| CTRI Number |
CTRI/2024/11/077136 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| 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
|
“A Study Comparing Glue and Traditional Methods for Fixing Mesh in Hernia Surgery†|
|
Scientific Title of Study
|
Comparison Of N-butyl 2-cyanoacrylate Glue Fixation
Versus Conventional Fixation of Polypropylene Mesh In
Patients Undergoing Lichtenstein Repair For Inguinal
Hernia: 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 |
DrSyed arif |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR(AIIMS RAIPUR) |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR
CHHATTISGARH 492099 India |
| Phone |
7995816017 |
| Fax |
|
| Email |
syed1997arif@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
RUBIK RAY |
| Designation |
ASSOCIATE PROFESSOR, GENERAL SURGERY |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR(AIIMS RAIPUR) |
| Address |
AIIMS RAIPUR, D BLOCK,4TH FLOOR,
SURGERY OFFICE.
Raipur CHHATTISGARH 492099 India |
| Phone |
9804659199 |
| Fax |
|
| Email |
dr.rubikray@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
TRIDIP DUTTA BURUAH |
| Designation |
ADDITIONAL PROFESSOR, GENERAL SURGERY |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES RAIPUR(AIIMS RAIPUR) |
| Address |
AIIMS RAIPUR, D BLOCK 4TH FLOOR, SURGERY OFFICE.
CHHATTISGARH 492099 India |
| Phone |
9109720246 |
| Fax |
|
| Email |
tridipduttabaruah@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
DrSyed arif |
| Address |
AIIMS RAIPUR, TATIBANDH, GREAT EASTERN ROAD, RIAPUR,
PIN CODE 492099. |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| SYED ARIF |
ALL INDIA INSTITUTE OF MEICAL SCIENCES. |
AIIMS RAIPUR D BLOCK 4TH FOOR GENERAL SURGERY OFFICE.
ROOM NO 3 Raipur CHHATTISGARH |
7995816017
syed1997arif@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE, AIIMS RAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
fixing prolene mesh in open inguinal hernia repair using N butyl 2 cyanoacrylate glue |
Using N-butyl-2-cyanoacrylate glue for Prolene mesh fixation in inguinal hernia repair and comparing it with conventional fixation methods in terms of post-operative pain, duration of surgery, and other related complications.
Details: After placing the Prolene mesh over the internal oblique/transverse abdominis, it will be fixed by applying drops of N-butyl-2-cyanoacrylate glue using a 2ml syringe. We need to wait for 10 seconds after applying the drops to ensure the glue dries and secures the mesh. The mesh will first be fixed at the pubic tubercle region, followed by fixation at the inguinal ligament and then over the transversus abdominis. The external oblique aponeurosis will then be closed, followed by skin closure. The patient will be followed up for 3 months (after 24 hours of surgery, 7 days, 15 days, 30 days, 60 days, and 3 months).
total duration of study is one and half years. |
| Comparator Agent |
Using Prolene suture for Prolene mesh fixation in inguinal hernia repair. |
After placing the Prolene mesh over the internal oblique/transverse abdominis, it will be fixed using Prolene 2-0 sutures. The mesh will first be secured at the pubic tubercle region, followed by fixation at the inguinal ligament, and then over the transversus abdominis. The external oblique aponeurosis will then be closed, followed by skin closure. The patient will be followed up for 3 months (after 24 hours of surgery, 7 days, 15 days, 30 days, 60 days, and 3 months).
total duration of study is for one and half years. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Male |
| Details |
Inclusion criteria:Patients planned for open hernioplasty for uncomplicated inguinal hernia
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
Recurrent inguinal hernia
Hernioplasty combined with any additional procedure
Patients who are immunocompromised due to any cause.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To show mesh fixation using n-butyl 2-cyanoacrylate glue gives better outcome than conventional mesh fixation in open hernia repair in terms of post operative groin pain score at 24hrs, 72hrs, 7days, 15days 1month and 3 month post op follow up. |
6months follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To document the operative time in both the methods.
To measure the magnitude of chronic groin pain at 03 months follow up.
To identify the rate of recurrence in patients undergoing hernioplasty.
|
patient will be followed for 6months |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
28/11/2024 |
| 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="1" Months="6" 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 is a prevalent surgical issue, affecting 3-8% of the global population, with a lifetime risk of 25% in males and 3% in females. It involves a weakness in the abdominal wall, allowing the protrusion of intra-abdominal contents. Inguinal hernias account for 75% of all hernias, with two-thirds being indirect (through the inguinal canal) and the rest direct (through Hesselbach’s triangle). Historically, various methods have been developed for hernia repair, starting with the strengthening of the external ring and anterior wall by Stormayr in 1559, Purman in 1692, and Czerny in 1877. The Bassini repair in 1887 focused on reconstructing the posterior wall, which was later modified by Shouldice in the 1940s to include four layers of fascia and aponeurosis for added strength. The most recent and widely used method is the Lichtenstein repair, introduced in 1984 and modified in the 1990s, which uses a polypropylene mesh for tension-free onlay open mesh hernioplasty. However, mesh fixation with prolene suture can lead to complications such as seroma or hematoma formation, increased surgery duration, urinary retention, transient testicular pain and swelling, scrotal edema, infection, post-operative pain (inguinodynia), and rarely, recurrence. Chronic pain can be neuropathic, due to direct nerve damage, perineural fibrosis, or damage from staples, tacks, or suture materials, or non-neuropathic, due to folded mesh, periosteal reaction, or scar tissue formation. To mitigate these complications, alternative methods for mesh fixation have been developed, including absorbable and non-absorbable tacks, cyanoacrylate or fibrin glues, bovine and porcine gelatin, PEG polymer, bovine albumin cross-linked with glutaraldehyde, lightweight and self-gripping mesh, and laparoscopic fixation, which has been found to reduce post-operative pain due to fewer fixation points. These advancements aim to improve patient outcomes and reduce complications in inguinal hernia repair.
JUSTIFICATION:
Several previous
studies have demonstrated that patients in the N butyl 2 cyanoacrylate glue
group experienced significantly less postoperative groin pain and shorter
surgery duration compared to the Conventional suture group.(7) However, there
is a lack of similar studies and awareness regarding the use of glue for mesh
fixation in central India population. Therefore, this study aims to compare the
efficacy of n butyl 2 cyanoacrylate glue for mesh fixation with conventional
mesh fixation in central India group of population. |