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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pudendal Neuralgia, Neuralgia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Primary outcome measures
- Evaluate the 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves [Time frame: Pré-operatively, and then post-operatively : every day the first month, then once a week until the 4th month then at 1 year year after surgery]
Secondary outcome measures (5)
- Report all complications during the follow-up [Time frame: 2 days, 4 months, 1 year after surgery]
- Evaluate the effect of the surgical technique on anxiety [Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery]
- Evaluate the effect of the surgical technique on depression [Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery]
- Evaluate the effect of the surgical technique on post-traumatic stress syndrome [Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery]
- Evaluate the impact on quality of life [Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- UBOSGA — Bordeaux
Identifiers
NCT: NCT06796595 · UBOSGA 2025/01