Umbilical Hernia RepairNCT07367321
Comparison of Onlay Mesh Repair and Sublay Mesh Repair in Umbilical Hernia Surgery
A study testing Onlay Mesh Repair and Sublay Mesh Repair in people with Umbilical Hernia Repair and Onlay Mesh, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Umbilical Hernia Repair, Onlay Mesh
- What is being tested?
- Onlay Mesh Repair and Sublay Mesh Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, 34147
About this study
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.
Read the 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.
- Conditions
- Umbilical Hernia Repair, Onlay Mesh
- Being tested
- Onlay Mesh Repair, Sublay Mesh Repair
- Keywords
- umbilical hernia repair, onlay mesh repair, sublay mesh repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onlay Mesh RepairProcedure or surgery
Umbilical hernia repair performed with mesh placement on the anterior fascia following primary fascial closure.
Sublay Mesh RepairProcedure or surgery
Umbilical hernia repair performed with mesh placement beneath the fascia in the retromuscular or preperitoneal plane.
| Study group | Role | What they receive |
|---|---|---|
| Onlay Mesh Repair Group | Active comparator | Patients undergoing elective umbilical hernia repair with onlay mesh placement on the anterior fascia. Receives: 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). Receives: Procedure: Sublay Mesh Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days after surgery
Secondary outcomes (2)
Hernia Recurrence Rate
Occurrence of recurrent umbilical hernia detected during postoperative follow-up.
Measured: Up to 6 months after surgery
Postoperative Pain Score
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.
Measured: First 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical Hernia RepairStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either onlay mesh repair or sublay mesh repair in parallel groups.
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nurettin Şahin, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367321
- Sponsor's protocol ID
- BSK-UMH-ONLAY-SUBLAY-2026
- Status last verified
- Jun 2026
- First submitted
- 18 Jan 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Onlay Mesh Repair and Sublay Mesh Repair in Umbilical Hernia Surgery
- ClinicalTrials.gov ID
- NCT07367321
- Acronym / sponsor ID
- BSK-UMH-ONLAY-SUBLAY-2026
- Conditions
- Umbilical Hernia Repair, Onlay Mesh
- Keywords
- umbilical hernia repair, onlay mesh repair, sublay mesh repair
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Bakirkoy Dr. Sadi Konuk Research and Training HospitalOther government
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to either onlay mesh repair or sublay mesh repair in parallel groups.
| Arm | Type | Receives |
|---|---|---|
| Onlay Mesh Repair Group | Active comparator | Procedure: Onlay Mesh RepairPatients undergoing elective umbilical hernia repair with onlay mesh placement on the anterior fascia. |
| Sublay Mesh Repair Group | Active comparator | Procedure: Sublay Mesh RepairPatients undergoing elective umbilical hernia repair with sublay mesh placement beneath the fascia (retromuscular or preperitoneal plane). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Onlay Mesh RepairUmbilical hernia repair performed with mesh placement on the anterior fascia following primary fascial closure. | Procedure or surgery | Onlay Mesh Repair Group |
| Sublay Mesh RepairUmbilical hernia repair performed with mesh placement beneath the fascia in the retromuscular or preperitoneal plane. | Procedure or surgery | Sublay Mesh Repair Group |
Primary outcome
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.
2 secondary outcomes
Hernia Recurrence Rate
Time frame: Up to 6 months after surgery
Postoperative Pain Score
Time frame: First 7 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onlay Mesh Repair and Sublay Mesh Repair in people with Umbilical Hernia Repair and Onlay Mesh, run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complication Rate (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2026.