Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate the 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves
研究概览
简要总结
Pudendal and inferior cluneal neuralgias are responsible for chronic pelvicperineal pain. These two neuralgias are associated in approximately 25% of cases. In the event of failure of first-line multimodal medical treatment, a mini-invasive robot-assisted laparoscopic decompression can be proposed. These surgeries carry the risk of neurapraxia, leading to a temporary increase in neuropathic pain and numbness in the nerve sensitive area, a motoric or neurovegetative disturbance (pudendal).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old
- •Patients presenting a pudendal and/or inferior cluneal neuralgias with failure of the medical treatment
- •Patient having given consent after reading the information note
排除标准
- •Inoperable patients (contraindications to anesthesia or surgery) surgical contraindications)
- •Person deprived of liberty or under guardianship
- •Person under court protection
- •Pregnant or breast-feeding woman
结局指标
主要结局
Evaluate the 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves
时间窗: Pré-operatively, and then post-operatively : every day the first month, then once a week until the 4th month then at 1 year year after surgery
Numeric pain scale (0 "no pain" to 10 "maximal pain")
次要结局
- Report all complications during the follow-up(2 days, 4 months, 1 year after surgery)
- Evaluate the impact on quality of life(Pré-operatively, 2 days, 4 months, 1 year after surgery)
- Evaluate the effect of the surgical technique on anxiety(Pré-operatively, 2 days, 4 months, 1 year after surgery)
- Evaluate the effect of the surgical technique on depression(Pré-operatively, 2 days, 4 months, 1 year after surgery)
- Evaluate the effect of the surgical technique on post-traumatic stress syndrome(Pré-operatively, 2 days, 4 months, 1 year after surgery)