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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- 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)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
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)
Time Frame: 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 Outcomes
- Evaluate the effect of the surgical technique on anxiety(Pré-operatively, 2 days, 4 months, 1 year after surgery)
- Report all complications during the follow-up(2 days, 4 months, 1 year after surgery)
- Evaluate the effect of the surgical technique on depression(Pré-operatively, 2 days, 4 months, 1 year after surgery)
- Evaluate the effect of the surgical technique on post-traumatic stress syndrome(Pré-operatively, 2 days, 4 months, 1 year after surgery)
- Evaluate the impact on quality of life(Pré-operatively, 2 days, 4 months, 1 year after surgery)
- Report all complications during the follow-up(2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery)
- 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)
- 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)
- 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)
- 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)
- 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))