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临床试验/NCT05041283
NCT05041283Unknown不适用

Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy

University of Ulm6 个研究点 分布在 1 个国家目标入组 258 人开始时间: 2021年5月21日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
258
试验地点
6
主要终点
Quality of bowel preparation

研究概览

简要总结

In order to improve bowel preparation for colonoscopy and consequently enhance detection rate of malignant and premalignant findings, a prospective, randomized and controlled three-arm study was developed. Patients who undergo ambulatory colonoscopy are randomly assigned into a control group with standard preparation, a phone call supported preparation group or a group supported by an artificial intelligence based chatbot. Primary endpoint is defined as quality of bowel preparation (Boston Bowel Preparation Score), secondary endpoints are patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation and the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support.

详细描述

Adequate bowel preparation is crucial for detection of adenoma and polyps of the colon, which can transform into malignant and premalignant lesions. In particular ambulatory performed colonoscopy is often insufficient due to inadequate preparation by patients at home. To focus this issue, a artificial intelligence based chatbot was developed to help patients who undergo bowel preparation by answering questions concerning bowel preparation. To compare the effect of this program, a three-arm randomized, controled multicentric clinical trial was developed. All patients who undergo ambulatory colonoscopy and meet the inclusion criteria (18 y.o., informed consent, WhatsApp access) were randomized in a standard preparation group (medical briefing and preparation brochure), a group receiving phone calls with instructions for bowel preparation and a third group with access to the chat bot answering questions concerning bowel preparation and examination conduct. As the primary end point, the quality of bowel preparation measured as Boston Bowel Preparation Scale was defined. As secondary endpoints patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation, the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support were measured.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

  • informed consent
  • smartphone with access to WhatsApp
  • indication for ambulatory colonoscopy
  • ASA I or II

排除标准

  • no informed consent given or possible
  • no access to a smartphone with WhatsApp
  • <18 years old
  • Pregnancy/Lactation
  • Allergy to Moviprep©
  • ASA (American Society of Anesthesiologists) state >II
  • extended abdominal surgery in past history
  • no indication for ambulatory colonoscopy

结局指标

主要结局

Quality of bowel preparation

时间窗: During colonoscopy

evaluated with the Boston Bowel Preparation Scale (0-9, 1=worst preparation, 9= best preparation)

次要结局

  • Patients satisfaction with bowel preparation(Immediately after the intervention)
  • Coecal intubation(During colonoscopy)
  • Patients satisfaction with preparation support(Within 3 days after the intervention)
  • Comprehensiveness of bowel preparation(During colonoscopy)
  • Polyp and adenoma detection rate(During colonoscopy)
  • Anxiety referred to colonoscopy(Within 3 days before the intervention and 3 days after the intervention; 8 items with binary answer yes/no))
  • Sedation dose(During colonoscopy)

研究者

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Seufferlein

Prof. Dr. med.

University of Ulm

研究点 (6)

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