Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone

October 1, 2022 updated by: Alaa Mstafa Hassan Sewefy, Minia University

Concomitant Cholecystectomy With Bariatric Surgery Versus Delayed Post Bariatric Cholecystectomy for Obesity With Gallstone

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61511
        • Faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: concomitant cholecystectomy
concomitant cholecystectomy with bariatric procedure
Procedure: concomitant cholecystectomy
delayed cholecystectomy
Other Names:
  • delayed cholecystectomy
Active Comparator: delayed cholecystectomy
Procedure: concomitant cholecystectomy
delayed cholecystectomy
Other Names:
  • delayed cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of complications
Time Frame: one year
the incidence of complications of cholecystectomy or of left of gallstone
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time of cholecystectomy
Time Frame: 30-90 minutes
operative time of cholecystectomy
30-90 minutes
%EWL
Time Frame: one year
percentage of excess weight loss
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2021

Primary Completion (Actual)

July 5, 2022

Study Completion (Actual)

July 24, 2022

Study Registration Dates

First Submitted

July 18, 2021

First Submitted That Met QC Criteria

July 18, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 1, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fac.med 21.32

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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