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NCT Number: NCT06578767

Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias : the X-DECO Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Report all complications during the follow-up

    Time frame: 2 days, 4 months, 1 year after surgery

    Complications are evaluated with Clavien-Dindo classification (Grade I to V(death))

  2. Evaluate the effect of the surgical technique on anxiety

    Time frame: Pré-operatively, 2 days, 4 months, 1 year 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)

  3. Evaluate the effect of the surgical technique on depression

    Time frame: Pré-operatively, 2 days, 4 months, 1 year 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)

  4. Evaluate the effect of the surgical technique on post-traumatic stress syndrome

    Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery

    Post-traumatic stress syndrome is evaluated with PCL-5 (post-traumatic stress disorder checklist with a PTSD since score 38

  5. Evaluate the impact on quality of life

    Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery

    Quality of life is evaluated with SF-36 (36-item Short Form Health Survey)

Study contacts

Contact information is provided by the study sponsor or research team.

Olivier Celhay, M.D

CONTACT

[email protected]

+33(0)5 56 11 61 44

Sponsors and collaborators

Lead sponsor

UBOSGA

Other

Registry information

Official study 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)

Acronym: X-DECO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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