NCT03883178

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

Completed NA Last updated 20 March 2019

What this trial tests

NA trial testing Minimal-invasive endoscopic transgluteal approach in Pudendopathie in 30 participants. Completed in 29 January 2019.

Timeline

16 May 2017

Primary endpoint
29 January 2019

29 January 2019

Quick facts

Lead sponsor	Katleen JOTTARD
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	16 May 2017
Primary completion	29 January 2019
Estimated completion	29 January 2019
Sites	1 location across Belgium

Drugs / interventions tested

• Minimal-invasive endoscopic transgluteal approach

Conditions studied

• Pudendopathie — all drugs for Pudendopathie →
• Clunealgie — all drugs for Clunealgie →

Sponsor

Katleen JOTTARD

Who can join

18 and older, any sex, with Pudendopathie or Clunealgie. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A minimally invasive, endoscopic transgluteal procedure for pudendal nerve and inferior cluneal nerve neurolysis in case of entrapment: 3- and 6-month results. The ENTRAMI technique for neurolysis.
   Jottard K, Bruyninx L, Bonnet P, De Wachter S. · · 2020 · cited 4× · PMID 31828369 · DOI 10.1007/s00384-019-03480-2