NCT02272322Unknown不适用
Transvaginal Treatment of Symptomatic Cystocele Grade II-III Using Cousin Biomesh Soft Prolaps or Allium Medical Endofast Reliant
Slabbaert Koen1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Absence of recurrence
研究概览
简要总结
This observational study will evaluate treatment of symptomatic cystocele grade II-III with Cousin Biomesh and Allium Medical Endofast Reliant. Data about 100 patients will be collected. Follow-up till 3 years after the procedure. Primary endpoint is absence of recurrence.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient is a woman
- •Patient is between 40 and 90 years old
- •Patient has to sign the informed consent form prior to the procedure
- •Patient has to agree with the scheduled follow-up visits on month 1, month 6, year 1, year 2 and year 3
- •Patient has symptomatic anterior prolapse
排除标准
- •Recurrence cystocele
- •Patient is pregnant
- •Patient has a wish to become pregnant
- •Patient is taking Plavix, Sintrom, Marcoumar, Marevan, Brilique, Efient, Ticlid, Xarelto, Eliquis or Pradaxa. If intake is stopped prior to procedure, patient is allowed to be included.
- •Patient is taking LMWH in a dose of more than 40 mg/day
- •Patient has a life expectancy < 1 year
- •Patient has a known connective tissue disease
- •Patient has a history of surgery of the anterior vaginal wall or pelvis
- •A scheduled hysterectomy during the index-procedure
结局指标
主要结局
Absence of recurrence
时间窗: 3 years
次要结局
- Technical success(day 1)
- Procedural success(30 days)
- Peroperative complications(day 1)
- Postoperative complications(3 years)
- Quality of life(3 years)
研究者
Slabbaert Koen
MD
Regionaal Ziekenhuis Heilig Hart Tienen
研究点 (1)
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