Clunealgie Clinical Trial
Official title:
New Endoscopic Minimal Invasive Approach for Pudendal Nerve and Inferior Cluneal Nerve Neurolysis: a Clinical Study
| Verified date | March 2019 |
| Source | Brugmann University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | January 29, 2019 |
| Est. primary completion date | January 29, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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: |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | CHU Brugmann | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Katleen JOTTARD |
Belgium,
Beco J, Climov D, Bex M. Pudendal nerve decompression in perineology: a case series. BMC Surg. 2004 Oct 30;4:15. — View Citation
Erdogru T, Avci E, Akand M. Laparoscopic pudendal nerve decompression and transposition combined with omental flap protection of the nerve (Istanbul technique): technical description and feasibility analysis. Surg Endosc. 2014 Mar;28(3):925-32. doi: 10.1007/s00464-013-3248-1. Epub 2013 Oct 23. — View Citation
Konschake M, Brenner E, Moriggl B, Hörmann R, Bauer S, Foditsch E, Janetschek G, Künzel KH, Sievert KD, Zimmermann R. New laparoscopic approach to the pudendal nerve for neuromodulation based on an anatomic study. Neurourol Urodyn. 2017 Apr;36(4):1069-1075. doi: 10.1002/nau.23090. Epub 2016 Aug 4. — View Citation
Labat JJ, Riant T, Robert R, Amarenco G, Lefaucheur JP, Rigaud J. Diagnostic criteria for pudendal neuralgia by pudendal nerve entrapment (Nantes criteria). Neurourol Urodyn. 2008;27(4):306-10. — View Citation
Ploteau S, Salaud C, Hamel A, Robert R. Entrapment of the posterior femoral cutaneous nerve and its inferior cluneal branches: anatomical basis of surgery for inferior cluneal neuralgia. Surg Radiol Anat. 2017 Aug;39(8):859-863. doi: 10.1007/s00276-017-1825-z. Epub 2017 Feb 24. — View Citation
Robert R, Labat JJ, Bensignor M, Glemain P, Deschamps C, Raoul S, Hamel O. Decompression and transposition of the pudendal nerve in pudendal neuralgia: a randomized controlled trial and long-term evaluation. Eur Urol. 2005 Mar;47(3):403-8. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | |
| Primary | 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 | |
| Primary | Surgery duration | Surgery duration | 24 hours | |
| Primary | Adverse events during surgery | Exhaustive list of the adverse events occuring during surgery | 24 hours | |
| Primary | Adverse events after surgery | Exhaustive list of the adverse events occuring after surgery. | 48 hours | |
| Primary | Conversion rate | Rate of conversions from the minimal-invasive endoscopic transgluteal approach to the open transgluteal approach during the surgery. | 24 hours | |
| Primary | Number of trocars used during surgery | Number of 5 mm trocars used in transgluteal position during the surgery. | 24 hours |