The Permacol Dutch Cohort Study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

• Amphia, Breda, the Netherlands

  collaborator UNKNOWN

• Catharina Ziekenhuis Eindhoven

  collaborator OTHER

• Franciscus, Roosendaal, the Netherlands

  collaborator UNKNOWN

• Groene Hart, Gouda, the Netherlands

  collaborator UNKNOWN

• Havenziekenhuis

  collaborator OTHER

• Lievensberg, Bergen op Zoom, the Netherlands

  collaborator UNKNOWN

• Medical Center Haaglanden

  collaborator OTHER

• MC Leeuwarden, Leeuwarden, the Netherlands

  collaborator UNKNOWN

• Meander MC, Amersfoort, the Netherlands

  collaborator UNKNOWN

• Maastricht University Medical Center

  collaborator OTHER

• Nij Smellinghe, Drachten, the Netherlands

  collaborator UNKNOWN

• OLVG, Amsterdam, the Netherlands

  collaborator UNKNOWN

• Orbis MC, Sittard, the Netherlands

  collaborator UNKNOWN

• Reinier de Graaf Groep

  collaborator OTHER

• Rijnstate, Arnhem, the Netherlands

  collaborator UNKNOWN

• Spaarne ziekenhuis, Hoofddorp, the Netherlands

  collaborator UNKNOWN

• Tergooi ziekenhuizen, Hilversum, the Netherlands

  collaborator UNKNOWN

• The Elisabeth-TweeSteden Hospital

  collaborator OTHER

• UMC Groningen, Groningen, the Netherlands

  collaborator UNKNOWN

• UMC Utrecht, Utrecht, the Netherlands

  collaborator UNKNOWN

• VieCuri, Venlo, the Netherlands

  collaborator UNKNOWN

• Waterland, Purmerend, the Netherlands

  collaborator UNKNOWN

• Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands

  collaborator UNKNOWN

• Erasmus Medical Center

  lead OTHER

Principal Investigators

• Ruth Kaufmann, MD · Erasmus Medical Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-04-30

Primary Completion

2013-11-30

Completion

2014-05-31

Countries

• Netherlands

Study Locations