Robotic Decompression of the Pudendal Nerve in Pudendal Neuralgia
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スポンサー
University Hospital, Strasbourg, France
臨床試験: NCT03876977
BioSeek: NCT03876977
キーワード
概要
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
日付
| 最終確認済み: | 07/31/2019 |
| 最初に提出された: | 03/11/2019 |
| 提出された推定登録数: | 03/11/2019 |
| 最初の投稿: | 03/14/2019 |
| 最終更新が送信されました: | 08/18/2019 |
| 最終更新日: | 08/20/2019 |
| 実際の研究開始日: | 09/30/2019 |
| 一次完了予定日: | 09/30/2019 |
| 研究完了予定日: | 11/30/2022 |
状態または病気
Robotic Decompression
介入/治療
Procedure: Robotic laparoscopic decompression
段階
-
アームグループ
| 腕 | 介入/治療 |
|---|---|
| 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 |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | 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 |
結果
主な結果の測定
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.
