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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Early laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP.
Laparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct.
Damanhur Medical National Institute
Damanhur, Behira, Egypt
recurrence of biliary events
the occurence of acute cholecystitism biliary colics, common bile duct stonem pancreatitisand cholangitis after ERCP while waiting for laparoscopic cholecystectomy
Time frame: up to 3 months after surgery
operative time
time from the first incision of skin to skin closure and completion of surgery
Time frame: during surgery
pancreatitis
acute inflammation of the pancreas : abdominal pain, elevated lipase and amylase ( more than 3 folds) and/or findings specific for the pancreatitits on imaging.
Time frame: 3 months after surgery
conversion to open surgery
termination of the laparoscopic procedure and perfome the surgery by the conventional open surgery
Time frame: During surgery
Bleeding
Intraoperative or postoperative bleeding that requires blood transfusion
Time frame: during surger and up to 3 weeks
the presence of intraoperative adhesions
Adhesions around the gallbladder and at the Calot\'s triangle
Time frame: During surgery
Bile leak
the leak of bile through the drain or intraabdominally
Time frame: up to 1 week after surgery
Wound infection
Any evidence of infection in the wounds : redness, pain or discharge of infected fluids from the wounds
Time frame: up to 3 months after surgery
hospital stays
the sum the length of stay after ERCP and laparoscopic cholecystectomy including readmission for complication management
Time frame: from admission to the end of post operative follow up at 3 months after surgery
post oprative pain
the degree pain described by the patients after surgery on the visual rating scale
Time frame: after surgery and up to 3 days
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