About this trial
The objective of our study is to evaluate the efficacy of the laparoscopic robot-assited approach after 1 year of follow-up, on pain experience, and anxiety, depression, post-traumatic stress syndrome and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Absence of any "Nantes criteria",
Patient non suitable for surgery/general anesthesia
Trial population
This cohort study is a pilot study to evaluate decompression of pudendal and inferior cluneal nerves using robot-assisted laparoscopy for entrapment neuralgias
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Evaluate the efficacy of the surgical technique on pain experience related to pudendal and inferior cluneal chronic entrapment neuralgias, using a composite criteria (Numeric pain scale, time seated, PGIC score)
Numeric pain scale (0 "no pain" to 10 "maximal pain"), time seated (\> 30 min,\> 60min or unlimited) Patients' Global Impression of Change (PGIC) scale (1 "very hightly improved" to 7 "very hightly worsened") are combined to create a composite criteria (significant improvement to complete improvement)
Secondary outcomes
Report all complications during the follow-up
Complications are evaluated with Clavien-Dindo classification (Grade I to V(death))
Evaluate the effect of the surgical technique on anxiety
Anxiety is evaluated with STAI (State Trait Anxiety Inventory-form) (anxious personality since STAI score 51 for women, and score 61 for men)
Evaluate the effect of the surgical technique on depression
Depression is evaluated with Beck inventory (mild to moderate depression since score 10, moderate depression since score 19, severe depression since score 30)
Evaluate the effect of the surgical technique on post-traumatic stress syndrome
Post-traumatic stress syndrome is evaluated with PCL-5 (post-traumatic stress disorder checklist with a PTSD since score 38