented with a mixture of keto-analogs of amino acids and essential amino acids, and with dialysis. 相似文献
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Is there a role for bladder preserving strategies in the treatment of muscle-invasive bladder cancer? 总被引:2,自引:0,他引:2
Kuczyk M Turkeri L Hammerer P Ravery V;European Society for Oncological Urology 《European urology》2003,44(1):57-64
Single modality bladder sparing therapy for muscle-invasive bladder cancer, including transurethral resection, systemic chemotherapy or radiotherapy have been demonstrated to result in insufficient local control of the primary tumor as well as decreased long-term survival of the patients when compared to radical cystectomy. Therefore, multimodality treatment protocols that aim at bladder preservation and involve all of the aforementioned approaches have been established. Arguments for combining systemic chemotherapy with radiation are to sensitize tumor tissue to radiotherapy and to eradicate occult metastases that have already developed in as many as 50% of patients at the time of first diagnosis. It has been shown that the clinical outcome observed with this approach approximates that after radical cystectomy. Additionally, a substantial number of patients survive with an intact bladder. However, bladder preserving approaches are costly, and require close co-operation between different clinical specialists as well as very close follow-up. The good long-term results obtained after cystectomy and creation of an orthotopic neobladder make the possible advantage of a bladder preservation strategy questionable in consideration of quality of life issues. Additionally, side effects related to bladder sparing therapy may result in an increased morbidity and mortality in those patients who in fact need to undergo surgery due to recurrent or progressive disease. Multimodality bladder sparing treatment is a therapeutic option that can be offered to the patient at centres that have a dedicated multidisciplinary team at their disposal. However, radical cystectomy remains the standard of care for muscle-invasive bladder tumors. 相似文献
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Yuriko Yamanishi Tomonori Yamanishi Hakujyu Tajima Shunya Ikeda 《International journal of urology》2018,25(10):863-870
Objectives
To assess the cost‐effectiveness of mirabegron 50 mg relative to tolterodine extended release 4 mg for the treatment of overactive bladder if used as the first‐line treatment in Japan.Methods
A Markov model was developed to simulate the cost‐effectiveness of the mirabegron first‐line treatment (and tolterodine second‐line) versus tolterodine first‐line treatment (and mirabegron second‐line) taken for 5 years from the randomized European‐Australian study (SCORPIO trial) and single technology appraisal assessment report by the National Institute for Health and Care Excellence. The incremental cost‐effectiveness ratio was calculated with utility value by quality‐adjusted life year with cost using the medical fee and the drug price tariff in 2016. For the study of transition of treatment status, our analytical model was established. The transition probabilities of severity states were calculated based on the probabilities for the mean numbers of incontinence episodes/day and micturition episodes/day in mirabegron‐treated and tolterodine‐treated patients in the single technology appraisal assessment report.Results
The 5‐year expected effect per patient was 3.860 quality‐adjusted life years for first‐line mirabegron and 3.839 quality‐adjusted life years for first‐line tolterodine. The 5‐year expected cost per patient was ¥526 191 for first‐line mirabegron, and ¥472 390 for first‐line tolterodine. The incremental cost‐effectiveness ratio was ¥2 565 927/quality‐adjusted life year. This value was below the willingness‐to‐pay threshold of ¥5 million/quality‐adjusted life year. In more severe states, the incremental cost‐effectiveness ratio exceeded ¥5 million.Conclusions
First‐line mirabegron appears to be more cost‐effective than first‐line tolterodine. In patients with severe symptoms, first‐line mirabegron is not economically preferable.14.
