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临床试验/NCT03883178
NCT03883178已完成不适用

New Endoscopic Minimal Invasive Approach for Pudendal Nerve and Inferior Cluneal Nerve Neurolysis: a Clinical Study

Katleen JOTTARD1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年5月16日最近更新:
适应症
干预措施

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

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

Experimental

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

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Katleen JOTTARD

Deputy Chief of Clinic

Brugmann University Hospital

研究点 (1)

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