New Endoscopic Minimal Invasive Approach for Pudendal Nerve and Inferior Cluneal Nerve Neurolysis: a Clinical Study
NCT ID: NCT03883178
Last Updated: 2019-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2017-05-16
2019-01-29
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Neurolysis
Minimal-invasive endoscopic transgluteal approach
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.
Interventions
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Minimal-invasive endoscopic transgluteal approach
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Katleen JOTTARD
OTHER
Responsible Party
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Katleen JOTTARD
Deputy Chief of Clinic
Principal Investigators
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Katleen Jottard
Role: PRINCIPAL_INVESTIGATOR
CHU Brugmann
Locations
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CHU Brugmann
Brussels, , Belgium
Countries
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References
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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. doi: 10.1002/nau.20505.
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.
Beco J, Climov D, Bex M. Pudendal nerve decompression in perineology: a case series. BMC Surg. 2004 Oct 30;4:15. doi: 10.1186/1471-2482-4-15.
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.
Konschake M, Brenner E, Moriggl B, Hormann R, Bauer S, Foditsch E, Janetschek G, Kunzel 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.
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. doi: 10.1016/j.eururo.2004.09.003.
Jottard K, Bruyninx L, Bonnet P, De Wachter S. Endoscopic trans gluteal minimal-invasive approach for nerve liberation (ENTRAMI technique) in case of pudendal and/or cluneal neuralgia by entrapment: One-year follow-up. Neurourol Urodyn. 2020 Sep;39(7):2003-2007. doi: 10.1002/nau.24462. Epub 2020 Jul 17.
Jottard K, Bruyninx L, Bonnet P, De Wachter S. 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. Int J Colorectal Dis. 2020 Feb;35(2):361-364. doi: 10.1007/s00384-019-03480-2. Epub 2019 Dec 11.
Other Identifiers
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CHUB-neurolysis
Identifier Type: -
Identifier Source: org_study_id
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