NCT02751736Unknown不适用
The Effect Of Probiotics From Kimchi (CJLP243) On Bowel Function Restoration After Ileostomy Closure In Patients With Rectal Cancer: A Pilot Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- Memorial Sloan Kettering Cancer Center bowel function index
研究概览
简要总结
The study will investigate whether Probiotics(CJLP243) given just before and after ileostomy repair operation in patient with rectal cancer improve a bowel function.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 20-75
- •with rectal cancer
- •s/p low anterior resection (double stapled anastomosis)
排除标准
- •Metastatic cancer
- •Pregnancy
- •Valvular heart disease
- •s/p intersphincteric resection (index surgery)
- •h/o anastomotic leakage (index surgery)
- •medically unfit (cardiopulmonary dysfunction, sepsis etc)
结局指标
主要结局
Memorial Sloan Kettering Cancer Center bowel function index
时间窗: Postoperative weeks 3
Subscale: frequency score
Low Anterior Resection Syndrome score
时间窗: Postoperative weeks 3
次要结局
- Memorial Sloan Kettering Cancer Center bowel function index(Postoperative week 1)
- Low Anterior Resection Syndrome score(Postoperative week 1)
- Change of bowel functions index(Between postoperative week 1 to 3)
- EORTC C30(Postoperative week 1 and 3)
- EORTC CR (Colorectal) 29(Postoperative week 1 and 3)
- Postoperative complication(till Postoperative weeks 3)
研究者
Heung-Kwon Oh
Clinical Associate Professor
Seoul National University Bundang Hospital
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