NCT05803668

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 7, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

July 18, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

March 27, 2023

Last Update Submit

July 14, 2023

Conditions

Cholelithiasis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

patients who developed gall stones

patients who did not develope gall stones

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients underwent Bariatric Surgery

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of general surgery of sohag university hospital

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 7, 2023

Study Start

March 1, 2023

Primary Completion

February 28, 2024

Study Completion

February 28, 2024

Last Updated

July 18, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)