Continuous Small Stitch Technique for Anterior Colporrhaphy: a Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)
研究概览
简要总结
A descent of the anterior vaginal wall is the most common form of female pelvic organ prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a "standard procedure", its exact steps are not well standardized.
We developed a small stitch anterior colporrhaphy (SSTAC) in an effort to increase the strength and durability of AC
Objectives
The aim of this pilot study is to demonstrate the feasibility and complication rate of the SSTAC and to assess the anatomical and functional outcomes after this method of cystocele repair.
详细描述
A prospective case series evaluation of SSTAC following the recommendations of IDEAL-Collaboration (www.ideal-collaboration.net) will be performed. The newly developed procedure will be tested in a group of 10 patients, who equals stage 2a in the development and innovation of surgical innovations. In this stage safety and technical success is the main outcome. As technical modifications may be common during stage 2a and their nature and timing should be meticulously recorded, the videotaping during all surgical procedures will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •women older than 18 years of age
- •Able to read, understand and sign informed consent
- •symptomatic cystocele described as Points Aa or Ba >= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q)
排除标准
- •previous urogynecological operation
- •gynecologic malignancy
- •planned concomitant incontinence operation
- •other contraindications for surgery
- •pregnancy
- •systemic glucocorticoid treatment
- •contraindication for the surgery
结局指标
主要结局
the most distal point of the anterior vaginal wall- postoperative anterior vaginal support described as Point Ba (POP-Q score)
时间窗: 4-6 weeks, 3 months
The changes in POPQ score preoperatively and three months after the anterior colporrhaphy with the new small stitch technic will be analyzed.
次要结局
未报告次要终点
研究者
Halpern Ksenia
Dr.
Medical University of Vienna