Concomitant Versus Delayed Cholecystectomy for Management... | NCT04980417

Studies
Concomitant Versus Delayed Cholecystectomy for Management of Obesity With Gallstone

NCT04980417

Sponsor

Minia University

Status

Completed

Last Update Posted

Oct 4, 2022Actual

Enrollment

150Actual

Phase

Not Applicable

Conditions

Morbid Obesity
Gallstone

Interventions

concomitant cholecystectomy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 21, 2021Actual

Primary Completion Date

Jul 5, 2022Actual

Completion Date

Jul 24, 2022Actual

First Submitted Date

Jul 18, 2021

First Submission Date that Met QC Criteria

Jul 18, 2021

First Posted Date

Jul 28, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2022

Last Update Posted Date

Oct 4, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Alaa Mstafa Hassan Sewefy, Assistant professor & consultant of general surgery, Department of Surgery, Minia university hospital, Egypt, Minia UniversityPrincipal Investigator

Lead Sponsor

Minia UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
concomitant cholecystectomy	Experimental	concomitant cholecystectomy with bariatric procedure	Procedure: concomitant cholecystectomy
delayed cholecystectomy	Active Comparator	delayed cholecystectomy	Procedure: concomitant cholecystectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
concomitant cholecystectomy	Procedure	delayed cholecystectomy	concomitant cholecystectomy delayed cholecystectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of medicine		Minya		61511	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D009767	Obesity, Morbid
D042882	Gallstones

Ancestor Terms

ID	Term
D009765	Obesity
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided