View clinical trials related to Gallstones.
Filter by:Its main objective is to evaluate the clinical outcome (including patient reported outcomes) and health economic assessment (HTA) of a new re-usable system for Single Port Laparoscopic Surgery - ENDOCONE SYSTEM developed by Prof Cuschieri by undertaking a randomised controlled prospective clinical trial (RCT) on specific operations performed (on a random allocation basis) by either the traditional multi-port laparoscopic approach or the Single Port- ENDOCONE system by Karl Storz. To this effect, 300 patients meeting the trial inclusion criteria will be randomised over a three year period to have the operation by either of the two approaches.
Virtual reality devices are widely accepted tools to familiarize surgical novices with the principles of laparoscopy. Free Virtual reality training will be tested against basic training and efficacy assessed in a randomized controlled trial of surgical novices.
Our institution performs therapeutic ERCP (Endoscopic retrograde cholangiopancreatography ), Endoscopic Ultrasound (EUS) and Interventional Endoscopy in around 1000 patients a year. Procedures such as biliary and/or pancreatic sphincterotomy, stents placement (metallic or plastic) and removal for revision, cysts and pseudocysts drainage are conducted in patients suffering from pancreatico-biliary disorders, gastrointestinal disorders and esophageal disorders. The investigators would like to assess prospectively the efficacy and safety of these routine procedures to permit identification of technical details about the procedures or other factors which might be associated with outcome or results. Assessment of these details would help us with problem identification and recommendations to improve health outcomes and quality of life in these patients.
Laparoscopic Cholecystectomy (LC) is the treatment of choice for symptomatic gallstone disease. Single-port access cholecystectomy (SL) has been recently introduced using only one, trans-umbilical placed port. The method has been denominated as ''scarless.'' However, it is unknown whether SL significantly improves body and cosmesis images as well as the quality of life (QoL), reported directly by the patients. Furthermore SL promises to reduce postoperative pain and to be cost-effective due a faster postoperative recovery. The aim of this Double Blind Randomized Controlled Trial (RCT) is to demonstrate whether SL is superior to LC in improving patients', body and cosmesis images as well as QoL and to analyse cost-efficiency. Based on the sample size calculations, a total of 110 patients will be randomised to either LC or SL. The primary endpoint will be the cosmetic score. Costs, pain, time to convalescence, quality of life and complications and will also be compared as secondary endpoints. This study will provide evidence-based patient-oriented information regarding the SL procedure and its further use.
Background: Single port access surgery is a rapidly progressing surgical approach which allows performance of standard laparoscopic surgery through a single transparietal port instead of multiple port accesses. Objective: Demonstrate the validity of Single port access (SPA) cholecystectomy compared to multiple ports laparoscopic cholecystectomy. Hypothesis: SPA cholecystectomy is associated with decreased parietal and body image trauma compare to multiple ports laparoscopic cholecystectomy. SPA cholecystectomy should be associated with better cosmetic results, may improve postoperative recovery due to lower parietal pain. SPA cholecystectomy may also be associated with decreased rate of parietal complications as lower numbers of transparietal port are placed. Methods: All patients offered cholecystectomy, either SPA or multiport cholecystectomy, included in the study will have recognized biliary pathology for which formal indication cholecystectomy are recognized internationally. Surgical technique, either for SPA cholecystectomy or for multiple ports cholecystectomy, will be the same except, that one surgical technique is achieved through a single transparietal port and the other through multiple ports. Randomization will be performed before surgeries after patients have given their informed consent to the study. No specific test or cost will be necessitated by the study. Patients will be informed orally and will receive a short study summary, allowing them to give an informed consent. Endpoints: - Morbidity - Body image and Cosmetic results - Post-operative pain (opioid sparing effect) - Operative time - Hospital stay
This is an observational study of pain and outcomes from patients undergoing transgastric NOTES removal of their appendix or gallbladder. Subjects who elect to have a transgastric NOTES removal of their appendix or gallbladder and agree to be in this study (through signature on the informed consent form) will be followed per standard of care, with additional follow-up for data collection including the following: - Subjects will complete a 7 day pain/temperature log after surgery - Subjects will receive a phone call at 6 months and at 1 year after surgery to capture data related to safety, adverse events, hospitalizations and patient satisfaction Additional data related to pain and outcomes will be collected at baseline/screening and at follow-up as necessary.
The purpose of the study is to assess whether combined intraoperative ERCP and CBD clearance with laparo-endoscopic rendez-vous during laparoscopic cholecystectomy (one stage approach) is or not superior to the standard practice of preoperative ERCP, sphincterotomy and CBD clearance followed by laparoscopic cholecystectomy (two stage approach) in patients with combined cholelithiasis and choledocholithiasis.