跳至主要内容
临床试验/NCT04996888
NCT04996888
Unknown
不适用

A Prospective Multicenter Study on the Effect of Preoperative Automatic Reminder System on Colonoscopy

Renmin Hospital of Wuhan University1 个研究点 分布在 1 个国家目标入组 829 人2021年8月4日
适应症Colonoscopy

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Colonoscopy
发起方
Renmin Hospital of Wuhan University
入组人数
829
试验地点
1
主要终点
the rate of adequate bowel preparation
最后更新
4年前

概览

简要总结

In this study, the investigators proposed an artificial intelligence-based preoperative automatic reminder system on colonocopy, which can improve the quality of bowel preparation and the rate of polyps and adenomas detection.

详细描述

Despite advances in bowel preparation methods, bowel preparation is inadequate in up to one-third of all colonoscopies in reported series. Inadequate bowel cleansing results in negative con-sequences for the examination, including incomplete visualization of the colon, missed lesions(22-48%), procedural difficulties, prolonged procedure time and reduced time interval until follow-up, and an estimated 12-22% increase in overall colonoscopy cost. The adequacy of a bowel preparation is closely linked to patient compliance with both dietary and purge instructions. Previous work has shown that 18-23.5% of the patients with poor preparation had failed to follow preparation instructions. One study performed in Asia showed that non-compliance with bowel preparation instructions, lower education level, and a long wait for the colonoscopy appointment were independent risk factors for poor bowel preparation. A survey among doctors showed that gastroenterologists with the highest number of patients with inadequate bowel preparation believed that patients are unwilling to follow preparation instructions, struggle with the prescribed diet, and are unable to tolerate the full course of purgative. It is reasonable to hypothesis that efforts to improve education and maximize patient compliance during the preparatory period will enhance the efficacy of bowel preparation. A research has shown that telephone-based re-education about the details of bowel preparation on the day before colonoscopy significantly improved the quality of bowel preparation and polys detection rate. In recent years, artificial intelligence (AI) has been successfully applied in multiple medical fields. But there has not been an artificial-intelligence-based system which can automatically remind patients of the details of bowel preparation on the day before colonoscopy. In this study, we proposed an artificial intelligence-based preoperative automatic reminder system on colonoscopy, which can improve the quality of bowel preparation and the rate of polyps and adenomas detection.

注册库
clinicaltrials.gov
开始日期
2021年8月4日
结束日期
2022年1月31日
最后更新
4年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • Male or female between 50-75 years old;
  • Able to read, understand and sign informed consent
  • The investigator believes that the subjects can understand the process of the clinical study, are willing and able to complete all study procedures and follow-up visits, and cooperate with the study procedures
  • Outpatients requiring colonoscopy

排除标准

  • colorectal surgical history
  • Severe colonic stricture or obstructive tumor
  • Obvious gastroparesis or gastric outlet obstruction or intestinal infarction
  • Pregnant or lactating women
  • Dysphagia or impaired swallowing reflex or mental state
  • Intestinal obstruction or perforation is known
  • Severe chronic renal failure(CCR\< 30ml/min)
  • Severe congestive heart failure(NYHA ⅢorⅣ)
  • Uncontrolled hypertension( systolic pressure\>170mmHg,diastolic pressure\>100mmHg)
  • Dehydration or electrolyte disorder

结局指标

主要结局

the rate of adequate bowel preparation

时间窗: From the beginning to the end of colonoscopy

The numerator is the number of patients qualified for intestinal preparation, and the denominator is the number of all patients undergoing colonoscopy. The definition of intestinal preparation qualification is: e-bbps qualification is defined as colonoscopy with e-bbps ≥ 6; BBPS is defined as enteroscopy with scores ≥2 for ascending colon, transverse colon and descending colon. At the same time, if one or more of the following conditions are met, intestinal preparation is considered insufficient: (1) colonoscopy with e-bbps \<6 is insufficient( 2) Cancel colonoscopy due to poor intestinal preparation or personal reasons( 3) Incomplete colonoscopy.

次要结局

  • Detection rate of adenoma(A month)

研究点 (1)

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