| CTRI Number |
CTRI/2025/10/096641 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| 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
|
Comparing pain after surgery in patients undergoing hernia operation using two different techniques |
|
Scientific Title of Study
|
Comparing absorbable tackers vs fibrin glue mesh fixation in reducing postoperative pain and neuralgia in patients undergoing Extended laparoscopic total extraperitoneal inguinal hernia Repair (eTEP) - A double blinded randomized control 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 ANKIT KUMAR PANI |
| Designation |
JUNIOR RESIDENT,Dept of general surgery |
| Affiliation |
Jawaharlal institute of postgraduate medical sciences and research institute |
| Address |
hospital main block,dept of surgery,UNIT-6 jipmer Campus Rd, Jipmer Campus, Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7064227246 |
| Fax |
|
| Email |
ankit.pani2000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIJAYAKUMAR C |
| Designation |
ASSOCIATE PROFESSOR,Dept of GENERAL SURGERY |
| Affiliation |
Jawaharlal institute of postgraduate medical sciences and research institute |
| Address |
Hospital main block,Dept of GENERAL SURGERY, jipmer Campus Rd, Jipmer Campus, Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
8526617232 |
| Fax |
|
| Email |
vijaymmc01@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ANKIT KUMAR PANI |
| Designation |
JUNIOR RESIDENT, Dept of GENERAL SURGERY |
| Affiliation |
Jawaharlal institute of postgraduate medical sciences and research institute |
| Address |
hospital main block, Dept of GENERAL SURGERY,UNIT-6 jipmer Campus Rd, Jipmer Campus, Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7064227246 |
| Fax |
|
| Email |
ankit.pani2000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jipmer Campus Rd, Jipmer Campus, Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India |
|
|
Primary Sponsor
|
| Name |
JIPMER |
| Address |
Jipmer Campus Rd, Jipmer Campus, Dhanvantri Nagar Pondicherry PONDICHERRY 605006 India |
| 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 |
| ANKIT KUMAR PANI |
Jawaharlal Institute of Postgraduate Medical Education and Research |
Dept of general surgery,UNIT-6, Jipmer Campus Rd, Jipmer Campus, Dhanvantri Nagar
Pondicherry
PONDICHERRY
605006
India
Pondicherry
PONDICHERRY |
7064227246
ankit.pani2000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER INSTITUTIONAL 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 |
absorbable tackers |
mesh fixation using tackers in laparoscopic hernia repair takes 120 mins |
| Intervention |
fibrin glue |
mesh fixation using fibrin glue in laparoscopic hernia repair takes 120 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
all consenting patients planned for elective laparoscopic total extraperitoneal inguinal hernia repair |
|
| ExclusionCriteria |
| Details |
1. Complicated (strangulated, incarcerated, obstructed, etc.) inguinal hernia.
2. Hernia patients with disorders of hemostasias and coagulation
3. Chronic pain due to previously operated opposite side or due to any other medical problems
4. Patients undergoing concomitant surgeries along with mesh repair
5. Patients in whom surgery is converted from eTEP to TAPP or open mesh repair in view of intra-operative difficulty
6. Patients with recurrent hernias
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess efficacy in reducing postoperative pain and neuralgia between fibrin glue and absorbable tacker in extended laparoscopic inguinal hernia repair. |
pain is assessed at 6hr,12hr,24hr,1 week and one month after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the perioperative outcomes (local numbness and hematoma, seroma, rate of SSI, urinary retention, length of operation, intraoperative time for mesh fixation, Length of hospital stay and time to return to work) between the two groups |
recurrence rates & pain after 6 months & 1 yea, ssi
within 90 days, seroma formation within 1 month |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
07/01/2026 |
| 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 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
|
A double blinded randomised control trial comparing efficacy between absorbable tacker and fibrin glue in mesh fixation reducing postoperative pain and neuralgia in patients undergoing laparossopic eTEP.Fibrin glue has emerged as avery effective alternative to absorbable tacker for atraumatic mesh fixation with its efficacy, tolerability , and lack of adverse effect. one group in mesh fixation we will use 2-3 absorbable tacks fixing it to cooper’s ligament and abdominal wall .other group mesh will be secured with fibrin glue applied to transversalis fascia.All participants will receive standardized postoperative analgesia. |