NCT03876977终止不适用
Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia: A Randomized Controlled Trial
University Hospital, Strasbourg, France2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2020年8月8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
- 1
- 试验地点
- 2
- 主要终点
- Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain )
研究概览
简要总结
Primary purpose:
Show the pain improvement 3-month after robotic laparoscopic pudendal nerve decompression for pudendal neuralgia.
Primary outcomes:
Pain evaluated on a VAS before surgery and 3-month after surgery or surveillance Improvement is considered if pain decreased by at least 3/10 points on the VAS.
Secondary purposes:
- improvement of quality of life
- study of MRI performance to predict pudendal nerve entrapment topography
- show the feasibility and safety of robotic pudendal nerve decompression
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 70 years old
- •Pudendal neuralgia according to Nantes criteria
- •pudendal nerve entrapment reachable with robotic transperitoneal approach
排除标准
- •bilateral pain
- •history of pain ≥ 18 months
结局指标
主要结局
Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain )
时间窗: 3-months after surgery or surveillance
Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. Daily collection by the patient over 1 week in real life conditions. Achievement of an average of the scores over 1 week.
次要结局
未报告次要终点
研究者
研究点 (2)
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