Идёт набор NCT06093724

Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient, by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)

Без фазы С лечением Transgenderism

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: В протоколе указаны: Static and dynamic perineo-pelvic MRI.
Кому может быть актуально: Состояния в реестре: Transgenderism. Базовые параметры: от 18 лет · Мужчины.
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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Обзор

The research consists of adding to the usual MtF transgender patient undergoing vaginoplasty care course, static and dynamic perineo-pelvic MRI before, and at 6 and 24 months. The aim is to assess perineo-pelvic static's evolution, based on the appearance of a rectocele.

Подробное описание

Transgender people are estimated to be about 0,3 to 1 % of general population, and MtF reassignment surgery is raising. Vaginoplasty is not always necessary, but is usually an important step into gender transition. In France, surgical techniques' gold-standard is the peno-scrotal inversion vaginoplasty, which consists in the creation of a neo-vagina with peno-scrotal skin graft. Genital, perineum and pelvic anatomy is modified, without knowing in advance about functional and aesthetic results. MRI is the best way to assess soft tissue anatomy in the pelvis. Though, only few studies have assessed pre and post-operative imaging in patients undergoing vaginoplasty, and none have been prospective, neither have assessed the risk of rectocele. The issue is legitimate, because the surgery weakens elements of pelvic fixity, and fixity issues can appear secondarily.

MtF transgender patients operated for a vaginoplasty are undergoing static and dynamic MRI before the surgery, at 6 and at 24 post-operative months. We look after the appearance of a rectocele and it's evolution in time, as criteria for the assessment of pelvic fixity.

Follow-up is composed of several consultations including post-operative MRI, but also clinical measures, census of post-operative issues, and questionnaires for the assessment of secondary objectives.

Вмешательства

Диагностический тест Static and dynamic perineo-pelvic MRI
Static and dynamic perineo-pelvic MRI before surgery, and at 6 and 24 months after surgery.

Первичные конечные точки

Measurement comparison of the rectal bulge's size and classification [Срок оценки: 6 months and 24 months]

Вторичные конечные точки (11)

Rectocele [Срок оценки: 6 months and 24 months]
Rectocele [Срок оценки: 6 months and 24 months]
Reproducibility in the rectocele's measurement [Срок оценки: 6 months and 24 months]
Symptomatology pelvic fixity [Срок оценки: 6 months and 24 months]
Factors pelvic fixity [Срок оценки: 6 months and 24 months]
Skin-graft's neo-vagina's sizes [Срок оценки: 6 months and 24 months]
Imaging measures [Срок оценки: 6 months and 24 months]
Urinary quality [Срок оценки: 6 months and 24 months]
Self-imaging [Срок оценки: 6 months and 24 months]
Sexual quality [Срок оценки: 6 months and 24 months]
Post-operative issues [Срок оценки: Instantly, 6 months and 24 months]

Критерии участия

Критерии включения

Patient over 18 years old
Patient admitted in urology ward at Limoges' University Hospital for MtF sexual reassignment surgery by vaginoplasty
Patient affiliated or benefitting from a social security system
Patient free, informed, written and signed consent