跳至主要内容
临床试验/NCT01214252
NCT01214252已完成不适用

A Retrospective Study Evaluating the Use of Permacol Surgical Implant in the Repair of Abdominal Wall Defects

Medtronic - MITG1 个研究点 分布在 1 个国家目标入组 343 人开始时间: 2010年10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
343
试验地点
1
主要终点
Confirmed Hernia Recurrence

研究概览

简要总结

To evaluate short, mid and long term clinical outcomes associated with the use of Permacol in the treatment of abdominal wall defects.

研究设计

研究类型
Observational
时间视角
Retrospective

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

  • Equal or over 18 years of age
  • Had undergone surgical repair or reconstruction of abdominal wall defects, ventral hernias or incisional hernias using Permacol Surgical Implant.
  • At least 12 months of follow-up post date of surgery (-30 days)
  • Undergone open or laparoscopic repairs

排除标准

  • Had undergone inguinal, parastomal, diaphragmatic or paraesophageal/hiatal hernia repair
  • Any prior use of Permacol in abdominal wall repair

结局指标

主要结局

Confirmed Hernia Recurrence

时间窗: 12 months

Confirmed hernia or hernia recurrence: Proportion of patients treated with Permacol Surgical Implant who experienced hernia or hernia recurrence at the repair site. Hernia or recurrence is defined by hernia diagnosis during clinical assessment by surgeon or medical chart review

次要结局

  • Total Unconfirmed Hernia or Hernia Recurrence(12 Months)
  • Hernia or Hernia Recurrence by Year From Year 2 to Last Year Observed(Year 2 to Year 8)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验