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| Name | Class |
|---|---|
| Novus Scientific | INDUSTRY |
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Since abdominal wall hernia repair is currently performed with the use of a mesh, side effects associated with the mesh are frequently reported during long term follow-up. These side effects are related to shrinkage of the mesh, adhesions to the bowl, pain, and inflammation of the skin and bowl. To reduce or prevent these effects, a fully resorbing mesh has been developed, which provides sufficient support and strength to allow efficient recovery of the abdominal wall, but also disappear from your body in three years time, so that you no longer have any synthetic material in your body. Previous resorbing meshes also disappeared but over a much shorter period of time, so that the hernia was insufficiently healed, with recurrence as a result.
The TIGRâ„¢ mesh (the resorbable mesh used in the study) is in principle a synthetic mesh, made of two commonly used polymers, however it will retain 50% of its initial strength after six months. This in theory is enough to provide support of the collagen healing process during the initial wound-healing phase, but also to support the transition of initial collagen to functional collagen.
The aim of this study is to compare TIGRâ„¢ with large pore mesh used in the repair of the anterior abdominal wall repair (incisional hernia, umbilical hernia, etc..Inguinal hernias are not part of the study).
Therefore the patients will be divided into two groups, one group will be treated with a resorbing mesh, the other group will be treated with a permanent mesh. Otherwise there will be no difference in the medication or the surgical techniques used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Resorbable mesh | Experimental | Long-term resorbable mesh implanted to treat primary and secondary ventral hernia. |
|
| Non-resorbable mesh | Active Comparator | Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placing the resorbable mesh | Procedure | Surgery for primary and secondary ventral hernia repair with placing of resorbable mesh. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence rate at 3 years post-surgery. | Clinical evaluation and ultrasound evaluation after 3 years post-surgery. | 3 years post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Wound Morbidity 4 weeks post-surgery. | 4 weeks post-surgery | |
| Pain and discomfort after 1 year post-surgery. | After 1 year post-surgery | |
| Pain and discomfort after 3 years post-surgery. |
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Inclusion Criteria:
Primary and secondary ventral hernia
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederik Berrevoet, MD, PhD | University Hospital, Ghent | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghent University Hospital | Ghent | 9000 | Belgium | |||
| University Hospital Leuven |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Non-resorbable synthetic mesh. | Procedure | Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh. |
|
| After 3 years post-surgery |
| Recurrence rate by clinical examination 1 year post-surgery. | Clinical Examination to determine the recurrence rate. | After 1 year post-surgery. |
| Leuven |
| 3000 |
| Belgium |
| University of Copenhagen | Copenhagen | DK-2400 | Denmark |
| ul Jagalskiego | Wejherowo | 84-200 | Poland |
| Hospital de 12 Octobre | Madrid | Spain |
| Royal Infirmary of Edinburgh | Edinburgh | EH16 4SA | United Kingdom |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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