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| Name | Class |
|---|---|
| Unfallkrankenhaus Berlin | OTHER |
| Johann Wolfgang Goethe University Hospital | OTHER |
| Diakoniekrankenhaus Friederikenstift | OTHER |
| Krankenhaus Agatharied Hausham |
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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 to investigate the short and long term effects of the Strattice biological mesh. The investigators will also inquire why a biologic mesh was used and what the direct and indirect costs were.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complex abdominal wall repair Strattice | Complex abdominal wall repair Strattice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complex abdominal wall repair Strattice | Procedure | Not applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incisional hernia recurrence | This parameter will be assessed by taking a history of the patient, and performing physical examination. | At one year after initial operation |
| Postoperative complications | All postoperative complications and their treatment will be registered. | Postoperatively, until one year after initial operation |
| Survival | Any decease postoperatively | Postoperatively; until three years after initial operation |
| Measure | Description | Time Frame |
|---|---|---|
| EHS incisional hernia classification | Classification according to Ventral Hernia Working Group classification (Breuing et al. Surgery 2010; 148(3): 544-58). | Perioperatively (noted just before or just after operation) |
| Mesh explantations |
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Inclusion Criteria:
Exclusion Criteria:
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Patients operated by members of the ROKI group (Arbeitsgruppe für Rekonstruktion komplexer Inzisionaler Hernien); i.e. a group of German hernia surgeons using Strattice for complex abdominal wall surgery. This group of surgeons is willing to share their patient cases with the investigators to achieve more knowledge on this delicate topic.
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| Name | Affiliation | Role |
|---|---|---|
| Ruth Kaufmann, MD | Erasmus Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Trauma Hospital Berlin | Berlin | Germany | ||||
| Johann Wolfgang Goethe-University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32323007 | Derived | Kaufmann R, Isemer FE, Strey CW, Jeekel J, Lange JF, Woeste G. Non-cross-linked biological mesh in complex abdominal wall hernia: a cohort study. Langenbecks Arch Surg. 2020 May;405(3):345-352. doi: 10.1007/s00423-020-01881-4. Epub 2020 Apr 22. |
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| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C568444 | strattice |
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| UNKNOWN |
| Technical University of Munich | OTHER |
| St. Josefs-Hospital Wiesbaden GmbH | OTHER |
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|
Strattice mesh explantation after operation
| Postoperatively; until three years after initial operation |
| Additional "abdominal wall repair" operations | Additional "abdominal wall (hernia) repair" operations after initial implantation of Strattice | Postoperatively; until three years after initial operation |
| Indication of Strattice usage | Defined as preoperative conditions that influenced the decision (for instance: presence of stoma, fistulas, abscesses, etc.) | Perioperatively (noted just before or just after operation) |
| Quality of Life (questionnaire-based) | Measured with questionnaires (SF-36, EQ-5D-5L, BIQ) | Postoperatively; measured at one, two and three years after initial operation |
| Health economic analysis | Various cost-related parameters | Postoperatively; until one year after initial operation |
| Incisional hernia recurrence | This parameter will be assessed by taking a history of the patient, and performing physical examination. | At two and three years after initial operation |
| Frankfurt am Main |
| Germany |
| Diakoniekrankenhaus Friederikenstiftung | Hanover | Germany |
| Agatharied Hospital | Hausham | Germany |
| Klinikum rechts der Isar, Technical University of Munich | München | Germany |
| St. Josefs-Hospital Wiesbaden | Wiesbaden | Germany |