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Randomized Trial Comparing Gastric Bypass With and Without Cholecystectomy

NCT04324515 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-03-27

No results posted yet for this study

Summary

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.

Conditions

  • Roux-en-Y Gastric Bypass
  • Cholecystitis; Gallstone
  • Gallbladder Diseases

Interventions

PROCEDURE

Robotic gastric bypass with or without cholecystectomy

Study Arm: robotic gastric bypass without cholecystectomy Control Arm: robotic gastric bypass with cholecystectomy

Sponsors & Collaborators

  • University of Geneva, Switzerland

    lead OTHER

Principal Investigators

  • Minoa Jung, Dr · Visceral Surgery, Department of Surgery, University Hospital of Geneva

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2020-08-01
Completion
2022-03-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04324515 on ClinicalTrials.gov