NCT04980417

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

July 21, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2022

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 24, 2022

Completed
Last Updated

October 4, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

July 18, 2021

Last Update Submit

October 1, 2022

Conditions

Morbid ObesityGallstone

Outcome Measures

Primary Outcomes (1)

  • the incidence of complications

    the incidence of complications of cholecystectomy or of left of gallstone

    one year

Secondary Outcomes (2)

  • operative time of cholecystectomy

    30-90 minutes

  • %EWL

    one year

Study Arms (2)

concomitant cholecystectomy

EXPERIMENTAL

concomitant cholecystectomy with bariatric procedure

Procedure: concomitant cholecystectomy

delayed cholecystectomy

ACTIVE COMPARATOR

delayed cholecystectomy

Procedure: concomitant cholecystectomy

Interventions

concomitant cholecystectomyPROCEDURE

delayed cholecystectomy

Also known as: delayed cholecystectomy
concomitant cholecystectomydelayed cholecystectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of medicine

Minya, 61511, Egypt

Location

MeSH Terms

Conditions

Obesity, MorbidGallstones

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsCholelithiasisBiliary Tract DiseasesDigestive System DiseasesCholecystolithiasisGallbladder DiseasesCalculiPathological Conditions, Anatomical

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor & consultant of general surgery, Department of Surgery, Minia university hospital, Egypt

Study Record Dates

First Submitted

July 18, 2021

First Posted

July 28, 2021

Study Start

July 21, 2021

Primary Completion

July 5, 2022

Study Completion

July 24, 2022

Last Updated

October 4, 2022

Record last verified: 2022-10

Locations

EG(1)