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.
Study Type
OBSERVATIONAL
Enrollment
80
Not applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice)
Trauma Hospital Berlin
Berlin, Germany
Johann Wolfgang Goethe-University
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
Incisional hernia recurrence
This parameter will be assessed by taking a history of the patient, and performing physical examination.
Time frame: At one year after initial operation
Postoperative complications
All postoperative complications and their treatment will be registered.
Time frame: Postoperatively, until one year after initial operation
Survival
Any decease postoperatively
Time frame: Postoperatively; until three years after initial operation
EHS incisional hernia classification
Classification according to Ventral Hernia Working Group classification (Breuing et al. Surgery 2010; 148(3): 544-58).
Time frame: Perioperatively (noted just before or just after operation)
Mesh explantations
Strattice mesh explantation after operation
Time frame: Postoperatively; until three years after initial operation
Additional "abdominal wall repair" operations
Additional "abdominal wall (hernia) repair" operations after initial implantation of Strattice
Time frame: 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.)
Time frame: Perioperatively (noted just before or just after operation)
Quality of Life (questionnaire-based)
Measured with questionnaires (SF-36, EQ-5D-5L, BIQ)
Time frame: Postoperatively; measured at one, two and three years after initial operation
Health economic analysis
Various cost-related parameters
Time frame: 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.
Time frame: At two and three years after initial operation
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