Incidence of Cholelithiasis After Bariatric Surgery in So... | NCT05803668

Studies
Incidence of Cholelithiasis After Bariatric Surgery in Sohag University Hospital

NCT05803668

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jul 18, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Cholelithiasis

Interventions

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2023Actual

Primary Completion Date

Feb 28, 2024Estimated

Completion Date

Feb 28, 2024Estimated

First Submitted Date

Mar 27, 2023

First Submission Date that Met QC Criteria

Mar 27, 2023

First Posted Date

Apr 7, 2023Actual

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

Jul 14, 2023

Last Update Posted Date

Jul 18, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ahmed Salah Mohamed, Resident of general surgery of sohag university hospital, Sohag UniversityPrincipal Investigator

Lead Sponsor

Sohag UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

To study the incidence and predictors of developing symptomatic gallstone disease following bariatric surgery.

Detailed Description

To study the incidence and predictors of developing symptomatic gallstone disease following bariatric surgery.

A retrospective study with prospective collective data will be conducted including all patients underwent bariatric surgery in general surgical department, Sohag University between January 2015 and December 2022 who did not have gallstones in the preoperative abdominal ultrasound examinations.

Medical records will be reviewed. Demographic data such as age, gender, BMI, comorbidities as ( DM, hypertension and hyperlipidemia ) and time elapsed between the surgery to post-surgery US examination. The findings of the US examinations will be collected and analyzed. Data will be analyzed to obtain descriptive and inferential statistics.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patients who develop gall bladder stones after bariatric surgery	Evalution of gall bladder stone formation postoperaive and its relation with comorbidities	one year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All adult patients underwent bariatric surgery with minimum postoperative follow up period of one year duration will be included in the study.

Exclusion Criteria:

Patients who had cholecystectomy during the bariatric surgery.
Pediatric age.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients underwent Bariatric Surgery

Sampling Method

Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Type	Date	Date Unknown
Release	Jun 26, 2024
Reset	Oct 2, 2024

Submission Tracking

Estimated Results First Submitted Date

Jun 26, 2024

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Jun 26, 2024			Oct 2, 2024

Condition Browse Module

MeSH Terms

ID	Term
D002769	Cholelithiasis

Ancestor Terms

ID	Term
D001660	Biliary Tract Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
patients who developed gall stones
patients who did not develope gall stones