Capsule Endoscopy as an Alternative to Colonoscopy. Could the Number of Colonoscopies be Reduced?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 704
- 试验地点
- 6
- 主要终点
- percentage of patients who could avoid colonoscopy
研究概览
简要总结
This is a prospective, multicenter, interventional study assessing CE, in patients already scheduled for colonoscopy at tertiary referral hospitals, as a technique to reduce the number of unnecessary colonoscopies and identify patients to prioritize in endoscopy waiting lists.
详细描述
Study design Enrolled patients already scheduled for non-urgent colonoscopy according to local practice will be offered to undergo an early CE; in case of negative proof they will perform colonoscopy as already planned (scheduled colonoscopy); in patients with positive findings, requiring endoscopic treatment or intervention, colonoscopy will be performed within 30 days from CE (early colonoscopy).
Study population Patients who received the indication for colonoscopy as per clinical practice and subsequently identified as non-urgent procedures, according to locally established prioritization criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Iron deficiency anaemia with or without a colonoscopy performed within the last 5 years
- •Rectal bleeding/haematochezia in patients >50 years who have undergone a colonoscopy <5 years ago or <50 years with no risk factors for CRC
- •Chronic constipation/abdominal distension/abdominal pain/diarrhea
- •Suspected CRC due to clinical criteria (NICE guidelines 2015, updated in 2017) with no iFOBT performed
- •Recent change in bowel habits
- •Follow-ups: post-polypectomy syndrome, family history of CRC, hereditary syndromes, CRC surgery, Inflammatory Bowel Disease
排除标准
- •Study following an episode of complicated acute diverticulitis or with an uncertain diagnosis of acute diverticulitis
- •Evaluation following fragmented resection (recurrence ruled out)
- •Patients with a positive FIT
- •Pregnancy or breast-feeding
- •Any contraindication to Crohn's Capsule endoscopy such as known or suspected gastrointestinal obstruction, strictures or fistulas, a previous altered Patency capsule, dysphagia or other swallowing disorders and cardiac pacemakers or other implanted electromedical devices.
- •Allergy or known contraindication to the medications and preparations agents used in the procedure.
结局指标
主要结局
percentage of patients who could avoid colonoscopy
时间窗: 6 months
To evaluate the percentage of patients who could avoid colonoscopy by performing a previous CE
次要结局
- To compare CE and CC findings(6 months)
- CE diagnostic yield and adenoma detection rate (ADR)(6 months)
研究者
Begoña González Suárez
MD PhD
Hospital Clinic of Barcelona