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NCT05801250 Clinical Trial

A Deep Learning-based System for the Bowel Preparation Evaluation Before Colonoscopy

Bowel Preparation Clinical Trial

Official title:
A Deep Learning-based System for the Bowel Preparation Evaluation Before Colonoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05801250
Other study ID # 2022SDU-QILU-101
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2, 2023
Est. completion date June 10, 2023

Study information
Verified date March 2023
Source Shandong University
Contact Song yihao, BD
Phone 15098739370
Email 1019038804@qq.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Educational interventions provided to patients may improve colon cleansing. The aims of this study were to develop an AI platform which can help patients evaluate the adequacy of bowel cleansing without the aid of caregivers and to investigate whether there was a statistically positive correlation between the Image rating and the BBPS score.

Description:

Inadequate bowel preparation can have multiple negative effects on colonoscopy. It has been associated with significantly lower rates of detection of adenomas and advanced adenomas in two meta-analyses. An observational study revealed a threefold higher miss rate for adenomas ≥ 5 mm in size when bowel cleansing was inadequate. Early colorectal cancers might appear as very subtle mucosal lesions. To ensure detection, these lesions require careful and complete mucosal inspection and optimal bowel preparation. Studies in various international populations have found that inadequate cleansing is a factor in approximately 20%-70% of incomplete colonoscopies. A ≥ 90 % minimum standard for adequate bowel preparation has been recommended by the Quality Committee of the European Society of Gastrointestinal Endoscopy (ESGE). The Boston Bowel Preparation Scale (BBPS) is a rating scale used to evaluate the adequacy of bowel preparation. However ，the adequacy of bowel preparation before colonoscopy has the same significance. In clinical practice, the evaluation of bowel preparation before colonoscopy is mostly performed by the patients themselves. During bowel preparation, patients typically cannot accurately judge bowel readiness after taking laxatives. Many studies showed that educational interventions provided to patients and health care personnel may improve colon cleansing. However, patients often prepare their bowel during non-business hours such as the evening or early morning. Manual guidance during the patient's bowel preparation is not available. The aims of this study were to develop an AI platform which can help patients evaluate the adequacy of bowel cleansing without the aid of caregivers and to investigate whether there was a statistically positive correlation between the Image rating and the BBPS score.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 249
Est. completion date June 10, 2023
Est. primary completion date June 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - People sign an "informed consent form" - People able to use smartphone to follow the WeChat public account Exclusion Criteria: - People who have contraindications for colonoscopy - People who have known colorectal polyps - People with history of surgery in any part of the large bowel - People who refuse to join the study

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• AI Platform
AI platform can help patients evaluate the adequacy of bowel cleansing without the aid of caregivers.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Shandong University

Outcome
Type Measure Description Time frame Safety issue
Primary BBPS The Boston Bowel Preparation Scale (BBPS) is a rating scale used to evaluate the adequacy of bowel preparation. 3 months
Secondary ADR ADR, defined as the proportion of patients with one or more conventional adenomas. 3 months
See also
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Completed NCT02093156 - A Predictive Score Identifies Patients With Inadequate Bowel Preparation for Colonoscopy N/A
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Completed NCT03704571 - A Predictive Model for Inadequate Bowel Preparation N/A
Recruiting NCT05041283 - Impact of Artificial Intelligence-based Patient Reinforcement on Quality of Colonoscopy N/A
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Completed NCT02772250 - Bowel Preparation by Face-to-face Re-education on the Day of Colonoscopy for Outpatient: a RCT Phase 4