Biologic Mesh, Hernia of Abdominal Wall, Strattice
Conditions
Keywords
Complex abdominal wall hernia, Biologic mesh, Strattice
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 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.
Interventions
PROCEDUREComplex abdominal wall repair Strattice
Not applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice)
Sponsors
Unfallkrankenhaus Berlin
Johann Wolfgang Goethe University Hospital
Diakoniekrankenhaus Friederikenstift
Krankenhaus Agatharied Hausham
Technical University of Munich
St. Josefs-Hospital Wiesbaden GmbH
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
* Age of 18 years or older * Signed informed consent * Abdominal wall repair * Strattice mesh implantation prior to inclusion in BASE cohort
Exclusion criteria
* Age under 18 years * No signed informed consent * Other operation than abdominal wall repair * Other mesh than Strattice mesh
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incisional hernia recurrence | At one year after initial operation | This parameter will be assessed by taking a history of the patient, and performing physical examination. |
| Postoperative complications | Postoperatively, until one year after initial operation | All postoperative complications and their treatment will be registered. |
| Survival | Postoperatively; until three years after initial operation | Any decease postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Indication of Strattice usage | Perioperatively (noted just before or just after operation) | Defined as preoperative conditions that influenced the decision (for instance: presence of stoma, fistulas, abscesses, etc.) |
| Quality of Life (questionnaire-based) | Postoperatively; measured at one, two and three years after initial operation | Measured with questionnaires (SF-36, EQ-5D-5L, BIQ) |
| Mesh explantations | Postoperatively; until three years after initial operation | Strattice mesh explantation after operation |
| Incisional hernia recurrence | At two and three years after initial operation | This parameter will be assessed by taking a history of the patient, and performing physical examination. |
| Health economic analysis | Postoperatively; until one year after initial operation | Various cost-related parameters |
| Additional abdominal wall repair operations | Postoperatively; until three years after initial operation | Additional abdominal wall (hernia) repair operations after initial implantation of Strattice |
| EHS incisional hernia classification | Perioperatively (noted just before or just after operation) | Classification according to Ventral Hernia Working Group classification (Breuing et al. Surgery 2010; 148(3): 544-58). |
Countries
Germany
Outcome results
None listed