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临床试验/NCT04441242
NCT04441242已完成不适用

Use of Ambient Lighting During Colonoscopy and Its Effect on Adenoma Detection Rate and Eye Fatigue: a Pilot Study

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 1,109 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,109
试验地点
2
主要终点
Change in adenoma detection rate

研究概览

简要总结

A retrospective and prospective study to determine if the use of ambient lighting during screening colonoscopy is well tolerated and if ambient lighting will help physicians maintain adenoma detection rates while decreasing symptoms of eye strain as the day progresses.

详细描述

This study is a a single-center study at an independent community-based teaching hospital comparing adenoma detection rate in screening colonoscopies performed in low lighting with those performed with ambient lighting (75-150 lux). All cases included in the study involved adult patients undergoing screening colonoscopy with a participating gastroenterologist. Diagnostic colonoscopies, history of colon resection, colorectal cancer, and cases performed in children, pregnant women, and prisoners were excluded from analysis. Cases involving gastroenterology fellows were also excluded. Retrospective data was collected over a six month period from January 2017 to June 2017, followed by a prospective arm the during the same calendar months the subsequent year (January 2018 to June 2018).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • Adults undergoing screening colonoscopy
  • Procedure performed by a participating gastroenterologist

排除标准

  • Any diagnostic colonoscopies
  • History of colon resection
  • History of colorectal cancer
  • Pregnant women
  • Prisoners
  • Cases involving trainees, including gastroenterology fellows

结局指标

主要结局

Change in adenoma detection rate

时间窗: 6 months

Adenoma detection rate, comparing change from first case of the day to the last. Ranges from 0-99%, with greater increases adenoma detection rate (ADR) being more favorable.

Eye strain score

时间窗: 6 months

Eye strain score, as calculated from survey responses completed by physicians. Ranges from 0 - 60, with lower scores indicating less severe symptoms (therefore, lower scores are more favorable).

次要结局

  • Adenoma detection rate (overall)(Participants each assessed on one day during 6 month study period)
  • Satisfaction by staff(6 months)
  • Adenoma detection rate (first case vs last case of the day)(Participants each assessed on one day during 6 month study period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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