跳至主要内容
临床试验/NCT02168231
NCT02168231Unknown不适用

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

Erasmus Medical Center6 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ruth Kaufmann, MD

PhD fellow

Erasmus Medical Center

研究点 (6)

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