| CTRI Number |
CTRI/2025/09/095317 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
19/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARING RECOVERY AND QUALITY OF LIFE AFTER ROBOTIC VERSUS LAPAROSCOPIC SURGERY FOR GROIN HERNIA |
|
Scientific Title of Study
|
COMPARISON OF CHANGE IN QUALITY OF LIFE BETWEEN
ROBOTIC AND LAPAROSCOPIC TAPP IN INGUINAL HERNIA;
A NON - INFERIORITY 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 |
Dr Rajinder Parshad |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room-419, 4th floor Surgery block, AIIMS Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868397715 |
| Fax |
|
| Email |
drrajinderparshad@aiims.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suman Bagaria |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of surgical disciplines, surgery block, Aiims New Delhi
New Delhi
DELHI
110029
India |
| Phone |
6378421991 |
| Fax |
|
| Email |
suman08bagaria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajinder Parshad |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room-419, 4th floor Surgery block, AIIMS Delhi
New Delhi
DELHI
110029
India |
| Phone |
9868397715 |
| Fax |
|
| Email |
drrajinderparshad@aiims.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NONE |
| Type of Sponsor |
Other [] |
|
|
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 |
| PROFESSOR DR RAJINDER PARSHAD |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI |
DEPARTMENT OF SURGICAL DISCIPLINES, SURGERY BLOCK
New Delhi
DELHI |
9868397715
drrajinderparshad.aiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laparoscopic Trans-Abdominal Preperitoneal Hernioplasty |
Participants in comparator arm will undergo laparoscopic transabdominal preperitoneal hernioplasty. Surgeon satisfaction will be recorded using Likert scale, and surgeon workload will be assessed using SURG-TLX score. Operative time for each step will be recorded. Postoperative quality of life assessment will be done based on EURAHS QOL score. |
| Intervention |
Robotic Trans-Abdominal Preperitonial Hernioplasty |
Participants in this arm will undergo robotic transabdominal preperitoneal (r-TAPP) inguinal hernia repair. The procedure will be performed under general anesthesia using a robotic surgical system.Surgeon satisfaction will be recorded using a Likert scale, and surgeon workload will be assessed using the SURG-TLX score. Operative time for each step will be recorded. Postoperative care and assessment protocols will be identical to the comparator group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients will be included between
18 years and 70 years of age.
All primary unilateral and bilateral
inguinal hernia patients.
Patients consenting to participate
in the study after being explained
about the procedure and its
associated complications and
outcomes. |
|
| ExclusionCriteria |
| Details |
Recurrent hernia patients.
Patients with presence of any other
hernia.
Patients deemed unfit for
Anesthesia.
Patients with previous history of
lower midline abdominal surgery |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in quality of life – assessed using the EuraHS-QoL score at preoperative period,24hours, 7days, 1
month and 3 months |
0hour, 24hours, 7days, 1
month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative Pain – assessed using the Visual Analog Scale (VAS) at: 24 hours, 7
days, 1 month, 3 months postoperatively
Performing surgeon ergonomics using likert scale and SURG TLX score
Operative time (minutes)
Length of hospital stay (hours)
Postoperative complications – using Clavein dindo classification
Recurrence
mortality |
24hours, 7days, 1
month and 3 months |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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)
|
30/09/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
30/09/2025 |
| 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
|
The study titled "Comparison of Change in Quality of Life Between Robotic and Laparoscopic TAPP in Inguinal Hernia: A Non-Inferiority Randomised Controlled Trial" is a single-centre, single-blinded, prospective randomized controlled trial being conducted at AIIMS, New Delhi. It aims to evaluate whether robotic TAPP is non-inferior to laparoscopic TAPP in terms of postoperative quality of life, using the EURAHS-QoL score. A total of 38 patients with primary unilateral or bilateral inguinal hernia, aged between 18 and 70 years, will be enrolled and randomized into two groups. The primary outcome is the change in quality of life at 24 hours, 7 days, 1 month, and 3 months postoperatively. Secondary outcomes include operative time, postoperative complications, recurrence, hospital stay, chronic inguinodynia, as well as surgeon satisfaction (Likert scale) and workload (SURG-TLX score). The sample size was calculated to detect a 1-unit non-inferiority margin in QoL score with 90% power and 5% significance. All surgeries will be conducted using standardized techniques by trained surgeons, and no additional financial burden will be placed on participants. |