| CTRI Number |
CTRI/2023/09/057858 [Registered on: 20/09/2023] Trial Registered Prospectively |
| Last Modified On: |
29/05/2024 |
| 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
|
Comparision of cholecystectomy using laparoscopy vs mini-laparoscopy as a day care procedure |
|
Scientific Title of Study
|
COMPARISON BETWEEN MINI-LAPAROSCOPIC AND CONVENTIONAL LAPAROSCOPIC CHOLECYSTECTOMY AS A DAY CARE PROCEDURE – A RANDOMIZED CONTROLLED STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Harsha |
| Designation |
Post Graduate Resident Doctor |
| Affiliation |
Maulana Azad Medical College And Associated Lok Nayak Hospital |
| Address |
Department of Surgery
Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9468013094 |
| Fax |
|
| Email |
Harshajoon@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawanindra Lal |
| Designation |
Director Professor and Head of the department |
| Affiliation |
Maulana Azad Medical College And Associated Lok Nayak Hospital |
| Address |
Department of Surgery
Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9968604380 |
| Fax |
|
| Email |
profplal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Harsha |
| Designation |
Post Graduate Resident Doctor |
| Affiliation |
Maulana Azad Medical College And Associated Lok Nayak Hospital |
| Address |
Department of Surgery
Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi - 110002
Central
DELHI
110002
India |
| Phone |
9468013094 |
| Fax |
|
| Email |
Harshajoon@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi -110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and Associated Lok Nayak Hospital |
| Address |
Maulana Azad Medical College and Associated Lok Nayak Hospital, New Delhi 110002 |
| 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 Harsha |
Lok Nayak Hospital |
Room Number 416, Surgery OPD, Lok Nayak Hospital, New Delhi -110002
Central
DELHI |
9468013094
Harshajoon@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical College and Associated Hospitals |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Laparoscopic Cholecystectomy |
Conventional laparoscopic cholecystectomy - Traditional laparoscopic cholecystectomy will be performed using the four-port technique. Peumoperitoneum will be achieved by open technique. A 10 mm 30°telescope will be used at the umbilicus. Another 10 mm trocar will be used in the epigastrium which is the main working port for the surgeon. One 5 mm trocar in the anterior axillary line will be used for gall bladder fundus traction, and another 5 mm trocar in the mid clavicular line as the left-hand working port. Critical View of Safety will be achieved by carrying out dissection in the Calot’s triangle till two and only two structures, cystic artery, and cystic duct, are seen entering the gall bladder, which will then be clipped and cut. The gall bladder will then be dissected off the liver bed and extracted from the umbilical port. Expected total duration of the procedure is 47.3 min (SD - 20.8min ). |
| Intervention |
Mini-Laparoscopic Cholecystectomy |
Mini-laparoscopic cholecystectomy – Peumoperitoneum will be achieved by open technique. A 10 mm 30°telescope will be used at the umbilicus for vision. A 5mm trocar will be put in epigastrium, which will function as the surgeon’s right hand. A conventional Maryland grasper will be used in 5mm port site. In, mid clavicular line a 3mm incision will be given for placement of atraumatic grasper (Teleflex®), which will function as the left hand. Another 3mm incision will be made for placing a toothed grasper (Teleflex®) at anterior axillary line for the assistant to hold the gall bladder fundus. Critical View of Safety will be achieved by carrying out dissection in the Calot’s triangle. Cystic artery and cystic duct will then be clipped and cut. The gall bladder will then be dissected off the liver bed and extracted from the umbilical port. Expected total duration of the procedure is 64.8 ( SD - 27.7min ). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients eligible for day care surgery. (as per ASA guidelines for Ambulatory Anesthesia and Surgery |
|
| ExclusionCriteria |
| Details |
1. History of cholecystitis (Biliary colic lasting for >24hours or requiring hospitalization) within 2months
2. History of previous upper abdominal surgeries
3. Coagulopathies
4. Morbid Obesity
5. Choledocholithiasis
6. Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Operative time
2. Conversion of MLC/CLC to CLC/ Open cholecystectomy |
At the time of completion of Procedure (skin closure) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Intraoperative events [for e.g., bleeding, bile duct injury, gall bladder perforation, bowel injury etc.] |
During Procedure |
| 2. Post operative complications [for e.g., fever, bile leak, surgical site infection] |
Post operative day 1,3,7 and at 1 month |
| 3. Post operative pain using Visual Analogue Scale (VAS) score |
At 2,4,6,8,24,72 hour from surgery and at post operative day 7 |
| 4. Cosmetic outcome [measured as, average of Stony Brook Scar Evaluation Scale score (SBSES) of all the port sites by the investigator, and with a self-assessment scale for cosmetic results of 1 (not satisfied at all) to 5 (extremely satisfied) by the patient themselves |
At 1 month after operation |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/09/2023 |
| 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)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
This is a randomized controlled study designed to compare mini-laparoscopic(MLC) and conventional laparoscopic cholecystectomy(CLC) as a daycare procedure in terms of difference in operative time, intraoperative occurrences and post operative outcomes including cosmesis in a single center in New Delhi, India. The primary outcome measures will be operative time and conversion of MLC/CLC to CLC/Open Cholecystectomy, as recorded at the completion of procedure. The secondary outcomes will be intraoperative events, post operative complications, post operative pain using VAS score and Cosmetic outcome. The secondary outcomes will be recorded at post operative day 1,3,7 and at 1 month. |