NCT01984996终止不适用
Freedom Inguinal Hernia Repair System Study
Insightra Medical, Inc.16 个研究点 分布在 3 个国家目标入组 100 人开始时间: 2013年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals
研究概览
简要总结
The primary objective of this study is to evaluate patient quality-of-life (QOL) after inguinal hernia repair. "Carolinas Comfort Scale" (CCS) assessments will be held at regular intervals.
The secondary objective of the study is to follow short-term and long-term study-related complications/adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo routine inguinal hernia repair
- •Competent to give consent
- •Clinically relevant inguinal hernia (classification: NYHUS I, II, IIIa)
- •Defect size at operation is between 5mm and 35mm
- •Diagnosed with unilateral, direct, indirect or mixed inguinal hernia
- •Primary hernia at the operative site
- •Male or female
- •Life expectancy of at least 12 months
- •At least 18 years of age
排除标准
- •Signs of obvious local or systemic infection
- •Any previous surgery on the hernia operative site
- •Hernia is not in the inguinal area
- •Hernia is not identified as indirect or direct
- •Femoral hernias
- •Known collagen disorder
- •Presenting with unstable angina or NYHA class of IV
- •Known Pregnancy
- •Active drug user
- •Recurrence of a repair by any method
- •Patients with giant inguinoscrotal hernia or abdominal wall defect >35 mm in diameter - e.g. large direct or combined inguinal hernia type Nyhus IIIb / EHS P L/M 1/2/3
- •Immunosuppression, prednisone>15 mg/day, active chemotherapy
- •End stage renal disease
- •Abdominal ascites
- •Skin infection in area of surgical field
- •Peritoneum cannot be closed
结局指标
主要结局
Measure changes from baseline in Carolina Comfort Scale (CCS) scores at specified time intervals
时间窗: 1 week, 3, 6, 9, 12, 18, 24, and 36 months.
Measure quality of life for patients undergoing inguinal hernia repair.
次要结局
- Evaluate the 14-day pain and medication log(14 days)
研究者
研究点 (16)
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