NCT06599437

For Patients with Stones in Gallbladder and Bile Duct Stones At the Same Time, Surgical Removal of the Gallbladder with the Laparoscope is Done in the Same Admission Compared to Its Removal After 6 Weeks Following Successful Removel of the Stones from the Bile Ducts by the Side View Endoscope

Index Laparoscopic Cholecystectomy Following Clearance of Common Bile Duct Stones Via Endoscopic Retrograde Cholangiography

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Damanhour Medical National Institute · Other Government
• Sex: All
• Age: 80 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if early laparoscopic cholecystectomy is safe and feasible when performed during the same admission for patients with concomitant gallbladder and common bile duct stones after clearance of CBD stones via ERCP in comparison to Late laparoscopic cholecystectomy 6 weeks after ERCP. The main questions it aims to answer are: laparoscopic cholecystectomy * Does index laparoscopic cholecystectomy associate with less recurrence of biliary complications? * Is index laparoscopic cholecystectomy feasible and safe for the patients in terms of intraoperative difficulties, conversion to open, hospital stay, and postoperative complications than late laparoscopic cholecystectomy? the investigator will compare index laparoscopic cholecystectomy with late laparoscopic cholecystectomy 6 weeks after ERCP to see if index laparoscopic cholecystectomy is safe and feasible and associated with better outcomes. Participants will: Come to the outpatient clinic every week after intervention for follow-up for 3 months after surgery.

Detailed description

The study population of this randomized controlled trial study is those who underwent CBD stone clearance by ERCP. The included fifty patients were stratified randomly into two groups: early and delayed. Randomization was done using computer-generated random number sequences in concealed envelopes with a block randomization design. Laparoscopic cholecystectomy is performed on the next day after successful clearance of stones from CBD while, the patient is still admitted, for the early group and postponed 4 to 6 weeks for the delayed group after the patient is discharged home. Laparoscopic cholecystectomy was performed by the same surgical team for both groups.

Conditions

• Choledocholithiasis with Cholecystitis

Interventions

Type	Name	Description
PROCEDURE	laparoscopic cholecystectomy	Early laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP.
PROCEDURE	Late laparoscopic cholecystectomy	Laparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct.

Timeline

• Start date: 2021-12-01
• Primary completion: 2024-04-01
• Completion: 2024-08-15
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: Egypt