A comparison of early versus delayed surgery to remove gall bladder in patients with moderately severe and severe gallstone induced pancreatitis.
Phase 2
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2021/01/030746
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 Moderately severe or severe acute biliary pancreatitis diagnosed as per revised Atlanta classification
2 Fit for surgery
Exclusion Criteria
1.Age < 18 years or >70 years
2.Prior history of hepatobiliary surgery
3.American Society of Anaesthesiology class III or more
4.Significant co-morbidity such as chronic kidney disease (CKD-V), Decompensated cirrhosis or congestive heart failure
5.Patient unfit for surgery
6.Pregnancy
7.Refusal to give consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome: A composite outcome consisting of major pancreatobiliary events from the time of randomisation to surgery. <br/ ><br> <br/ ><br>1.Recurrence of AP based on clinical, biochemical, and imaging criteria <br/ ><br>2.Acute cholecystitis: defined according to Tokyo Guidelines <br/ ><br>3.Acute cholangitis: defined according to Tokyo guidelines <br/ ><br>4.Any other pancreatobiliary event requiring endoscopic or radiologic intervention such as Endoscopic retrograde Cholangiography <br/ ><br> <br/ ><br>Timepoint: 6 months
- Secondary Outcome Measures
Name Time Method Secondary outcome <br/ ><br>1.Complications <br/ ><br>2.Need for drainage procedure of pancreatic collections prior to surgery <br/ ><br>3.Conversion of laparoscopic cholecystectomy to open cholecystectomy <br/ ><br>4.Total operating time defined as the time taken from skin incision to skin closure. <br/ ><br>5.Difficulty of the procedure <br/ ><br>6.Cost of procedure: <br/ ><br>7.Cost effectiveness: <br/ ><br>8.Antibiotic use after laparoscopic cholecystectomy <br/ ><br>9.Patient satisfaction score <br/ ><br>10 Hospital stay: <br/ ><br>11N eed for readmission and interventions <br/ ><br>Timepoint: 6 months