| CTRI Number |
CTRI/2025/11/097639 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
18/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing Robotic and Laparoscopic Surgery for Treating Patients with Groin Hernia on Both Sides . |
|
Scientific Title of Study
|
ROBOTIC VERSUS LAPAROSCOPIC TRANS ABDOMINAL PRE-PERITONEAL REPAIR OF BILATERAL INGUINAL HERNIA : A RANDOMISED 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 |
Nishant Ranjan |
| Designation |
Junior Resident |
| Affiliation |
all india institute of medical sciences |
| Address |
Department of Surgical Disciplines , Surgical Block , AIIMS Hospital , New Delhi
Department of Surgical Disciplines , Surgical Block , AIIMS Hospital , New Delhi
South
DELHI
110029
India |
| Phone |
9430652391 |
| Fax |
|
| Email |
nishantranjan128@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemanga Bhattacharjee |
| Designation |
Professor , Dept of surgical Disciplines , AIIMS Delhi |
| Affiliation |
AIIMS , New Delhi |
| Address |
Room no 415, 4th floor Surgical block , AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
7838621462 |
| Fax |
|
| Email |
dr_hkb75@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemanga Bhattacharjee |
| Designation |
Professor , Dept of surgical Disciplines , AIIMS Delhi |
| Affiliation |
AIIMS , New Delhi |
| Address |
Room no 415, 4th floor Surgical block , AIIMS New Delhi
South
DELHI
110029
India |
| Phone |
7838621462 |
| Fax |
|
| Email |
dr_hkb75@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi |
|
|
Primary Sponsor
|
| Name |
not applicable |
| Address |
not applicable |
| Type of Sponsor |
Other [not applicable] |
|
|
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 Hemanga Bhattacharjee |
All India Institute of Medical Sciences, New Delhi |
Department Of Surgical Disciplines , Surgical block , Room no 415
South
DELHI |
7838621462
dr_hkb75@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee AIIMS ot block Ansari Nagar New Delhi-110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LAPAROSCOPIC TRANS ABDOMINAL PRE-PERITONEAL REPAIR OF BILATERAL INGUINAL HERNIA |
Laparoscopic TAPP Group
Port Placement: A 12 mm supraumbilical port for the laparoscopic telescope. Two 5
mm working ports will be inserted in the right and left para-rectus position at the level
of the umbilicus.
Mesh fixation: Mesh will be secured to the abdominal wall using absorbable tackers,
anchoring medially to Cooper’s ligament and laterally to the abdominal wall above the
iliopubic tract
Peritoneal flap will be closed with barbed suture (3-0 V-Loc) in both the arms.
In laparoscopic group 12 mm camera port site will be closed at the fascial level using
absorbable vicryl sutures (Port vicryl).
Skin closure will be done with 3-0 nylon suture. |
| Intervention |
ROBOTIC TRANS ABDOMINAL PRE-PERITONEAL REPAIR OF BILATERAL INGUINAL HERNIA |
Robotic TAPP Group
Port Placement: An 8 mm supraumbilical port will be utilized for the robotic
camera. Two additional 8 mm robotic working ports will be placed bilaterally, each
positioned at least 8 cm lateral to the camera port.
Mesh fixation : Mesh will be secured to the abdominal wall using two 3-0 vicryl
sutures ( one suture for fixing mesh on each side) anchoring medially to Cooper’s
ligament and laterally to the abdominal wall above the ilio-pubic tract |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Adult patients aged from 18 to 65 years.
2 Diagnosed with bilateral inguinal hernia (direct, indirect, or mixed) planned for elective minimally invasive repair.
3 ASA physical status I and II
4 Willingness to undergo either robotic or laparoscopic TAPP repair as per allocation. |
|
| ExclusionCriteria |
| Details |
1. Unilateral inguinal hernia.
2. Complicated hernias (for example obstructed, strangulated, incarcerated).
3. Patients with severe cardiopulmonary comorbidities (ASA III or higher).
4. Inability or unwillingness to comply with follow up schedule.
5. Patients having any infectious or inflammatory disease condition pre-operatively .
6. Patient on chronic analgesic use
7. Concomitant malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare postoperative pain at 24 hours, 7 days, 1 month, 3 months and one year
following surgery measured using the Visual Analog Scale (VAS) |
To compare postoperative pain at 24 hours, 7 days, 1 month, 3 months and one year
following surgery measured using the Visual Analog Scale (VAS) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare inflammatory stress response as measured by Serum CRP levels
|
at 24
hours and 7 days following surgery |
To compare operative duration: Measured from skin incision to skin closure (in
minutes). |
Intraop |
| To compare cost effectiveness |
Intraop and followup at 3 m and 1 year |
| To compare quality of life |
at 3 months and one year following surgery |
| To compare recurrence |
at 3 months and one year following surgery |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
02/12/2025 |
| 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="2"
Months="0"
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
|
Inguinal hernia repair is one of the most frequently performed surgical procedures globally, accounting for over 20 million operations annually¹. The condition has a lifetime risk of approximately 27% in men and 3% in women², making it a substantial contributor to surgical workloads worldwide. Among these cases, bilateral inguinal hernias form a significant subset, comprising up to 20–25% of all inguinal hernia presentations³. These cases are inherently more complex, requiring bilateral dissection, longer operative times, and greater attention to anatomical precision—particularly to avoid complications such as chronic groin pain or recurrence. Given these considerations, there is a pressing need for a prospective, study comparing both economic and clinical outcomes between R-TAPP and L-TAPP in bilateral hernia repair. The present study aims to address this by assessing postoperative pain direct and indirect costs and hernia recurrence using standardized methods in a tertiary care setting in India. By generating data that integrates cost analysis with patient outcomes, this study will provide valuable insights to inform surgical choice, guide institutional planning, and promote evidence-based, cost-conscious healthcare delivery. |