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CTRI Number  CTRI/2024/11/077336 [Registered on: 25/11/2024] Trial Registered Prospectively
Last Modified On: 23/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Early vs Delayed Laparoscopic Cholecystectomy in cases of Acute Calculous Cholecystitis- Are both equivalent? 
Scientific Title of Study   A Randomized Control Trial of Clinical Outcomes in Early vs Delayed Laparoscopic Cholecystectomy in cases of Acute Calculous Cholecystitis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SHUBHRIKA SINGHAL 
Designation  PG resident 
Affiliation  Lady Hardinge Medical College 
Address  Surgery Department, LHMC, SHAHEED BHAGAT SINGH MARG, NEW DELHI

New Delhi
DELHI
110001
India 
Phone  9808374707  
Fax    
Email  drshubhrika@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Kusum Meena 
Designation  Professor 
Affiliation  Lady Hardinge Medical College 
Address  Room no 311, Surgery Department, Lady Hardinge Medical College, Connaught place, New Delhi

New Delhi
DELHI
110001
India 
Phone  9868000080  
Fax    
Email  kusum.meena@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SHUBHRIKA SINGHAL 
Designation  PG resident 
Affiliation  Lady Hardinge Medical College 
Address  SURGERY DEPARTMENT, LHMC, SHAHEED BHAGAT SINGH MARG, NEW DELHI

New Delhi
DELHI
110001
India 
Phone  9808374707  
Fax    
Email  drshubhrika@gmail.com  
 
Source of Monetary or Material Support  
SURGERY DEPARTMENT, LADY HARDINGE MEDICAL COLLEGE, Delhi, India, 110001 
 
Primary Sponsor  
Name  LADY HARDINGE MEDICAL COLLEGE 
Address  DEPARTMENT OF SURGERY, LADY HARDINGE MEDICAL COLLEGE, SHAHEED BHAGAT SINGH MARG, NEW DELHI. INDIA, 110001 
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 
DR SHUBHRIKA SINGHAL  LADY HARDINGE MEDICAL COLLEGE  UNIT 6/7, DEPARTMENT OF SURGERY, LADY HARDINGE MEDICAL COLLEGE, SHAHEED BHAGAT SINGH MARG, NEW DELHI, 110001
New Delhi
DELHI 
9808374707

drshubhrika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH LHMC AND ASSOCIATED HOSPITALS, NEW DELHI  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K810||Acute cholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DELAYED LAPAROSCOPIC CHOLECYSTECTOMY   LAPAROSCOPIC CHOLECYSTECTOMY DONE AFTER 6 WEEKS OF CONSERVATIVE MANAGEMENT FOR ACUTE CALCULOUS CHOLECYSTITIS 
Intervention  EARLY LAPAROSCOPIC CHOLECYSTECTOMY  LAPAROSCOPIC CHOLECYSTECTOMY DONE WITHIN 72 HOURS OF PRESENTATION OF ACUTE CALCULOUS CHOLECYSTITIS 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult patients (above 18 years of age) with diagnosis of acute calculous cholecystitis  
 
ExclusionCriteria 
Details  1. Patients with CBD stone along with cholelithiasis.
2. Patients with moderate to severe acute pancreatitis.
3. Patients with previous upper abdominal surgery.
4. Patients unfit for laparoscopic surgery.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Mean duration of hospitalisation in early and delayed laparoscopic cholecystectomy
•Mean duration of surgery in early and delayed laparoscopic cholecystectomy
 

Baseline at the time of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
• Proportion of patients having bile duct injury in early & delayed laparoscopic cholecystectomy
• Proportion of patients having laparoscopic to open conversion in early & delayed laparoscopic cholecystectomy
• Proportion of patients developing surgical site infection in early & delayed laparoscopic cholecystectomy
 
Baseline at time of surgery
4 weeks after surgery 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   04/12/2024 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Gall stones are present in about 10 -15% of adult population in western world and 4-6% in Indian population. Between 1-4% of these adults become symptomatic every year, majority with biliary colic, but acute calculous cholecystitis is the main complication observed in patients of symptomatic gall stone disease and represents a major proportion of cases presenting to surgery emergency. Laparoscopic cholecystectomy is gold standard for management of symptomatic gall stone disease with complication rates of only 0.2%. However, the timing of surgery remains a topic of controversy. It can either be done early (mostly done within 72 hours of onset of symptoms) or can be delayed (conservative management followed by interval laparoscopic cholecystectomy after 6 weeks). The studies so far have shown some benefits of both creating a divide in the surgical community. Early surgery is infrastructurally more demanding and may require better skilled surgeon. However, delaying surgery exposes the people to gall stone related complications viz gall stone induced pancreatitis, cholangitis, choledocholithiasis, chronic cholecystitis, mucocele, empyema of gallbladder, gall stone ileus or even risk of gall bladder cancer. With this study we aim to see the clinical outcomes of early as well as delayed laparoscopic cholecystectomy in the management of cases of acute calculus cholecystitis and to compare which method of choice among ELC vs DLC has better outcome by comparing various parameters like duration of hospitalisation, duration of surgery, intraoperative difficulty, rate of conversion to open, post operative complications viz bile leak, surgical site infection and bile duct injury.

 
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