NCT01661829已完成不适用
A Randomised Controlled Trial for the Effect of Biofeedback Therapy for the Preveintion of Anterior Resection Syndrome in Rectal Cancer Patients Who Have Undergone Low Anterior Resection With Total Mesorectal Excision Following Neoadjuvant Chemoradiation Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Incidence of anterior resection syndrome after stoma closure
研究概览
简要总结
In patients who underwent sphincter preserving surgery with toal mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal function after stoma closure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •rectal cancer patients
- •neoadjuvant chemoradiation therapy (+)
- •sphincter saving surgery with total mesorectal excision (+)
- •temporary loop stoma (+)
- •adult who is 17 years or older
- •patinet who aggree with our study
- •if woman is childbearing age, her pregnancy test shoud be indentified 'negative'
排除标准
- •patients who have been enrolled to other clinical studies related to this study
- •patients who underwent diverting stoma before neoadjuvant chemoradiation
- •temporary end -ostomy (+)
- •uncontrolled metabolic or systemic disease
- •patients who do not understand the purpose of this study because of dementia or pshycologic problem
- •MRSA or Clostridium difficille (+)
- •Pregnant or during breast feeding
- •serious complication after sphincter saving surgery
结局指标
主要结局
Incidence of anterior resection syndrome after stoma closure
时间窗: 1 year after stoma closure
次要结局
未报告次要终点
研究者
Kye Bong-Hyeon
Assistant Clinical Professor
The Catholic University of Korea
研究点 (1)
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