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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07401446
Enrollment
350
Registered
2026-02-10
Start date
2020-08-01
Completion date
2025-09-15
Last updated
2026-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

incisional Hernia, Mesh repair, Onlay Mesh repair, sublay Mesh Repair

Brief 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.

Interventions

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

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

Sponsors

Hayat Abad Medical Complex, Peshawar
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

This was an open-label study. Due to the nature of the surgical interventions, neither participants nor healthcare providers nor outcome assessors were blinded to the assigned intervention.

Intervention model description

This study uses a parallel group randomized design in which eligible participants were randomly assigned to one of two intervention arms. One group underwent sublay mesh repair, and the other group underwent onlay mesh repair for incisional hernia. Participants received only the intervention assigned to their group, and outcomes were compared between the two groups over a three-month follow-up period.

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Complication Rate30 days after surgeryIncidence 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

MeasureTime frameDescription
Length of Hospital StayNumber of days From enrollment up to the hospital dischargeDuration of hospitalization following surgery in both study groups for this single disease.
Hernia Recurrence RateAssessed at 6 months and 12 months after surgeryNumber of patients with hernia recurrence within 6 months and 12 months postoperatively.
Operative TimeDuring the index surgical procedure (from skin incision to skin closure)Total duration of surgery from incision to closure for onlay and sublay procedures.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026