Clinical trial NCT06796595: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pudendal Neuralgia
Neuralgia
Lead sponsor: UBOSGA
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cohort study is a pilot study to 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

Brief summary: 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).


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

Primary outcomes:
measure: 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
timeFrame: 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 outcomes:
measure: Report all complications during the follow-up
timeFrame: 2 days, 4 months, 1 year after surgery
measure: Evaluate the effect of the surgical technique on anxiety
timeFrame: Pré-operatively, 2 days, 4 months, 1 year after surgery
measure: Evaluate the effect of the surgical technique on depression
timeFrame: Pré-operatively, 2 days, 4 months, 1 year after surgery
measure: Evaluate the effect of the surgical technique on post-traumatic stress syndrome
timeFrame: Pré-operatively, 2 days, 4 months, 1 year after surgery
measure: Evaluate the impact on quality of life
timeFrame: Pré-operatively, 2 days, 4 months, 1 year after surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: UBOSGA
Study officials:
References: