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

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

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Absence of any "Nantes criteria",

Patient non suitable for surgery/general anesthesia

Trial population

This cohort study is a pilot study to evaluate decompression of pudendal and inferior cluneal nerves using robot-assisted laparoscopy for entrapment neuralgias

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 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)

Time frame
Pré-operatively, 2 days, 4 months, 1 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, 2 years, 3 years, 4 years and 5 years 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, 2 years, 3 years, 4 years and 5 years 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, 2 years, 3 years, 4 years and 5 years 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, 2 years, 3 years, 4 years and 5 years after surgery

Other outcomes

Sponsors and contacts

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