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临床试验/NCT03268200
NCT03268200已完成不适用

The Effect of Segmental Re-examination of Colon for Adenoma Detection in Colonoscopy: a Randomized, Controlled Trial

The Catholic University of Korea2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2017年9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
450
试验地点
2
主要终点
Adenoma detection rate

研究概览

简要总结

The aim of this study was to determine whether segmental re-examination of the each segment (right colon, mid-colon, and left colon) could increase the proximal adenoma detection rate (ADR) and to evaluate the time-effectiveness of this approach.

详细描述

The investigators prospectively recruited patients (aged ≥45 and ≤75 years) who were scheduled to undergo colonoscopy at our center. Patients were excluded if they had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent. In addition, if the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score <2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.

A randomization list was generated with the randomization algorithm of random sorting, using Excel program. Included patients were randomly assigned to one of the two groups: segmental re-examination group, in which the each segment (right colon, mid-colon, and left colon) was examined twice segmentally; or control group, in which the withdrawal time in the each segment was about 2 minutes.

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
Single (Participant)

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients (aged ≥45 and ≤75 years) who were scheduled to un- dergo colonoscopy

排除标准

  • Patients who had advanced colonic cancer, prior resection of the proximal colon, inflammatory bowel disease, or polyposis syndrome, or were unable to provide informed consent.
  • If the quality of bowel preparation was unsatisfactory (Boston Bowel Preparation Scale [BBPS] score <2 in any segment of the colon), or if the cecum could not be intubated during the colonoscopy, patients were excluded.

结局指标

主要结局

Adenoma detection rate

时间窗: 7 days

次要结局

  • Withdrawal time(1 days)
  • per-patient polyp detection rate(7 days)
  • Per-patient adenoma detection rate (ADR) at each segment of colon(7 days)

研究者

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

Jeong-Seon Ji

Professor

The Catholic University of Korea

研究点 (2)

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