Actively Recruiting
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
Led by UBOSGA · Updated on 2025-01-28
20
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Pudendal and inferior cluneal neuralgias cause chronic pelvic and perineal pain, often occurring together in about 25% of cases. This observational study aims to evaluate a perioperative medical program designed to support nerve regeneration after robot-assisted laparoscopic surgery for these neuralgias. The study focuses on the effects of this program over a one-year follow-up period, assessing changes in neuropathic pain and other related symptoms. The study observes patients who have undergone mini-invasive robot-assisted laparoscopic decompression surgery of the pudendal and/or inferior cluneal nerves after first-line medical treatments have failed. The program aims to manage possible postoperative neurapraxia, which can cause temporary increases in neuropathic pain, numbness, and motor or neurovegetative disturbances. Researchers will assess these effects before surgery, daily during the first month after surgery, weekly until month four, and then again at one year. Participants will be monitored through evaluations of neuropathic pain characteristics and will be assessed for complications, anxiety, depression, post-traumatic stress syndrome, and quality of life at several points: before surgery, two days after, four months after, and one year after surgery. This comprehensive follow-up will help understand the program's impact on recovery and well-being over time.
CONDITIONS
Brief 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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Inoperable patients (contraindications to anesthesia or surgery)
- Person deprived of liberty or under guardianship
- Person under court protection
- Pregnant or breast-feeding woman
- Minors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 day
Participants undergo robot-assisted laparoscopic neurolyses of the pudendal and/or inferior cluneal nerves for chronic neuralgias.
1 surgery visit (in-person)
Duration - 1 year
Participants are monitored daily for the first month, then weekly until 4 months, and again at 1 year after surgery to evaluate pain characteristics, complications, psychological effects, and quality of life.
Daily visits for 1 month, then weekly visits until 4 months, and 1 visit at 1 year
Trial Site Locations
Total: 1 location
1
UBOSGA
Bordeaux, France, 33000
Actively Recruiting
Research Team
O
Olivier Celhay, M.D
A
Alexandra Dupire
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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