New Endoscopic Minimal Invasive Approach for Pudendal Nerve and Inferior Cluneal Nerve Neurolysis: a Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Conversion rate
研究概览
简要总结
Pudendal nerve and cluneal nerve entrapment can cause a neuropathic pain syndrome in one, many or all of the sensitive areas innervated by this nerve. In literature, several techniques for the liberation of the pudendal nerve have been described. Here, transvaginal, transperineal and abdominal laparoscopic approaches have been proposed, but none of the latter were able to visualize the entire course of the nerve or allowed to explore the main, currently identified sites of entrapment. Although there have been reports and series of case reports on different surgical approaches, until now, the transgluteal approach is the only one which is validated by a prospective randomized study comparing the medical treatment to these surgical approach.
The investigators already performed a study to describe for the first time a new endoscopic minimal invasive technique using a transgluteal approach which permits to visualize all the nerve structures of the gluteal region. They performed an anatomic description of the region reachable with this minimally invasive approach, and described the anatomic landmarks for the visualization of the pudendal and cluneal nerve and their neurolysis.
In this study, the investigators would like to put in clinical practice this minimal invasive approach for pudendal and cluneal neurolysis. They will perform this endoscopic approach, on patients suffering from pudendalgie or/and clunealgie, who are programmed for a surgical intervention by transgluteal approach.
The investigators would like to test the feasibility of the transgluteal trocar positioning and if necessary, optimize this first important step. Secondly, they will put in practice the step-by-step surgical approach that they have worked out during their cadaver study. Finally, they will perform the entire neurolysis and nerve transposition under endoscopic control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 suffering from pudendalgie and/ or clunealgie, according to the 5 Nantes criteria and who are candidates for transgluteal surgical treatment.
排除标准
- 未提供
研究组 & 干预措施
Neurolysis
干预措施: Minimal-invasive endoscopic transgluteal approach (Procedure)
结局指标
主要结局
Conversion rate
时间窗: 24 hours
Rate of conversions from the minimal-invasive endoscopic transgluteal approach to the open transgluteal approach during the surgery.
score on the SF-36 questionnaire
时间窗: Change from baseline at 3 months after surgery
SF-36 is a set of generic, coherent, and easily administered quality-of-life measures. It covers several health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions.The recommended scoring system for the SF-36 is a weighted Likert system for each item. The items in the subscales are summed to obtain a summary score for each subscale or dimension. Each of the 8 summary scores is linearly transformed on a scale of 0 (negative to health) to 100 (positive for health).
Pain intensity according to EVA scale
时间窗: Change from baseline at 6 months after surgery
Linear scale raging from 0 (no pain) to 10 (maximal pain).
Surgery duration
时间窗: 24 hours
Surgery duration
Adverse events after surgery
时间窗: 48 hours
Exhaustive list of the adverse events occuring after surgery.
Number of trocars used during surgery
时间窗: 24 hours
Number of 5 mm trocars used in transgluteal position during the surgery.
Adverse events during surgery
时间窗: 24 hours
Exhaustive list of the adverse events occuring during surgery
次要结局
未报告次要终点
研究者
Katleen JOTTARD
Deputy Chief of Clinic
Brugmann University Hospital
