Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia
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University Hospital, Strasbourg, France
临床试验: NCT03876977
BioSeek: NCT03876977
关键词
抽象
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
日期
| 最后验证: | 07/31/2019 |
| 首次提交: | 03/11/2019 |
| 提交的预估入学人数: | 03/11/2019 |
| 首次发布: | 03/14/2019 |
| 上次提交的更新: | 08/18/2019 |
| 最近更新发布: | 08/20/2019 |
| 实际学习开始日期: | 09/30/2019 |
| 预计主要完成日期: | 09/30/2019 |
| 预计完成日期: | 11/30/2022 |
状况或疾病
Robotic Decompression
干预/治疗
Procedure: Robotic laparoscopic decompression
相
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手臂组
| 臂 | 干预/治疗 |
|---|---|
| No Intervention: Non-invasive Neuropathic drugs Pudendal infiltration | |
| Experimental: Robotic laparoscopic decompression Robotic laparoscopic decompression of pudendal nerve entrapment. | Procedure: Robotic laparoscopic decompression Robotic laparoscopic decompression of pudendal nerve entrapment.
Transperitoneal Laparoscopic Robotic assistance |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Age 18 - 70 years old - Pudendal neuralgia according to Nantes criteria - pudendal nerve entrapment reachable with robotic transperitoneal approach Exclusion Criteria: - bilateral pain - history of pain ≥ 18 months |
结果
主要结果指标
1. Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain ) [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.
