Clinical trial NCT02166112: The Permacol Dutch Cohort Study
Official title: The Permacol Dutch Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hernia of Abdominal Wall
Biologic Implant
Infected Hernioplasty Mesh
Keywords: Hernia of Abdominal Wall
Biologic implant
Infected Hernioplasty Mesh
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Amphia, Breda, the Netherlands
name: Catharina Ziekenhuis Eindhoven
name: Franciscus, Roosendaal, the Netherlands
name: Groene Hart, Gouda, the Netherlands
name: Havenziekenhuis
name: Lievensberg, Bergen op Zoom, the Netherlands
name: Medical Center Haaglanden
name: MC Leeuwarden, Leeuwarden, the Netherlands
name: Meander MC, Amersfoort, the Netherlands
name: Maastricht University Medical Center
name: Nij Smellinghe, Drachten, the Netherlands
name: OLVG, Amsterdam, the Netherlands
name: Orbis MC, Sittard, the Netherlands
name: Reinier de Graaf Groep
name: Rijnstate, Arnhem, the Netherlands
name: Spaarne ziekenhuis, Hoofddorp, the Netherlands
name: Tergooi ziekenhuizen, Hilversum, the Netherlands
name: The Elisabeth-TweeSteden Hospital
name: UMC Groningen, Groningen, the Netherlands
name: UMC Utrecht, Utrecht, the Netherlands
name: VieCuri, Venlo, the Netherlands
name: Waterland, Purmerend, the Netherlands
name: Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands
First posted: 2014-06-18
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The design of the trial will be a cross sectional cohort study. We will be gathering information from all the centers in the Netherlands who have used the Permacol© mesh in the past to treat complicated abdominal wall defects. Patients will be asked to return to the hospitals outpatient clinic. A total of around 70 patients will be included into the study.

Brief summary: Incisional hernia is the most frequently seen long term complication in surgery causing much morbidity and even mortality in patients. Despite studies on the optimal closing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. It has been established that implementing a mesh reduces recurrence of the incisional hernia but still the results of repair are often disappointing. Incisional hernias can become increasingly complex due to complicated abdominal wall defects caused by a disturbed anatomy, fistulas, burst abdomen, wound and mesh infections. In these cases it is not save to repair the incisional hernia by means of a synthetic mesh and other augmentation tools need to be implemented.

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.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Complicated abdominal wall hernia repair
* Permacol© mesh implantation

Exclusion Criteria:

* No signed informed consent
* Operation other than Complicated abdominal wall hernia repair
* Implant other than Permacol© mesh implantation

Primary outcomes:
measure: Incisional Hernia recurrence
timeFrame: One and two year after initial operation
Secondary outcomes:
measure: Mesh explantations
timeFrame: Anytime after abdominal wall reconstruction with Permacol until two years after operation
measure: Postoperative complications
timeFrame: All postoperative complications are assessed until two years after initial operation
measure: Additional "abdominal wall repair" operations
timeFrame: After initial abdominal wall reconstruction with Permacol until two years after initial operation
measure: Indication of Permacol usage
timeFrame: Perioperatively
measure: Quality of Life
timeFrame: A year or longer after initial abdominal wall reconstruction until two years after initial operation
Other outcomes:
Locations:
city: Amersfoort
country: Netherlands
facility: Meander MC
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Bergen op Zoom
country: Netherlands
facility: Lievensberg
city: Breda
country: Netherlands
facility: Amphia
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Den Haag
country: Netherlands
facility: MC Haaglanden
city: Drachten
country: Netherlands
facility: Nij Smellinghe
city: Eindhoven
country: Netherlands
facility: Catharina
city: Gouda
country: Netherlands
facility: Groene Hart
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Heerlen
country: Netherlands
facility: Atrium MC
city: Hilversum
country: Netherlands
facility: Tergooi ziekenhuizen
city: Hoofddorp
country: Netherlands
facility: Spaarne ziekenhuis
city: Leeuwarden
country: Netherlands
facility: MC Leeuwarden
city: Maastricht
country: Netherlands
facility: MUMC+
city: Purmerend
country: Netherlands
facility: Waterland
city: Roosendaal
country: Netherlands
facility: Franciscus
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Rotterdam
country: Netherlands
facility: Havenziekenhuis
city: Sittard
country: Netherlands
facility: Orbis MC
city: Tilburg
country: Netherlands
facility: TweeSteden
city: Utrecht
country: Netherlands
facility: UMC Utrecht
city: Venlo
country: Netherlands
facility: VieCuri
Study officials:
affiliation: Erasmus Medical Center
name: Ruth Kaufmann, MD
role: STUDY_CHAIR
References:
citation: 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.