The Change in Vaginal Axis on MRI After Uterus Preserving Laparoscopic Lateral Mesh Suspension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Vaginal axis
研究概览
简要总结
Laparoscopic lateral mesh suspension is emerged as a practical, safe and feasible alternative to sacropexy to treat female genital apical prolapse. Investigators hypothesized that uterus-preserving lateral suspension provides a better anatomical positioning.
详细描述
Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may properly mimic cardinal ligament and restore the normal vaginal axis. To prove the null hypothesis, it is planned to compare the vaginal axis on Magnetic Resonans Imaging taken preoperatively and postoperatively in patients who are scheduled for lateral mesh suspension for apical prolapse.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female genital prolapse
排除标准
- •Patients who had pouch of Douglas obliteration
- •Patients with enterocele
- •Patients who have any congenital or acquired anatomic and reproductive anomaly
结局指标
主要结局
Vaginal axis
时间窗: at 6th months after the operation
From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated. The angles between the pubococcygeal line and lower vaginal segment (angle A), between the levator plate and the pubococcygeal (angle B) and between lower and upper vaginal segments (angle C) will be measured.
Vaginal distances
时间窗: at 6th months after the operation
The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.
次要结局
- Urge Symptoms(Evaluation at postoperative 6th month)
- Prolapse symptoms(Evaluation at postoperative 6th month)
- Sexual functions(Evaluation at postoperative 6th month)
研究者
OZAN DOGAN
Principal Investigator
Sisli Hamidiye Etfal Training and Research Hospital