Efficacy of Second Forward-view Examination of Left Colon for Adenoma Detection During Colonoscopy: a Multicenter, Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,516
- 试验地点
- 1
- 主要终点
- Left colon adenoma detection rate (LCADR)
研究概览
简要总结
The incidence of colorectal cancer in China is increasing year by year. Studies have shown that colorectal cancer is more common in the left colon，especially in the China. Our previous study also showed a higher rate of missed adenoma in the left colon than the right colon during colonoscopy. Additionally, prolonging withdrawal time could only improve the ADR of right colon, but had limited effect on the ADR of left colon in our previous research. Our aim is to evaluate the effect of a second forward view examination of the left colon on the detection of adenoma detection during colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose age are between 40-75, or aged 76-85 depending on his condition
- •Patients who have indications for screening
- •Patients who have signed inform consent form.
排除标准
- •Patients who have undergone colonic resection
- •Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
- •Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy
- •Patients with inflammatory bowel diseases
- •Patients with a history of abdominal surgery, or highly suspected or confirmed colorectal cancers by radiographic and laboratory tests Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
- •Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
- •Patients with failed cecal intubation
- •Patients with poor BPQ that necessitated a second bowel preparation
- •Patients with therapeutic colonoscopy for existing lesions
- •Patients refusing to participate or to provide informed consent
结局指标
主要结局
Left colon adenoma detection rate (LCADR)
时间窗: 60 minutes
LCADR is the number of patients with at least one adenoma in the left colon, divided by the total number of patients.
次要结局
- adenoma detection rate(ADR)(60 minutes)
- left colon adenomas per colonoscopy (LCAPC)(60 minutes)
研究者
Zhaoshen Li
MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator
Changhai Hospital