Skip to main content
Clinical Trials/NCT01622725
NCT01622725CompletedNot Applicable

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

University Hospital, Ghent6 sites in 5 countries95 target enrollmentStarted: February 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
95
Locations
6
Primary Endpoint
Recurrence rate at 3 years post-surgery.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Primary and secondary ventral hernia
  • •less than 20 cm in length
  • •less than 6 cm in width

Exclusion Criteria

  • Not provided

Arms & Interventions

Resorbable mesh

Experimental

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

Intervention: Placing the resorbable mesh (Procedure)

Non-resorbable mesh

Active Comparator

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

Intervention: Non-resorbable synthetic mesh. (Procedure)

Outcomes

Primary Outcomes

Recurrence rate at 3 years post-surgery.

Time Frame: 3 years post-surgery

Clinical evaluation and ultrasound evaluation after 3 years post-surgery.

Secondary Outcomes

  • Pain and discomfort after 1 year post-surgery.(After 1 year post-surgery)
  • Wound Morbidity 4 weeks post-surgery.(4 weeks post-surgery)
  • Recurrence rate by clinical examination 1 year post-surgery.(After 1 year post-surgery.)
  • Pain and discomfort after 3 years post-surgery.(After 3 years post-surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (6)

Loading locations...

Similar Trials