NCT07401446

Complication Rate of Onlay vs Sublay Mesh Repair in Incisional Hernia

Comparison of Complication Rates of Onlay vs Sublay Mesh Repair of Incisional Hernia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Hayat Abad Medical Complex, Peshawar · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial was conducted at the Department of Surgery, Hayatabad Medical Complex, Peshawar. Eligible patients with incisional hernia were randomized into two parallel groups: sublay mesh repair and onlay mesh repair. Procedures were performed by a single experienced general surgeon. Postoperative complications were assessed by an independent surgeon blinded to the type of procedure. Patients were followed for a period of three months to evaluate safety and recurrence outcomes.

Detailed description

Incisional hernia is a frequent postoperative complication following abdominal surgery and represents a significant source of morbidity due to discomfort, impaired quality of life, and risk of recurrence. Mesh reinforcement has become the standard approach for incisional hernia repair; however, the optimal anatomical position of mesh placement remains debated. Among the commonly used techniques, onlay mesh repair involves placement of mesh over the anterior rectus sheath, while sublay mesh repair places the mesh in the retromuscular preperitoneal plane. Each technique differs in operative dissection, tissue handling, and potential risk of postoperative complications. This randomized controlled trial was conducted at the Department of Surgery, Hayatabad Medical Complex, Peshawar, to compare postoperative outcomes of onlay versus sublay mesh repair in patients undergoing elective incisional hernia repair. Adult patients aged 18 to 60 years presenting with incisional hernia and meeting predefined eligibility criteria were enrolled after providing written informed consent. Patients with recurrent, strangulated, or obstructed hernias, severe comorbid conditions, high anesthetic risk, or morbid obesity were excluded to minimize confounding factors. Eligible participants were randomly allocated into two parallel groups using a lottery method. Patients assigned to Group A underwent sublay mesh repair, while those in Group B received onlay mesh repair. All surgical procedures were performed by a single experienced general surgeon to ensure procedural consistency. Standardized perioperative care protocols were followed for all patients. Postoperatively, patients were monitored during hospital admission and followed in outpatient clinics for a period of three months. Assessment of postoperative complications, including wound infection, seroma, hematoma, and hernia recurrence, was carried out by an independent surgeon who was blinded to the surgical technique used. This masking approach was adopted to reduce assessment bias. The primary objective of the study was to compare the overall postoperative complication rates between the two mesh placement techniques. Secondary objectives included evaluation of individual complication rates and recurrence during the follow-up period. Data were collected using a structured proforma and analyzed using standard statistical methods to determine differences between groups. The findings of this study aim to provide evidence-based guidance regarding the safety and effectiveness of mesh placement techniques in incisional hernia repair and to assist surgeons in selecting an optimal approach that minimizes postoperative complications and recurrence.

Conditions

• Hernia
• Ventral Hernia Repair
• Incisional Hernia Repair
• Abdominal Wall Hernia
• Synthetic Mesh

Interventions

Type	Name	Description
PROCEDURE	Sublay Mesh Repair	Patients underwent open incisional hernia repair with placement of polypropylene mesh in the retromuscular preperitoneal (sublay) plane.
PROCEDURE	Onlay Mesh Repair	Placement of polypropylene mesh over the anterior rectus sheath during open incisional hernia repair.

Timeline

• Start date: 2020-08-01
• Primary completion: 2025-08-31
• Completion: 2025-09-15
• First posted: 2026-02-10
• Last updated: 2026-02-10

Locations

1 site across 1 country: Pakistan