Robotic Decompression
Conditions
Brief summary
Primary purpose: Show the pain improvement 3-month after robotic laparoscopic pudendal nerve decompression for pudendal neuralgia. Primary outcomes: Pain evaluated on a VAS before surgery and 3-month after surgery or surveillance Improvement is considered if pain decreased by at least 3/10 points on the VAS. Secondary purposes: * improvement of quality of life * study of MRI performance to predict pudendal nerve entrapment topography * show the feasibility and safety of robotic pudendal nerve decompression
Interventions
PROCEDURERobotic laparoscopic decompression of pudendal nerve entrapment
Robotic laparoscopic decompression of pudendal nerve entrapment. Transperitoneal Laparoscopic Robotic assistance
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18 - 70 years old * Pudendal neuralgia according to Nantes criteria * pudendal nerve entrapment reachable with robotic transperitoneal approach
Exclusion criteria
* bilateral pain * history of pain ≥ 18 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. (0 no pain -10 extreme pain ) | 3-months after surgery or surveillance | Collection of the maximum pain intensity on a numerical scale (EN), calculated on 10 points. Daily collection by the patient over 1 week in real life conditions. Achievement of an average of the scores over 1 week. |
Countries
France
Outcome results
None listed