Program to improve nerve healing after laparoscopic surgery for chronic pelvic pain
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
This study is testing a robot-assisted surgery to see if it can help people with chronic pelvic pain from nerve issues feel better and heal more effectively after other treatments haven't worked.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ubosga Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT06796595 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients suffering from pudendal and inferior cluneal neuralgias, which cause chronic pelvic pain. It evaluates the outcomes of a minimally invasive robot-assisted laparoscopic decompression procedure after patients have not responded to standard medical treatments. The study aims to assess nerve regeneration and pain relief over a one-year follow-up period. By monitoring the effects of this surgical intervention, the study seeks to optimize recovery and improve patient quality of life.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have experienced treatment failure for pudendal and/or inferior cluneal neuralgias.
Not a fit: Patients who are inoperable due to surgical contraindications or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance nerve healing and reduce chronic pain for patients suffering from these conditions.
How similar studies have performed: While similar approaches have been explored, this specific program's focus on nerve regeneration post-surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bordeaux
- Ubosga — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Olivier Celhay, M.D
- Email: celhay.ubsg33@gmail.com
- Phone: +33(0)5 56 11 61 44
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.