FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
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 
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  
Status 
Not Applicable 
 
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.


 
Close