NCT01557101已完成4 期
Effectiveness of Colon Capsule Endoscopy as Colorectal Cancer Method of Screening in The Familiar-Risk Population
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer
研究概览
简要总结
The purpose of this study is to determine if the adherence to screening in first grade relatives of patients with CCR is higher than optical colonoscopy.
详细描述
The purpose of this study is to compare the adherence and effectiveness of colon capsule endoscopy (CCE-2) versus conventional colonoscopy to screen first-degree relatives of patients with colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Asymptomatic first-degree relatives (parents, siblings or children) of CRC patients aged less than 60 years or with two or more first-degree relatives of any age.
- •Signing of informed consent.
排除标准
- •Personal history of adenoma or CRC.
- •History of hereditary CRC.
- •Chronic inflammatory disease.
- •Presence of digestive symptoms.
- •Patients with swallowing problems (dysphagia).
- •Personal history of gastrointestinal surgery.
- •Enteritis radioactive.
- •Renal failure.
- •Congestive heart failure
- •Allergy or other contraindication to Bysacodyl to PEG or phosphates.
- •Pregnancy.
- •Suspected bowel obstruction or intestinal strictures or fistulas known.
- •Colectomy.
- •Paralysis with impaired intestinal motility.
- •Any other process that the investigator's discretion to make inadequate participation.
研究组 & 干预措施
COLON CAPSULE ENDOSCOPY
Other
干预措施: COLON CAPSULE ENDOSCOPY ADHERENCE (Procedure)
OPTICAL COLONOSCOPY
Other
干预措施: OPTICAL COLONOSCOPY ADHERENCE (Procedure)
结局指标
主要结局
Participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer
时间窗: 6 month follow up
Assess whether colon capsule endoscopy increases participation to colorectal cancer screening in first-degree relatives of patients with colorectal cancer
次要结局
未报告次要终点
研究者
研究点 (2)
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