Abdominal Wall Repair With Strattice in Germany: a Cohort Study

Study Overview
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Brief Summary
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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.

Official Title
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Abdominal Wall Repair With Strattice in Germany: a Cohort Study (BASE Cohort)

Conditions
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Hernia of Abdominal Wall, Biologic Mesh, Strattice

Intervention / Treatment
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* Procedure: Complex abdominal wall repair Strattice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Complex abdominal wall repair Strattice<br>Complex abdominal wall repair Strattice | Procedure: Complex abdominal wall repair Strattice<br>* Not applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice)<br>* Other names: Non-cross-linked biologic mesh;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Complex abdominal wall hernia, Biologic mesh, Strattice