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Completed

NCT Number: NCT07401446

Complication Rate of Onlay vs Sublay Mesh Repair in Incisional Hernia

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hayatabad Medical Complex

Peshawar, KPK, 25000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults aged 18-60 years.
  • Patients diagnosed with primary incisional hernia on clinical examination.
  • Hernia suitable for open surgical repair with mesh.
  • Both male and female patients.
  • Patients able and willing to provide written informed consent.

Exclusion criteria

  • Obstructed or strangulated hernia on presentation.
  • Recurrent incisional hernia.
  • Patients with BMI > 40.
  • Patients with debilitating chronic diseases, including:
  • Chronic liver disease
  • Chronic renal impairment
  • Chronic cardiac disease
  • Chronic pulmonary disease
  • Patients with American Society of Anesthesiologists (ASA) physical status ≥ 3.
  • Patients unfit for general anesthesia.
  • Patients unable or unwilling to follow up for postoperative assessment.

Treatment and study plan

Sublay Mesh Repair

Procedure

Patients underwent open incisional hernia repair with placement of polypropylene mesh in the retromuscular preperitoneal (sublay) plane.

Onlay Mesh Repair

Procedure

Placement of polypropylene mesh over the anterior rectus sheath during open incisional hernia repair.

Primary outcomes

  1. Postoperative Complication Rate

    Time frame: 30 days after surgery

    Incidence of complications within 30 days after surgery, including wound infection, seroma, hematoma, and hernia recurrence, in patients undergoing onlay versus sublay mesh repair of incisional hernia.

Secondary outcomes

  1. Length of Hospital Stay

    Time frame: Number of days From enrollment up to the hospital discharge

    Duration of hospitalization following surgery in both study groups for this single disease.

  2. Hernia Recurrence Rate

    Time frame: Assessed at 6 months and 12 months after surgery

    Number of patients with hernia recurrence within 6 months and 12 months postoperatively.

  3. Operative Time

    Time frame: During the index surgical procedure (from skin incision to skin closure)

    Total duration of surgery from incision to closure for onlay and sublay procedures.

Sponsors and collaborators

Lead sponsor

Hayat Abad Medical Complex, Peshawar

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

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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