| CTRI Number |
CTRI/2025/02/080518 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
09/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study of Laparoscopic Hernia Repair in patients of Ventral Hernia to evaluate short term outcomes |
|
Scientific Title of Study
|
A prospective study of laparoscopic IPOM repair in 25 cases OF ventral 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 |
Dr Vibhor Sachdeva |
| Designation |
MS Student |
| Affiliation |
Government Medical College Amritsar |
| Address |
Surgery ward - 3,
Department of General Surgery,
Government Medical College Amritsar,
Circular Road,
Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
7988584580 |
| Fax |
|
| Email |
svibhor1996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Rakesh Sharma |
| Designation |
Professor and Guide |
| Affiliation |
Government Medical College Amritsar |
| Address |
Surgery ward - 3,
Department of General Surgery,
Government Medical College Amritsar,
Circular Road,
Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
7009164040 |
| Fax |
|
| Email |
docrakesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Rakesh Sharma |
| Designation |
Professor and Guide |
| Affiliation |
Government Medical College Amritsar |
| Address |
Surgery ward - 3,
Department of General Surgery,
Government Medical College Amritsar,
Circular Road,
Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
7009164040 |
| Fax |
|
| Email |
docrakesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College, Circular Road, Amritsar, Punjab - 143001 |
| Guru Nanak Dev Hospital, Medical Enclave, Amritsar, Punjab - 143001 |
|
|
Primary Sponsor
|
| Name |
Vibhor Sachdeva |
| Address |
Department of General Surgery, GMC Amritsar, Circular road, amritsar 143001 |
| 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 Vibhor Sachdeva |
Guru Nanak Dev Hospital, Amritsar |
JR room no 1, Surgery Ward -3,General Surgery Department, Government Medical college, Circular Road, Amritsar, Punjab
Amritsar
PUNJAB |
7988584580
svibhor1996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GMC Amritsar Instituional Ethics Committee |
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 |
| Intervention |
Laparoscopic IPOM repair |
Dual layer Composite mesh (PROCEED) with prolene and cellulose layer is used to reduce the hernia contents. Mesh is fixed to the abdominal wall using either Non absorbable tackers (SECURE STRAP) or non absorbable sutures ( Prolene) |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Uncomplicated Primary ventral or incisional hernia defects
2.Midline defect with an expected hernia width equal to or less than 10cm.
3.Elective hernia repair
4.Considered eligible for hernia repair through a minimally-invasive approach
|
|
| ExclusionCriteria |
| Details |
1) Lateral Hernia
2) Emergency procedure (for irreducible, strangulated or obstructed hernia)
3) Body Mass Index (BMI) greater than 40
4) Hernia defects considered to require an open approach.
5) Patient with associated groin hernia
6) Pregnant women
7) Recurrent Hernia
8) Associated Abdominal wall infection |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post-operative pain |
Post-operative pain calculated using Vas score changes at day1, day 7 and day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| mesh fixation time |
measured during operation |
| operative time |
measured during operation |
| duration of hospital stay |
days post operation |
| time to return to daily activity |
days taken to return to work counted from the day of operation |
| any postop complication like ssi, seroma, early recurrence |
upto 30 days post operation |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
27/02/2025 |
| 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="2"
Days="0" |
|
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [svibhor1996@gmail.com].
- For how long will this data be available start date provided 30-04-2025 and end date provided 30-07-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This prospective
study evaluates the short-term outcomes of laparoscopic intraperitoneal onlay
mesh (IPOM) repair in patients with midline primary ventral and incisional hernia. 25 patients with
midline ventral hernias (defect size <10 cm) will be selected based on specific
inclusion criteria. The primary
objectives is to assess postoperative pain using changes in vas scores at different post op days(day 1, day 7, day 30). Secondary objectives are operative time, mesh fixation time, , hospital stay, seroma formation, and recurrence rates at 30 days, time to
return to normal activities, and pain relief requirements 30 days
post-discharge. |