NCT02678936撤回4 期
Anal fistUla Repair With Platelet-Rich plasmA (AURoRA)
University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家开始时间: 2015年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Healing rate
研究概览
简要总结
Anal fistula is a very common disease with a high impact on life quality. The only commonly accepted treatment option is surgery. A wide range of operations and techniques have been developed all suffering from a relatively high recurrence rate.
The investigators propose the combination of the mucosal advancement flap with application of platelet-rich plasma (PRP) in the fistulectomy site. This study aims to test the hypothesis that by applying PRP the healing rate of complicated anal fistulas can be improved in comparison to a control group where the operation is performed without addition of PRP.
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
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •complicated anal fistula with patient fit for surgical treatment
- •minimum 6 weeks after
- •written informed consent
排除标准
- •pregnancy
- •drug abuse, drug substitution program
- •homeless (follow-up difficult)
- •restricted in legal capacity
- •simple fistulas requiring fistulotomy
- •complicated fistulas requiring an anus praeter naturalis
结局指标
主要结局
Healing rate
时间窗: 2 Years
次要结局
- Influence of risk factor smoking on healing rate(2 years)
- Influence of sex on healing rate(2 years)
- Influence of risk factor high BMI on healing rate(2 years)
- Influence of risk factor chronic renal failure on healing rate(2 years)
研究者
研究点 (2)
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