About this trial
The quality of bowel preparation hinges on how well patients follow the prep-drug regimen, so intensive education is essential. Phone calls, texts, short videos, and mini-programs have all been shown to boost compliance and improve prep quality. Still, we also need a way to spot-early-those patients who are likely to prep poorly so we can step in with a rescue plan.
In our pilot work the investigators built an AI-assisted mini-program that lets patients photograph their effluent and get an instant quality read-out. The single-center RCT showed excellent performance. Because these findings came from one center, the investigators are now launching a multicenter study to test the tool more broadly. Patients will use the AI mini-program at home; if the algorithm predicts inadequate prep it will prompt them to come in early or alert staff so the investigators can initiate a rescue protocol and, ultimately, improve bowel-cleansing quality.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years
Undergoing colonoscopy at a participating site
Able to defecate in a toilet (or in a setting where stool characteristics can be observed) after taking the bowel-prep solution
Proficient in using a smartphone
Disqualifiers
American Society of Anesthesiologists (ASA) class III or IV;
Gastric-outlet or intestinal obstruction; ③ Active gastrointestinal bleeding; ④ Enterostomy (colostomy/ileostomy); ⑤ Status post total colectomy.
Trial design
Parallel
Treatments tested in this trial
The app group
Other interventionAfter taking the bowel-prep solution, patients in the app group are instructed to photograph their final stool in the toilet and upload the image through our smartphone app. The AI algorithm immediately scores the prep quality. If the image is rated "poor" or "inadequate," the app displays an alert advising the patient to come to the hospital early or contact clinical staff; clinical staffs then review the photo and decide whether a rescue preparation is needed. The standard rescue was an additional packet of polyethylene glycol. If the image is rated "adequate," the patient is told the prep is acceptable and should proceed to the appointment, where clinical staffs will use the uploaded photo to confirm eligibility for colonoscopy.
Treatment groups
Trial outcomes
Primary outcomes
Compare the bowel preparation quality between the app group and the control group.
The rate of adequate and excellent bowel preparation.
Secondary outcomes
Evaluate the diagnostic performance of the app-based assessment.
Sensitivity, specificity, negative predictive value, positive predictive value
cecal intubation rate
cecal intubation time
withdrawal time (excluding polypectomy and biopsy)
Locations
Sponsors and contacts
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Sixth Affiliated Hospital, Sun Yat-sen University
Lead sponsor
Tianjin Haihe Hospital
Collaborator
Guangdong Second Provincial General Hospital
Collaborator
Dongguan Hospital of Traditional Chinese Medicine
Collaborator
Cangzhou Central Hospital
Collaborator
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