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

Damanhour Medical National Institute

Status: Completed

Conditions: Choledocholithiasis with Cholecystitis

Treatments: Procedure: laparoscopic cholecystectomy; Procedure: Late laparoscopic cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06599437

HD000192

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: Under 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patients with concomitant gallbladder and common bile duct stone who underwent clearance of common bile duct stones by ERCP

Exclusion Criteria: patients with any of the following:

• Severe pancreatitis
• Suspicion of post-ERCP bleeding or perforation,
• Associated malignancy
• Those in whom ERCP failed to clear the CBD stones

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Early same admission laparoscopic cholecystectomy ( group A)

Active Comparator group

Description:

Early laparoscopic cholecystectomy is performed on next day within 24 hours after common bile duct stone removal by ERCP.

Treatment:

Procedure: laparoscopic cholecystectomy

Late laparoscopic cholecystectomy ( group B)

Active Comparator group

Description:

Late laparoscopic cholecystectomy is performed 6 weeks after common bile duct stones clearance

Treatment:

Procedure: Late laparoscopic cholecystectomy