Study to evaluate ideal time for cholecystectomy after moderate and severe acute pancreatitis
Phase 2
- Conditions
- Health Condition 1: K851- Biliary acute pancreatitisHealth Condition 2: O- Medical and Surgical
- Registration Number
- CTRI/2023/07/055474
- Lead Sponsor
- All India Institute of Medical Sciences, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Moderately severe or severe biliary AP diagnosed as per revised Atlanta classification
2. Fit for surgery-
A) anaesthetist the patient is fit for surgery
B) Absence of large collection in right upper abdomen
Exclusion Criteria
1.Age < 18 years or >70 years
2.Prior history of hepatobiliary surgery
3.American Society of Anesthesiology class III or more
4.Significant co-morbidity such as chronic kidney disease (CKD-V), Decompensated
cirrhosis or congestive heart failure
6.Pregnancy
7.Refusal to give consen
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A composite outcome of major pancreatic-biliary events from the <br/ ><br>time of randomization to surgery or major cholecystectomy <br/ ><br>related complications i. e. <br/ ><br>A. By comparing the recurrence of acute pancreatitis, cholangitis, <br/ ><br>cholecystitis or <br/ ><br>other pancreatic-biliary events requiring any invasive intervention. <br/ ><br>B. By comparing the major surgical complications like <br/ ><br>conversion of laparoscopic to open procedure, hollow viscus <br/ ><br>injury, biliary injury or vascular injuryTimepoint: Time of pancreatitis to time of surgery <br/ ><br>1 week post surgery <br/ ><br>3 week post surgery <br/ ><br>3 month post surgery
- Secondary Outcome Measures
Name Time Method - Minor Surgical Complications <br/ ><br>? Need for drainage procedure for peripancreatic fluid collection <br/ ><br>? Total operating time <br/ ><br>? Difficulty of the procedure <br/ ><br>? Intra operative complications <br/ ><br>? Cost of procedure <br/ ><br>? Cost effectiveness <br/ ><br>? Antibiotic use after surgery <br/ ><br>? Patient satisfaction score <br/ ><br>? Total length of hospital stay <br/ ><br>? Need for readmission & interventionsTimepoint: Time of pancreatitis to time of surgery <br/ ><br>1 week post surgery <br/ ><br>3 week post surgery <br/ ><br>3 month post surgery