跳至主要内容
临床试验/NCT05553977
NCT05553977招募中不适用

Design and Validation of an Artificial Intelligence System to Detect the Quality of Colon Cleansing Before Colonoscopy

Hospital Universitario de Canarias1 个研究点 分布在 1 个国家目标入组 667 人开始时间: 2022年10月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
667
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 design and validate a convolutional neural network (CNN) with the ability to discriminate between pictures of effluents with different qualities of bowel cleansing and in a second time to prospectively assess in a cohort of patients the agreement between the result of the last rectal effluent quality assessed by the CNN and the cleansing quality assessed during the colonoscopy assessed by a validated scale (Boston Bowel Preparation Scale, BBPS). Patients will be prepared with polyethylene glycol (PEG), PEG plus ascorbic acid (PEG-Asc) or sodium picosulfate-oxide magnesium solution (PS).

详细描述

The patient perception of the last bowel movement before the colonoscopy has been shown a powerful predictor of bowel cleansing rated during colonoscopy. A large study involving 1011 patients distributed in a derivation cohort (633 patients) and a validation cohort (378 patients) using a set of 4 pictures resembling bowel cleansing qualities showed a moderate agreement with the BBPS. In addition, a good agreement was found when the staff perception and patient perception of the last bowel movement were compared. These findings offer an excellent opportunity to test rescue cleansing interventions the same day of the examination, before colonoscopy.

Over the last two years, artificial intelligence applications have wrought a substantial breakthrough in several disciplines, including endoscopy. Machine learning and its more advanced form deep learning, refers to the development of algorithms (convolutional neural networks) with the ability to learn and perform certain tasks. In the endoscopy setting, computer vision applications have been stated as research priority field. Based on all this experience, the aim of this study was to design and to validate a convolutional neural network capable of automatically predicting the quality of the patient cleansing at home after the intake of the bowel cleansing solution and before attending the colonoscopy. The other aim was to prospectively assess in a cohort of patients the agreement between the result of the last rectal effluent quality assessed by the convolutional neural network and the cleansing quality assessed during the colonoscopy assessed by a validated scale (Boston Bowel Preparation Scale, BBPS) This study is nested in an observational prospective study conducted at the Open Access Endoscopy Unit of the Hospital Universitario de Canarias between February 2021 and May 2021 (NCT04702646). A total of 633 consecutive outpatients with a scheduled colonoscopy participated in this study (a total of 266 patients (42%) sent at least one picture). After this study, patients in whom an outpatient colonoscopy was requested, were asked to provide pictures of their effluents during bowel preparation intake. A subgroup of these images will be classified by the personal of our unit in adequate and inadequate and will be used to train the convolutional neural network. Another set of images will be used to validate the convolutional neural network. Additionally, the investigators will validate in-vivo the convolutional neural network comparing its classification of the effluent quality with a validated colon cleansing scale during the colonoscopy.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age >18, to sign the informed consent,
  • Patients with indication of outpatient colonoscopy
  • Patients ingesting the bowel preparation

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

研究组 & 干预措施

Consecutive patients for outpatient colonoscopy

The researchers will offer to participate in the study to patients scheduled for a colonoscopy who meet all the inclusion criteria and none of the exclusion criteria

干预措施: Bowel preparation for colonoscopy (Drug)

Consecutive patients for outpatient colonoscopy

The researchers will offer to participate in the study to patients scheduled for a colonoscopy who meet all the inclusion criteria and none of the exclusion criteria

干预措施: Colonoscopy (Procedure)

结局指标

主要结局

Quality of bowel cleansing assessed by the Boston Bowel Preparation Scale

时间窗: 1 years

Quality of bowel cleansing assessed by the Boston Bowel Preparation Scale. This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (proximal, transverse and distal). The maximum score is 9 points

Effluent characteristics

时间窗: 1 year

Effluent characteristics. Set of 4 pictures categorized in adequate preparation (clear liquid, clear liquid with lumps) and inadequate preparation (dark liquid, or dark liquid with solid particles). The concolutional Neural Network will be trained with effluent images and validated.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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