The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Trial

Study Overview
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Brief Summary
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The use of mesh in the repair of umbilical hernias is a gold standard. The best location of the mesh remains a matter of discussion, i.e. it might be placed inside the peritoneal cavity (open intraperitoneal onlay mesh) or between the peritoneum and the muscle layers, so not in contact with the viscera (retromuscular or preperitoneal). The Rebound mesh consists of polypropylene, i.e. the most used fabric for meshes, in combination with a nitinol memory ring. This ring allows the surgeon to position the mesh more flat, with less wrinkling and subsequently better tissue ingrowth. It also saves time for both patient's anesthesia and the surgery. This type of mesh (one coated with PTFE for intra-abdominal use and one pure polypropylene for preperitoneal use), will be used in this multicentric trial, to evaluate the best procedure in terms of efficacy, safety and postoperative complications.

Official Title
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The Flemish Umbilical Nitinol Mesh Trial, a Multicenter Randomized Controlled Trial.

Conditions
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Umbilical Hernia

Intervention / Treatment
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* Procedure: Intraperitoneal mesh placement
* Procedure: Preperitoneal mesh placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: written informed consent from the patient or his/her legal representative primary umbilical hernia requiring elective surgical repair diameter between 0 and 3 cm Exclusion Criteria: no written informed consent incisional hernia at the level of the umbilicus recurrent umbilical hernia, as they have to be considered an incisional hernia emergency surgery (incarcerated hernia) pregnancy non-compliance

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intraperitoneal mesh placement<br>Mesh placement inside the peritoneal cavity | Procedure: Intraperitoneal mesh placement<br>* Mesh placement inside the peritoneal cavity.<br>|
| Active Comparator: Preperitoneal mesh placement<br>Mesh placement between peritoneum and muscle layer. | Procedure: Preperitoneal mesh placement<br>* Mesh placement between peritoneum and muscle layer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation time between preperitoneal mesh placement versus intraperitoneal mesh placement. | Time registration of the operating time will be extracted from the hospital electronic patient files. | Total duration of the operation with an expected average of approximately 45 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical wound morbidity complication rate. |  | Up to 1 year. | 
| Recurrence Rate | Clinical examination will be performed. No ultrasound, unless doubt about recurrence. | up to 2 years | 
| Pain evaluation | A questionnaire and Visual Analog Scale (VAS) will be filled out. The patient is asked whether he or she has pain. Answer NO: VAS = 0, Yes: patient will determine the exact VAS score. | within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years | 
| Discomfort evaluation. | A questionnaire and Visual Analog Scale (VAS) will be filled out. The patient is asked whether he or she has discomfort. Answer NO: VAS = 0, Yes: patient will determine the exact VAS score. | Within 2 weeks prior to surgery, after 4 weeks, after 1 year and after 2 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical Hernia