Comparison of Onlay Mesh Repair and Sublay Mesh Repair in Umbilical Hernia Surgery

NCT07367321 | Not Yet Recruiting

• 1 other identifier: BSK-UMH-ONLAY-SUBLAY-2026
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Umbilical hernia is a common condition that is frequently treated with surgical mesh repair to reduce recurrence rates. Among the commonly used techniques, onlay mesh repair and sublay mesh repair are widely performed; however, there is ongoing debate regarding their comparative effectiveness and safety. The aim of this study is to compare onlay mesh repair and sublay mesh repair in patients undergoing elective umbilical hernia surgery, with respect to postoperative complications, recurrence rates, operative outcomes, and length of hospital stay. By evaluating clinical outcomes associated with each technique, this study seeks to contribute evidence to guide the selection of the most appropriate surgical approach for umbilical hernia repair.

Conditions

Onlay Mesh; Umbilical Hernia Repair

Keywords

umbilical hernia repair; onlay mesh repair; sublay mesh repair

Outcome Measures

Primary Outcomes (1)

• Postoperative Complication Rate

  Postoperative complications occurring after umbilical hernia surgery, including surgical site infection, seroma, hematoma, wound-related complications, and other procedure-related adverse events.

  Within 30 days after surgery

Secondary Outcomes (2)

• Hernia Recurrence Rate

  Up to 6 months after surgery

• Postoperative Pain Score

  First 7 days after surgery

Study Arms (2)

Onlay Mesh Repair Group

ACTIVE COMPARATOR

Patients undergoing elective umbilical hernia repair with onlay mesh placement on the anterior fascia.

Procedure: Onlay Mesh Repair

Sublay Mesh Repair Group

ACTIVE COMPARATOR

Patients undergoing elective umbilical hernia repair with sublay mesh placement beneath the fascia (retromuscular or preperitoneal plane).

Procedure: Sublay Mesh Repair

Interventions

Onlay Mesh Repair PROCEDURE

Umbilical hernia repair performed with mesh placement on the anterior fascia following primary fascial closure.

Onlay Mesh Repair Group

Sublay Mesh Repair PROCEDURE

Umbilical hernia repair performed with mesh placement beneath the fascia in the retromuscular or preperitoneal plane.

Sublay Mesh Repair Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 to 90 years
• Patients diagnosed with small or medium-sized umbilical hernia according to the European Hernia Society (EHS) classification
• Patients scheduled for elective umbilical hernia surgery
• Patients who provide written informed consent

You may not qualify if:

• Patients younger than 18 years or older than 90 years
• Patients undergoing emergency umbilical hernia surgery
• Patients with bowel obstruction
• Patients with chronic kidney failure
• Patients with a history of previous abdominal surgery involving the stomach, duodenum, small intestine, or colon

Sponsors & Collaborators

• Bakirkoy Dr. Sadi Konuk Research and Training Hospital: lead

Study Sites (1)

Bakırköy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, 34147, Turkey (Türkiye)

Location

Central Study Contacts

Nurettin Sahin, MD

CONTACT

+905444156661; dr.nurettinsahin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant General Surgeon

Model Details: Participants are assigned to either onlay mesh repair or sublay mesh repair in parallel groups.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)