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临床试验/NCT02166112
NCT02166112已完成不适用

The Permacol Dutch Cohort Study

Erasmus Medical Center24 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2013年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
77
试验地点
24
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 investigate the short and long term effects of the Permacol© biological mesh. Also the investigators will be inquiring why a biologic mesh was used, what is the true indication to use a biological mesh.

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

  • Signed informed consent
  • Complicated abdominal wall hernia repair
  • Permacol© mesh implantation

排除标准

  • No signed informed consent
  • Operation other than Complicated abdominal wall hernia repair
  • Implant other than Permacol© mesh implantation

结局指标

主要结局

Incisional Hernia recurrence

时间窗: One and two year after initial operation

This parameter will be assessed by taking a history of the patient and assessing operation room reports.

次要结局

  • Quality of Life(A year or longer after initial abdominal wall reconstruction until two years after initial operation)
  • Postoperative complications(All postoperative complications are assessed until two years after initial operation)
  • Indication of Permacol usage(Perioperatively)
  • Mesh explantations(Anytime after abdominal wall reconstruction with Permacol until two years after operation)
  • Additional "abdominal wall repair" operations(After initial abdominal wall reconstruction with Permacol until two 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 (24)

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