Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.

Study Overview
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Brief Summary
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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 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.

Official Title
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Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.

Conditions
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Primary and Secondary Ventral Hernia

Intervention / Treatment
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* Procedure: Placing the resorbable mesh
* Procedure: Non-resorbable synthetic mesh.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary and secondary ventral hernia less than 20 cm in length less than 6 cm in width Exclusion Criteria:

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Resorbable mesh<br>Long-term resorbable mesh implanted to treat primary and secondary ventral hernia. | Procedure: Placing the resorbable mesh<br>* Surgery for primary and secondary ventral hernia repair with placing of resorbable mesh.<br>|
| Active Comparator: Non-resorbable mesh<br>Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia. | Procedure: Non-resorbable synthetic mesh.<br>* Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventral hernia