Biologic Implant, Hernia of Abdominal Wall, Infected Hernioplasty Mesh
Conditions
Keywords
Hernia of Abdominal Wall, Biologic implant, Infected Hernioplasty Mesh
Brief 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.
Interventions
PROCEDUREPermacol 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
Amphia, Breda, the Netherlands
Catharina Ziekenhuis Eindhoven
Franciscus, Roosendaal, the Netherlands
Groene Hart, Gouda, the Netherlands
Havenziekenhuis
Lievensberg, Bergen op Zoom, the Netherlands
Medical Center Haaglanden
MC Leeuwarden, Leeuwarden, the Netherlands
Meander MC, Amersfoort, the Netherlands
Maastricht University Medical Center
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
Erasmus Medical Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional Hernia recurrence | 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
| Measure | Time frame | Description |
|---|---|---|
| Mesh explantations | 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. |
| Postoperative complications | 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. |
| Additional abdominal wall repair operations | 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. |
| Indication of Permacol usage | Perioperatively | The indication for usage of Permacol was noted just before or just after operation. |
| Quality of Life | 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). |
Countries
Netherlands
Outcome results
None listed