The Permacol Dutch Cohort Study

Study Overview
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Brief Summary
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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.

Official Title
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The Permacol Dutch Cohort Study

Conditions
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Hernia of Abdominal Wall, Biologic Implant, Infected Hernioplasty Mesh

Intervention / Treatment
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* Procedure: Permacol mesh placement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Permacol mesh placement<br>No intervention performed | Procedure: Permacol mesh placement<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hernia of Abdominal Wall, Biologic implant, Infected Hernioplasty Mesh