Clinical trial NCT06578767: Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pudendal Neuralgia
Keywords: pudendal
inferior cluneal
robot
surgery
decompression
neurolysis
laparoscopy
Lead sponsor: UBOSGA
Sponsor class: OTHER
First posted: 2024-08-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This cohort study is a pilot study to evaluate decompression of pudendal and inferior cluneal nerves using robot-assisted laparoscopy for entrapment neuralgias

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.

Eligibility 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

Primary outcomes:
measure: 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)
timeFrame: Pré-operatively, 2 days, 4 months, 1 year after surgery
Secondary outcomes:
measure: Report all complications during the follow-up
timeFrame: 2 days, 4 months, 1 year after surgery
measure: Evaluate the effect of the surgical technique on anxiety
timeFrame: Pré-operatively, 2 days, 4 months, 1 year after surgery
measure: Evaluate the effect of the surgical technique on depression
timeFrame: Pré-operatively, 2 days, 4 months, 1 year after surgery
measure: Evaluate the effect of the surgical technique on post-traumatic stress syndrome
timeFrame: Pré-operatively, 2 days, 4 months, 1 year after surgery
measure: Evaluate the impact on quality of life
timeFrame: Pré-operatively, 2 days, 4 months, 1 year after surgery
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: UBOSGA
state: Gironde
Study officials:
affiliation: UBOSGA
name: Olivier Celhay, M.D
role: PRINCIPAL_INVESTIGATOR
References: