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临床试验/NCT01025960
NCT01025960已完成不适用

Comparison of Detection of Polyps During Both Insertion and Withdrawal Phases of Colonoscopy Versus the Standard Practice of Detection of Polyps During the Withdrawal Phase of Colonoscopy: A Prospective Quality Improvement Study

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 768 人开始时间: 2009年11月1日最近更新:
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
768
试验地点
1
主要终点
Adenoma detection rates for each method

研究概览

简要总结

Colorectal cancer (CRC) is the third most common cancer and second leading cause of cancer deaths in western countries. Colonoscopy is a preferred colorectal screening modality since it has both diagnostic and therapeutic capability. Detection and removal of polyps at colonoscopy decreases the incidence and mortality from colorectal cancer.

Typical practice is to insert the colonoscope rapidly until it reaches the cecum (a pouch-like portion of the intestines, where the large bowel and the small bowel meet). The physician then withdraws the colonoscope slowly and looks for any polyps or abnormalities within the large bowel. The purpose of this study is to compare this standard practice to the approach whereby the physician examines the bowel as the scope is initially inserted AND as the colonoscope is withdrawn from patients' colons.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adult patients
  • •Patients able to provide an informed consent
  • •Patients undergoing colonoscopy

排除标准

  • •Pregnant women
  • •Patients with Familial Adenomatous Polyposis Syndromes (FAP)
  • •Patients with Hereditary Non-polyposis Colon Cancer Syndrome (HNPCC)
  • •Patients who have undergone previous surgical resection of the colon
  • •Patients who have been diagnosed with inflammatory bowel disease

研究组 & 干预措施

Standard Inspection Colonoscopy

Other

The colonoscope will be inserted rapidly to reach the cecum. Inspection of the large bowel will occur during the withdrawal of the colonoscope.

干预措施: Standard Inspection Colonoscopy (Procedure)

Dual Inspection Colonoscopy

Active Comparator

The large bowel will be inspected for polyps during the insertion of the colonoscope to the cecum, and during the withdrawal of the scope from the large bowel.

干预措施: Dual Inspection Colonoscopy (Procedure)

结局指标

主要结局

Adenoma detection rates for each method

时间窗: within the first 30 days after colonoscopy

次要结局

  • Comparison of procedure times for each method(1 year)
  • Percentage of patients with at least one adenoma detected by each method(1 year)
  • Comparison of percentage of adenomas classified as high risk for each method(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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