Health Condition 1: K80- Cholelithiasis Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Laparoscopic Cholecystectomy: Early vs Delayed Laparoscopic Cholecystectomy after Endoscopic Retrograde Cholangiopancreatography for Choledocholithiasis
Intervention2: Early Laparoscopi
Sponsors
ROUNAK MEHROTRA
Eligibility
Inclusion criteria
Inclusion criteria: Patients of 18 years and older who will undergo first successful ERCP with stone extraction and complete CBD clearance for gall stone disease with choledocholithiasis at Dept. of Gastroenterology.
Exclusion criteria
Exclusion criteria: 1. Not giving consent/declined surgery. 2. Post ERCP patients having active cholangitis (as diagnosed at Dept. of Gastroenterology). 3. Patients having Acute cholecystitis prior to ERCP. 4. Patients undergoing LC along with other concomitant surgery in the same setting. 5. Patients with suspected gall bladder carcinoma. 6. Patients with moderate to severe pancreatitis prior to ERCP (as diagnosed at Dept. of Gastroenterology). 7. Patients with ERCP induced pancreatitis (as diagnosed at Dept. of Gastroenterology). 8. Patients with cardiovascular, pulmonary disease, coagulopathy, end-stage liver disease or kidney dysfunction, unable to tolerate anaesthesia. (above 2 conditions i.e. 6 & 7 will themselves have inflammatory response in area of surgery i.e. peri choledochal region)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ Composite outcome comprising of 1. Conversion from laparoscopic to open surgery. 2. Intraoperative complications comprising of bile duct injury, vascular injury, bowel injury 3. Post-operative complications including post-operative pancreato-biliary events :- post-operative course up to period of one month leading to the diagnosis of bile duct injury, vascular injury, bowel injury or requirement of any endoscopic or radiological drainage procedure will be considered. 4. Interval pancreato-biliary events â?? in the waiting period of surgery in delayed group if the patient develops - ï?§ Recurrent CBD stone, ï?§ Acute Cholangitis defined according to Tokyo Guidelines TG 18/13, ï?§ Acute pancreatitis based on clinical, biochemical, and imaging criteria and ï?§ Acute cholecystitis defined according to Tokyo Guidelines TG 18/13 Timepoint: Follow up one month post surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| taken from skin incision to skin closure. Dissection time will be calculated from introduction of laparoscope in the peritoneal cavity till the dissection of GB from liver bed. â?¢ Hospital stay: The hospital stay will be calculated as the number of days in the hospital after surgery until the patient is deemed fit for discharge by the operating surgeon. â?¢ Need for readmission and interventions. Timepoint: Follow up one month post surgery | — |
Countries
India
Contacts
Public ContactROUNAK MEHROTRA
AIIMS
Outcome results
None listed