Clinical Trials Directory

Trials / Completed

CompletedNCT07140471

Comparison of Sublay and Onlay Mesh Repair in Ventral Hernia

Comparison of Sublay Versus Onlay Mesh Repair for Ventral Abdominal Wall Hernia: A Randomized Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
96 (actual)
Sponsor
Sana Ehsan ullah · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

This study is designed to compare two different surgical methods for repairing ventral abdominal wall hernias: sublay mesh repair and onlay mesh repair. Ventral hernias are common and occur when tissue pushes through a weak spot in the abdominal wall. Both sublay and onlay techniques involve placing a synthetic mesh to strengthen the abdominal wall, but the position of the mesh differs. This trial will evaluate postoperative outcomes, including surgical wound infections, seroma (fluid buildup), and hernia recurrence, over a six-month follow-up period. The findings are expected to help inform surgical decision-making, particularly in resource-limited hospitals.

Detailed description

This prospective, open-label, randomized controlled trial aims to compare outcomes between sublay and onlay mesh repair techniques in patients with ventral abdominal wall hernias. The study is being conducted at Recep Tayyip Erdogan Hospital, Muzaffargarh, Pakistan, from February 2022 to August 2023. A total of 96 patients aged 18-60 years with primary or incisional ventral hernias (defect size 40-100 mm) are included. Patients are randomized into two groups: Group A undergoes onlay mesh repair, and Group B undergoes sublay mesh repair. Both procedures involve placement of macroporous polypropylene mesh with appropriate overlap and standard fixation techniques. Primary outcomes include wound infection (as per CDC criteria), seroma formation (confirmed by ultrasound), and hernia recurrence (clinically and via ultrasonography) at six-month follow-up. Secondary outcomes include operative time, postoperative pain (measured via visual analog scale), and hospital stay duration. Data analysis will be performed using SPSS v26.0.

Conditions

Interventions

TypeNameDescription
PROCEDUREOnlay Mesh RepairPolypropylene mesh is placed over the anterior rectus sheath and fixed with Prolene sutures after hernia sac reduction.
PROCEDURESublay Mesh RepairPolypropylene mesh placed in the retrorectus space and fixed with Prolene sutures after Rectus Sheath Dissection

Timeline

Start date
2022-02-01
Primary completion
2023-08-28
Completion
2023-08-28
First posted
2025-08-24
Last updated
2025-08-24

Locations

1 site across 1 country: Pakistan

Source: ClinicalTrials.gov record NCT07140471. Inclusion in this directory is not an endorsement.