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Clinical Trial NCT06578767 (X-DECO) for Pudendal Neuralgia is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study 20

Recruiting
Clinical Trial NCT06578767 (X-DECO) is an observational study for Pudendal Neuralgia that is recruiting. It started on 31 July 2024 with plans to enroll 20 participants. Led by UBOSGA, it is expected to complete by 1 July 2025. The latest data from ClinicalTrials.gov was last updated on 10 October 2024.
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 ischia...Show More
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)

Conditions
Pudendal Neuralgia
Other Study IDs
  • X-DECO
  • CERU_2024-034
NCT ID Number
NCT06578767
Start Date (Actual)
2024-07-31
Last Update Posted
2024-10-10
Completion Date (Estimated)
2025-07
Enrollment (Estimated)
20
Study Type
Observational
Status
Recruiting
Keywords
pudendal
inferior cluneal
robot
surgery
decompression
neurolysis
laparoscopy
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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)
Pré-operatively, 2 days, 4 months, 1 year after surgery
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Report all complications during the follow-up
Complications are evaluated with Clavien-Dindo classification (Grade I to V(death))
2 days, 4 months, 1 year after surgery
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)
Pré-operatively, 2 days, 4 months, 1 year after surgery
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)
Pré-operatively, 2 days, 4 months, 1 year after surgery
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
Pré-operatively, 2 days, 4 months, 1 year after surgery
Evaluate the impact on quality of life
Quality of life is evaluated with SF-36 (36-item Short Form Health Survey)
Pré-operatively, 2 days, 4 months, 1 year after surgery
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • 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

  • Absence of any "Nantes criteria",
  • Patient non suitable for surgery/general anesthesia
UBOSGA logoUBOSGA
Study Central Contact
Contact: Olivier Celhay, M.D, +33(0)5 56 11 61 44, [email protected]
1 Study Locations in 1 Countries

Gironde

UBOSGA, Bordeaux, Gironde, 33000, France
Olivier Celhay, MD, Contact, +33(0)5 56 11 61 44, [email protected]
Alexandra Dupire, Contact, +33(0)6 07 87 05 56, [email protected]
Olivier Celhay, MD, Principal Investigator
Recruiting