Status not kept up to date
Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy
NCT04324515 · University of Geneva, Switzerland · Updated 27 March 2020
- What is being tested
- Robotic gastric bypass with or without cholecystectomy
- For
- Roux-en-Y Gastric Bypass; Cholecystitis; Gallstone; Gallbladder Diseases
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 90 people. The full rules are on the registry page.
- Where
- Switzerland
- When
- Starts or started 18 July 2018, ends 1 March 2022. Registered 27 March 2020.
- Results
- None posted yet.
In the researchers' words
The main objective of this pilot study is to show feasibility to collect peri-operative and postoperative clinical data of the study group of gastric bypass without cholecystectomy compared with the control group of gastric bypass with cholecystectomy. Our hypothesis is that the approach without cholecystectomy would be superior in terms of a decrease of perioperative adverse events and postoperative complications, as well as lenght of operation, lenght of hospital stay, overall costs with a very low risk of biliary complication in the follow up. These findings could be helpful to build a baseline for a future randomized controlled multicenter study allowing significance of these results and help orientate surgeons towards best surgical care of the gallbladder with confirmed absence of stones in the obese patient undergoing gastric bypass.
Sites
- Visceral Surgery, Department of Surgery, University Hospital GenevaGeneva, Switzerland
