A Deep Learning-based System for the Bowel Preparation Evaluation Before Colonoscopy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Song yihao, BD
- Phone Number: 15098739370
- Email: 1019038804@qq.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: AI platform
All the patients in these group were asked to scan a QR code using smartphone to follow the WeChat public account.The WeChat public account can automatically push clear written instructions for bowel preparation. Including dietary advice ，how to consume the laxatives and remind patients to upload pictures.Patients will receive a reminder to upload stool images from the WeChat public account. After uploading their images, the patients received an evaluation result of "pass" or "not pass" . For patients who received results of "not pass," the system displayed tips instructing the patients to drink more water, or walk to improve the bowel preparation quality. |
AI platform can help patients evaluate the adequacy of bowel cleansing without the aid of caregivers.
|
|
No Intervention: Manual guidance
A leaflet with clear written instructions on how to consume the laxatives was given to patients in these group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
BBPS
Time Frame: 3 months
|
The Boston Bowel Preparation Scale (BBPS) is a rating scale used to evaluate the adequacy of bowel preparation.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ADR
Time Frame: 3 months
|
ADR, defined as the proportion of patients with one or more conventional adenomas.
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Li yanqing, Professor, Qilu Hospital, Shandong University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2022SDU-QILU-101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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