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临床试验/NCT02985944
NCT02985944已完成不适用

Effect of a Longer Withdrawal Time or of the Use of a Wide-angle Endoscope on the Adenoma Detection Rate of Screening Colonoscopy

ASST Rhodense1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
ASST Rhodense
入组人数
1,000
试验地点
1
主要终点
Adenoma detection rate

研究概览

简要总结

Colonoscopy outcome is strictly related to the adenoma detection rate (ADR). An endoscopy withdrawal time >6min has been suggested to increase the ADR since it allows for thorough evaluation of the several hidden areas of the colon. The FUSE, full spectrum endoscopy system, has been demonstrated to reduce the rate of missed lesions due to its wide-angle view. In the present study the authors evaluate the impact of WT on ADR for High Definition Standard Endoscopes with just a single imager to the FUSE endoscope.

详细描述

Introduction Colonoscopy outcome is strictly related to the adenoma detection rate. An endoscopy withdrawal time >6min has been suggested to increase the adenoma detection rate since it allows for accurate evaluation of the several hidden areas of the colon. The FUSE endoscope has been demonstrated also to reduce the rate of missed lesions due to its wide angle view.

Aim of the study to evaluate the impact on the adenoma detection rate either of the use of a FUSE endoscope or of interventions directed at optimizing withdrawal time.

to assess the impact of different factors in influencing the withdrawal time

Methods A prospective non-randomized observational single-center study involving consecutive outpatients, aged 18-85 yr, undergoing colonoscopy with different indications. Previous abdominal colon resection, obstruction, inadequate preparation and incomplete examination were exclusion criteria.

In a 3-month period 4 expert endoscopists will performed 500 colonoscopies either with standard endoscope or with FUSE without a dedicated withdrawal time protocol. Colonoscopy withdrawal times will be measured without the endoscopists' knowledge of being monitored.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Indication for colonoscopy, age 18-85

排除标准

  • Previous abdominal colon resection, colon obstruction, inadequate preparation and incomplete examination

结局指标

主要结局

Adenoma detection rate

时间窗: Up to 10 days from the end of endoscopy

The rate of patient with at least one adenoma detected at colonoscopy

次要结局

  • Factors affecting the withdrawal time(Up to 10 days from the end of endoscopy)

研究者

发起方
ASST Rhodense
申办方类型
Other
责任方
Principal Investigator
主要研究者

gianpiero manes

Head of th Gastroenterology Unit

ASST Rhodense

研究点 (1)

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