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

Ghent University Hospital (UZ)

Status: Completed

Conditions: Primary and Secondary Ventral Hernia

Treatments: Procedure: Placing the resorbable mesh; Procedure: Non-resorbable synthetic mesh.

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01622725

2012/223

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Primary and secondary ventral hernia

  • less than 20 cm in length
  • less than 6 cm in width

Exclusion Criteria:

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups

Resorbable mesh

Experimental group

Description:

Long-term resorbable mesh implanted to treat primary and secondary ventral hernia.

Treatment:

Procedure: Placing the resorbable mesh

Non-resorbable mesh

Active Comparator group

Description:

Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia.

Treatment:

Procedure: Non-resorbable synthetic mesh.