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Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone

Primary Purpose

Morbid Obesity, Gallstone

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
concomitant cholecystectomy
Sponsored by
Minia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

concomitant cholecystectomy

delayed cholecystectomy

Arm Description

concomitant cholecystectomy with bariatric procedure

delayed cholecystectomy

Outcomes

Primary Outcome Measures

the incidence of complications
the incidence of complications of cholecystectomy or of left of gallstone

Secondary Outcome Measures

operative time of cholecystectomy
operative time of cholecystectomy
%EWL
percentage of excess weight loss

Full Information

First Posted
July 18, 2021
Last Updated
October 1, 2022
Sponsor
Minia University
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1. Study Identification

Unique Protocol Identification Number
NCT04980417
Brief Title
Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone
Official Title
Concomitant Cholecystectomy With Bariatric Surgery Versus Delayed Post Bariatric Cholecystectomy for Obesity With Gallstone
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
July 5, 2022 (Actual)
Study Completion Date
July 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Minia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Gallstone

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
concomitant cholecystectomy
Arm Type
Experimental
Arm Description
concomitant cholecystectomy with bariatric procedure
Arm Title
delayed cholecystectomy
Arm Type
Active Comparator
Arm Description
delayed cholecystectomy
Intervention Type
Procedure
Intervention Name(s)
concomitant cholecystectomy
Other Intervention Name(s)
delayed cholecystectomy
Intervention Description
delayed cholecystectomy
Primary Outcome Measure Information:
Title
the incidence of complications
Description
the incidence of complications of cholecystectomy or of left of gallstone
Time Frame
one year
Secondary Outcome Measure Information:
Title
operative time of cholecystectomy
Description
operative time of cholecystectomy
Time Frame
30-90 minutes
Title
%EWL
Description
percentage of excess weight loss
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BMI > 35 presence of gallstone fit for laparoscopic surgery Exclusion Criteria: BMI < 35 unfit for surgery refuse to share in the study
Facility Information:
Facility Name
Faculty of medicine
City
Minya
ZIP/Postal Code
61511
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone

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