| CTRI Number |
CTRI/2024/10/075816 [Registered on: 24/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized study to compare two laparoscopic methods of ventral hernia repair in terms of post operative pain and other complications |
|
Scientific Title of Study
|
A prospective, randomised controlled study to compare Intraperitoneal Onlay Mesh plus repair versus Transabdominal Pre peritoneal Mesh plus repair for patients with primary 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 |
Varnik Goel |
| Designation |
Junior resident |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Room no. 311, dept of surgical disciplines, Surgery block, AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
8218598006 |
| Fax |
|
| Email |
varnikgoel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamal Kataria |
| Designation |
Additional Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Faculty office, 4th floor,Surgery block, AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9212678920 |
| Fax |
|
| Email |
drkamalkataria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamal Kataria |
| Designation |
Additional Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Faculty office, 4th floor, Surgery block, AIIMS New Delhi
New Delhi
DELHI
110049
India |
| Phone |
9212678920 |
| Fax |
|
| Email |
drkamalkataria@gmail.com |
|
|
Source of Monetary or Material Support
|
| Surgery block, AIIMS New Delhi, New Delhi, India- 110049 |
|
|
Primary Sponsor
|
| Name |
Varnik Goel |
| Address |
Surgery block, AIIMS New Delhi, 110049, India |
| 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 |
| Varnik Goel |
AIIMS |
New Delhi, India- 110049
New Delhi
DELHI |
8218598006
varnikgoel@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for PG research AIIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, (2) ICD-10 Condition: K439||Ventral hernia without obstructionor gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraperitoneal onlay mesh plus repair |
To compare the average pain scores (VAS) between the two groups during first 24 hours postoperatively.
Average total duration is around 120 minutes |
| Comparator Agent |
Trans abdominal pre peritoneal mesh plus repair |
To compare the average pain scores (VAS) between the two groups during first 24 hours postoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with small to medium sized hernias
2. Patients who are fit for general anaesthesia and laparoscopy
3. Providing consent and willing to follow up for 6 months |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Age less than 18 years
3. Patients undergoing emergency surgery
4. Complex and/or large sized hernias
5. Parastomal or recurrent hernias
6. Patients unfit for general anaesthesia
7. Patients not willing to follow up |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the average pain scores (VAS) between the two groups during first 24 hours post-operatively (average of pain scores at 6 hours, 12 hours and 24 hours) |
6 hours, 12 hours, 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Pain scores (VAS) at 6 hours, 12 hours, 48 hours, 2 weeks, 1 month, 3 months and 6 months post operatively
2. To compare the length of hospital stay and operative duration
3. Hernia recurrence during the follow up period
4. Seroma rate, hematoma, any surgical site infection during the follow up period
5. Mesh infection during the follow up period |
6 hours, 12 hours, 48 hours, 2 weeks, 1 month, 3 months and 6 months post operatively |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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)
|
14/11/2024 |
| 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)
|
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
|
Various methods have been designed to treat the ventral abdominal hernias. Initially, open surgeries were mainly performed. However, over the last few decades, laparoscopic treatment of ventral hernias have gained much popularity. Two important laparoscopic methods of ventral abdominal hernia repair- Intraperitoneal onlay mesh plus repair and transabdominal pre peritoneal mesh plus repair are being widely used. Through this RCT, we will be focusing on comparing these two surgical procedures in terms of postoperative pain and other postoperative complications like seroma formation, hernia recurrence, mesh infection and operative time. |