跳至主要内容
临床试验/NCT00581412
NCT00581412已完成不适用

Composite Graft Use in Abdominal Sacrocolpopexy Reduces Erosion Rates

University of California, Irvine1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年9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
60
试验地点
1
主要终点
The erosion rates of composite biologic/syntheric grafts and synthetic-only grafts will be compared.

研究概览

简要总结

This study is to determine whether the use of a composite biologic/synthetic graft during abdominal sacrocolpopexy leads to a lower rate of erosion while maintaining durability.

详细描述

This study will examine the erosion rate of a composite graft that is being used during abdominal sacrocolpopexy. The composite graft is composed of a dual layer of biological and syntheric material. Biological grafts have the advantage of significantly reducing erosion rates, but the longevity of biologic graft is uncertain. On the other hand, synthetic grafts have the advantage in that they are durable, but have higher erosion rates through the vagina and require re-operation in a small percentage of patients. This study will look at whether or not the use of a composite greaft carries the advantages of both types of materials and leads to decreased rates of erosion while maintaining longevity. The cost effectiveness of this new type of graft will also be reviewed since the disavantage of utilizing both the synthetic and biologic graft is that it will increase the cost.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients who underwent abdominal sacrocolpopexy with Drs. Noblett and Lane from 2001 to present

排除标准

  • 未提供

结局指标

主要结局

The erosion rates of composite biologic/syntheric grafts and synthetic-only grafts will be compared.

时间窗: To the point of graft erosion after abdominal sacrocolpopexy

次要结局

  • Cost effectiveness will be examined by comparing the price of a composite graft to the cost of re-operation due to erosion of a synthetic-only graft.(To the point of graft erosion after abdominal sacrocolpopexy)

研究者

申办方类型
Other

研究点 (1)

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