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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early same admission laparoscopic cholecystectomy ( group A) | Active Comparator | Early laparoscopic cholecystectomy is performed on next day within 24 hours after common bile duct stone removal by ERCP. |
|
| Late laparoscopic cholecystectomy ( group B) | Active Comparator | Late laparoscopic cholecystectomy is performed 6 weeks after common bile duct stones clearance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopic cholecystectomy | Procedure | Early laparoscopic cholecystectomy in the same admission after atone clearance from the bile ducts via ERCP. |
|
| Measure | Description | Time Frame |
|---|---|---|
| recurrence of biliary events | the occurence of acute cholecystitism biliary colics, common bile duct stonem pancreatitisand cholangitis after ERCP while waiting for laparoscopic cholecystectomy | up to 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| operative time | time from the first incision of skin to skin closure and completion of surgery | 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. |
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Inclusion Criteria:
Exclusion Criteria: patients with any of the following:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Damanhur Medical National Institute | Damanhur | Beheira | 22951 | Egypt |
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| Late laparoscopic cholecystectomy | Procedure | Laparoscopic cholecystectomy is performed 6 weeks after clearance of stones from the common bile duct. |
|
| 3 months after surgery |
| conversion to open surgery | termination of the laparoscopic procedure and perfome the surgery by the conventional open surgery | During surgery |
| Bleeding | Intraoperative or postoperative bleeding that requires blood transfusion | during surger and up to 3 weeks |
| the presence of intraoperative adhesions | Adhesions around the gallbladder and at the Calot's triangle | During surgery |
| Bile leak | the leak of bile through the drain or intraabdominally | 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 | up to 3 months after surgery |
| hospital stays | the sum the length of stay after ERCP and laparoscopic cholecystectomy including readmission for complication management | 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 | after surgery and up to 3 days |
| ID | Term |
|---|---|
| D042883 | Choledocholithiasis |
| ID | Term |
|---|---|
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002769 | Cholelithiasis |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |
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