Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A multicenter prospective randomized controlled trial comparing closure versus non-closure of the hernia defect between 2 and 5 cm in width using a tissue separating mesh (Physiomeshâ„¢) in laparoscopic ventral hernia repair.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closure | Active Comparator |
| |
| Non-Closure | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closure of hernia defect. | Procedure | Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seroma formation after 4 weeks. | The seroma formation is checked by clinical evaluation. | 4 weeks after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain, discomfort and esthetic evaluation after 4 weeks. | Pain, discomfort and esthetic evaluation is performed after 4 weeks by clinical evaluation and the Visual Analogue Scale. | 4 weeks after surgery. |
| Pain, discomfort and esthetic evaluation after 1 year. |
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, FACS | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algemeen Stedelijk Ziekenhuis | Aalst | Belgium | ||||
| Imelda Hospital |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| No closure of the hernia defect. | Procedure | Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique). |
|
Pain, discomfort and esthetic evaluation is performed after 1 year by clinical evaluation and the Visual Analogue Scale. |
| 1 year after surgery. |
| Pain, discomfort and esthetic evaluation after 2 years. | Pain, discomfort and esthetic evaluation is performed after 2 years by clinical evaluation and the Visual Analogue Scale. | 2 years after surgery. |
| Bonheiden |
| Belgium |
| St Vincentius Hospital | Deinze | Belgium |
| Ghent University Hospital | Ghent | 9000 | Belgium |
| Maria Middelares | Ghent | 9000 | Belgium |
| Hôpital Mont Godinne | Namur | Belgium |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided