| CTRI Number |
CTRI/2026/04/108172 [Registered on: 10/04/2026] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [Pilot Study] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to evaluate the safety and results of a new surgical technique for inguinal hernia repair. |
|
Scientific Title of Study
|
Safety, Feasibility and Early Outcomes of the Hybrid Trans-Rectus Extraperitoneal
Procedure (HyTREPP) for Inguinal Hernia: A Pilot Study (HyTREPP- Pilot) |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bishesh Kumar Chaurasiya |
| Designation |
Junior Resident |
| Affiliation |
JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RECHARCH |
| Address |
Department of General Surgery
JIPMER Hospital
Dhanvantari Nagar
Puducherry – 605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9198813830 |
| Fax |
|
| Email |
drck.bishesh016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Reddy Abhinaya P |
| Designation |
Associate Professor |
| Affiliation |
JAWAHARLAL INSTITUTE OF POST GRADUATE MEDICAL EDUCATION AND RECHARCH |
| Address |
Department of Surgery, Institute block, Dhanwantari nagar, JIPMER
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8195014433 |
| Fax |
|
| Email |
reddy.kmc2k6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bishesh Kumar Chaurasiya |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER) |
| Address |
Department of General surgery, 2nd floor, lInstitute block, Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Puducherry, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9198813830 |
| Fax |
|
| Email |
drck.bishesh016@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional resources from the Department of Surgery, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry will be used. No external funding support. |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of postgraduate medical education and research (Jipmer) |
| Address |
Jawaharlal institute of postgraduate medical education and research (Jipmer) dhanvantri nagar, Puducherry - 605006 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Bishesh Kumar Chaurasiya |
JIPMER |
Department of Surgery, Institute Block, 2nd floor, JIPMER hospital, Dhanvantri Nagar, Puducherry, 605006
Pondicherry
PONDICHERRY |
9198813830
drck.bishesh016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee – Interventional Studies, JIPMER, Puducherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hybrid Trans-Rectus Extraperitoneal procedure (HyTREPP) |
Patients with inguinal hernia will undergo repair using the Hybrid Trans-Rectus Extraperitoneal Procedure (HyTREPP). This technique combines open trans-rectus access with laparoscopic extraperitoneal mesh placement for inguinal hernia repair. The study evaluates safety, feasibility, and early postoperative outcomes. |
| Comparator Agent |
Not Applicable |
Single arm pilot study. No comparator group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All consenting patients above 18 years of age with
primary unilateral uncomplicated inguinal hernia
planned for elective inguinal hernia repair. |
|
| ExclusionCriteria |
| Details |
1. Previous lower abdominal surgeries.
2. Obese patients (Basal metabolic index (BMI)
less than 35)
3. Hernia patients with disorder of hemostasis and
coagulation.
4. Patients in whom mesh placement is
contraindicated (chronic kidney disease with as-
cites, Chronic liver disease with ascites)
5 . Inguinal hernia repair concomitant with other
surgeries (Hydrocele, Appendectomy etc.)
6 . Patients unwilling for a three month follow up. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the feasibility and safety of the HYTREPP mesh repair of inguinal hernia |
Post-operative complications within 30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain assessed using Visual Analog Scale (VAS) |
Postoperative day 1, day 3, and day 7 |
| Operative time required for completion of HyTREPP procedure |
Intraoperative |
| Duration of postoperative hospital stay |
At discharge |
| Postoperative complications including seroma, hematoma, wound infection, and urinary retention |
Within 30 days after surgery |
| Clinical recurrence of inguinal hernia |
Follow-up at 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
01/06/2026 |
| 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="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
|
This pilot study aims to evaluate the safety, feasibility, and early outcomes of the Hybrid Trans-Rectus Extraperitoneal Procedure (HyTREPP) for inguinal hernia repair. The study will assess operative feasibility, postoperative complications, pain, and early recovery in patients undergoing this technique. |