Comparison of Sublay and Onlay Mesh Repair in Ventral Hernia

NCT ID: NCT07140471

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-01
• Study Completion Date: 2023-08-28

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.

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

Ventral Hernia; Incisional Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Onlay Mesh Repair

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

Group Type: ACTIVE_COMPARATOR

Onlay Mesh Repair

Intervention Type: PROCEDURE

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

Sublay Mesh Repair

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

Group Type: EXPERIMENTAL

Sublay Mesh Repair

Intervention Type: PROCEDURE

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

Interventions

Onlay Mesh Repair

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

Intervention Type: PROCEDURE

Sublay Mesh Repair

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sana Ehsan ullah

OTHER

Sponsor Role: lead

Responsible Party

Sana Ehsan ullah

Principal Investigator and Senior Registrar

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Recep Tayyip Erdogan Hospital

Muzaffargarh, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IHHN_IRB_2023_05_026

Identifier Type: -

Identifier Source: org_study_id