Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh. (TIGR)
Recruitment status was: Recruiting
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.
|Primary and Secondary Ventral Hernia||Procedure: Placing the resorbable mesh Procedure: Non-resorbable synthetic mesh.|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.|
- Recurrence rate at 3 years post-surgery. [ Time Frame: 3 years post-surgery ]Clinical evaluation and ultrasound evaluation after 3 years post-surgery.
- Wound Morbidity 4 weeks post-surgery. [ Time Frame: 4 weeks post-surgery ]
- Pain and discomfort after 1 year post-surgery. [ Time Frame: After 1 year post-surgery ]
- Pain and discomfort after 3 years post-surgery. [ Time Frame: After 3 years post-surgery ]
- Recurrence rate by clinical examination 1 year post-surgery. [ Time Frame: After 1 year post-surgery. ]Clinical Examination to determine the recurrence rate.
|Study Start Date:||February 2013|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Resorbable mesh
Long-term resorbable mesh implanted to treat primary and secondary ventral hernia.
Procedure: Placing the resorbable mesh
Surgery for primary and secondary ventral hernia repair with placing of resorbable mesh.
Active Comparator: Non-resorbable mesh
Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia.
Procedure: Non-resorbable synthetic mesh.
Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622725
|Contact: Frederik Berrevoet, MD, PhD||Frederik.Berrevoet@ugent.be|
|Ghent University Hospital||Recruiting|
|Ghent, Belgium, 9000|
|Contact: Frederik Berrevoet, MD, PhD +32(0)93324892 Frederik.Berrevoet@ugent.be|
|Principal Investigator: Frederik Berrevoet, MD, PhD|
|University Hospital Leuven||Recruiting|
|Leuven, Belgium, 3000|
|Contact: Marc Miserez, MD, PhD Marc.firstname.lastname@example.org|
|Principal Investigator: Marc Miserez, MD, PhD|
|University of Copenhagen||Recruiting|
|Copenhagen, Denmark, DK-2400|
|Contact: Lars Nannestad Jorgensen, MD, DrMSc Larsnjorgensen@hotmail.com|
|Principal Investigator: Lars Nannestad Jorgensen, MD, DrMSc|
|Wejherowo, Poland, 84-200|
|Contact: Maciej Smietanski, MD, PhD email@example.com|
|Principal Investigator: Maciej Smietanski, MD, PhD|
|Hospital de 12 Octobre||Recruiting|
|Contact: Maria Teresa Butron Vila, MD|
|Principal Investigator: Maria Teresa Butron Vila, MD|
|Royal Infirmary of Edinburgh||Recruiting|
|Edinburgh, United Kingdom, EH16 4SA|
|Contact: Andrew de Beaux, MD FRCS MBcChB Andrew.Debeaux@luht.scot.nhs.uk|
|Principal Investigator: Andrew de Beaux, MD FRCS MBChB|
|Principal Investigator:||Frederik Berrevoet, MD, PhD||University Hospital, Ghent|