The Permacol Dutch Cohort Study

NCT02166112 | Completed

• 1 other identifier: Permacol Dutch Cohort Study
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 24

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.

Conditions

Hernia of Abdominal Wall; Biologic Implant; Infected Hernioplasty Mesh

Keywords

Hernia of Abdominal Wall; Biologic implant; Infected Hernioplasty Mesh

Outcome Measures

Primary Outcomes (1)

• Incisional Hernia recurrence

  This parameter will be assessed by taking a history of the patient and assessing operation room reports.

  One and two year after initial operation

Secondary Outcomes (5)

• Mesh explantations

  Anytime after abdominal wall reconstruction with Permacol until two years after operation

• Postoperative complications

  All postoperative complications are assessed until two years after initial operation

• Additional "abdominal wall repair" operations

  After initial abdominal wall reconstruction with Permacol until two years after initial operation

• Indication of Permacol usage

  Perioperatively

• Quality of Life

  A year or longer after initial abdominal wall reconstruction until two years after initial operation

Study Arms (1)

Permacol mesh placement

No intervention performed

Procedure: Permacol mesh placement

Interventions

Permacol mesh placement PROCEDURE

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.

Permacol mesh placement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Amphia, Breda, the Netherlands: collaborator
• Catharina Ziekenhuis Eindhoven: collaborator
• Franciscus, Roosendaal, the Netherlands: collaborator
• Groene Hart, Gouda, the Netherlands: collaborator
• Havenziekenhuis: collaborator
• Lievensberg, Bergen op Zoom, the Netherlands: collaborator
• Medical Center Haaglanden: collaborator
• MC Leeuwarden, Leeuwarden, the Netherlands: collaborator
• Meander MC, Amersfoort, the Netherlands: collaborator
• Maastricht University Medical Center: collaborator
• Nij Smellinghe, Drachten, the Netherlands: collaborator
• OLVG, Amsterdam, the Netherlands: collaborator
• Orbis MC, Sittard, the Netherlands: collaborator
• Reinier de Graaf Groep: collaborator
• Rijnstate, Arnhem, the Netherlands: collaborator
• Spaarne ziekenhuis, Hoofddorp, the Netherlands: collaborator
• Tergooi ziekenhuizen, Hilversum, the Netherlands: collaborator
• The Elisabeth-TweeSteden Hospital: collaborator
• UMC Groningen, Groningen, the Netherlands: collaborator
• UMC Utrecht, Utrecht, the Netherlands: collaborator
• VieCuri, Venlo, the Netherlands: collaborator
• Waterland, Purmerend, the Netherlands: collaborator
• Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands: collaborator

Study Sites (24)

Meander MC

Amersfoort, Netherlands

Location

Onze Lieve Vrouwe Gasthuis

Amsterdam, Netherlands

Location

Rijnstate

Arnhem, Netherlands

Location

Lievensberg

Bergen op Zoom, Netherlands

Location

Amphia

Breda, Netherlands

Location

Reinier de Graaf Gasthuis

Delft, Netherlands

Location

Nij Smellinghe

Drachten, Netherlands

Location

Catharina

Eindhoven, Netherlands

Location

Groene Hart

Gouda, Netherlands

Location

UMC Groningen

Groningen, Netherlands

Location

Atrium MC

Heerlen, Netherlands

Location

Tergooi ziekenhuizen

Hilversum, Netherlands

Location

Spaarne ziekenhuis

Hoofddorp, Netherlands

Location

MC Leeuwarden

Leeuwarden, Netherlands

Location

MUMC+

Maastricht, Netherlands

Location

Waterland

Purmerend, Netherlands

Location

Franciscus

Roosendaal, Netherlands

Location

Erasmus University Medical Center

Rotterdam, Netherlands

Location

Havenziekenhuis

Rotterdam, Netherlands

Location

Orbis MC

Sittard, Netherlands

Location

MC Haaglanden

The Hague, Netherlands

Location

TweeSteden

Tilburg, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

VieCuri

Venlo, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 30946996 DERIVED

MeSH Terms

Conditions

Hernia, Abdominal

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ruth Kaufmann, MD

  Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 18, 2014
• Study Start: April 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: May 1, 2014
• Last Updated: April 7, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (24)