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 (REGEN)

January 27, 2025 updated by: UBOSGA
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).

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • UBOSGA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Olivier CELHAY

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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")
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 days, 4 months, 1 year after surgery
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)
Pré-operatively, 2 days, 4 months, 1 year after surgery
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)
Pré-operatively, 2 days, 4 months, 1 year after surgery
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
Pré-operatively, 2 days, 4 months, 1 year after surgery
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)
Pré-operatively, 2 days, 4 months, 1 year after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UBOSGA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 23, 2025

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBOSGA 2025/01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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