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.

Study Overview

• Status: Completed
• Conditions: Hernia of Abdominal Wall; Biologic Implant; Infected Hernioplasty Mesh
• Intervention / Treatment: Procedure: Permacol mesh placement

• Study Type: Observational
• Enrollment (Actual): 77

Contacts and Locations

Study Locations

• Netherlands
  • Amersfoort, Netherlands
    • Meander MC
  • Amsterdam, Netherlands
    • Onze Lieve Vrouwe Gasthuis
  • Arnhem, Netherlands
    • Rijnstate
  • Bergen op Zoom, Netherlands
    • Lievensberg
  • Breda, Netherlands
    • Amphia
  • Delft, Netherlands
    • Reinier de Graaf Gasthuis
  • Den Haag, Netherlands
    • MC Haaglanden
  • Drachten, Netherlands
    • Nij Smellinghe
  • Eindhoven, Netherlands
    • Catharina
  • Gouda, Netherlands
    • Groene Hart
  • Groningen, Netherlands
    • UMC Groningen
  • Heerlen, Netherlands
    • Atrium MC
  • Hilversum, Netherlands
    • Tergooi ziekenhuizen
  • Hoofddorp, Netherlands
    • Spaarne Ziekenhuis
  • Leeuwarden, Netherlands
    • MC Leeuwarden
  • Maastricht, Netherlands
    • MUMC+
  • Purmerend, Netherlands
    • Waterland
  • Roosendaal, Netherlands
    • Franciscus
  • Rotterdam, Netherlands
    • Erasmus University Medical Center
  • Rotterdam, Netherlands
    • Havenziekenhuis
  • Sittard, Netherlands
    • Orbis MC
  • Tilburg, Netherlands
    • TweeSteden
  • Utrecht, Netherlands
    • UMC Utrecht
  • Venlo, Netherlands
    • VieCuri

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Permacol mesh placement; No intervention performed	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mesh explantations	This parameter will be assessed by taking a history of the patient and assessing operation room reports.	Anytime after abdominal wall reconstruction with Permacol until two years after operation
Postoperative complications	This parameter will be assessed by taking a history of the patient and assessing patient reports and operation room reports.	All postoperative complications are assessed until two years after initial operation
Additional "abdominal wall repair" operations	This parameter will be assessed by taking a history of the patient and assessing patient reports and operation room reports.	After initial abdominal wall reconstruction with Permacol until two years after initial operation
Indication of Permacol usage	The indication for usage of Permacol was noted just before or just after operation.	Perioperatively
Quality of Life	This parameter will be assessed various questionnaires (ShortForm-36, EuroQOL (EQ-5D-5L), and Body Image Questionnaire).	A year or longer after initial abdominal wall reconstruction until two years after initial operation

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Maastricht University Medical Center; Catharina Ziekenhuis Eindhoven; Medical Center Haaglanden; Havenziekenhuis; The Elisabeth-TweeSteden Hospital; Amphia, Breda, the Netherlands; Franciscus, Roosendaal, the Netherlands; Groene Hart, Gouda, the Netherlands; Lievensberg, Bergen op Zoom, the Netherlands; MC Leeuwarden, Leeuwarden, the Netherlands; Meander MC, Amersfoort, the Netherlands; Nij Smellinghe, Drachten, the Netherlands; OLVG, Amsterdam, the Netherlands; Orbis MC, Sittard, the Netherlands; Reinier de Graaf gasthuis, Delft, the Netherlands; Rijnstate, Arnhem, the Netherlands; Spaarne ziekenhuis, Hoofddorp, the Netherlands; Tergooi ziekenhuizen, Hilversum, the Netherlands; 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
• Investigators: Study Chair: Ruth Kaufmann, MD, Erasmus Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 17, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 5, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Hernia of Abdominal Wall; Biologic implant; Infected Hernioplasty Mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia
• Other Study ID Numbers: Permacol Dutch Cohort Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No