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
77 participants
OBSERVATIONAL
2013-04-30
2014-05-31
Brief Summary
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In the recent years the use of biological meshes has been gaining popularity. Recent reports of the use of collagen-based prosthesis have suggested that they support new vessel growth, do not excite a significant foreign body reaction, form fewer adhesions, are well incorporated into host tissues with minimal wound contraction, and can be used in grossly contaminated wounds with fewer infective complications. Biologic meshes are harvested from a source tissue and processed for medical use but they vary widely in their processing methods. They include tissues of human or animal origins, both chemically cross-linked and non cross-linked processes, and submucosal, pericardial, or dermal tissue sources. Current studies investigating the effectiveness of these meshes are small and have short periods of follow-up. These shortcomings can be explained to high cost of the meshes and unclear indication when to use a biological mesh.
The aim of this study is investigate the short and long term effects of the Permacol© biological mesh. Also the investigators will be inquiring why a biologic mesh was used, what is the true indication to use a biological mesh.
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Permacol mesh placement
No intervention performed
Permacol mesh placement
All patients were treated for a complex abdominal wall hernia by implantation of Permacol mesh. This intervention took place before patients were included in the cohort.
Interventions
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Permacol mesh placement
All patients were treated for a complex abdominal wall hernia by implantation of Permacol mesh. This intervention took place before patients were included in the cohort.
Eligibility Criteria
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Inclusion Criteria
* Complicated abdominal wall hernia repair
* Permacol© mesh implantation
Exclusion Criteria
* Operation other than Complicated abdominal wall hernia repair
* Implant other than Permacol© mesh implantation
18 Years
ALL
No
Sponsors
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Amphia, Breda, the Netherlands
UNKNOWN
Catharina Ziekenhuis Eindhoven
OTHER
Franciscus, Roosendaal, the Netherlands
UNKNOWN
Groene Hart, Gouda, the Netherlands
UNKNOWN
Havenziekenhuis
OTHER
Lievensberg, Bergen op Zoom, the Netherlands
UNKNOWN
Medical Center Haaglanden
OTHER
MC Leeuwarden, Leeuwarden, the Netherlands
UNKNOWN
Meander MC, Amersfoort, the Netherlands
UNKNOWN
Maastricht University Medical Center
OTHER
Nij Smellinghe, Drachten, the Netherlands
UNKNOWN
OLVG, Amsterdam, the Netherlands
UNKNOWN
Orbis MC, Sittard, the Netherlands
UNKNOWN
Reinier de Graaf Groep
OTHER
Rijnstate, Arnhem, the Netherlands
UNKNOWN
Spaarne ziekenhuis, Hoofddorp, the Netherlands
UNKNOWN
Tergooi ziekenhuizen, Hilversum, the Netherlands
UNKNOWN
The Elisabeth-TweeSteden Hospital
OTHER
UMC Groningen, Groningen, the Netherlands
UNKNOWN
UMC Utrecht, Utrecht, the Netherlands
UNKNOWN
VieCuri, Venlo, the Netherlands
UNKNOWN
Waterland, Purmerend, the Netherlands
UNKNOWN
Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands
UNKNOWN
Erasmus Medical Center
OTHER
Responsible Party
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Ruth Kaufmann, MD
PhD fellow
Principal Investigators
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Ruth Kaufmann, MD
Role: STUDY_CHAIR
Erasmus Medical Center
Locations
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Meander MC
Amersfoort, , Netherlands
Onze Lieve Vrouwe Gasthuis
Amsterdam, , Netherlands
Rijnstate
Arnhem, , Netherlands
Lievensberg
Bergen op Zoom, , Netherlands
Amphia
Breda, , Netherlands
Reinier de Graaf Gasthuis
Delft, , Netherlands
Nij Smellinghe
Drachten, , Netherlands
Catharina
Eindhoven, , Netherlands
Groene Hart
Gouda, , Netherlands
UMC Groningen
Groningen, , Netherlands
Atrium MC
Heerlen, , Netherlands
Tergooi ziekenhuizen
Hilversum, , Netherlands
Spaarne ziekenhuis
Hoofddorp, , Netherlands
MC Leeuwarden
Leeuwarden, , Netherlands
MUMC+
Maastricht, , Netherlands
Waterland
Purmerend, , Netherlands
Franciscus
Roosendaal, , Netherlands
Erasmus University Medical Center
Rotterdam, , Netherlands
Havenziekenhuis
Rotterdam, , Netherlands
Orbis MC
Sittard, , Netherlands
MC Haaglanden
The Hague, , Netherlands
TweeSteden
Tilburg, , Netherlands
UMC Utrecht
Utrecht, , Netherlands
VieCuri
Venlo, , Netherlands
Countries
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References
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Kaufmann R, Timmermans L, van Loon YT, Vroemen JPAM, Jeekel J, Lange JF. Repair of complex abdominal wall hernias with a cross-linked porcine acellular matrix: cross-sectional results of a Dutch cohort study. Int J Surg. 2019 May;65:120-127. doi: 10.1016/j.ijsu.2019.03.023. Epub 2019 Apr 1.
Other Identifiers
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Permacol Dutch Cohort Study
Identifier Type: -
Identifier Source: org_study_id
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