| CTRI Number |
CTRI/2026/01/101541 [Registered on: 19/01/2026] Trial Registered Prospectively |
| Last Modified On: |
16/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Understanding pain and recovery in patients whose hernia mesh is fixed with glue or with tackers during minimally invasive groin hernia surgery |
|
Scientific Title of Study
|
A Multi-Centre, Prospective Observation Real- World Evidence study Comparing Mesh Fixation using Glue to Mesh fixation using tackers in patients undergoing Laparoscopic/Robotic Inguinal Hernia |
| 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 Vivek Bindal |
| Designation |
Director and Head Institute of Minimal Access Metabolic & Bariatric Surgery |
| Affiliation |
Max Super Speciality Hospital Vaishali(A unit of Crosslay Remedies Limited) |
| Address |
Max Super Speciality Hospital Vaishali(A unit of Crosslay Remedies Limited) W 3 Sector 1 Vaishali
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9999931958 |
| Fax |
|
| Email |
vivek.bindal@maxhealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vivek Bindal |
| Designation |
Director and Head Institute of Minimal Access Metabolic & Bariatric Surgery |
| Affiliation |
Max Super Speciality Hospital Vaishali (A unit of Crosslay Remedies Limited) |
| Address |
Max Super Speciality Hospital Vaishali (A unit of Crosslay Remedies Limited) W 3 Sector 1 Vaishali
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9999931958 |
| Fax |
|
| Email |
vivek.bindal@maxhealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amir Iqbal |
| Designation |
Associate Consultant Institute of Minimal Access Metabolic & Bariatric Surgery |
| Affiliation |
Max Super Speciality Hospital Vaishali(A unit of Crosslay Remedies Limited) |
| Address |
Max Super Speciality Hospital Vaishali(A unit of Crosslay Remedies Limited) W 3 Sector 1 Vaishali
Ghaziabad
UTTAR PRADESH
201012
India |
| Phone |
9437205586 |
| Fax |
|
| Email |
amriq14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Max Super Speciality Hospital Patparganj(A unit of Balaji Medical & Diagnostic Research Centre)108 A Indraprastha Ext Patparganj Delhi 110092 India |
| Max Super Speciality Hospital Vaishali(A unit of Crosslay Remedies Limited) W 3 Sector 1 Vaishali Ghaziabad UP 201012 India |
|
|
Primary Sponsor
|
| Name |
Max Super Speciality Hospital VaishaliA unit of Crosslay Remedies Limited |
| Address |
Max Super Speciality Hospital Vaishali(A unit of Crosslay Remedies Limited) W 3 Sector 1 Vaishali Ghaziabad UP 201012 India |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vivek Bindal |
Max Super Speciality Hospital Vaishali (A Unit of Crosslay Remedies Limited) |
Max Super Speciality Hospital Vaishali (A Unit of Crosslay Remedies Limited) 4th floor Institute of Minimal access Bariatric and Robotic Surgery Department W 3 Sector 1 Vaishali Ghaziabad 201012
Ghaziabad
UTTAR PRADESH |
9999931958
vivek.bindal@maxhealthcare.com |
| Dr Vivek Bindal |
Max Super Specialty Hospital Patparganj (A Unit of balaji Medical and Diagnostic Research Centre) |
Max Super Specialty Hospital Patparganj (A Unit of Balaji Medical and Diagnostic Research Centre) Room no 1032 Ground floor New Building, 108-A, Indraprastha Extension Patparganj New Delhi 110092
New Delhi
DELHI |
9999931958
vivek.bindal@maxhealthcare.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Max Super Speciality Hospital Patparganj (A Unit of Balaji Medical & Diagnostic Research Centre) |
Approved |
| Institutional Ethics Committee Max Super Speciality Hospital Vaishali (A Unit of Crosslay Remedies Limited) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults greater than 18 years old
Patients diagnosed with unilateral or bilateral uncomplicated inguinal hernia less than 3 cm
Patients requiring laparoscopic or robotic inguinal hernia repair with mesh
fixation using glue or tackers Patients who consent to participate in the study and adhere to the follow up schedule
|
|
| ExclusionCriteria |
| Details |
Patients with recurrent hernias
Patients with irreducible hernia
Patients with contraindications to laparoscopic/robotic procedures
Patients with a history of glue or tacker hypersensitivity
Patients with other significant comorbidities (example uncontrolled diabetes active infection) that may affect surgical outcomes
Patients unwilling or unable to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain as measured by the Visual Analogue Scale (VAS) at 1 day, 1 week, 1 month and 3 months post-surgery |
Post-operative pain as measured by the Visual Analogue Scale (VAS) at 1 day, 1 week, 1 month and 3 months post-surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 Recurrence of Hernia To evaluate the recurrence rates of inguinal hernia in patients treated with n-butyl 2 cyanoacrylate glueversus mechanical tackers over a 3 month period
2 Post-operative Complications To assess the occurrence of complications at 1 day 1 week 1 month & 3 months post-surgery
3 Quality of Life (QoL) To evaluate the quality of life using the EuraHS QoL questionnaire at 1 week 1 month & 3 months post-surgery
4 Other Measures
o Mean time of operation To assess the duration of the surgical procedure for both fixation methods
o Requirement of analgesics To compare the amount of analgesic medication required by patients in the two groups
o Time to return to work To measure the number of days it takes for patients to return to work after surgery |
Secondary Outcome should be access after end of study |
|
|
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)
|
10/02/2026 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [NIL].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Laparoscopic/robotic
inguinal hernia repair has become a widely accepted surgical approach due to
its advantages over open repair including reduced postoperative pain, faster
recovery and better cosmetic outcomes A critical aspect of this procedure is
mesh fixation which plays a key role in preventing recurrence but may also
contribute to complications such as chronic postoperative pain Traditionally mechanical fixation using tackers has been the most common method however it
is associated with tissue trauma neurovascular injury and an increased risk
of chronic pain.
In recent years atraumatic mesh fixation with tissue adhesive has increasingly become the
method of choice It is the recommended mesh fixation method by the
International Hernia Society Guidelines for groin hernia management It offers a less invasive approach that may reduce nerve damage and
tissue irritation with favorable biological properties including
biodegradability hemostatic capability and strong tissue adhesion have the
potential to enhance healing and minimize postoperative discomfort However despite its theoretical advantages there is lack of comprehensive evidence from
India which directly compares the clinical outcomes of adhesive glue versus
traditional mechanical fixation methods in laparoscopic or robotic inguinal hernia
repair
This study aims to
address this gap by comparing clinical outcomes including postoperative pain,
complications and recurrence rates, between patients undergoing mesh fixation
with n butyl 2 cyano acrylate glue and those treated with mechanical tackers
during laparoscopic or robotic inguinal hernia repair |