Prospective Imaging Assessment of Perineo-pelvic Static's Evolution After Sexual Reassignment Surgery in MtF Transgender Patient, by Peno-scrotal Inversion Vaginoplasty Technique (TRANSPELV)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Measurement comparison of the rectal bulge's size and classification
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patient admitted for vulvoplasty surgery
- •Patient admitted for second vaginoplasty surgical gesture
- •Contraindication of realizing an MRI
结局指标
主要结局
Measurement comparison of the rectal bulge's size and classification
时间窗: 6 months and 24 months
Comparison and classification by pre-operative and post-operative MRI
次要结局
- Reproducibility in the rectocele's measurement(6 months and 24 months)
- Skin-graft's neo-vagina's sizes(6 months and 24 months)
- Symptomatology pelvic fixity(6 months and 24 months)
- Imaging measures(6 months and 24 months)
- Urinary quality(6 months and 24 months)
- Factors pelvic fixity(6 months and 24 months)
- Self-imaging(6 months and 24 months)
- Sexual quality(6 months and 24 months)
- Post-operative issues(Instantly, 6 months and 24 months)
- Rectocele(6 months and 24 months)