| CTRI Number |
CTRI/2025/11/097167 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
10/11/2025 |
| 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 monocryl sutures and skin staplers for skin closure in inguinal hernia surgery: a one-year study on infection and pain at kle hospital, belagavi |
|
Scientific Title of Study
|
To study the efficacy and safety of monocryl subcuticular sutures vs skin staplers in skin Closure in inguinal hernia lichenstein tension free mesh repair comparing surgical site infection and post operative pain: a one year randomized clinical trial study at kle dr prabhakar kore hospital, belagavi
|
| 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 Shantanu Kumar Shahi |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal nehru medical college |
| Address |
Department of general surgery, jawaharlal nehru medical college, nehru nagar, belagavi
Nehru nagar, belagavi, karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
7991129278 |
| Fax |
|
| Email |
Shahisanu1359@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhijit shrikant gogate |
| Designation |
Professor |
| Affiliation |
jawaharlal nehru medical college |
| Address |
Department of general surgery,Jawaharlal nehru medical college, nehru nagar, belagavi
nehru nagar, belagavi, karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9844001879 |
| Fax |
|
| Email |
gogateabhijit@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhijit shrikant gogate |
| Designation |
Professor |
| Affiliation |
jawaharlal nehru medical college |
| Address |
Department of general surgery,Jawaharlal nehru medical college, nehru nagar, belagavi
nehru nagar, belagavi, karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
9844001879 |
| Fax |
|
| Email |
gogateabhijit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of general surgery, jnmc belagavi, kles dr Prabhakar kore hospital and mrc, nehru nagar, belagavi, karnataka, india 590010 |
|
|
Primary Sponsor
|
| Name |
Dr Shantanu kumar shahi |
| Address |
Department of general surgery, jawaharlal nehru medical college, nehru nagar, belagavi, karnataka , india 590010 |
| 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 |
| Dr Shantanu kumar shahi |
kle dr prabhakar kore hospital and medical resarch centre |
Department of general surgery, jawaharlal nehru medical college, nehru nagar, belagavi, karnataka 590010
Belgaum
KARNATAKA |
7991129278
Shahisanu1359@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Jnmc institutional ethics committe |
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 |
| Intervention |
Metallic skin stappler |
Skin closure in lichenstein tension free mesh hernioplasty using skin stapplers using 10 to 15 clips per patient of a stapler. |
| Comparator Agent |
Monocryl Suture |
Skin closure in lichenstein tension free mesh hernioplasty using 3-0 monocryl subcuticular continuos suture |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
18 to 75 years old, undergoing elective lichenstein tension free mesh inguinal hernioplasty, asa grade 1 or 2, willing to give consent |
|
| ExclusionCriteria |
| Details |
Complicated hernias, patients with metal allergy, patients with recurrent hernia, patients on immunosuppressive therapy, hiv patients |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the development of surgical site infection using asepsis score in skin closure
To evaluate post operative pain through VAS in skin closure with subcuticular vs skin staplers |
Pod zero, three and ten |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare formation of hypertrophic scars in skin closure measured using POSAS score |
1 month, 2 month, 3 month |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
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)
|
22/11/2025 |
| 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 - NO
|
|
Brief Summary
|
It is a comparative study for skin closure using metallic skin staplers and monocryl 3-0 subcuticular sutures in lichenstein tension free inguinal mesh hernioplasty to compare surgical site infection using Asepsis score and post operative pain using Vas score as primary outcomes and to compare the quality of surgical scar using POSAS score as secondary outcome. |