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

January 25, 2026 updated by: Nurettin Şahin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Umbilical hernia repair is one of the most commonly performed general surgical procedures. The use of prosthetic mesh has been shown to significantly reduce recurrence rates compared with primary suture repair. Among mesh-based techniques, onlay and sublay mesh repairs are frequently utilized, each with distinct technical characteristics and potential advantages and disadvantages.

In onlay mesh repair, the mesh is placed over the anterior fascia following primary fascial closure, whereas in sublay mesh repair, the mesh is positioned in the retromuscular or preperitoneal plane. While sublay mesh repair is often considered to provide better mesh integration and lower recurrence rates, it may be associated with longer operative times and increased technical complexity. Conversely, onlay mesh repair is technically simpler but has been associated with higher rates of wound-related complications in some studies. The optimal technique for umbilical hernia repair remains a subject of ongoing investigation.

This study is designed as a comparative clinical analysis of patients undergoing elective umbilical hernia surgery using either onlay mesh repair or sublay mesh repair. Adult patients who meet the eligibility criteria will be included. Demographic characteristics, hernia features, operative details, and perioperative outcomes will be recorded.

Primary outcome measures will include postoperative complication rates and hernia recurrence. Secondary outcome measures will include operative time, length of hospital stay, and early postoperative morbidity. Patients will be followed postoperatively according to standard clinical practice to assess surgical outcomes.

The results of this study are expected to provide comparative data on the safety and effectiveness of onlay and sublay mesh repair techniques in umbilical hernia surgery and to support evidence-based decision-making in clinical practice.

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Onlay Mesh Repair Group
Patients undergoing elective umbilical hernia repair with onlay mesh placement on the anterior fascia.
Procedure: Onlay Mesh Repair
Umbilical hernia repair performed with mesh placement on the anterior fascia following primary fascial closure.
Active Comparator: Sublay Mesh Repair Group
Patients undergoing elective umbilical hernia repair with sublay mesh placement beneath the fascia (retromuscular or preperitoneal plane).
Procedure: Sublay Mesh Repair
Umbilical hernia repair performed with mesh placement beneath the fascia in the retromuscular or preperitoneal plane.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Complication Rate
Time Frame: Within 30 days after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hernia Recurrence Rate
Time Frame: Up to 6 months after surgery
Occurrence of recurrent umbilical hernia detected during postoperative follow-up.
Up to 6 months after surgery
Postoperative Pain Score
Time Frame: First 7 days after surgery
Postoperative pain assessed using the Visual Analog Scale for Pain, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate worse pain severity.
First 7 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BSK-UMH-ONLAY-SUBLAY-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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