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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUBOSGA

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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")

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

Secondary outcomes

1

Report all complications during the follow-up

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

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

Evaluate the effect of the surgical technique on anxiety

Anxiety is evaluated with STAI (State Trait Anxiety Inventory-form) (anxious personality since STAI score 51 for women, and score 61 for men)

Time frame
Pré-operatively, 2 days, 4 months, 1 year after surgery
3

Evaluate the effect of the surgical technique on depression

Depression is evaluated with Beck inventory (mild to moderate depression since score 10, moderate depression since score 19, severe depression since score 30)

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

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

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

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

Other outcomes

Sponsors and contacts

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