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

NCT06578767 | Recruiting

• 1 other identifier: CERU_2024-034
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pudendal Neuralgia

Keywords

pudendal; inferior cluneal; robot; surgery; decompression; neurolysis; laparoscopy

Outcome Measures

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)

  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 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 decompression of pudendal and inferior cluneal nerves using robot-assisted laparoscopy for entrapment neuralgias

You may qualify if:

• 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

You may not qualify if:

• Absence of any "Nantes criteria",
• Patient non suitable for surgery/general anesthesia

Sponsors & Collaborators

• UBOSGA: lead

Study Sites (1)

UBOSGA

Bordeaux, Gironde, 33000, France

RECRUITING

MeSH Terms

Conditions

Pudendal Neuralgia

Condition Hierarchy (Ancestors)

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

Study Officials

• Olivier Celhay, M.D

  UBOSGA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Celhay, M.D

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 29, 2024
• Study Start: July 31, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: October 10, 2024

Record last verified: 2024-10

Locations

FR (1)