| CTRI Number |
CTRI/2025/05/086738 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
10/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Comparative study between TAPP And Lichtenstein Techniques for inguinal hernia surgery. |
|
Scientific Title of Study
|
A Comparative study between TAPP And Lichtenstein Techniques for inguinal hernia surgery:A prospective study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shubham Chaubey |
| Designation |
Junior Resident |
| Affiliation |
GSVM MEDICAL COLLEGE AND LLR HOSPITAL |
| Address |
Department of General Surgery Gsvm medical college and LLR HOSPITAL kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9795831095 |
| Fax |
|
| Email |
chaubeyshubham047@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G D yadav |
| Designation |
Professor, Head of department, department of general Surgery, GSVM kanpur |
| Affiliation |
GSVM MEDICAL COLLEGE AND LLR HOSPITAL KANPUR |
| Address |
Department of General Surgery LLR HOSPITAL, GSVM medical college, kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9415092218 |
| Fax |
|
| Email |
yadavgd71@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shubham Chaubey |
| Designation |
Junior Resident |
| Affiliation |
Gsvm medical college and LLR HOSPITAL KANPUR |
| Address |
Department of general Surgery, LLR hospital, GSVM Medical college, kanpur
Kanpur Nagar
UTTAR PRADESH
208002
India |
| Phone |
9795831095 |
| Fax |
|
| Email |
chaubeyshubham047@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gsvm medical college and LLR HOSPITAL KANPUR pincode 208002 |
|
|
Primary Sponsor
|
| Name |
Shubham Chaubey |
| Address |
Department of General Surgery,LLR Hospital,GSVM Medical college, kanpur, Uttar Pradesh, India pincode 208002 |
| 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 Shubham Chaubey |
GSVM Medical college and LLR HOSPITAL |
Surgery wards,Department of General Surgery
Kanpur Nagar
UTTAR PRADESH |
9795831095
chaubeyshubham047@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee ( For Biomedical Health and Research), GSVM MEDICAL COLLEGE KANPUR |
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 |
Lichtenstein Repair |
Lichtenstein hernia repair is a widely used surgical technique for fixing inguinal hernia.Standard of care.It is considered a tension-free mesh repair, meaning it reinforces the weakened area with synthetic mesh rather than suturing tissues under tension. |
| Intervention |
TAPP (Transabdominal Preperitoneal) |
TAPP Hernia Repair stands for TransAbdominal PrePeritoneal hernia repair. It is a minimally invasive (laparoscopic) surgical technique used to repair inguinal hernias. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Between 18 years and 80 years, of either
sex, having hernia of the following types: unilateral or bilateral un-
complicated inguinal hernia, primary inguinal hernia, or
direct and indirect inguinal hernia. |
|
| ExclusionCriteria |
| Details |
Patient who are not fit for general anaesthesia ,obstructed/incarcerated hernia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Operative time
Surgical site infection
Seroma
Postoperative ileus
Bowel or Visceral injury
Vascular complications
Mesh infection
Recurrences
Post operative pain |
Intraoperative
Postoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Cost effectiveness of the two procedure
Quality of Life assessment |
3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/05/2025 |
| 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="0"
Months="0"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A Comparative Study Between TAPP and Lichtenstein Techniques for Inguinal Hernia Surgery.The study will be conducted in surgery department of GSVM MEDICAL COLLEGE KANPUR INDIA.Sample size of 60 patient . Primary outcomes measure will be operative time , surgical site infection, Seroma , postoperative ileus, Bowel or Viscera injury, mesh infection , recurrence , post operative pain and secondary outcomes are cost effectiveness and Quality of Life |