Comparison of Sublay and Onlay Mesh Repair in Ventral Hernia

NCT07140471 | Completed

• 1 other identifier: IHHN_IRB_2023_05_026
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventral Hernia; Incisional Hernia

Keywords

Sublay Mesh Repair; Onlay Mesh Repair; Polypropylene Mesh; Hernia Surgery; Wound Infection; Seroma Formation; Hernia Recurrence; Randomized Controlled Trial; Open Hernia Repair

Outcome Measures

Primary Outcomes (3)

• Incidence of surgical wound infection

  Wound infection was assessed based on CDC criteria: fever \>38°C, erythema, purulent discharge, or swelling at the surgical site. Evaluated daily during hospitalization and at 2-week follow-up.

  Within 30 days after surgery

• Incidence of seroma formation

  Seroma defined as subcutaneous fluid accumulation confirmed by clinical exam and ultrasonography. Evaluated during follow-up visits.

  Within 30 days postoperatively

• Hernia recurrence rate

  Recurrence assessed through physical examination and confirmed via ultrasonography at 6 months after surgery.

  6-month follow-up

Secondary Outcomes (3)

• Mean operative time

  Time in minutes from skin incision to skin closure, recorded intraoperatively.

• Length of postoperative hospital stay

  From the day of surgery until hospital discharge (average of 3-7 days).

• Postoperative pain score

  At 6 hours, 24 hours, and 48 hours after surgery, and then every 48 hours thereafter until hospital discharge

Study Arms (2)

Onlay Mesh Repair

ACTIVE COMPARATOR

Participants underwent onlay mesh repair, where the polypropylene mesh was placed over the anterior rectus sheath after hernia reduction and defect closure.

Procedure: Onlay Mesh Repair

Sublay Mesh Repair

EXPERIMENTAL

Participants underwent sublay mesh repair, where the polypropylene mesh was placed in the retrorectus space after posterior sheath dissection.

Procedure: Sublay Mesh Repair

Interventions

Onlay Mesh Repair PROCEDURE

Polypropylene mesh is placed over the anterior rectus sheath and fixed with Prolene sutures after hernia sac reduction.

Onlay Mesh Repair

Sublay Mesh Repair PROCEDURE

Polypropylene mesh placed in the retrorectus space and fixed with Prolene sutures after Rectus Sheath Dissection

Sublay Mesh Repair

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 60 years
• Primary or incisional ventral abdominal wall hernia
• Hernia defect size between 40-100 mm
• Duration of hernia ≥6 months
• Suitable for open mesh hernioplasty
• Written informed consent provided

You may not qualify if:

• Diabetes mellitus \>5 years
• Chronic liver disease
• Obstructed or strangulated hernia
• Immunocompromised status
• Severe cardiopulmonary disease or contraindications to general anesthesia
• Pregnant or lactating women
• Inability to attend follow-up visits

Sponsors & Collaborators

• Sana Ehsan ullah: lead

Study Sites (1)

Recep Tayyip Erdogan Hospital

Muzaffargarh, Punjab Province, 34200, Pakistan

Location

MeSH Terms

Conditions

Hernia, Ventral; Incisional Hernia; Wound Infection

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This was an open-label study with no masking.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Senior Registrar

Model Details: Participants were randomized into two parallel arms: one receiving onlay mesh repair and the other receiving sublay mesh repair.

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 24, 2025
• Study Start: February 1, 2022
• Primary Completion: August 28, 2023
• Study Completion: August 28, 2023
• Last Updated: August 24, 2025

Record last verified: 2025-08

Locations

PA (1)