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Completed

NCT Number: NCT02166112

The Permacol Dutch Cohort Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Meander MC, Amersfoort, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Incisional Hernia recurrence

    Time frame: One and two year after initial operation

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

Secondary outcomes

  1. Mesh explantations

    Time frame: Anytime after abdominal wall reconstruction with Permacol until two years after operation

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

  2. Postoperative complications

    Time frame: All postoperative complications are assessed until two years after initial operation

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

  3. Additional "abdominal wall repair" operations

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

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

  4. Indication of Permacol usage

    Time frame: Perioperatively

    The indication for usage of Permacol was noted just before or just after operation.

  5. Quality of Life

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

    This parameter will be assessed various questionnaires (ShortForm-36, EuroQOL (EQ-5D-5L), and Body Image Questionnaire).

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

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

Registry information

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jun 18, 2014
Registry last updated
Apr 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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