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| Name | Class |
|---|---|
| Johnson & Johnson | INDUSTRY |
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For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or the use of mesh continues.
About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of using this patch, recent experience showed several drawbacks both in design and efficacy (3).
With the recent development of the Proceed Ventral Patch (PVP), new elements have been introduced to overcome some of these issues.
The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the intra-abdominal position in the treatment of small ventral hernias.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proceed Ventral Patch placement | Experimental | Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proceed Ventral Patch placement | Device | Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of adequately placed patches | At T 0 days |
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative morbidity rate | Within 30 days | |
| Pre- and postoperative pain | At T 0 day, T 30 days and T 1 year | |
| Number of patients needed a repositioning of the patch |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederik Berrevoet, MD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Hospital | Bonheiden | Belgium | ||||
| University Hospital Ghent |
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| Label | URL |
|---|---|
| Website of University Hospital Ghent | View source |
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| ID | Term |
|---|---|
| D006554 | Hernia, Umbilical |
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
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| At T 0 days |
| Reasons for inadequate positioning | At T 0 days |
| Number of repositioning necessary | At T 0 days |
| Complication ratio | At 1 year |
| Recurrence rate at 1 year | At 1 year |
| Ghent |
| 9000 |
| Belgium |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |