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NCT04980417 Clinical Trial

Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone

Morbid Obesity Clinical Trial

Official title:
Concomitant Cholecystectomy With Bariatric Surgery Versus Delayed Post Bariatric Cholecystectomy for Obesity With Gallstone

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04980417
Other study ID # fac.med 21.32
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 21, 2021
Est. completion date July 24, 2022

Study information
Verified date October 2022
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date July 24, 2022
Est. primary completion date July 5, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• concomitant cholecystectomy
delayed cholecystectomy

Locations
Country Name City State
Egypt Faculty of medicine Minya

Sponsors (1)
Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary the incidence of complications the incidence of complications of cholecystectomy or of left of gallstone one year
Secondary operative time of cholecystectomy operative time of cholecystectomy 30-90 minutes
Secondary %EWL percentage of excess weight loss one year
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