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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  
SELF 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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