Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone

NCT ID: NCT04980417

Last Updated: 2022-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-21

Study Completion Date

2022-07-24

Brief Summary

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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

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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

Conditions

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Morbid Obesity Gallstone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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concomitant cholecystectomy

concomitant cholecystectomy with bariatric procedure

Group Type EXPERIMENTAL

concomitant cholecystectomy

Intervention Type PROCEDURE

delayed cholecystectomy

delayed cholecystectomy

delayed cholecystectomy

Group Type ACTIVE_COMPARATOR

concomitant cholecystectomy

Intervention Type PROCEDURE

delayed cholecystectomy

Interventions

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concomitant cholecystectomy

delayed cholecystectomy

Intervention Type PROCEDURE

Other Intervention Names

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delayed cholecystectomy

Eligibility Criteria

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Inclusion Criteria

* BMI \> 35
* presence of gallstone
* fit for laparoscopic surgery

Exclusion Criteria

* BMI \< 35
* unfit for surgery
* refuse to share in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Alaa Mstafa Hassan Sewefy

Assistant professor & consultant of general surgery, Department of Surgery, Minia university hospital, Egypt

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of medicine

Minya, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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fac.med 21.32

Identifier Type: -

Identifier Source: org_study_id

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