Choledocholithiasis with Cholecystitis
Conditions
Keywords
choledocholithiasis, ERCP, Early 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.
Interventions
PROCEDURElaparoscopic cholecystectomy
Early laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP.
PROCEDURELate laparoscopic cholecystectomy
Laparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct.
Sponsors
Damanhour Medical National Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| operative time | during surgery | time from the first incision of skin to skin closure and completion of surgery |
| 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 |
| Bile leak | up to 1 week after surgery | the leak of bile through the drain or intraabdominally |
Countries
Egypt
Outcome results
None listed