NCT00924755Unknown4 期
Early Outcome of Inguinal Hernia Repair With Biomerix Surgical Mesh Using the Lichtenstein Technique
适应症
试验速览
- 阶段
- 4 期
- 发起方
- Biomerix
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Technical success with no complications through 6 weeks.
研究概览
简要总结
The purpose of this study is to assess the early outcomes when using the Biomerix Revive™ as a tension-free onlay patch, Lichtenstein-style, in patients who are candidates for primary, unilateral, open inguinal hernia repair.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •male ≥19 years old
- •symptomatic and palpable inguinal hernia
- •candidate for unilateral, primary, open inguinal hernia repair using the Lichtenstein technique
- •will comply with required follow-up study visits
- •willing and able to provide written informed consent
排除标准
- •life expectancy of <3 years
- •strangulated hernia
- •urologic disorder and/or previous urologic surgery in the testicular area (with the exception of prostate surgery)
- •active abdominal surgical condition such as bowel obstruction or perforation
- •local or systemic infection or peritonitis
- •known disease that impairs wound healing
- •anti-platelet therapy (other than aspirin) for >7 days preceding the surgical procedure
- •previous ipsilateral groin incision
- •receiving immunosuppressive therapy and/or has undergone radiation therapy to the affected groin area
- •uncontrolled insulin-dependent diabetic with Hgb1Ac greater than 8
- •advanced cirrhosis with Child-Turcott Class of C or higher
- •severe COPD requiring home oxygen
- •diagnosed with chronic pain syndrome or is undergoing treatment for pain management
- •candidate for another major surgical procedure with the inguinal hernia repair
- •enrolled in another investigational study that may confound the results of this study
- •known drug abuser
- •on anti-psychotic medications
- •Worker's Compensation case
结局指标
主要结局
Technical success with no complications through 6 weeks.
时间窗: 6 weeks
次要结局
- Hernia recurrence(1 year)
- Pain and functional status(10 day, 6 weeks, 6 months 1 year)
- Incidence of complications(10 days, 6 weeks, 6 months, 1 year)
研究者
研究点 (4)
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