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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.
ClinicalTrials.gov, NCT04324515

Sites

  • Visceral Surgery, Department of Surgery, University Hospital GenevaGeneva, Switzerland