Randomized Trial of Sacrospinous Ligament Fixation Versus McCall Culdoplasty in Women Undergoing Vaginal Hysterectomy and Repairs for Prolapse
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 312
- 试验地点
- 2
- 主要终点
- Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q).
研究概览
简要总结
To date no study has determined prospectively which technique is superior to prevent recurrent Pelvic Organ Prolapse (POP) after vaginal hysterectomy- a major unmet clinical need. The aim of the study is to determine objective anatomical recurrent prolapse after Sacrospinous Ligament Fixation (SLF) vs McCall.
详细描述
The aim of the study is to determine objective anatomical recurrent prolapse after SLF vs McCall. The study is designed as a Randomized Controlled Trial (RCT). Primary study endpoint will be at 12 months, secondary study endpoint at 24 months. The following parameters will be evaluated after one year: anatomical outcome, Quality of Life (QoL), sexual health, reoperations, and complications.
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
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •declined/ failed conservative treatment for POP
- •planned vaginal hysterectomy with anterior/posterior colporrhaphy as indicated
- •any symptomatic POP or stage II prolapse in any compartment
- •at least stage I prolapse in the apical department
- •women between 35 and 80 years of age
- •good German language skills
- •any concomitant prolapse surgery (anterior, posterior vaginal repair, suburethral tapes) as indicated
- •concomitant salpingo-oophorectomy if indicated
排除标准
- •Unwillingness to participate
- •Neurological disorders
- •Previous hysterectomy
- •Desire to have children
- •Connective tissue disorders (i.e. Ehlers-Danlos syndrome, Marfan syndrome)
结局指标
主要结局
Number of patients with stage 2 or higher on the Pelvic Organ Prolapse Quantification System (POP-Q).
时间窗: 12 months after surgery
POP-Q stage 2 or higher means any point of the POP-Q system being -1 related to the hymen or below
次要结局
- Subjective cure(12 months after surgery)
- Quality of life as determined by a questionnaire(12 months after surgery)
- Reoperation rate(12 months after surgery)
- Sexual health(12 months after surgery)