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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pudendopathie, Clunealgie

Intervention / Treatment
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* Procedure: Minimal-invasive endoscopic transgluteal approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from pudendalgie and/ or clunealgie, according to the 5 Nantes criteria and who are candidates for transgluteal surgical treatment. Exclusion Criteria: None

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurolysis<br> | Procedure: Minimal-invasive endoscopic transgluteal approach<br>* Every patient, suffering from a pudendopathie or clunealgie, conform the Nantes criteria, and who are candidates for a surgical treatment through the transgluteal open approach, will be asked their permission to perform the procedure through a minimal-invasive endoscopic transgluteal approach.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| score on the SF-36 questionnaire | 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). | Change from baseline at 3 months after surgery | 
| Pain intensity according to EVA scale | Linear scale raging from 0 (no pain) to 10 (maximal pain). | Change from baseline at 3 months after surgery | 
| Pain intensity according to EVA scale | Linear scale raging from 0 (no pain) to 10 (maximal pain). | Change from baseline at 6 months after surgery | 
| Surgery duration | Surgery duration | 24 hours | 
| Adverse events during surgery | Exhaustive list of the adverse events occuring during surgery | 24 hours | 
| Adverse events after surgery | Exhaustive list of the adverse events occuring after surgery. | 48 hours | 
| Conversion rate | Rate of conversions from the minimal-invasive endoscopic transgluteal approach to the open transgluteal approach during the surgery. | 24 hours | 
| Number of trocars used during surgery | Number of 5 mm trocars used in transgluteal position during the surgery. | 24 hours |