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| Name | Class |
|---|---|
| Amphia, Breda, the Netherlands | UNKNOWN |
| Catharina Ziekenhuis Eindhoven | OTHER |
| Franciscus, Roosendaal, the Netherlands | UNKNOWN |
| Groene Hart, Gouda, the Netherlands |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Permacol mesh placement | No intervention performed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Kaufmann, MD | Erasmus Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Meander MC | Amersfoort | Netherlands | ||||
| Onze Lieve Vrouwe Gasthuis |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30946996 | Derived | 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. |
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| UNKNOWN |
| Havenziekenhuis | OTHER |
| Lievensberg, Bergen op Zoom, the Netherlands | UNKNOWN |
| Medical Center Haaglanden | OTHER |
| MC Leeuwarden, Leeuwarden, the Netherlands | UNKNOWN |
| Meander MC, Amersfoort, the Netherlands | UNKNOWN |
| Maastricht University Medical Center | OTHER |
| Nij Smellinghe, Drachten, the Netherlands | UNKNOWN |
| OLVG, Amsterdam, the Netherlands | UNKNOWN |
| Orbis MC, Sittard, the Netherlands | UNKNOWN |
| Reinier de Graaf Groep | OTHER |
| Rijnstate, Arnhem, the Netherlands | UNKNOWN |
| Spaarne ziekenhuis, Hoofddorp, the Netherlands | UNKNOWN |
| Tergooi ziekenhuizen, Hilversum, the Netherlands | UNKNOWN |
| The Elisabeth-TweeSteden Hospital | OTHER |
| UMC Groningen, Groningen, the Netherlands | UNKNOWN |
| UMC Utrecht, Utrecht, the Netherlands | UNKNOWN |
| VieCuri, Venlo, the Netherlands | UNKNOWN |
| Waterland, Purmerend, the Netherlands | UNKNOWN |
| Zuyderland Medisch Centrum, Sittard-Geleen, the Netherlands | UNKNOWN |
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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 |
| Amsterdam |
| Netherlands |
| Rijnstate | Arnhem | Netherlands |
| Lievensberg | Bergen op Zoom | Netherlands |
| Amphia | Breda | Netherlands |
| Reinier de Graaf Gasthuis | Delft | Netherlands |
| Nij Smellinghe | Drachten | Netherlands |
| Catharina | Eindhoven | Netherlands |
| Groene Hart | Gouda | Netherlands |
| UMC Groningen | Groningen | Netherlands |
| Atrium MC | Heerlen | Netherlands |
| Tergooi ziekenhuizen | Hilversum | Netherlands |
| Spaarne ziekenhuis | Hoofddorp | Netherlands |
| MC Leeuwarden | Leeuwarden | Netherlands |
| MUMC+ | Maastricht | Netherlands |
| Waterland | Purmerend | Netherlands |
| Franciscus | Roosendaal | Netherlands |
| Erasmus University Medical Center | Rotterdam | Netherlands |
| Havenziekenhuis | Rotterdam | Netherlands |
| Orbis MC | Sittard | Netherlands |
| MC Haaglanden | The Hague | Netherlands |
| TweeSteden | Tilburg | Netherlands |
| UMC Utrecht | Utrecht | Netherlands |
| VieCuri | Venlo | Netherlands |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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