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临床试验/NCT05871814
NCT05871814已完成不适用

Strategy for Decreasing Inadequate Bowel Cleansing in Colonoscopy Based on an Artificial Intelligence System: A Randomized and Controlled Study

University of La Laguna1 个研究点 分布在 1 个国家目标入组 774 人开始时间: 2023年9月15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
发起方
入组人数
774
试验地点
1
主要终点
Quality of bowel cleansing assessed by the Boston Bowel Preparation Scale

研究概览

简要总结

The main purpose of the study is to assess if a strategy based on a mobile application linked to a neural network is useful for guiding colon cleansing in a more personalized way is better than the usual care defined as regular oral and written instructions. The secondary aim will be the acceptance of this artificial intelligence device defined as the proportion of patients assigned to the intervention group that actually used the device.

详细描述

The patient's perception of colon cleanliness prior to undergoing a colonoscopy has been studied as a predictor of colon cleanliness quality, demonstrating to be a powerful predictor of inadequate cleanliness. A convolutional neural network developed by our group, trained with photographs of rectal effluents at different moments of colon preparation, has achieved high diagnostic accuracy. Based on all this experience, the next step would be to evaluate in a randomized clinical trial whether this neural network integrated into a computer application associated with cleaning recommendations improves the colon cleanliness quality of patients compared to a control group, being the objective of this project Therefore, the main purpose of the study is to assess if a strategy based on a mobile application linked to a neural network is useful for guiding colon cleansing in a more personalized way is better than the usual care defined as regular oral and written instructions. The secondary aim will be the acceptance of this artificial intelligence device defined as the proportion of patients assigned to the intervention group that actually used the device. Consecutive outpatient patients meeting inclusion criteria and none of the exclusion criteria who have been requested to undergo colonoscopy will be included in the study and randomized to mobile artificial intelligence application or control group The intervention group will receive a response from the AI system in order to determine the quality of colon cleansing: adequate preparation or inadequate preparation. In addition, the system will issue specific recommendations based on the quality of cleansing. Patients assigned to the control group will undergo colonoscopy preparation according to standard recommendations.

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 (Investigator)

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

  • •Age ≥ 18 years.
  • •Patients referred for outpatient colonoscopy
  • •Sign informed consent

排除标准

  • •Incomplete colonoscopy (except for poor bowel preparation)
  • •Contraindication for colonoscopy
  • •Allergies.
  • •Refusal to participate in the study or impairment to sign the informed consent.
  • •Colectomy (more than 1 segment)
  • •Dementia with difficulty in the intake of the preparation.
  • •Inability to use the smartphone application

研究组 & 干预措施

Colon preparation guided by an artificial intelligence device

Experimental

Regular oral and written information will be provided to this group. In addition, participants will take a picture of the last rectal effluent with the smart phone that have to upload to a server. A convolutional neural network will assess whether the bowel preparation is correct or not (clean or not). The system will issue specific recommendations based on the quality of cleansing.

干预措施: Colon preparation guided by an artificial intelligence device (Device)

Control group

Active Comparator

Regular oral and written information will be provided to this group

干预措施: Colon preparation guided by an artificial intelligence device (Device)

结局指标

主要结局

Quality of bowel cleansing assessed by the Boston Bowel Preparation Scale

时间窗: 3 months

The Boston Bowel Preparation Scale assesses the quality of bowel cleansing in the three segments of the colon (proximal, transverse, and distal) on a scale of 0 (no preparation) to 3 points (excellent preparation), with a maximum score of 9 points.

次要结局

  • Participation rate(3 months)

研究者

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

Manuel Hernandez-Guerra, MD

Medical Doctor

University of La Laguna

研究点 (1)

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