Comparison of Early (i.e. within 7 days of admission) and Late (i.e. after 6 weeks of episode) Laparoscopic Cholecystectomy in patients of acute mild gall stone induced pancreatitis in a randomised controlled study

Not yet recruiting

• Conditions: Biliary acute pancreatitis,

• Registration Number: CTRI/2020/06/025974
• Lead Sponsor: Maulana Azad Medical College

Brief Summary

This is study is a randomised, open label, parallel group single centre trial comparing the feasibility  of laparoscopic cholecystectomy in early (within 7 days) and late (after 6 weeks) operative intervention in acute mild gall stone induced pancreatitis. The primary outcome measures will be conversion rates from laparoscopic to open cholecystectomy and intra operative time. The secondary outcomes will be intra operative difficulty of dissection faced by the surgeon according to Nassar classification and  occurrence of operative complications. Also the frequency of recurrence of gall stone related complications will be determined in patients undergoing interval laparoscopic cholecystectomy.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-09
• Last Update Posted: 2020-12-06

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients of acute mild gall stone induced pancreatitis as defined by Revised Atlanta Classification.

Exclusion Criteria

• Patients with CBD stones 2.
• Patients having upper abdominal surgeries.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful completion of procedure in both groups and rates of conversion to open	One week (within same admission) and 6 weeks after acute attack of mild pancreatitis
cholecystectomy and Time taken for completion of surgery (Skin to skin time)	One week (within same admission) and 6 weeks after acute attack of mild pancreatitis

Secondary Outcome Measures

Name	Time	Method
To determine the frequency of recurrence of gall stone related biliary and pancreatic	complications in patients undergoing interval laparoscopic cholecystectomy.
To determine the difficulty of dissection (as per Nassar Classification) and	complications (Intra operative and Post-Operative) in patients undergoing early and

Trial Locations

Locations (1)

Maulana Azad Medical College; 🇮🇳 Central, DELHI, India

Maulana Azad Medical College

🇮🇳Central, DELHI, India

Astha Nayyar

Principal investigator

9868361114

nayyarastha@gmail.com