| CTRI Number |
CTRI/2026/02/102755 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
01/02/2026 |
| 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
|
A study to explore the possibility of completing the removal of gall bladder laparoscopically without an assistant using standard instruments. |
|
Scientific Title of Study
|
Assessment on Feasibility of Assistance Free Laparoscopic Cholecystectomy Using Conventional Instruments |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Piyush Kumar Singh |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical sciences Saifai Etawah |
| Address |
Department of General Surgery
Room 207 Second Floor Old OPD Building
Uttar Pradesh University of Medical sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9910677207 |
| Fax |
|
| Email |
pksingh050799@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vipin Kumar Gupta |
| Designation |
Professor |
| Affiliation |
Uttar Pradesh University of Medical sciences Saifai Etawah |
| Address |
Department of General Surgery
Room 207 Second Floor Old OPD Building
Uttar Pradesh University of Medical sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9412590152 |
| Fax |
|
| Email |
docvipingupta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Piyush Kumar Singh |
| Designation |
Junior Resident |
| Affiliation |
Uttar Pradesh University of Medical sciences Saifai Etawah |
| Address |
Department of General Surgery
Room 207 Second Floor Old OPD Building
Uttar Pradesh University of Medical sciences Saifai Etawah
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9910677207 |
| Fax |
|
| Email |
pksingh050799@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar Pradesh University of Medical sciences Saifai Etawah |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh University of Medical Sciences Saifai Etawah |
| Address |
Uttar Pradesh University of Medical sciences Saifai Etawah-206130
Uttar Pradesh
India |
| 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 |
| Prof Dr Vipin Gupta |
Uttar Pradesh University of Medical Sciences Saifai Etawah |
Department of General Surgery
Room 207 Second Floor Old OPD Building
Uttar Pradesh University of Medical sciences Saifai Etawah
Etawah
UTTAR PRADESH |
9412590152
docvipingupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttar Pradesh University of Medical Sciences Saifai Etawah |
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: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laparoscopic Cholecystectomy |
Conventional Laparoscopic Cholecystectomy an assistant using a three of four -port technique with conventional laparoscopic instruments for 18 months |
| Intervention |
Laparoscopic Cholecystectomy |
Laparoscopic Cholecystectomy without an assistant using a three-port technique with conventional laparoscopic instruments for 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Day(s) |
| Age To |
65.00 Day(s) |
| Gender |
Both |
| Details |
Patients aged 18–65 years Diagnosed with symptomatic cholelithiasis or chronic calculous cholecystitis
ASA Grade I and II
Consenting to undergo laparoscopic cholecystectomy under this novel approach |
|
| ExclusionCriteria |
| Details |
Suspected or Proven Gall Bladder Malignancy.
history of Upper abdominal surgery
ASA grade III/IV |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine whether the procedure can be completed without an assistant using a three-port technique with conventional laparoscopic instruments. |
Baseline
After the Procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Operative time |
Baseline
After the Procedure |
| Intraoperative complications |
Baseline
During the procedure |
| Conversion to open surgery |
Baseline
During the procedure |
| Conversion to assisted laparoscopy |
Baseline
During the procedure |
To identify the technical challenges encountered during the procedure without an assistant:
1 Scope fogging or movement
2 Difficulty with exposure or retraction
3 Instrument collisions |
Baseline
During the procedure |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
16/02/2026 |
| 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)
|
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
|
Is assistant-less laparoscopic cholecystectomy using a conventional three-port technique feasible and safe in routine surgical practice. Shift to Assistance Free Surgery in Laparoscopy:
Laparoscopic cholecystectomy traditionally requires an assistant to handle the camera and instruments. This study explores performing the procedure independently, without an assistant, which has both technical and ergonomic challenges. Use of Conventional Instruments Without Specialized Equipment: Some assistant free surgeries in the literature utilize robotic arms, mechanical holders, or articulating scopes. This study investigates the feasibility of doing it with readily available instruments, making it more accessible and cost-effective, especially in low-resource settings. Feasibility and Safety Data in a Novel Setting: Preliminary data on operative time, complication rate, conversion rate, and surgeon ergonomics provide early insight into whether it can be a safe and reproducible technique. Such data might be scarce, especially in the context of general hospitals in developing countries. Potential Impact on Surgical Training and Resource Optimization: If proven feasible, the method could reduce dependency on trained assistants, which is particularly valuable in rural or under-resourced environments. This might also influence training curricula for laparoscopic surgeons, promoting techniques that enhance independence. |