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临床试验/NCT01675934
NCT01675934撤回不适用

Right-sided Retroflexion With Standard Adult Versus Pediatric Colonoscopes

Medical College of Wisconsin2 个研究点 分布在 1 个国家开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes.

研究概览

简要总结

Screening colonoscopy has been shown to be less effective in preventing colorectal cancer in the proximal colon compared to the distal colon. Possible reasons for this include bowel preparation often being worse in the proximal colon as well as flat depressed lesions being more common in the proximal colon.

Retroflexion is commonly regarded as standard practice in the rectum, but retroflexion in the proximal colon is not currently routinely performed due to concerns of perforation and possibly because of the increased time required.

Proximal colon retroflexion has been shown to be safe and effective without any complications, but data regarding ability to retroflex with certain types of colonoscopes is limited. Endoscopists interchangeably use standard adult colonoscopes or pediatric colonoscopes. Studies have not been performed to comparatively evaluate the success rates of standard adult and pediatric colonoscopes and whether either type of instrument confers a greater polyp detection rate.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients over the age 18 undergoing screening or surveillance colonoscopy

排除标准

  • Age less than 18
  • History of ulcerative colitis or Crohn's disease
  • History of polyposis syndromes
  • History of colon resection
  • Colonoscopy being performed for diagnostic purposes (ie. bleeding, abdominal pain, alternating bowel habits)

结局指标

主要结局

Percentage of cases in which right-sided retroflexion is successful with the adult and pediatric colonoscopes.

时间窗: After 50% and 100% of patient enrollment is complete.

次要结局

  • Adenoma detection rate in forward and retroflexed views.(After 50% and 100% of patient enrollment is complete.)
  • Reasons for failure of retroflexion.(After 50% and 100% of patient enrollment is complete.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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