UBOSGA
Bordeaux, Gironde, 33000, France
Location status: Recruiting
Location contact
Alexandra Dupire
CONTACT
Olivier Celhay, MD
CONTACT
Olivier Celhay, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06578767
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bordeaux, Gironde, 33000, France
Location status: Recruiting
Alexandra Dupire
CONTACT
Olivier Celhay, MD
CONTACT
Olivier Celhay, MD
PRINCIPAL_INVESTIGATOR
Pudendal and inferior cluneal neuralgias are responsible for chronic pelvic perineal pain. The compression of both of the nerves are thought to be associated in approximately 25% of the pudendal neuralgias. The failure of the isolated pudendal decompression led in the early 2000s to the identification of an entrapment syndrome of the posterior femoral cutaneous nerve and its inferior cluneal branche around the ischial tuberosity. This subsequent neuralgia affects the posterior part of the perineum, lower buttock, and the posterior part of the thigh, without any associated neuro-vegetative symptoms, unlike in pudendal neuralgia. In case of failure of the medical treatment, the open trans-gluteal decompression was proposed as a gold standard. However, this technique remains invasive and requires a long recovery. In a previous study, the investigators demonstrated the feasibility of double decompression via a minimally invasive robot-assisted laparoscopic approach, and described a 4-step technique.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Pré-operatively, 2 days, 4 months, 1 year after surgery
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: 2 days, 4 months, 1 year after surgery
Complications are evaluated with Clavien-Dindo classification (Grade I to V(death))
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)
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)
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
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)
Contact information is provided by the study sponsor or research team.
UBOSGA
Other
Decompression of Pudendal and Inferior Cluneal Nerves Using Robot-assisted Laparoscopy for Entrapment Neuralgias: Results After 1 Year of Follow-up (the X-DECO Study)
Acronym: X-DECO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07356102
Nerve Compression Syndromes, Nervous System Diseases
Ankara, Turkey (Türkiye)
View Trial DetailsNCT06872437
Nerve Compression Syndromes, Nervous System Diseases
Paris, France
View Trial DetailsNCT06796595
Nerve Compression Syndromes, Nervous System Diseases
Bordeaux, France
View Trial DetailsNCT06644261
Chronic Pelvic Pain Syndrome, Nerve Compression Syndromes
Louisville, Kentucky, United States
View Trial Details