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

NCT06796595 | Recruiting

• 1 other identifier: UBOSGA 2025/01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Pudendal Neuralgia; Neuralgia

Outcome Measures

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

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

  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

Secondary Outcomes (5)

• Report all complications during the follow-up

  2 days, 4 months, 1 year after surgery

• Evaluate the effect of the surgical technique on anxiety

  Pré-operatively, 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This cohort study is a pilot study to 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UBOSGA: lead

Study Sites (1)

UBOSGA

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Pudendal Neuralgia; Neuralgia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Olivier Celhay, M.D

CONTACT

+33(0)5 56 11 61 44; celhay.ubsg33@gmail.com

Alexandra Dupire

CONTACT

+33(0)6 07 87 05 56; arc.ubosga@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 28, 2025
• Study Start: January 23, 2025
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)