Uterine Preserving Apical Prolapse Correction With Laparoscopic Lateral Mesh Suspension: Initial Experience by Defining Anatomic and Subjective Success
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 主要终点
- Change from baseline POP-Q measurements (mm) at 18th month.
研究概览
简要总结
This study is aimed to share our clinical experience in an uterine-preserving laparoscopic lateral suspension of apical prolapses with mesh operation after minor modifications in technique. Transperineal ultrasonography and several questionnaires are used for objective and subjective outcomes.
详细描述
Vaginal length, bladder neck mobility and pelvic floor biometry with anteroposterior hiatal diameter and pelvic organ descent measurements are measured by transperineal ultrasonography to assess anatomic success in the preoperative and at postoperative 18th months if available.
Female Sexual Function Index (FSFI), Michigan Incontinence Severity Index (M-ISI), Prolapse Quality of Life questionnaire (PQoL), Pelvic Organ Prolapse Symptom Score (POP-SS) and Visual Analog Score (VAS) are used to assess subjective success in the preoperative and at postoperative 18th months if available.
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研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •>18 years old symptomatic women with pelvic organ prolapse needing surgery.
- •Patients who are not comfortable with using or refusing pessary
- •Refusing sacrocolpopexy due to its serious surgical risk
排除标准
- •Patients who prefer sacrocolpopexy
- •Any cue for gynecologic oncological condition
- •Patients who approves Le Fort colpocleisis among who does not have any sexual intercourse
结局指标
主要结局
Change from baseline POP-Q measurements (mm) at 18th month.
时间窗: 18 months
Prolapse degree; Point Ba/C/Bp
次要结局
- Subjective Success - Change from baseline Female Sexual Function Index (FSFI) to measure sexual dysfunction at 18th month.(18 months)
- Subjective Success - Change from baseline Prolapse Quality of Life questionnaire (PQoL) to measure quality of life according to pelvic organ prolapse at 18th month.(18 months)
- Failure (%)(18 months)
- Subjective Success - Change from baseline Pelvic Organ Prolapse Symptom Score (POP-SS) to measure quality of life according to pelvic organ prolapse at 18th month.(18 months)
- Subjective Success - Change from baseline Visual Analog Score (VAS) for pain at 18th month.(18 months)
- Change from baseline Pelvic Hiatus measurements (mm) at 18th month.(18 months)
- Change from baseline Pelvic biometry measurements at 18th month.(18 months)
- Subjective Success - Change from baseline Michigan Incontinence Severity Index (M-ISI) to measure urinary incontinence at 18th month.(18 months)
- Change from baseline bladder neck mobility measurements at 18th month.(18 months)
研究者
MURAT YASSA
Principal Investigator
Fatih Sultan Mehmet Training and Research Hospital