Exploring the Clinical Value of an AI-Assisted Patient Self-Assessment App for Bowel Preparation: A Multicenter Study

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSixth Affiliated Hospital, Sun Yat-sen University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • The app group

    Other intervention

    After 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

524 Participants
are divided into 2 treatment groups
Group A: The App groupExperimental treatment 1 intervention
Group B: The control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Compare the bowel preparation quality between the app group and the control group.

The rate of adequate and excellent bowel preparation.

Time frame
Periprocedural

Secondary outcomes

1

Evaluate the diagnostic performance of the app-based assessment.

Sensitivity, specificity, negative predictive value, positive predictive value

Time frame
Periprocedural
2

cecal intubation rate

Time frame
Periprocedural
3

cecal intubation time

Time frame
Periprocedural
4

withdrawal time (excluding polypectomy and biopsy)

Time frame
Periprocedural

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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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