One Session Vs Staged Management of Calcular Obstructive Jaundice

Not Applicable

Recruiting

• Conditions: Calcular Obstructive Jaundice; Gall Bladder Disease
• Interventions: Procedure: one session ERCP then LC; Procedure: one session LC then ERCP; Procedure: staged managment

• Registration Number: NCT05979233
• Lead Sponsor: Minia University

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2023-07-30
• Study First Submitted QC: 2023-07-30
• Study Start: 2023-08-05
• Study First Posted: 2023-08-07
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-11
• Last Update Posted: 2023-10-13
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
one session ERCP then LC	one session ERCP then LC	one session ERCP then LC
one session LC then ERCP	one session LC then ERCP	one session LC then ERCP
staged managment	staged managment	ERCP then interval laparoscopic cholecystectomy

Primary Outcome Measures

Name	Time	Method
total cost	6 months	total cost in Egyptian pound
hospital stay	6 months	total hospital stay in days

Secondary Outcome Measures

Name	Time	Method
complications	30 days	early postoperative complications

Trial Locations

Locations (1)

Faculty of medicine; 🇪🇬 Minya, Egypt