Colorectal Polypectomy Upon Insertion And Withdrawal Or Upon Withdrawal Only?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Polyp detection
研究概览
简要总结
The investigators aim to assess the procedure time and miss rate of polyps when performing polypectomy in the colon on the way up* and down** or only on the way down**.
(* advancing the scope to the cecum, ** pulling back the scope after intubation of the cecum). Our hypothesis is that using the strategy to remove all visible polyps firstly on the way up and secondly on the way down is less time consuming and misses less polyps as with the strategy to remove polyps only on the way down.
详细描述
Patients with a referral for a complete colonoscopy were included in the study. Polyps were removed upon insertion and withdrawal of the colonoscope in Group A or only upon withdrawal of the instrument in Group B according to a computer-generated randomization list.
The following inclusion criteria were used: referral for a complete colonoscopy and age of 18 years and older. All patients with polyps detected during colonoscopy were included. In order to compare the time required for the entire endoscopy between the two treatment groups, we only included patients with polyps of up to 10 mm in diameter.
The following exclusion criteria were applied: colonoscopy due to bleeding, high likelihood of colonic stenosis or severe inflammation, inflammatory bowel disease (IBD), hereditary colonic polyp disease (FAP or HNPCC), contraindications for polypectomy, such as coagulopathy, use of anti-clotting medication (anticoagulation, high-dose heparin aspirin, NSAIDs), polyps >10 mm in diameter (that cannot be removed through the biopsy channel and have to be removed by basket or polyp grasper; the use of these devices necessitates removal and consecutive re-insertion of the endoscope, making a comparison of the time intervals between the two groups impossible), suboptimal bowel preparation (presence of significant amounts of fecal remnants that could not be removed by flushing of the colon over the colonoscope and that did not allow clear visualization of the mucosa), and missing signed informed consent form.
The randomization was done as soon as the first polyp was detected. When no polyps were detected, the case was regarded as screening failure and excluded from the study.
Randomization was performed into the following two groups:
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Need for a complete colonoscopy
- •18 years of age and older
排除标准
- •Need for urgent colonoscopy due to bleeding
- •High likelihood of colonic stenosis or severe inflammation
- •Known inflammatory bowel disease (IBD)
- •Known familiarity adenomatous polyposis (FAP)
- •Contraindications for polypectomy such as coagulopathy, use of anti-clotting medication (anticoagulation, aspirin, NSAIDs)
- •Missing signed consent
研究组 & 干预措施
Polyp removal upon insertion and withdrawal
干预措施: Polyp removal upon insertion and withdrawal (Procedure)
Polyp removal upon withdrawal only
干预措施: Polyp removal upon withdrawal only (Procedure)
结局指标
主要结局
Polyp detection
时间窗: 2004 - 2007
次要结局
未报告次要终点
研究者
Stephan Wildi
Stephan M. Wildi, Principle Investigator
University of Zurich
