NCT00968773Unknown4 期
Rebound Hernia Repair Device Trial
Minnesota Medical Development, Inc.4 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2009年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Presence of hernia recurrence
研究概览
简要总结
This is a post-market study of the Rebound Hernia Repair Device to further establish the safety, efficacy, and utility of the Rebound Hernia Repair Device in a controlled population. The Rebound Hernia Repair Device will be used for its approved indication in comparison to "standard" hernia mesh. Two-way students t-tests, Chi squared analysis and ANOVA will be used to detect differences in variables. The study is sufficiently powered to detect a 25% difference.
The study data will include quality of life assessments, visual analogue scale , SF-36, Carolinas Comfort Scale), recurrence of hernia (technical failure), use of medications (pain) and complications/adverse events.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 to 80 years of age
- •Unilateral or bilateral inguinal hernia (moderate in size), primary in nature
排除标准
- •Unable to provide informed consent
- •Assessed as ASA 3 or 4
- •Renal failure;creatinine greater than 2.0mg percent
- •Ascites as determined by clinical suspicion/ultrasound confirmation
- •Known pregnancy
- •Femoral hernias
- •Diabetes requiring injectable insulin
- •Prior lower abdominal surgery through lower midline or Pfannenstiel incision
- •TAPP approach
- •Requiring anticoagulants during surgery
- •Participation in another study involving another device or drug
- •Emergent procedures for hernia incarceration and strangulation
- •Recurrent inguinal hernias
结局指标
主要结局
Presence of hernia recurrence
时间窗: 2 years
次要结局
- Pain and discomfort to patients using VAS(2 years)
研究者
研究点 (4)
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