NCT00673400已完成不适用
Morbidity and Functional Outcome of Stapled TransAnal Rectal Resection (STARR) With Contour® TranstarTM in Obstructed Defecation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Quality of Life
研究概览
简要总结
The stapled transanal rectal resection (STARR procedure) is an effective treatment for obstructed defecation syndrome (ODS) caused by intussusception and rectocele. Recently a new technique has been developed using the new Contour® TranstarTM stapler, which was specifically designed to facilitate the STARR procedure. The investigators would like to evaluate the morbidity and quality of life.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rectocele
- •Intussusception
排除标准
- •Non operability
- •inflammatory bowel disease
结局指标
主要结局
Quality of Life
时间窗: 6 months after intervention
Quality of life is measured by Fecal incontinence quality of life (FIQL) Possible range of score 0 - 4 (Depression/Self perception 4.4) 0 = worst condition * Fecal Incontinence Quality of Life (FIQL) (Rockwood, Dis Colon Rectum (2000) 43:9)
次要结局
- Morbidity(1 year)
- Hospitalization(1 day to 1 year (until release from hospital))
研究者
F. Hetzer
Leitender Arzt
Cantonal Hospital of St. Gallen
研究点 (2)
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