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

K

Katleen JOTTARD

Status

Completed

Conditions

Clunealgie
Pudendopathie

Treatments

Procedure: Minimal-invasive endoscopic transgluteal approach

Study type

Interventional

Funder types

Other

Identifiers

NCT03883178
CHUB-neurolysis

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Neurolysis
Experimental group
Treatment:
Procedure: Minimal-invasive endoscopic transgluteal approach

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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