| CTRI Number |
CTRI/2026/01/101234 [Registered on: 15/01/2026] Trial Registered Prospectively |
| Last Modified On: |
12/01/2026 |
| 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
|
A clinical trial to compare the outcome of ultralight weight and lightweight mesh in inguinal hernia surgery |
|
Scientific Title of Study
|
A comparative study of the outcome of ultralight weight and light weight polypropylene mesh in Lichtenstein repair of inguinal hernia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ekansh Hemant Singh |
| Designation |
Junior Resident |
| Affiliation |
Ganesh Shankar Vidyarthi Memorial Medical College |
| Address |
Department of general surgery, LLR Hospital, GSVM Medical College, Swaroop Nagar , Kanpur
Swaroop nagar
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9721268563 |
| Fax |
|
| Email |
ekansh1805@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Raj Kumar Singh |
| Designation |
Professor |
| Affiliation |
Ganesh Shankar Vidyarthi Memorial Medical College |
| Address |
Department of General Surgery, Ganesh Shankar Vidyarthi Memorial Medical College , Swaroop Nagar , Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
8572917122 |
| Fax |
|
| Email |
rksingh.surg@mail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ekansh Hemant Singh |
| Designation |
Junior Resident |
| Affiliation |
Ganesh Shankar Vidyarthi Memorial Medical College |
| Address |
Department of general surgery ,LLR Hospital,Ganesh Shankar Vidyarthi Memorial Medical College , Swaroop Nagar , Kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9721268563 |
| Fax |
|
| Email |
ekansh1805@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of General Surgery ,Ganesh Shankar Vidyarthi Memorial Medical College, Swaroop Nagar, Kanpur Uttar Pradesh ,India 208002 |
|
|
Primary Sponsor
|
| Name |
Ganesh Shankar Vidyarthi Memorial Medical College |
| Address |
Ganesh Shankar Vidyarthi Memorial Medical College, Swaroop Nagar, Kanpur , Uttar Pradesh 208002 |
| Type of Sponsor |
Government 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 |
| D Ekansh Hemant Singh |
Department of General Surgery , LLR Hospital,Ganesh Shankar Vidyarthi Memorial Medical College |
Swaroop Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH |
9721268563
ekansh1805@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee, GSVM Medical College |
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 |
| Comparator Agent |
hernioplasty with light weight mesh |
Lichtenstein repair of inguinal hernia with light weight mesh which weighs less than 45 gsm |
| Intervention |
hernioplasty with ultralight weight mesh |
Lichtenstein repair of inguinal hernia with ultralight weight mesh |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
unilateral or bilateral inguinal hernia |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. PAIN AND DISCOMFORT
2. RECURRENCE |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/01/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Randomised control trial to compare and analyse the differences between Ultralight weight (<35g/m2) and light weight (>35 to 70 g/m2) Polypropylene Mesh (7.5 by 15 cm) in Lichtenstein repair of inguinal hernia at tertiary care centre for 1. Pain and discomfort 2. Recurrence |