| 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
|
|
|
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
|
|
|
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. |