| CTRI Number |
CTRI/2026/01/100846 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| 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
|
Comparison of Mesh Fixation with Cyanoacrylate Glue versus Polypropylene Sutures in Patients Undergoing Lichtenstein Hernioplasty |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial of Mesh Fixation with Cyanoacrylate Glue versus Polypropylene Sutures in Patients Undergoing Lichtenstein Hernioplasty |
| Trial Acronym |
CYANO-HERNIA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KARAVIND KUMAR |
| Designation |
M.S.GENERAL SURGERY post graduate resident SMVMCH Puducherry. |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
No.2 radio station road
Near servite English High school nehru nagar karaikal
Pondicherry
PONDICHERRY
609605
India |
| Phone |
9445959309 |
| Fax |
|
| Email |
aravind2.1993@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR.S.BABU |
| Designation |
PROFESSOR ,DEPARTMENT OF GENERAL SURGERY |
| Affiliation |
Professor |
| Address |
Sri Manakula Vinayagar medical college and hospital, Kalitheerthalkuppam, madagadipet,
PUDUCHERRY-605107.
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9442119573 |
| Fax |
|
| Email |
Drsbabu459@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
KARAVIND KUMAR |
| Designation |
M.S.GENERAL SURGERY post graduate resident SMVMCH Puducherry. |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
No.2 radio station road
Near servite English High school nehru nagar karaikal
PONDICHERRY
609605
India |
| Phone |
9445959309 |
| Fax |
|
| Email |
aravind2.1993@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self-funded, postgraduate thesis study. No external or industry funding. Institutional facilities (SMVMCH) will support routine clinical and surgical requirements. |
|
|
Primary Sponsor
|
| Name |
KARAVIND KUMAR POST GRADUATE Department of General surgery |
| Address |
Clinical department,
Department of General surgery,
2nd floor, hospital block,Sri Manakula Vinayagar medical college and hospital, Kalitheerthalkuppam, madagadipet, PUDUCHERRY-605107.
|
| 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 Aravind Kumar K |
Sri Manakula Vinayagar Medical College and Hospital |
Department of General surgery, Kalitheerthalkuppam, madagadipet, PONDICHERRY
Pondicherry
PONDICHERRY |
9445959309
aravind2.1993@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH-ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult patients diagnosed with primary unilateral or bilateral inguinal hernia undergoing elective Lichtenstein tension-free hernioplasty.
|
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Polypropylene Suture Mesh Fixation | In the comparator group, mesh fixation during Lichtenstein tension-free inguinal hernioplasty will be performed using 3-0 polypropylene (Prolene) sutures. The mesh will be anchored to the pubic tubercle, inguinal ligament, and conjoint tendon with interrupted sutures, following the standard Lichtenstein technique. | | 2 | Intervention Arm | Procedure | - | Lichtenstein inguinal hernioplasty with mesh fixation using cyanoacrylate glue | (Procedure Reference: Lichtenstein tension-free mesh hernioplasty as described in standard surgical textbooks (Bailey & Love’s Short Practice of Surgery)., Procedure details: Lichtenstein tension-free inguinal hernioplasty will be performed through a standard open inguinal approach. After dissection of the inguinal canal & reduction of the hernial sac, a polypropylene mesh will be placed over the posterior wall of the inguinal canal. The mesh will be fixed using cyanoacrylate glue, applied topically at standard fixation points. The wound will be closed in layers.)
(1) Medicine Name: Cyanoacrylate tissue adhesive, Reference: Cyanoacrylate tissue adhesive as described in standard surgical practice and literature., Route: Topical, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(ml), Frequency: od, Duration: 1 Days |
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1. Adult patients aged 18–65 years.
2. Patients diagnosed with primary unilateral or bilateral inguinal hernia.
3. Patients planned for elective Lichtenstein tension-free hernioplasty.
4. Patients who are fit for surgery under spinal or general anesthesia.
5. Patients who are willing to participate and able to provide written informed consent. |
|
| ExclusionCriteria |
| Details |
1. Recurrent inguinal hernia.
2. Complicated hernias (strangulated, obstructed, incarcerated).
3. Femoral hernia or other types of groin hernias.
4. Patients requiring emergency surgery.
5. Patients with severe comorbidities (e.g., uncontrolled diabetes, severe cardiac or pulmonary disease) that increase surgical risk.
6. Known allergy or sensitivity to cyanoacrylate glue.
7. Patients with immunocompromised conditions.
8. Patients unwilling or unable to provide informed consent.
9. Pregnant or lactating women. |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Post-operative pain assessed using the Visual Analogue Scale (VAS).
|
Baseline (pre-operative)
4 weeks post-operative
8 weeks post-operative
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
seroma
hematoma
wound infection
chronic groin pain |
week, 1 month, 3 month |
|
|
Target Sample Size
|
Total Sample Size="88"
Sample Size from India="88"
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 |
|
Date of First Enrollment (India)
|
30/01/2026 |
| 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="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 repair is one of the most commonly performed general surgical procedures. Mesh fixation in Lichtenstein tension-free hernioplasty is traditionally done using polypropylene sutures, but this may increase postoperative pain, operative time, and risk of nerve entrapment. Cyanoacrylate surgical glue has emerged as an alternative method for mesh fixation that may reduce pain and operative time without compromising surgical outcomes.
This randomized controlled trial aims to compare mesh fixation using cyanoacrylate glue versus polypropylene sutures in adult patients undergoing elective Lichtenstein inguinal hernia repair. The study will evaluate postoperative pain, operative time, postoperative complications, return to activities, hospital stay, recurrence, and patient satisfaction. The findings may help determine whether glue fixation can be recommended as a safe and effective alternative to suture fixation in routine hernia surgery.
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