| CTRI Number |
CTRI/2024/05/067740 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
05/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Diagnostic
Screening
Process of Care Changes |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different Laparoscopic methods for gall bladder removal |
|
Scientific Title of Study
|
Three port verses standard Four port Laparoscopic Cholecystectomy: Randomized Controlled Trial
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subhangi Parmar |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
5th Floor ,General Surgery Department, Jawaharlal Nehru Medical College, Sawangi Meghe,
India
Wardha
MAHARASHTRA
442004
India |
| Phone |
9904032731 |
| Fax |
|
| Email |
parmar.subhangi15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rajesh Gattani |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
5th Floor ,General Surgery Department, Jawaharlal Nehru Medical College, Sawangi Meghe,
India
Wardha
MAHARASHTRA
442004
India |
| Phone |
9373108181 |
| Fax |
|
| Email |
sakshigattani@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajesh Gattani |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
5th Floor ,General Surgery Department, Jawaharlal Nehru Medical College, Sawangi Meghe,
India
MAHARASHTRA
442004
India |
| Phone |
9373108181 |
| Fax |
|
| Email |
sakshigattani@gamil.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research , Wardha , 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi Meghe Wardha , 442001 |
| 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 |
| Dr Subhangi parmar |
Acharya Vinoba Bhave Rural Hospital |
Datta Meghe Institute of Higher Education & Research, Wardha, Maharashtra 442001
Wardha
MAHARASHTRA |
9904032731
parmar.subhangi15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education & Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K87||Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cholecystectomy |
3 port Laparoscopic Removal of Gall blabber |
| Comparator Agent |
Cholecystectomy |
4 port Laparoscopic Removal of Gall blabber |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All Cases of gallstone disease.
Patients undergoing prophylactic laparoscopic cholecystectomy
Patients of CBD stone treated with endoscopic removal and CBD stenting |
|
| ExclusionCriteria |
| Details |
Empyema Of GB
Jaundice Or Abnormal Liver Function Tests
Cholangitis
Portal Hypertension
GB Carcinoma
Enteric Fistula
Patients Who Had Any Contraindications to Laparoscopic Surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparing rates of Operative, Intra operative and postoperative complications between Three port and Four port Laparoscopic cholecystectomy |
Assessment will be done within 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of hospitalization post-surgery. |
Assessment will be done within 4 weeks |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Gallbladder is a pear-shaped helping digestive organ located in the right upper abdomen. The functions of the gall bladder include storage, concentration, and release of bile into the intestine by simultaneous contraction of the gall bladder. Gallbladder disease is the most common digestive problem that may require hospitalization.The comprehensive review on three-port versus four-port laparoscopic cholecystectomy provides valuable insights from multiple studies, offering a nuanced understanding of the optimal approach for this common surgical procedure. The included studies consistently indicate that the three-port technique is a feasible and safe alternative to the traditional four- port method. While there may be variations in operative time, the three-port approach consistently demonstrates advantages such as reduced postoperative pain, decreased analgesic requirements, and shorter hospital stays. Notably, the three-port technique proves to be more cost-effective, contributing to a potentially quicker return to work and superior cosmetic outcomes. Surgeon experience and careful patient selection emerge as pivotal factors influencing the success of either technique. The findings underscore the importance of considering the specific clinical scenario, patient characteristics, and surgeon proficiency when choosing between the three-port and four-port laparoscopic cholecystectomy approaches. This study will be done at Acharya Vinoba Bhave Rural Hospital. |