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| Name | Class |
|---|---|
| Shaikh Zayed Hospital, Lahore | OTHER |
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This randomized controlled trial aims to compare the mean operative time and outcomes of early versus delayed laparoscopic cholecystectomy after ERCP in patients with cholelithiasis and choledocholithiasis. Patients will be randomized into two groups: early cholecystectomy (within 72 hours of ERCP) and delayed cholecystectomy (≥1 month after ERCP). Outcomes include operative time, intra-operative blood loss, hospital stay, and conversion to open cholecystectomy
Gallstones are among the most common surgical problems worldwide, and up to 20% of patients with gallstones also present with stones in the common bile duct. Standard care involves clearance of bile duct stones, typically by Endoscopic Retrograde Cholangiopancreaticography (ERCP), followed by removal of the gallbladder by laparoscopic cholecystectomy (LC).
The timing of cholecystectomy after ERCP remains debated. Early LC (within 72 hours) has been associated with fewer recurrent biliary events, reduced hospital stay, and potentially easier operative conditions. However, delayed LC (after one month) continues to be widely practiced due to institutional factors and scheduling constraints.
This randomized controlled trial at Sheikh Zayed Hospital, Lahore, is designed to evaluate whether early LC after ERCP offers measurable advantages compared with delayed LC. Patients with confirmed cholelithiasis and choledocholithiasis will be randomized into two groups: early surgery and delayed surgery. The trial will provide local evidence to guide surgical practice, focusing on operative efficiency and patient recovery.
By clarifying the optimal timing of LC after ERCP in our patient population, the study aims to support evidence-based surgical decision-making, improve outcomes, and potentially reduce healthcare costs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early laparoscopic cholecystectomy | Experimental | Patients will undergo laparoscopic cholecystectomy within 72hours followed by successful ERCP |
|
| Delayed Laparoscopic cholecystectomy | Active Comparator | Patients will undergo laparoscopic cholecystectomy 2 weeks or more after successful ERCP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early laparoscopic cholecystectomy | Procedure | Laparoscopic removal of gall bladder within 72hours of laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Operative time | Duration of surgery measured from the first incision to closure of the last incision. | During surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Length of Hospital Stay | Total number of days from hospital admission to discharge. | From admission to discharge (up to 30 days) |
| Intraoperative Blood Loss | Blood loss measured in milliliters from suction apparatus during surgery. |
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Inclusion criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Rija Zainab, MS General surgery | Contact | +92-304-4050582 | rijazainab09@gmail.com | |
| Dr. Muhammad Imran Anwar, FCPS, FRCS | Contact | +92 300 9442600 | imran_anwar21@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Rija Zainab, MS General surgery | Shaikh Zayed Hospital, Lahore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shaikh Zayed hospital Lahore | Recruiting | Lahore | Punjab Province | 54000 | Pakistan |
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Parallel Assignment (Two arms, Early vs Delayed Laparoscopic cholecystectomy)
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| Delayed Laparoscopic cholecystectomy | Procedure | Laparoscopic removal of gall bladder 2 weeks or more after successful ERCP |
|
| During Surgery |
| Conversion to Open Cholecystectomy | Number of patients requiring conversion from laparoscopic to open surgery | During Surgery |