| CTRI Number |
CTRI/2025/12/099168 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
15/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing outcome between Onlay and Sublay mesh repair in treatment of ventral hernias |
|
Scientific Title of Study
|
A randomized control trial to evaluate the effectiveness of onlay and sublay mesh repair in the treatment 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 |
U Kavitha |
| Designation |
Post graduate in general surgery |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Aarupadai Veedu Medical College
C block,Department of general surgery ,Aarupadai Veedu Medical College ,Kirumpapakkum ,Pondicherry
Pondicherry
607402
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9655275757 |
| Fax |
|
| Email |
Kavithauthiraswamy96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. T.RAMACHANDRUDU |
| Designation |
Professor |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Aarupadai Veedu Medical College
C block,Department of general surgery ,Aarupadai Veedu Medical College ,Kirumpapakkum ,Pondicherry
Pondicherry
607402
India
Pondicherry
PONDICHERRY
607403
India |
| Phone |
8608702876 |
| Fax |
|
| Email |
ramachandrvudu.subramanian@avmc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
U Kavitha |
| Designation |
Post graduate in general surgery |
| Affiliation |
Aarupadai Veedu Medical College |
| Address |
Aarupadai Veedu Medical College
C block,Department of general surgery ,Aarupadai Veedu Medical College ,Kirumpapakkum ,Pondicherry
Pondicherry
607402
India
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9655275757 |
| Fax |
|
| Email |
Kavithauthiraswamy96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aarupadai Veedu Medical College,Kirumpapakkum,Pondicherry,607403 |
|
|
Primary Sponsor
|
| Name |
Aarupadai Veedu Medical College |
| Address |
Aarupadai Veedu Medical College
C block ,Department of general surgery ,Kirumpapakkum,Pondicherry -607402 |
| Type of Sponsor |
Private 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 |
| Drkavitha |
Aarupadai Veedu Medical College |
Room no. 10, C block, Department of General surgery, Aarupadai Veedu Medical
College and hospital, Kirumampakkam, Pondicherry 607402
Pondicherry
PONDICHERRY |
9655275757
Kavithauthiraswamy96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human 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 |
Arm A – Onlay Mesh Repair.
Ventral hernia repair using polypropylene mesh placed in the onlay (suprafascial) position.
Arm B – Sublay Mesh Repair.
Ventral hernia repair using polypropylene mesh placed in the sublay (retromuscular/preperitoneal) position. |
Arm A – Onlay Mesh Repair
Patients randomized to this arm will undergo open ventral hernia repair using onlay mesh technique.
After reduction of hernia contents and primary closure of the fascial defect, a polypropylene mesh will be placed over the anterior rectus sheath (suprafascial plane) . The mesh will be fixed using non-absorbable sutures.
Arm B – Sublay Mesh Repair
Patients randomized to this arm will undergo open ventral hernia repair using sublay mesh technique.
Following reduction of hernia contents, a retromuscular/preperitoneal space will be created. The fascial defect will be closed, and a polypropylene mesh will be placed posterior to the rectus muscles (sublay position) with a minimum 5 cm overlap on all sides.
|
| Comparator Agent |
Onlay versus sublay mesh repair in the treatment of ventral hernia . |
If arm A is onlay mesh repair then comparator agent will be sublay mesh repair.
If arm B is sublay mesh repair then comparator agent will be onlay mesh repair. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 to 75 years diagnosed with primary or incisional ventral hernia.
2.Fit for elective surgical repair using mesh.
3.Consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Recurrent hernias.
2.Immunocompromised patients or on steroids.
3. Emergency hernia surgeries.
4.Known hypersensitivity to cyanoacrylate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the duration of surgery and early postoperative complications
like seroma, surgical site infections, flap necrosis and duration of hospital stay in sublay
and onlay mesh repair in the treatment of ventral hernias |
Assessing post operative seroma formation,flap necrosis on 6hrs,1 day,3rd and 7th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the duration of surgery & early postoperative complications
like seroma, surgical site infections, flap necrosis & duration of hospital stay in sublay & onlay mesh repair in the treatment of ventral hernia. Need for postoperative interventions, such as aspiration of seroma or wound resuturing, within the first 7 postoperative days.early wound-related morbidity, including wound edema or hematoma, assessed during the early postoperative period. |
Time-specific assessment of postoperative seroma formation at 6 hours, postoperative day 1 day 3 & day 7.
Time-specific assessment of flap necrosis at 6 hours, postoperative day 1 day 3 & day 7.
Postoperative pain assessment, measured using the Visual Analogue Scale (VAS) at 24 hours, day 3, & day 7.
|
|
|
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 4 |
|
Date of First Enrollment (India)
|
30/12/2025 |
| 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="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
|
After the clearance from the IRC and IEC, sampling of 80 patients for onlay mesh repair and sublay mesh repair attending op and IP service during the study period mentioned, fulfilling the inclusion and exclusion criteria already listed above will be recruited for the study, after obtaining informed consent .The nature, purpose, and the roles in the study will be explained in detailed, including the information that their non-participation in the study would not affect the quality of the treatment that they are to receive and that they are free exit the study at any time. After assuring that their response would remain confidential, an informed written consent for the same shall be obtained from the all participants .Patients will be subjected to clinical examination and evaluated for vitals and clinical signs. Investigations such complete blood count, urine routine and microscopy, urea, electrolytes,serum creatinine and liver function test will be done Patients will be randomized into two groups of 40 patients in each group. Onlay mesh repair and sublay mesh repair will be performed for both the groups by the same surgeon. In one group onlay mesh repair and in the other group sublay mesh repair will be performed .Duration of surgery intra operative complications, ease of use (surgeon perceived), post operative complication, duration of post operative hospital stay evaluated. |