Идёт набор NCT06578767

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

— Наблюдательное Pudendal Neuralgia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Pudendal Neuralgia. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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)

Обзор

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.

Подробное описание

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.

Первичные конечные точки

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) [Срок оценки: Pré-operatively, 2 days, 4 months, 1 year after surgery]

Вторичные конечные точки (6)

Report all complications during the follow-up [Срок оценки: 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery]
Evaluate the effect of the surgical technique on anxiety [Срок оценки: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery]
Evaluate the effect of the surgical technique on depression [Срок оценки: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery]
Evaluate the effect of the surgical technique on post-traumatic stress syndrome [Срок оценки: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery]
Evaluate the impact on quality of life [Срок оценки: Pré-operatively, 2 days, 4 months, 1 year, 2 years, 3 years, 4 years and 5 years after surgery]
Long-term efficacy of the surgical technique on pain experience using the composite criteria [Срок оценки: 24, 36, 48 and 60 months after surgery (24 months ± 2 months; 36, 48 and 60 months ± 3 months)]

Критерии участия

Критерии включения

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