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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2014 by University Hospital, Ghent.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01622725
First Posted: June 19, 2012
Last Update Posted: December 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Novus Scientific
Information provided by (Responsible Party):
University Hospital, Ghent
  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
Intervention Model: Parallel Assignment
Masking: Double (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.

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 ]
    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 ]
  • 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.


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622725


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

Locations
Belgium
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.miserez@uzleuven.be   
Principal Investigator: Marc Miserez, MD, PhD         
Denmark
University of Copenhagen Recruiting
Copenhagen, Denmark, DK-2400
Contact: Lars Nannestad Jorgensen, MD, DrMSc       Larsnjorgensen@hotmail.com   
Principal Investigator: Lars Nannestad Jorgensen, MD, DrMSc         
Poland
ul Jagalskiego Recruiting
Wejherowo, Poland, 84-200
Contact: Maciej Smietanski, MD, PhD       smietanski@herniaweb.org   
Principal Investigator: Maciej Smietanski, MD, PhD         
Spain
Hospital de 12 Octobre Recruiting
Madrid, Spain
Contact: Maria Teresa Butron Vila, MD         
Principal Investigator: Maria Teresa Butron Vila, MD         
United Kingdom
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         
Sponsors and Collaborators
University Hospital, Ghent
Novus Scientific
Investigators
Principal Investigator: Frederik Berrevoet, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT01622725     History of Changes
Other Study ID Numbers: 2012/223
First Submitted: June 15, 2012
First Posted: June 19, 2012
Last Update Posted: December 5, 2014
Last Verified: December 2014

Keywords provided by University Hospital, Ghent:
ventral hernia

Additional relevant MeSH terms:
Neoplasm Metastasis
Hernia
Hernia, Ventral
Neoplastic Processes
Neoplasms
Pathologic Processes
Pathological Conditions, Anatomical
Hernia, Abdominal