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CTRI Number  CTRI/2023/06/054523 [Registered on: 28/06/2023] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Comparison of two different mesh outcomes in laparoscopic inguinal hernia surgery 
Scientific Title of Study   Light weight mesh vs Ultralight weight 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  Kodidala Sri Charitha 
Designation  Junior Resident 
Affiliation  Kasturba Medical College and Hospital 
Address  Department of General Surgery, 3rd floor, New OPD block, Kasturba Hospital, Manipal, Udupi.

Udupi
KARNATAKA
576104
India 
Phone  7760750058  
Fax    
Email  kodidala.kmcmpl2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Pavan Madhukar Bhat 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College and Hospital 
Address  Department of General Surgery, 3rd floor, New OPD block, Kasturba Hospital, Manipal, Udupi.

Udupi
KARNATAKA
576104
India 
Phone  9731243720  
Fax    
Email  pavan.bhat@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Pavan Madhukar Bhat 
Designation  Assistant Professor 
Affiliation  Kasturba Medical College and Hospital 
Address  Department of General Surgery, 3rd floor, New OPD block, Kasturba Hospital, Manipal, Udupi.

Udupi
KARNATAKA
576104
India 
Phone  9731243720  
Fax    
Email  pavan.bhat@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital 
 
Primary Sponsor  
Name  Kodidala Sri Charitha 
Address  Department of General surgery, 3rd floor, New OPD block, Kasturba hospital, manipal, udupi 576104 
Type of Sponsor  Other [Self] 
 
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 Kodidala Sri Charitha  Kasturba Medical College and Hospital  Department of General Surgery , 3rd floor, New OPD block, Kasturba Hospital, Manipal, Udupi 576104
Udupi
KARNATAKA 
7760750058

kodidala.kmcmpl2022@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All adult patients with unilateral
/Bilateral groin hernia who underwent elective laparoscopic inguinal hernia repair 
 
ExclusionCriteria 
Details  1. Recurrent inguinal hernia 2. Patients with history of previous surgery in the
inguino-scrotal region 3. Patients who underwent any other surgery concurrent with laparoscopic
inguinal hernia repair.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare outcomes of light weight mesh vs ultralight weight mesh in laparoscopic inguinal hernia repair in terms of Postoperative pain (Postoperative day 0,1,2), Chronic groin pain, Seroma formation  Day 0, Day 1, Day 2 
 
Secondary Outcome  
Outcome  TimePoints 
To compare outcomes of light weight mesh vs ultralight weight mesh in laparoscopic inguinal hernia repair in terms of Hospital stay, Other intraoperative & postoperative complications, Mesh infection, Time to return to routine activities, Recurrence  1 month, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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)   05/07/2023 
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)
Modification(s)  
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
Modification(s)  
l

Hernioplasty by prosthetic mesh has become gold standard for repair of Inguinal hernia. Mesh repair has become so important in hernia surgery that some understanding of mesh technology is essential for the modern surgeon. The composition and structure of prosthetic meshes varies widely, which influence in the healing process following meshplasty. The use of synthetic mesh substantially reduce the risk of hernia recurrence.

However, polypropylene meshes have been found to cause chronic inflammatory reactions that persist for years and can have potentially negative effects. These effects include chronic pain and feeling of a foreign body in the groin area, which can influence the patient’s quality of life. It was recorded that the incidence of chronic pain after mesh inguinal hernia happens in about 11 % of patients, and still, 3 % report severe pain 1 year after hernia repair. It has been surmised that the extent of the foreign body reaction with its provoked scar tissue is correlated with the amount of the synthetic material used. This led to the development of so-called lightweight mesh characterized by a reduction in the polypropylene volume, an increase in the pore size, or different web structure.

The light weight mesh (LWM) has larger pore size (3-5mm), low weight per unit area(<50gm/m2), stimulates less inflammatory reaction and provides greater elasticity and more flexibility.

The Ultralight weight mesh (ULWM) has larger pore size , lowest weight per unit (<35gm/m2)

The Aim of this study is to compare Light weight mesh vs Ultralight weight mesh repair outcome in Laparoscopic Inguinal Hernia Repair. The objectives are to qualitatively and quantitatively compare the immediate post-operative and chronic inguinal pain. To assess the two types of meshes in terms of their propensity to have post-operative seroma formation, wound infection. To compare chronic inguinal stiffness/Inguinodynia. To evaluate for incidence of recurrence on follow up.

Inclusion criteria: All adult patients (>18 years) with unilateral /Bilateral groin hernia who underwent elective laparoscopic inguinal hernia repair                             

Exclusion Criteria: 1. Recurrent inguinal hernia 2. Patients with history of previous surgery in the inguino-scrotal region 3. Patients who underwent any other surgery concurrent with laparoscopic inguinal hernia repair.


Patient will be approached for participating in the study and will be explained the details of this study. Once the patient agrees, informed consent will be taken. The case will then be recruited into the study in either Light weight mesh or Ultralight weight mesh group depending on intra-op decisions made by the treating surgeon. There will be no pre study randomization. We will assess the factors like intra operative complications, post-operative pain on immediate post-operative days(POD) as follows- POD1, POD2. We will also assess postoperative complications, days of hospital stay after surgery and patients will be followed up at the end of 1, 3 and 6 months via telephonic conversation postoperatively for any chronic pain, recurrence.

 
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