Complication Rate of Onlay vs Sublay Mesh Repair in Incisional Hernia

NCT07401446 | Completed DMC

• 1 other identifier: HMC-QAD-F No. IREB-1221
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

incisional Hernia; Mesh repair; Onlay Mesh repair; sublay Mesh Repair

Outcome Measures

Primary Outcomes (1)

• Postoperative Complication Rate

  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.

  30 days after surgery

Secondary Outcomes (3)

• Length of Hospital Stay

  Number of days From enrollment up to the hospital discharge

• Hernia Recurrence Rate

  Assessed at 6 months and 12 months after surgery

• Operative Time

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

Study Arms (2)

Sublay Mesh Repair

EXPERIMENTAL

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

Procedure: Sublay Mesh Repair

Onlay Mesh Repair

ACTIVE COMPARATOR

Patients underwent open incisional hernia repair with placement of polypropylene mesh over the anterior rectus sheath (onlay technique).

Procedure: Onlay Mesh Repair

Interventions

Sublay Mesh Repair PROCEDURE

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

Sublay Mesh Repair

Onlay Mesh Repair PROCEDURE

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

Onlay Mesh Repair

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead

Study Sites (1)

Hayatabad Medical Complex

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (6)

• Burger JW, Luijendijk RW, Hop WC, Halm JA, Verdaasdonk EG, Jeekel J. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004 Oct;240(4):578-83; discussion 583-5. doi: 10.1097/01.sla.0000141193.08524.e7.

  PMID: 15383785 RESULT

• Walming S, Angenete E, Block M, Bock D, Gessler B, Haglind E. Retrospective review of risk factors for surgical wound dehiscence and incisional hernia. BMC Surg. 2017 Feb 22;17(1):19. doi: 10.1186/s12893-017-0207-0.

  PMID: 28222776 RESULT

• Pereira C, Gururaj S. Onlay Versus Sublay Mesh Repair for Incisional Hernias: A Systematic Review. Cureus. 2023 Jan 24;15(1):e34156. doi: 10.7759/cureus.34156. eCollection 2023 Jan.

  PMID: 36713818 RESULT

• Kohler A, Beldi G. [Recurrence after hernia surgery: complication or natural course?] Chirurg. 2014 Feb;85(2):112-6.

  RESULT

• Rayman S, Gorgov E, Assaf D, Carmeli I, Nevo N, Rachmuth J, Mnouskin Y. Quality of life, post-operative complications, and hernia recurrence following enhanced-view Totally Extra-Peritoneal (eTEP) Rives-Stoppa for incisional and primary ventral hernia repair. Updates Surg. 2023 Oct;75(7):1971-1978. doi: 10.1007/s13304-023-01572-x. Epub 2023 Jun 28.

  PMID: 37378814 RESULT

• Omar I, Zaimis T, Townsend A, Ismaiel M, Wilson J, Magee C. Incisional Hernia: A Surgical Complication or Medical Disease? Cureus. 2023 Dec 15;15(12):e50568. doi: 10.7759/cureus.50568. eCollection 2023 Dec.

  PMID: 38222215 RESULT

MeSH Terms

Conditions

Hernia; Hernia, Abdominal; Incisional Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 10, 2026
• Study Start: August 1, 2020
• Primary Completion: August 31, 2025
• Study Completion: September 15, 2025
• Last Updated: February 10, 2026

Record last verified: 2026-01

Locations

PA (1)