Abdominal Wall Repair With Strattice in Germany: a Cohort Study (BASE Cohort)
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Incisional hernia recurrence
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 18 years or older
- •Signed informed consent
- •Abdominal wall repair
- •Strattice mesh implantation prior to inclusion in BASE cohort
排除标准
- •Age under 18 years
- •No signed informed consent
- •Other operation than abdominal wall repair
- •Other mesh than Strattice mesh
结局指标
主要结局
Incisional hernia recurrence
时间窗: At one year after initial operation
This parameter will be assessed by taking a history of the patient, and performing physical examination.
Postoperative complications
时间窗: Postoperatively, until one year after initial operation
All postoperative complications and their treatment will be registered.
Survival
时间窗: Postoperatively; until three years after initial operation
Any decease postoperatively
次要结局
- Mesh explantations(Postoperatively; until three years after initial operation)
- Incisional hernia recurrence(At two and three years after initial operation)
- Health economic analysis(Postoperatively; until one year after initial operation)
- EHS incisional hernia classification(Perioperatively (noted just before or just after operation))
- Additional "abdominal wall repair" operations(Postoperatively; until three years after initial operation)
- Indication of Strattice usage(Perioperatively (noted just before or just after operation))
- Quality of Life (questionnaire-based)(Postoperatively; measured at one, two and three years after initial operation)
研究者
Ruth Kaufmann, MD
PhD fellow
Erasmus Medical Center
