Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up

NCT ID: NCT06796595

Last Updated: 2025-01-28

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-23

Study Completion Date

2027-01-31

Brief Summary

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Pudendal and inferior cluneal neuralgias are responsible for chronic pelvicperineal pain. These two neuralgias are associated in approximately 25% of cases. In the event of failure of first-line multimodal medical treatment, a mini-invasive robot-assisted laparoscopic decompression can be proposed. These surgeries carry the risk of neurapraxia, leading to a temporary increase in neuropathic pain and numbness in the nerve sensitive area, a motoric or neurovegetative disturbance (pudendal).

Detailed Description

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Conditions

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Pudendal Neuralgia Neuralgia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years old
* Patients presenting a pudendal and/or inferior cluneal neuralgias with failure of the medical treatment
* Patient having given consent after reading the information note

Exclusion Criteria

* Inoperable patients (contraindications to anesthesia or surgery) surgical contraindications)
* Person deprived of liberty or under guardianship
* Person under court protection
* Pregnant or breast-feeding woman
* Minors
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UBOSGA

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UBOSGA

Bordeaux, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Olivier Celhay, M.D

Role: CONTACT

+33(0)5 56 11 61 44

Alexandra Dupire

Role: CONTACT

+33(0)6 07 87 05 56

Facility Contacts

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Olivier CELHAY

Role: primary

+33(0)5 56 11 61 44

Alexandra DUPIRE

Role: backup

+33(0)6 07 87 05 56

Other Identifiers

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UBOSGA 2025/01

Identifier Type: -

Identifier Source: org_study_id

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