Primary and Secondary Ventral Hernia Clinical Trial
— TIGROfficial title:
Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
| Verified date | May 2024 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 TIGR™ 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 TIGR™ 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.
| Status | Completed |
| Enrollment | 95 |
| Est. completion date | December 31, 2023 |
| Est. primary completion date | August 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Primary and secondary ventral hernia - less than 20 cm in length - less than 6 cm in width Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Ghent University Hospital | Ghent | |
| Belgium | University Hospital Leuven | Leuven | |
| Denmark | University of Copenhagen | Copenhagen | |
| Poland | ul Jagalskiego | Wejherowo | |
| Spain | Hospital de 12 Octobre | Madrid | |
| United Kingdom | Royal Infirmary of Edinburgh | Edinburgh |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent | Novus Scientific |
Belgium, Denmark, Poland, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Recurrence rate at 3 years post-surgery. | Clinical evaluation and ultrasound evaluation after 3 years post-surgery. | 3 years post-surgery | |
| Secondary | Wound Morbidity 4 weeks post-surgery. | 4 weeks post-surgery | ||
| Secondary | Pain and discomfort after 1 year post-surgery. | After 1 year post-surgery | ||
| Secondary | Pain and discomfort after 3 years post-surgery. | After 3 years post-surgery | ||
| Secondary | Recurrence rate by clinical examination 1 year post-surgery. | Clinical Examination to determine the recurrence rate. | After 1 year post-surgery. |