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NCT Number: NCT06796595

Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up

Pudendal and inferior cluneal neuralgias are responsible for chronic pelvicperineal pain. These two neuralgias are associated in approximately 25% of cases. In the event of failure of first-line multimodal medical treatment, a mini-invasive robot-assisted laparoscopic decompression can be proposed. These surgeries carry the risk of neurapraxia, leading to a temporary increase in neuropathic pain and numbness in the nerve sensitive area, a motoric or neurovegetative disturbance (pudendal).

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Key information

Conditions

Pudendal Neuralgia Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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/or inferior cluneal neuralgias with failure of the medical treatment
  • Patient having given consent after reading the information note

Exclusion criteria

  • Inoperable patients (contraindications to anesthesia or surgery) surgical contraindications)
  • Person deprived of liberty or under guardianship
  • Person under court protection
  • Pregnant or breast-feeding woman
  • Minors

Treatment and study plan

Primary outcomes

  1. Evaluate the 1-year effectiveness of a perioperative medical program on the characteristics of neuropathic pain related to postoperative neurapraxia, following robot-assisted laparoscopic neurolyses of the pudendal and inferior cluneal nerves

    Time frame: Pré-operatively, and then post-operatively : every day the first month, then once a week until the 4th month then at 1 year year after surgery

    Numeric pain scale (0 "no pain" to 10 "maximal pain")

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.

Alexandra Dupire

CONTACT

[email protected]

+33(0)6 07 87 05 56

Olivier Celhay, M.D

CONTACT

[email protected]

+33(0)5 56 11 61 44

Sponsors and collaborators

Lead sponsor

UBOSGA

Other

Registry information

Acronym: REGEN

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 28, 2025
Registry last updated
Jan 28, 2025

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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