Bmc Surg
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Randomized Controlled Trial Multicenter Study
A historically controlled, single-arm, multi-centre, prospective trial to evaluate the safety and efficacy of MonoMax suture material for abdominal wall closure after primary midline laparotomy. ISSAAC-Trial [NCT005725079].
Several randomized controlled trials have compared different suture materials and techniques for abdominal wall closure with respect to the incidence of incisional hernias after midline laparotomy and shown that it remains, irrespective of the methods used, considerably high, ranging from 9% to 20%. The development of improved suture materials which would reduce postoperative complications may help to lower its frequency. ⋯ This historically controlled, single-arm, multi-centre, prospective ISSAAC trial aims to assess whether the use of an ultra-long-lasting absorbable monofilament suture material is safe and efficient.
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Randomized Controlled Trial
The one-stop trial: does electronic referral and booking by the general practitioner (GPs) to outpatient day case surgery reduce waiting time and costs? A randomized controlled trial protocol.
Waiting time and costs from referral to day case outpatient surgery are at an unacceptably high level. The waiting time in Norway averages 240 days for common surgical conditions. Furthermore, in North Norway the population is scattered throughout a large geographic area, making the cost of travel to a specialist examination before surgery considerable. Electronic standardised referrals and booking of day case outpatient surgery by GPs are possible through the National Health Network, which links all health care providers in an electronic network. New ways of using this network might reduce the waiting time and cost of outpatient day case surgery. ⋯ Poor communication between primary and secondary care often results in inefficiencies and unsatisfactory outcomes. We hypothesised that standardised referrals would improve the quality of information, making it feasible to use a one-stop approach for all patients undergoing surgery on an outpatient basis for inguinal hernia, pilonidal sinus and gallstones. In this study we wanted to investigate the waiting time and cost-effectiveness of direct electronic referral and booking of outpatient surgery compared to the traditional patient pathway, where the patient is seen at the outpatient clinic prior to surgery.
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Randomized Controlled Trial Multicenter Study Comparative Study
Preoperative biliary drainage for periampullary tumors causing obstructive jaundice; DRainage vs. (direct) OPeration (DROP-trial).
Surgery in patients with obstructive jaundice caused by a periampullary (pancreas, papilla, distal bile duct) tumor is associated with a higher risk of postoperative complications than in non-jaundiced patients. Preoperative biliary drainage was introduced in an attempt to improve the general condition and thus reduce postoperative morbidity and mortality. Early studies showed a reduction in morbidity. However, more recently the focus has shifted towards the negative effects of drainage, such as an increase of infectious complications. Whether biliary drainage should always be performed in jaundiced patients remains controversial. The randomized controlled multicenter DROP-trial (DRainage vs. Operation) was conceived to compare the outcome of a 'preoperative biliary drainage strategy' (standard strategy) with that of an 'early-surgery' strategy, with respect to the incidence of severe complications (primary-outcome measure), hospital stay, number of invasive diagnostic tests, costs, and quality of life. ⋯ The DROP-trial is a randomized controlled multicenter trial that will provide evidence whether or not preoperative biliary drainage is to be performed in patients with obstructive jaundice due to a periampullary tumor.
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Randomized Controlled Trial Multicenter Study Comparative Study
The Sigma-trial protocol: a prospective double-blind multi-centre comparison of laparoscopic versus open elective sigmoid resection in patients with symptomatic diverticulitis.
Diverticulosis is a common disease in the western society with an incidence of 33-66%. 10-25% of these patients will develop diverticulitis. In order to prevent a high-risk acute operation it is advised to perform elective sigmoid resection after two episodes of diverticulitis in the elderly patient or after one episode in the younger (< 50 years) patient. Open sigmoid resection is still the gold standard, but laparoscopic colon resections seem to have certain advantages over open procedures. On the other hand, a double blind investigation has never been performed. The Sigma-trial is designed to evaluate the presumed advantages of laparoscopic over open sigmoid resections in patients with symptomatic diverticulitis. ⋯ The Sigma-trial is a prospective, multi-center, double-blind, randomized study to define the role of laparoscopic sigmoid resection in patients with symptomatic diverticulitis.
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Inguinal hernia repair is one of the most frequently performed procedures in Switzerland (15'000/year). The most common complication postoperatively is development of chronic pain in up to 30% of all patients irrespective of the operative technique. ⋯ Using a group sequential study design the minimum number of patients are enrolled to reach a valid conclusion before the end of the study. To limit subjectivity, both a VAS and the Pain Matcher device are used for the evaluation of pain. This allows us also to compare these two methods and further assess the use of Pain Matcher in clinical routine. The occurrence of chronic pain after inguinal hernia repair has been in focus of several clinical studies but the reduction of it has been rarely investigated. We hope to significantly reduce the occurrence of this complication with our investigated intervention.