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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05979233
Other study ID # fac.med.23.42
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 5, 2023
Est. completion date February 20, 2024

Study information

Verified date October 2023
Source Minia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

to compare the outcomes between doing ERCP and laparoscopic cholecystectomy in one session Vs staged management


Description:

to compare the outcomes between 3 groups: in the 1st group we will do ERCP then laparoscopic cholecystectomy in the same session, in the 2nd group we will do laparoscopic cholecystectomy then ERCP in the same session in group 3 we will do staged management


Recruitment information / eligibility

Status Recruiting
Enrollment 110
Est. completion date February 20, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - age from 18-70 year - combined CBD and gall stone - stone less than 1.5 cm - fit for surgery - no upper abdominal surgery Exclusion Criteria: - age <18 and >70 - unfit for surgery - stone more than 1.5 cm - upper abdominal surgery

Study Design


Intervention

Procedure:
staged managment
staged management
one session ERCP then LC
one session ERCP then LC
one session LC then ERCP
one session LC then ERCP

Locations

Country Name City State
Egypt Faculty of medicine Minya

Sponsors (1)

Lead Sponsor Collaborator
Minia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary total cost total cost in Egyptian pound 6 months
Primary hospital stay total hospital stay in days 6 months
Secondary complications early postoperative complications 30 days
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