Filimon C Novac C Gheorghiu V Costache C Pricop C Todosi L Negru I Suditu N Caba D Roznovanu S Rusu E Mihaela R 《Revista medico-chirurgical?? a Societ????ii de Medici ??i Naturali??ti din Ia??i》1997,101(1-2):170-173
The authors present their experience of 122 partial cystectomy cases made on a number of 288 vesical tumors in our clinic, during 5 years (1986-1991) from which 23 are superficial tumors and 99 are infiltrative ones. The treatment of vesical tumors can be done in many ways; this partial cystectomy must be completed with an other therapeutic method: irradiation on chemotherapy in conformity with the anatomo-pathological form, the steady and tumoral grading. 相似文献
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Jan Krhut Alois Martan Roman Zachoval Tomas Hanus Lukas Horcicka Kamil Svabík Peter Zvara 《International urology and nephrology》2018,50(3):433-439
Purpose
To evaluate the feasibility of discontinuing treatment with mirabegron once symptoms have subsided in patients with overactive bladder (OAB).Methods
The present study evaluated a total of 159 female OAB patients (age 62.9 ± 12.36), each of which were prescribed 50 mg/day mirabegron (Time point 1—T1). Data obtained from voiding diaries and patient-reported outcome variables were assessed during follow-up visits at months 1, 3, 6, 12, 18 (T2), and 21 (T4). At the 18-month visit, patients with an Urgency Bother-Visual Analog Scale score of ≤ 50% were advised to stop treatment with mirabegron. Upon re-emergence or worsening of OAB symptoms, patients were allowed to start taking medication again at their discretion (T3). Statistical analysis was performed using a Chi-square test. An ANOVA analysis and a two-sample t test were used to evaluate differences between groups.Results
A total of 56 out of 159 (35.3%) patients took 50 mg of mirabegron daily between T1 and T2. A total of 17 out of 56 patients (30.4%) did not meet the criteria for mirabegron discontinuation (Group A). A total of 24 out of 56 patients (42.9%) stopped taking the medication temporarily, but later returned to treatment (Group B). The average time span between T2 and T3 was 53.9 days. Fifteen of 56 patients (26.8%) ceased treatment with mirabegron without starting it again before T4 (Group C). The average time span between T2 and T4, in Group C, was 124.7 days.Conclusion
A small percentage of OAB patients were able to discontinue mirabegron due to symptom cessation.16.
Tobias Ficnar Claudius Middelberg Bernd Rademacher Stefan Hessling Raphael Koch Ludger Figgener 《Head & face medicine》2013,9(1):1-10
Introduction
Painful temporomandibular disorders (TMDs) are usually treated with physiotherapy, self-exercises, medication-based therapy and splint therapy. For splint therapy different types of splints are available. Therefore this randomized controlled study compared the effectiveness of a semi-finished occlusal appliance (SB) with a laboratory-made occlusal appliance (SS) in myofascial pain patients.Method
The trial subjects allocated to the experimental groups with the (SB) occlusal appliance and those provided with a laboratory-made occlusal appliance (SS) did, in addition, receive conservative treatment (self-exercises, drug-based and manual therapy). The control group was given conservative therapy (CO) only. Overall, a total of 63 patients participated in the study with each group consisting of 21 subjects.Results
When the first follow-up examination took place (14 days after splint insertion) mouth opening within the SB group was significantly enlarged. When the second examination was conducted (2.5 months after splint insertion) mouth opening was significantly enlarged in both splint groups when compared with the initial value. In the control group, no significant enlargement of mouth opening was detected. At no point there was a significant reduction in the number of pressure-sensitive areas of the TMJ. On palpation of the masticatory muscles however, a significant reduction in the number of pressure-sensitive areas could be observed within the CO group and the SS group after 2.5 months. When comparing pain reduction (muscle/joint pain) and mouth opening, no significant differences could be detected between the treatments.Conclusion
The results suggest that TMD should be treated conservatively. In cases of restricted mouth opening, the additional use of occlusal appliances can eliminate the patient’s discomfort more quickly. In this context, the tested, semi-finished occlusal appliance appears to offer an immediately available, temporary alternative to laboratory-made splints. 相似文献17.
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Mahé I Grenard AS Caulin C Bergmann JF 《Presse medicale (Paris, France : 1983)》2003,32(25):1170-1174
FREQUENCY AND CONSEQUENCES: The incidence of atrial fibrillation (AF) increases regularly with age and affects nearly 10% of persons aged over 80. The risk of thromboembolism (notably stroke) associated is enhanced the older the patient and the more cardiovascular risk factors she/he exhibits. ADVANTAGES AND RISKS OF ANTICOAGULANTS: Treatment with anticoagulants is the only treatment that has demonstrated its efficacy in reducing the risks of thromboembolism, however there is a risk of haemorrhage. IN PRACTICE: A patient with AF exhibits both a risk of thromboembolism and a risk of haemorrhage. When confronted with such patients, the practitioner must choose an antithrombotic (anticoagulant or anti-arrhythmic agent) after careful objective and individual assessment of all the risks present in a given patient. 相似文献
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Kang Chen Dong Chen Chuangxin Lan Xiongfa Liang Tao Zeng Jian Huang Xiaolu Duan Zhenzhen Kong Shujue Li Hans-Göran Tiselius Alberto Gurioli Xiaogang Lu Guohua Zeng Wenqi Wu 《International urology and nephrology》2018,50(1):29-33