| CTRI Number |
CTRI/2025/11/096801 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
01/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study between standard four port laparoscopic cholecystectomy versus three port laparoscopic cholecystectomy. |
|
Scientific Title of Study
|
A Comparative study between conventional four port versus three port laparoscopic cholecystectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinali Gupta |
| Designation |
junior resident |
| Affiliation |
Shri Ram Murthi Samarak, Institute of Medical Sciences |
| Address |
GENERAL SURGERY DEPARTMENT,
Shri Ram Murthi Samarak, Institute of Medical Sciences, BARIELLY, 13KM BAREILLY NAINITAL ROAD, BHOJIPURA, Bareilly.
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
8700394566 |
| Fax |
|
| Email |
vinaligupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Kumar Singh |
| Designation |
Associate Professor |
| Affiliation |
Shri Ram Murthi Samarak, Institute of Medical Sciences |
| Address |
GENERAL SURGERY DEPARTMENT,
Shri Ram Murthi Samarak, Institute of Medical Sciences, BARIELLY, 13KM BAREILLY NAINITAL ROAD, BHOJIPURA, Bareilly.
Bareilly
UTTAR PRADESH
243202
India |
| Phone |
9458707282 |
| Fax |
|
| Email |
dr.amit@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinali Gupta |
| Designation |
junior resident |
| Affiliation |
Shri Ram Murthi Samarak, Institute of Medical Sciences |
| Address |
GENERAL SURGERY DEPARTMENT,
Shri Ram Murthi Samarak, Institute of Medical Sciences, BARIELLY, 13KM BAREILLY NAINITAL ROAD, BHOJIPURA, Bareilly.
UTTAR PRADESH
243202
India |
| Phone |
8700394566 |
| Fax |
|
| Email |
vinaligupta@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shri Ram Murti Smarak Institute of Medical Sciences Bareilly |
| Address |
Shri Ram Murti Smarak Institute of Medical Sciences, Bareilly 13.2 Km Milestone on Bareilly - Nainital Road, Bhojipura, Bareilly-243202, UP, India |
| Type of Sponsor |
Private 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 |
| Vinali Gupta |
Shri Ram Murthi Samarak, Institute of Medical Sciences, |
General surgery Office, General Surgery Department,
Shri Ram Murthi Samarak, Institute of Medical Sciences, Bareilly, 13KM Bareilly Nainital Road, Bhojipura, Bareilly, 243202.
Bareilly
UTTAR PRADESH |
08700394566
vinaligupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRMS IMS, Bareilly |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K808||Other cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Four port laparoscopic cholecystectomy. Group A |
Patients will be randomly allocated a group based on computer generated numbers (Group A). This is a standard accepted procedure. |
| Intervention |
Three port laparoscopic cholecystectomy. Group B |
Patients will be randomly allocated a group based on computer generated numbers (Group B). This is a procedure is followed and will be compared to the four port laparoscopic cholecystectomy. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with symptomatic gallstone disease who are candidates for elective laparoscopic cholecystectomy.
Patients with benign gallbladder polyps (greater than 10 mm).
Ability to give written informed consent and comply with the study protocol and follow-up. |
|
| ExclusionCriteria |
| Details |
Acute cholecystitis or other severe inflammation requiring emergency surgery
Cholelithiasis with choledocholithiasis
Gallstone induced pancreatitis
Suspected malignancy or gallbladder mass
Patients with history of upper abdominal surgery
Morbid obesity (BMI greater or equal to 40)
Patients unfit for anaesthesia
Pregnant females
Patient with liver cirrhosis/ portal hypertension
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the clinical outcomes of conventional four port laparoscopic cholecystectomy versus three port laparoscopic cholecystectomy in patients undergoing elective laparoscopic cholecystectomy. |
1 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare operative & postoperative parameters between conventional four port & three port laparoscopic cholecystectomy in terms of-
Operative duration
Intraoperative complications
Post operative pain
Length of hospital stay
Time taken to resume activities of daily living (ADL). |
1 week (7 days Post Operative) |
|
|
Target Sample Size
|
Total Sample Size="86"
Sample Size from India="86"
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)
|
12/11/2025 |
| 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 Applicable |
| 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
|
This study will compare both the conventional gold standard four port laparoscopic cholecystectomy and upcoming three port. Hypothesis- there is a significant difference in the clinical outcomes of conventional four port and three port laparoscopic cholecystectomy, indicating that one technique may offer advantages over the other in terms of patient recovery, pain management, and overall surgical efficiency without putting the patient in any added risk. Comparison will be made on the basis of: Intraoperative outcomes: operative time (in minutes), intraoperative bleeding, biliary spillage, biliary injury, and postoperative outcomes: postoperative pain (vas scale at 6, 12, and 24 hours), dosage of analgesic used in grams (gm), hospital stay in days, time for return to activities of daily living in days, postoperative complications (biliary spillage, biliary injury, bleeding) and patient satisfaction.
|