Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
NCT ID: NCT01622725
Last Updated: 2024-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
95 participants
INTERVENTIONAL
2013-02-28
2023-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Resorbable mesh
Long-term resorbable mesh implanted to treat primary and secondary ventral hernia.
Placing the resorbable mesh
Surgery for primary and secondary ventral hernia repair with placing of resorbable mesh.
Non-resorbable mesh
Non-resorbable synthetic mesh implanted to treat primary and secondary ventral hernia.
Non-resorbable synthetic mesh.
Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh.
Interventions
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Placing the resorbable mesh
Surgery for primary and secondary ventral hernia repair with placing of resorbable mesh.
Non-resorbable synthetic mesh.
Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh.
Eligibility Criteria
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Inclusion Criteria
* less than 20 cm in length
* less than 6 cm in width
18 Years
ALL
No
Sponsors
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Novus Scientific
INDUSTRY
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Frederik Berrevoet, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Ghent
Locations
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Ghent University Hospital
Ghent, , Belgium
University Hospital Leuven
Leuven, , Belgium
University of Copenhagen
Copenhagen, , Denmark
ul Jagalskiego
Wejherowo, , Poland
Hospital de 12 Octobre
Madrid, , Spain
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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2012/223
Identifier Type: -
Identifier Source: org_study_id
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