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

This study is not yet open for participant recruitment.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Novus Scientific
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT01622725
First received: June 15, 2012
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Primary and Secondary Ventral Hernia
Procedure: Placing the resorbable mesh
Procedure: Non-resorbable synthetic mesh.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Recurrence rate at 3 years post-surgery. [ Time Frame: 3 years post-surgery ] [ Designated as safety issue: No ]
    Clinical evaluation and ultrasound evaluation after 3 years post-surgery.


Secondary Outcome Measures:
  • Wound Morbidity 4 weeks post-surgery. [ Time Frame: 4 weeks post-surgery ] [ Designated as safety issue: No ]
  • Pain and discomfort after 1 year post-surgery. [ Time Frame: After 1 year post-surgery ] [ Designated as safety issue: No ]
  • Pain and discomfort after 3 years post-surgery. [ Time Frame: After 3 years post-surgery ] [ Designated as safety issue: No ]
  • Recurrence rate by clinical examination 1 year post-surgery. [ Time Frame: After 1 year post-surgery. ] [ Designated as safety issue: No ]
    Clinical Examination to determine the recurrence rate.


Estimated Enrollment: 268
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)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary and secondary ventral hernia

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

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01622725

Contacts
Contact: Frederik Berrevoet, MD, PhD Frederik.Berrevoet@ugent.be

Locations
Belgium
Ghent University Hospital Not yet 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 Not yet recruiting
Leuven, Belgium, 3000
Contact: Marc Miserez, MD, PhD       Marc.miserez@uzleuven.be   
Principal Investigator: Marc Miserez, MD, PhD         
Denmark
University of Copenhagen Not yet recruiting
Copenhagen, Denmark, DK-2400
Contact: Lars Nannestad Jorgensen, MD, DrMSc       Larsnjorgensen@hotmail.com   
Principal Investigator: Lars Nannestad Jorgensen, MD, DrMSc         
Poland
ul Jagalskiego Not yet recruiting
Wejherowo, Poland, 84-200
Contact: Maciej Smietanski, MD, PhD       smietanski@herniaweb.org   
Principal Investigator: Maciej Smietanski, MD, PhD         
Spain
Hospital de 12 Octobre Not yet recruiting
Madrid, Spain
Contact: Maria Teresa Butron Vila, MD         
Principal Investigator: Maria Teresa Butron Vila, MD         
United Kingdom
Royal Infirmary of Edinburgh Not yet 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         
Sponsors and Collaborators
University Hospital, Ghent
Novus Scientific
Investigators
Principal Investigator: Frederik Berrevoet, MD, PhD Ghent University Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01622725     History of Changes
Other Study ID Numbers: 2012/223
Study First Received: June 15, 2012
Last Updated: February 1, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by University Hospital, Ghent:
ventral hernia

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 15, 2014