Superiority of Perineoplasty as Concomitant Surgical Procedure During Pelvic Organ Prolapse Repair; a Comparative Cohort Trial (SUPPORT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 305
- 试验地点
- 2
- 主要终点
- Surgical success
研究概览
简要总结
The goal of this study is to evaluate whether adding perineoplasty is, in comparison to performing vaginal prolapse surgery without adding perineoplasty, superior with respect to efficacy and cost-effectiveness and non-inferior with respect to morbidity, in patients undergoing vaginal surgical correction of pelvic organ prolapse at 24 months after surgery.
详细描述
Preoperative measurements, performed at baseline:
- Patient characteristics (age, BMI, smoking, obstetric history)
- Physical examination including POP-Q score. The genital hiatus (gh) at rest (as part of the POP-Q) will be used to assess the wideness of the vaginal introitus.
- Pelvic Floor Distress Inventory (PFDI-20) questionnaire and Patient Global Impression of Severity (PGI-S)
- Pelvic Floor Ultrasound 2DStudy measurements;
- Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-ir), Dutch Perineal Support Questionnaire (DPSQ), General Quality of Life (EQ-5D-5L), Medical Consumption Questionnaire (iMCQ) and Productivity Cost Questionnaire (iPCQ)
- Patient and surgeons considerations with respect to level III repair;
Postoperative measurements:
- Regular physical check-up will be at 4-8 weeks after procedure.
- Physical examination including POP-Q score
- Patient Global Impression of Improvement score (PGI-I)
- Pelvic Floor Ultrasound 2D
- iMCQ, iPCQ, EQ-5D-5L questionnaire
Extra follow up:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Female patient >18 years of age
- •Complaints of pelvic organ prolapse
- •Indication for prolapse surgery (level I and/or level II repair)
- •Genital hiatus (GH) according to POP-Q staging of ≥4 cm and ≤7 cm
排除标准
- •Unable to understand the Dutch language
- •Pregnancy at baseline or intendancy to become pregnant during the study period
- •Patients with previous surgery for POP (previous mid urethral sling operations for urinary stress incontinence not excluded)
- •Unwilling and / or incapable of giving informed consent
结局指标
主要结局
Surgical success
时间窗: 12 months
composite outcome defined as meeting the 3 following conditions: \[1\] "much improved" or "improved" in response to the patient global impression of improvement questionnaire, \[2\] no re-intervention performed in the same compartment within the first 12 months after index surgery, \[3\] no stage 2 or more POP in the operated compartment.
次要结局
- Effectiveness(24 months)
- Anatomical outcomes(24 months)
- Morbidity(24 months)
- Societal costs(24 months)
研究者
Marjolein Spiering
MSc
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)