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
|
|
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
|
|
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. |