Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medri | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraperitoneal mesh placement | Experimental | Mesh placement inside the peritoneal cavity |
|
| Preperitoneal mesh placement | Active Comparator | Mesh placement between peritoneum and muscle layer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraperitoneal mesh placement | Procedure | Mesh placement inside the peritoneal cavity. |
|
| 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. |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Frederik Berrevoet, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASZ Aalst | Aalst | 9300 | Belgium | |||
| Ghent University Hospital |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D006554 | Hernia, Umbilical |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006555 | Hernia, Ventral |
| D046449 | Hernia, Abdominal |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Preperitoneal mesh placement | Procedure | Mesh placement between peritoneum and muscle layer. |
|
| 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. |
| Ghent |
| 9000 |
| Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |