| CTRI Number |
CTRI/2024/01/061752 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
17/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [mesh vs glue] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of hernia repair using suture versus glue fixation. |
|
Scientific Title of Study
|
A comparative study of suture mesh fixation versus cyanoacrylate glue fixation in lichtenstein inguinal hernioplasty-A 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 Hariprasad T |
| Designation |
Junior resident |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of General Surgery Pondicherry Institute of Medical Sciences,Ganapathichettikulam, Kalapet,Puducherry 605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
7339083980 |
| Fax |
91-413-2656273 |
| Email |
dr.hari.ms2110@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.Nirmal kumar |
| Designation |
Professor |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of general surgery Pondicherry Institute of Medical Sciences,
Kalapet,
puducherry 605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
9944368936 |
| Fax |
|
| Email |
nirmal3106@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Hariprasad T |
| Designation |
Junior resident |
| Affiliation |
Pondicherry Institute of Medical Sciences |
| Address |
Department of General Surgery Pondicherry Institute of Medical Sciences,Kalapet,puducherry 605014
Pondicherry
PONDICHERRY
605014
India |
| Phone |
09944368936 |
| Fax |
|
| Email |
dr.hari.ms2110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of general surgery Pondicherry institute of medical sciences |
|
|
Primary Sponsor
|
| Name |
Pondicherry Institute of Medical |
| Address |
Pondicherry Institute of Medical Sciences,Kalapet,puducherry 605014 |
| Type of Sponsor |
Private medical college |
|
|
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 Hariprasad |
Pondicherry Institute of Medical Sciences |
Department of General Surgery, Pondicherry Institute of Medical
Sciences,Ganapathichettikulam Kalapet Puducherry-605014
Pondicherry
PONDICHERRY |
07339083980
dr.hari.ms2110@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS INSTITUTE ETHICS COMMITTEE (IEC) |
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 |
2-0 Polypropylene suture |
A standard 6 cm × 11 cm sized mesh is required for inguinal
hernia. The lateral end of the mesh is split at the lower 1/3rd and upper 2/3rd junction to accommodate the spermatic cord. The lower margin of
the mesh is fixed to the inguinal ligament starting medially at the fascia
over the pubic tubercle extending laterally along the inguinal ligament beyond the deep inguinal ring using 2-0 polypropylene suture.Post operative parameters like pain,seroma,haematoma,erythema,surgical site infection,recurrence which will be followed up for a total duration of 6 months. |
| Intervention |
N-butyl cyanoacrylate glue |
The mesh is fixed using N-butyl Cyano-acrylate at five places namely, the pubic tubercle medially, over conjoint tendon superiorly,
near inguinal ligament inferiorly, internal oblique muscle laterally and
around the neo-deep ring and 6x11cm polypropylene mesh is placed over the internal oblique muscle and conjoint tendon. A constant pressure of 5 minutes is applied over the mesh and the adequacy of
adherence of mesh is confirmed Post operative parameters noted like pain,haematoma,seroma,erythema,numbness,surgical site infection recurrence which will be followed up for a total duration of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Male |
| Details |
Patients with inguinal hernia above 18 years of age
Uncomplicated inguinal hernias
Complete/incomplete hernia
Unilateral/bilateral
Direct/indirect |
|
| ExclusionCriteria |
| Details |
Recurrent-inguinal hernias
Patients who want Laparoscopic inguinal-hernia repair
Patients on long term analgesic or steroid treatment |
|
|
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 measure the effect of cyanoacrylate glue in
reducing postoperative complications like persistent pain and recurrence rate in comparison to suture mesh fixation in Lichtenstein hernia repair. |
Post operative pain assessment will be done for 24 hours and recurrence rate will be assessed for the next 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the incidence of
1. Surgical site infection
2. Haematoma
3. Persistent numbness
4. Erythema
5. Postoperative length of stay (days)
5. Return to normal activities among those in whom mesh was fixed with Cyanoacrylate and sutures. |
Persistent pain and recurrence measured at 0, 1, 3 and 6 month Surgical site infection, Haematoma, Seroma , Persistent
numbness and Return to normal activity measured at 0, 1, 3 and 6 month. |
|
|
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 4 |
|
Date of First Enrollment (India)
|
29/01/2024 |
| 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
|
It was found that the group in which N-butyl cyanoacrylate glue was compartively better than 2-0 Polypropylene suture mesh fixtaion in lichtensein inguinal hernioplasty.In aspects of decreased pain,surgical infection,haematoma, seroma formation and recurrence of inguinal hernia post operatively. |