Pudendal Neuralgia
Conditions
Keywords
pudendal, inferior cluneal, robot, surgery, decompression, neurolysis, laparoscopy
Brief summary
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.
Detailed description
Pudendal and inferior cluneal neuralgias are responsible for chronic pelvic perineal pain. The compression of both of the nerves are thought to be associated in approximately 25% of the pudendal neuralgias. The failure of the isolated pudendal decompression led in the early 2000s to the identification of an entrapment syndrome of the posterior femoral cutaneous nerve and its inferior cluneal branche around the ischial tuberosity. This subsequent neuralgia affects the posterior part of the perineum, lower buttock, and the posterior part of the thigh, without any associated neuro-vegetative symptoms, unlike in pudendal neuralgia. In case of failure of the medical treatment, the open trans-gluteal decompression was proposed as a gold standard. However, this technique remains invasive and requires a long recovery. In a previous study, the investigators demonstrated the feasibility of double decompression via a minimally invasive robot-assisted laparoscopic approach, and described a 4-step technique.
Interventions
None listed
Sponsors
UBOSGA
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Pré-operatively, 2 days, 4 months, 1 year after surgery | 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
| Measure | Time frame | Description |
|---|---|---|
| Report all complications during the follow-up | 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery | Complications are evaluated with Clavien-Dindo classification (Grade I to V(death)) |
| Evaluate the effect of the surgical technique on anxiety | Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery | 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 | Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery | 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 | Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery | Post-traumatic stress syndrome is evaluated with PCL-5 (post-traumatic stress disorder checklist with a PTSD since score 38 |
| Evaluate the impact on quality of life | Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery | Quality of life is evaluated with SF-36 (36-item Short Form Health Survey) |
| Long-term efficacy of the surgical technique on pain experience using the composite criteria | 24, 36, 48 and 60 months after surgery (24 months ± 2 months; 36, 48 and 60 months ± 3 months) | Numeric pain scale (0 "no pain" to 10 "maximal pain"), time seated (\>30 min, \>60 min or unlimited) and Patients' Global Impression of Change (PGIC) scale (1 to 7) are combined into a composite criterion (significant to complete improvement), assessed annually from 2 to 5 years after surgery. |
Countries
France
Contacts
CONTACTOlivier Celhay, M.D
PRINCIPAL_INVESTIGATOROlivier Celhay, M.D
UBOSGA
Outcome results
None listed