| CTRI Number |
CTRI/2026/04/107760 [Registered on: 07/04/2026] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare error rates and efficiency of surgeons while using 2D and 3D endovision systems in laparoscopic gall bladder and inguinal hernia surgery |
|
Scientific Title of Study
|
Randomized Controlled Trial Comparing 3D Endovision and 2D UHD- 4K Endovision System in Laparoscopic Hernia and Gallbladder Surgery: Impact on Surgical Performance and Clinical Outcomes |
| Trial Acronym |
Nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1334-6318 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mahendra Pratap Singh |
| Designation |
Additional Professor and Head of Department |
| Affiliation |
All India Institute Of Medical Science, Bathinda |
| Address |
Room no. 413, 4th floor, Department of Surgical Disciplines, AIIMS bathinda, Mandi Dabwali Road, near Giani Zail Singh College, in Bathinda, Punjab, 151001
Bathinda
PUNJAB
151001
India |
| Phone |
9407549239 |
| Fax |
|
| Email |
drmpsingh2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vikram Saini |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Science, Bathinda |
| Address |
Room no. 417, Department of surgical disciplines, 4th floor, AIIMS Bathinda, Mandi Dabwali Road, near Giani Zail Singh College, in Bathinda, Punjab, 151001
Bathinda
PUNJAB
151001
India |
| Phone |
9467577996 |
| Fax |
|
| Email |
vikramsaini2006@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vikram Saini |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute Of Medical Science, Bathinda |
| Address |
Room no. 417, department of Surgical Disciplines, 4th floor, AIIMS Bathinda , Mandi Dabwali Road, near Giani Zail Singh College, in Bathinda, Punjab, 151001
Bathinda
PUNJAB
151001
India |
| Phone |
9467577996 |
| Fax |
|
| Email |
vikramsaini2006@hotmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Shreyans Jain |
| Address |
AIIMS, BTI, Mandi Dabwali Road, near Giani Zail Singh College, in Bathinda, Punjab, 151001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shreyans Jain |
AIIMS, BTI |
Operation theatre 10,12; Elective OT, 1st floor, AIIMS Bathinda, Mandi Dabwali Road, near Giani Zail Singh College, in Bathinda, Punjab, 151001
Bathinda
PUNJAB |
8766050509
jshreyans01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| All India Institute Of Medical Science, Bathinda: Institutional Ethics Committeee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K40||Inguinal hernia, (2) ICD-10 Condition: K80||Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
2D Endovision System |
A 2D endovision system uses a single optical channel and image sensor (CCD/CMOS) to capture and display planar images of the operative field on a monitor. Depth perception is absent, so spatial judgment is inferred from monocular cues such as shading, motion parallax, and anatomical familiarity. While cost-effective and widely adopted, 2D systems can limit precision in complex minimally invasive procedures.
|
| Intervention |
3D Endovision System |
A 3D endovision system employs dual optical channels or stereoscopic cameras to acquire two offset images corresponding to left and right eyes. These images are processed and displayed on a 3D monitor, often requiring polarized or active-shutter glasses, to generate true depth perception. Enhanced stereopsis improves hand–eye coordination, spatial accuracy, and task efficiency, particularly in advanced laparoscopic and robotic surgeries, albeit with increased system complexity and cost. |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Elective laparoscopic cholecystectomy
2. Elective laparoscopic TAPP or TEP repair (including complicated hernia repair)
3. Well versed with the 4K and 3D Endovision system with at least experience of 10 cases on the system
|
|
| ExclusionCriteria |
| Details |
1. Emergency procedures
2. Irreducible/ obstructed or strangulated hernia requiring emergency procedure
3. Lack of experience using 4K or 3D Endovision system with surgical experience of less than 10 cases
4. Surgical procedures converted intra-operatively from laparoscopic to open surgical procedure
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Primary Outcomes
•Total operative time (minutes)
•Hernia sac dissection time (minutes)
•Mesh placement time (minutes)
•Peritoneal closure time (minutes)
•Error rate
•Technical skill checklist
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Intraoperative complications
•Conversion to open surgery (if any)
•Surgeon fatigue & subjective experience |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="144"
Sample Size from India="144"
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)
|
20/04/2026 |
| 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="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 is a prospective,
single blinded, single centre- randomized controlled trial which aims to compare the error rates and efficiency in doing laparoscopic gall bladder and inguinal hernia surgeries while using 2D and 3D endovision systems respectively.. Primary Objective of the study is to compare the
error rates using Technical Skills Checklist in 3 -dimensional (3D) endovision
versus ultra-high-definition 4-K endovision system for laparoscopic hernia and
gall bladder surgery.. Secondary objectives are to compare the total time taken as
well as the time taken in various phases of the surgery using either 3D or 2D
Endovision system by an experienced surgeon (experience of more than 10 cases
on either system). We also aim to compare the surgeon satisfaction
and workload assessment using SURG-TLX (Surgery task load index) scale for
surgery done using 3 -dimensional (3D) endovision versus 2D ultra-high-definition
4-K endovision system. This study includes 144 participants over a duration of 1.5 years. Our
study design addresses gaps in generalizability, long-term effects, and
economic viability in previously conducted similar studies. |