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CTRI Number  CTRI/2020/06/025974 [Registered on: 18/06/2020] Trial Registered Prospectively
Last Modified On: 12/06/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   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 
Scientific Title of Study   Comparison of early and delayed laparoscopic cholecystectomy in patients of acute mild gall stone induced pancreatitis – A Randomised Controlled Study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Astha Nayyar 
Designation  Post Graduate trainee 
Affiliation  Maulana Azad Medical College 
Address  Surgery Office, B L Taneja Block, Maulana Azad Medical College

Central
DELHI
110002
India 
Phone  9868361114  
Fax    
Email  nayyarastha@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sudhir Jain 
Designation  Director Professor 
Affiliation  Maulana Azad Medical College 
Address  Room No. 214, Surgery office, B L Taneja Block,

New Delhi
DELHI
110002
India 
Phone  9968604381  
Fax    
Email  sudhirkumar11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Astha Nayyar 
Designation  PG Trainee 
Affiliation  Maulana Azad Medical College 
Address  Room No 214, Surgery Office, B L Taneja Block, Maulana Azad Medical College

New Delhi
DELHI
110002
India 
Phone  9868361114  
Fax    
Email  nayyarastha@gmail.com  
 
Source of Monetary or Material Support  
Maulana Azad Medical College 
 
Primary Sponsor  
Name  Maulana Azad Medical College 
Address  2, Bahadur Shah Zafar Marg, New Delhi 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Astha Nayyar  Maulana Azad Medical College  2, Bahadur Shah Zafar Marg
Central
DELHI 		 9868361114

nayyarastha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, MAMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K851||Biliary acute pancreatitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Delayed Laparoscopic Cholecystectomy  Patients having acute mild gall stone induced pancreatitis will undergo standard interval laparoscopic cholecystectomy at 6 weeks from the 6 week episode 
Intervention  Early Laparoscopic Cholecystectomy  Patients having acute mild gall stone induced pancreatitis will undergo laparoscopic cholecystectomy within 7 days of admission 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Patients of acute mild gall stone induced pancreatitis as defined by Revised Atlanta Classification. 
 
ExclusionCriteria 
Details  1. Patients with CBD stones
2. Patients having upper abdominal surgeries. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Successful completion of procedure in both groups and rates of conversion to open
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  
Outcome  TimePoints 
To determine the frequency of recurrence of gall stone related biliary and pancreatic
complications in patients undergoing interval laparoscopic cholecystectomy.
 		 1 week and 6 weeks of acute mild gall stone pancreatitis 
To determine the difficulty of dissection (as per Nassar Classification) and
complications (Intra operative and Post-Operative) in patients undergoing early and
delayed laparoscopic complications. 		 1 week and 6 weeks of acute mild gall stone pancreatitis episode 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/09/2020 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

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. 
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