Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone

Not Applicable

Completed

• Conditions: Gallstone; Morbid Obesity
• Interventions: Procedure: concomitant cholecystectomy

• Registration Number: NCT04980417
• Lead Sponsor: Minia University

Brief Summary

in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients

Detailed Description

in this study we compare the results of concomitant cholecystectomy with bariatric surgery versus delayed cholecystectomy for management of gallstone in obese patients. patients will be divided into 2 group: group1, will be operated by the bariatric surgery and cholecystectomy in the same session. group 2 will be operated by cholecystectomy at least 6 months after bariatric surgery or whenever develop complications

Study Timeline

• Study First Submitted: 2021-07-18
• Study First Submitted QC: 2021-07-18
• Study Start: 2021-07-21
• Study First Posted: 2021-07-28
• Primary Completion: 2022-07-05
• Study Completion: 2022-07-24
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-01
• Last Update Posted: 2022-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• BMI > 35
• presence of gallstone
• fit for laparoscopic surgery

Exclusion Criteria

• BMI < 35
• unfit for surgery
• refuse to share in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
concomitant cholecystectomy	concomitant cholecystectomy	concomitant cholecystectomy with bariatric procedure
delayed cholecystectomy	concomitant cholecystectomy	delayed cholecystectomy

Primary Outcome Measures

Name	Time	Method
the incidence of complications	one year	the incidence of complications of cholecystectomy or of left of gallstone

Secondary Outcome Measures

Name	Time	Method
operative time of cholecystectomy	30-90 minutes	operative time of cholecystectomy
%EWL	one year	percentage of excess weight loss

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Minya, Egypt