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

Not Applicable

Completed

Interventions: Procedure: laparoscopic cholecystectomy
Procedure: Late laparoscopic cholecystectomy

Brief 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.

Recruitment & Eligibility

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:

Arm && Interventions

Group	Intervention	Description
Early same admission laparoscopic cholecystectomy ( group A)	laparoscopic cholecystectomy	Early laparoscopic cholecystectomy is performed on next day within 24 hours after common bile duct stone removal by ERCP.
Late laparoscopic cholecystectomy ( group B)	Late laparoscopic cholecystectomy	Late laparoscopic cholecystectomy is performed 6 weeks after common bile duct stones clearance

Primary Outcome Measures

Name	Time	Method
recurrence of biliary events	up to 3 months after surgery	the occurence of acute cholecystitism biliary colics, common bile duct stonem pancreatitisand cholangitis after ERCP while waiting for laparoscopic cholecystectomy

Secondary Outcome Measures

Name	Time	Method
operative time	during surgery	time from the first incision of skin to skin closure and completion of surgery
pancreatitis	3 months after surgery	acute inflammation of the pancreas : abdominal pain, elevated lipase and amylase ( more than 3 folds) and/or findings specific for the pancreatitits on imaging.
conversion to open surgery	During surgery	termination of the laparoscopic procedure and perfome the surgery by the conventional open surgery
Bleeding	during surger and up to 3 weeks	Intraoperative or postoperative bleeding that requires blood transfusion
the presence of intraoperative adhesions	During surgery	Adhesions around the gallbladder and at the Calot\'s triangle
Bile leak	up to 1 week after surgery	the leak of bile through the drain or intraabdominally
Wound infection	up to 3 months after surgery	Any evidence of infection in the wounds : redness, pain or discharge of infected fluids from the wounds
hospital stays	from admission to the end of post operative follow up at 3 months after surgery	the sum the length of stay after ERCP and laparoscopic cholecystectomy including readmission for complication management
post oprative pain	after surgery and up to 3 days	the degree pain described by the patients after surgery on the visual rating scale

Locations (1): Damanhur Medical National Institute
🇪🇬
Damanhur, Behira, Egypt