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临床试验/NCT01989650
NCT01989650已完成不适用

The Effect of Taking Break During Colonoscopy Session on Adenoma Detection, a Prospective, Randomized Control Study

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,379 人开始时间: 2012年2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
1,379
试验地点
1
主要终点
Adenoma detection rate

研究概览

简要总结

Recent research has suggested that endoscopist fatigue may significantly affect the polyp detection rate. There have been no studies on interventions that may reduce endoscopist fatigue and therefore improve colonoscopy performance.

We want to determine whether a break in the middle of colonoscopy session would maintain a more stable adenoma detection rate

详细描述

In recent years, there has been a dramatic increase in the volume of endoscopic procedures performed in most endoscopy centers. With the growing awareness of colorectal cancer screening, there is increasing demand for colonoscopy which has increased the workload of endoscopists in every healthcare system. There are studies showing that physician fatigue impairs quality of care and performance in other medical specialties such as anesthesia and surgery. Colonoscopy by nature is repetitive and frequently prolonged which can promote distractibility and fatigability. Studies from western countries have showed that afternoon colonoscopies are associated with lower adenoma detection rate (ADR) compared with the morning colonoscopies and physician fatigue has been hypothesized as a potential contributor. Previous studies also showed that the polyp detection rate decreases hour-by-hour throughout the day and the colonoscopy completion rate appears to decline with successive procedures due to endoscopist fatigue. The most recent study using the queue position as a surrogate marker for endoscopist fatigue had showed that both the later colonoscopy start time and increasing number of preceding endoscopic procedures are associated with decreasing polyp detection rate. It is not surprising that endoscopist fatigue may contribute to a significant decline in the effectiveness of colonoscopy and yet it is probably not realistic to reduce the number of colonoscopy procedures per session given the heavy clinical demand. There have been no studies on any intervention that may improve the performance of colonoscopy. It would be reasonable to postulate that taking a break half way through the colonoscopy session may alleviate endoscopist fatigue and hence improve the polyp detection rate. This study aims to evaluate the effect of introducing a break in the middle of a colonoscopy session on the quality of colonoscopy performance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

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

入选标准

  • •All patients who underwent colonoscopies in the afternoon session at the endoscopy unit in AHNH were eligible for inclusion in this study.

排除标准

  • •Emergency inpatient colonoscopy
  • •Patient with history of colorectal cancer , FAP or IBD

研究组 & 干预措施

Break

Active Comparator

A break of 15 minute will be provided after 3rd colonoscopy in a session of 6 colonoscopies in total

干预措施: Break (Other)

Break

Active Comparator

A break of 15 minute will be provided after 3rd colonoscopy in a session of 6 colonoscopies in total

干预措施: No break (Other)

No break

No Intervention

No break will be provided

结局指标

主要结局

Adenoma detection rate

时间窗: 2 years

次要结局

  • Complication rate(2 years)
  • Withdrawal time(2 years)
  • Patient pain score(2 years)
  • Colonoscopy insertion time(2 years)
  • Cecal intubation rate(2 years)
  • Patient satisfaction score(2 years)

研究者

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

Aric Josun Hui

Dr.

Chinese University of Hong Kong

研究点 (1)

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