Does Concomitant Transobturator Lateral Suspension Improve Anterior Colporrhaphy Outcomes? A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Objective Recurrence Rate
研究概览
简要总结
Anterior colporrhaphy (AC) is commonly used for anterior vaginal wall prolapse, but suffers high recurrence rates. This randomized trial assessed whether adding transobturator lateral suspension (TOLS) to AC decreases objective recurrence without compromising patient outcomes. In a cohort of 44 women (POP-Q ≥ 2), AC alone was compared to AC+TOLS over a 1-year follow-up. Results showed significantly lower objective recurrence with the added suspension.
详细描述
Conducted prospectively at University Medical Centre Maribor (Slovenia), this single-surgeon RCT randomized women with symptomatic anterior vaginal prolapse (POP-Q stage ≥ 2) to receive either standard AC or AC plus bilateral TOLS via non-absorbable suture across the obturator foramen. Primary outcome was objective anatomical recurrence (POP-Q ≥ 2) at 1 year. Secondary outcomes included subjective recurrence, satisfaction (Likert), operative time, postoperative and pelvic sidewall pain, and validated QOL instruments (UIQ-7, CRAIQ-7, POPIQ-7, PFIQ, POPDI-6, UDI-6, PFDI, PISQ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Adult women with symptomatic anterior vaginal wall prolapse (POP-Q stage ≥ 2)
- •Eligible for native tissue repair
- •Provided written informed consent
排除标准
- •Previous anterior vaginal wall prolapse repair
- •Predominant apical or posterior compartment defect
结局指标
主要结局
Objective Recurrence Rate
时间窗: 1 year postoperative
Anatomical recurrence defined as POP-Q stage ≥ 2 in anterior compartment
次要结局
- Pelvic Sidewall Pain(1 year postoperative.)
- Subjective Recurrence Rate(1 year postoperative)
- Postoperative Pain(1 year postoperative.)
- Patient Satisfaction(1 year postoperative)
- Operative time(1 year postoperative)
研究者
Rok Sumak
Assistant
University Medical Centre Maribor