Clinical trial NCT01622725: Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
Official title: Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary and Secondary Ventral Hernia
Keywords: ventral hernia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Novus Scientific
First posted: 2012-06-19
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Primary and secondary ventral hernia

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

Exclusion Criteria:

Primary outcomes:
measure: Recurrence rate at 3 years post-surgery.
timeFrame: 3 years post-surgery
Secondary outcomes:
measure: Wound Morbidity 4 weeks post-surgery.
timeFrame: 4 weeks post-surgery
measure: Pain and discomfort after 1 year post-surgery.
timeFrame: After 1 year post-surgery
measure: Pain and discomfort after 3 years post-surgery.
timeFrame: After 3 years post-surgery
measure: Recurrence rate by clinical examination 1 year post-surgery.
timeFrame: After 1 year post-surgery.
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Copenhagen
country: Denmark
facility: University of Copenhagen
city: Wejherowo
country: Poland
facility: ul Jagalskiego
city: Madrid
country: Spain
facility: Hospital de 12 Octobre
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary of Edinburgh
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: