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临床试验/NCT01607827
NCT01607827已完成不适用

Colorectal Polypectomy Upon Insertion And Withdrawal Or Upon Withdrawal Only?

University of Zurich2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2004年4月最近更新:
适应症
干预措施

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

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

Active Comparator

干预措施: Polyp removal upon insertion and withdrawal (Procedure)

Polyp removal upon withdrawal only

No Intervention

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephan Wildi

Stephan M. Wildi, Principle Investigator

University of Zurich

研究点 (2)

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