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Completed

NCT Number: NCT07140471

Comparison of Sublay and Onlay Mesh Repair in Ventral Hernia

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.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Incisional Hernia Infections Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Wound Infection

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Recep Tayyip Erdogan Hospital

Muzaffargarh, Punjab Province, 34200, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Onlay Mesh Repair

Procedure

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

Sublay Mesh Repair

Procedure

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

Primary outcomes

  1. Incidence of surgical wound infection

    Time frame: Within 30 days after surgery

    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.

  2. Incidence of seroma formation

    Time frame: Within 30 days postoperatively

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

  3. Hernia recurrence rate

    Time frame: 6-month follow-up

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

Secondary outcomes

  1. Mean operative time

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

    During surgery

  2. Length of postoperative hospital stay

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

    Number of days from surgery to discharge recorded for each participant.

  3. Postoperative pain score

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

    Pain evaluated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain) during inpatient stay.

Sponsors and collaborators

Lead sponsor

Sana Ehsan ullah

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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