| CTRI Number |
CTRI/2025/07/091650 [Registered on: 24/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective longitudinal study |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Partially absorbable versus non absorbable mesh used in laparoscopic surgery for inguinal hernia repair |
|
Scientific Title of Study
|
A Prospective Comparative Study of Partially Absorbable Mesh vs Non-
Absorbable Mesh in Laparoscopic Inguinal Hernia Repair |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gopika Sreeja Vijay |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of General Surgery
3rd floor, Smt, Sharada Madhav Pai OPD
Kasturba Hospital
Manipal, 576104
Udupi KARNATAKA 576104 India |
| Phone |
9080800068 |
| Fax |
|
| Email |
gopika.kmcmpl2024@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sunil Krishna M |
| Designation |
Professor and Head of Unit |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of General Surgery
3rd floor, Smt, Sharada Madhav Pai OPD
Kasturba Hospital
Manipal, 576104
Udupi KARNATAKA 576104 India |
| Phone |
9986516627 |
| Fax |
|
| Email |
sunilkrishna@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Gopika Sreeja Vijay |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Hospital, Manipal |
| Address |
Department of General Surgery
3rd floor, Smt, Sharada Madhav Pai OPD
Kasturba Hospital
Manipal, 576104
KARNATAKA 576104 India |
| Phone |
9080800068 |
| Fax |
|
| Email |
gopika.kmcmpl2024@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal
Madhav Nagar, Manipal, 576104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
nil |
| Address |
nil |
| 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 Gopika Sreeja Vijay |
Kasturba Hospital, Manipal |
Department of General Surgery
3rd floor, Smt Sharada Madhav Pai OPD, Kasturba Hoapital, Manipal, 576104 Udupi KARNATAKA |
9080800068
gopika.kmcmpl2024@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba MedicalCollege and Kasturba Hospital Institutional Ethics Committee - 2 |
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, (2) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1.Fit for laparoscopic surgical
repair under general anesthesia
2.Willing to provide informed
consent and comply with follow-
up schedule |
|
| ExclusionCriteria |
| Details |
1.Femoral hernia, complicated hernias, or those needing emergency repair
2.Recurrent inguinal hernia
3.Major comorbidities or immunocompromised states affecting surgical safety |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to compare the postoperative pain, complications (seroma formation, urinary retention and mesh infection), foreign body sensation, hernia recurrence in both the groups. (partially absorbable mesh and non absorbable mesh )
Help in optimal mesh selection |
Preoperative data collection
Intraoperative data collection
Postoperative
POD1
1-2Weeks
3Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="72" Sample Size from India="72"
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)
|
15/08/2025 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 one of the most common abdominal wall hernias encountered in clinical practice, and laparoscopic mesh repair has become a widely accepted standard of care. However, long-term complications such as chronic groin pain, foreign body sensation, and mesh-related discomfort continue to affect patient quality of life. Non-absorbable polypropylene meshes, while effective in preventing recurrence, have been associated with these persistent postoperative issues. In response, partially absorbable composite meshes have been developed to reduce the permanent foreign material load in the body, potentially enhancing patient comfort without compromising surgical outcomes. The purpose of this trial is to prospectively compare the clinical effectiveness and safety of partially absorbable mesh versus non-absorbable mesh in laparoscopic inguinal hernia repair. By evaluating postoperative pain, complications, and recurrence rates, the study aims to identify which mesh type offers better postoperative outcomes, thereby helping surgeons in optimal mesh selection and improving long-term results in hernia surgery.
|