Robot-assisted surgery for nerve entrapment pain relief
Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias: Results After 1 Year of Follow-up (the X-DECO Study)
This study is testing if robot-assisted surgery can help people with chronic pelvic pain caused by nerve entrapment feel better when 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, Gironde) |
| Trial ID | NCT06578767 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a robot-assisted laparoscopic approach to decompress the pudendal and inferior cluneal nerves in patients suffering from chronic pelvic pain. It focuses on patients who have not responded to medical treatment and have specific diagnostic criteria indicating nerve entrapment. The study will assess changes in pain levels, anxiety, depression, post-traumatic stress syndrome, and overall quality of life over a one-year follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with diagnosed pudendal and inferior cluneal nerve entrapment who have not found relief through medical treatments.
Not a fit: Patients without positive 'Nantes criteria' or those unsuitable for surgery or general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce chronic pain and improve the quality of life for patients with pudendal and inferior cluneal neuralgias.
How similar studies have performed: Previous studies have shown the feasibility of minimally invasive approaches for similar conditions, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years old * Patients presenting a pudendal and inferior cluneal entrapment neuralgia with 5 positive"Nantes criteria", and failure of the medical treatment * Patient having given consent after reading the information note Exclusion Criteria: * Absence of any "Nantes criteria", * Patient non suitable for surgery/general anesthesia
Where this trial is running
Bordeaux, Gironde
- Ubosga — Bordeaux, Gironde, France (Recruiting)
Study contacts
- Principal investigator: Olivier Celhay, M.D — Ubosga
- 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.