Completed

NCT Number: NCT03883178

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

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.

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Key information

Conditions

Pudendopathie Clunealgie

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Brugmann

Brussels, 1020, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minimal-invasive endoscopic transgluteal approach

Procedure

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.

Primary outcomes

score on the SF-36 questionnaire

Time frame: 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

Time frame: Change from baseline at 3 months after surgery

Linear scale raging from 0 (no pain) to 10 (maximal pain).
Pain intensity according to EVA scale

Time frame: Change from baseline at 6 months after surgery

Linear scale raging from 0 (no pain) to 10 (maximal pain).
Surgery duration

Time frame: 24 hours

Surgery duration
Adverse events during surgery

Time frame: 24 hours

Exhaustive list of the adverse events occuring during surgery
Adverse events after surgery

Time frame: 48 hours

Exhaustive list of the adverse events occuring after surgery.
Conversion rate

Time frame: 24 hours

Rate of conversions from the minimal-invasive endoscopic transgluteal approach to the open transgluteal approach during the surgery.
Number of trocars used during surgery

Time frame: 24 hours

Number of 5 mm trocars used in transgluteal position during the surgery.

Sponsors and collaborators

Lead sponsor

Katleen JOTTARD

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Mar 20, 2019
Registry last updated: Mar 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.