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临床试验/NCT01026935
NCT01026935已完成不适用

The Effect of Mesh Type on Pain After Surgery for Inguinal Hernia. Randomized Clinical Trial of Lichtenstein Operation With Sutured Polypropylene Patch or Self-adhesive ProGrip Patch.

Helsinki University Central Hospital3 个研究点 分布在 1 个国家目标入组 398 人开始时间: 2008年2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
398
试验地点
3
主要终点
postoperative complaints

研究概览

简要总结

For the present study, 400 consecutive men with unilateral primary inguinal hernia are randomized to Lichtenstein repair using either light weight polypropylene mesh (38g/m2) or light weight ProGrip mesh. ProGrip mesh adheres to tissues with polylactic micro hooks without suturing. The primary aim is to examine, whether the ProGrip mesh produces less pain than sutured polypropylene mesh. Secondary outcomes are operation time and convalescence as well as recurrence rate. ProGrip mesh is supposed to be faster to apply as no sutures are needed, which may compensate for its higher cost. The patients are blinded to which mesh they receive.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

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

  • primary unilateral inguinal hernia

排除标准

  • not willing to participate
  • not capable to understand or fill in the questionnaires

结局指标

主要结局

postoperative complaints

时间窗: One year

次要结局

  • Recurrence rate(One year)

研究者

申办方类型
Other

研究点 (3)

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