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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colonoscopy; Bowel Preparation for Colonoscopy
• Intervention / Treatment: Other: The app group

• Study Type: Interventional
• Enrollment (Estimated): 524
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age ≥ 18 years
2. Undergoing colonoscopy at a participating site
3. Able to defecate in a toilet (or in a setting where stool characteristics can be observed) after taking the bowel-prep solution
4. Proficient in using a smartphone
5. Willing to participate voluntarily

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The App group; 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.	Other: The app group; 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.
No Intervention: The control group; The control group followed the conventional procedure: before the examination, clinical staffs asked questions and relied on the patient's verbal description of their stool to judge the adequacy of bowel preparation. If the prep was deemed inadequate, the standard rescue was an additional packet of polyethylene glycol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the bowel preparation quality between the app group and the control group.	The rate of adequate and excellent bowel preparation.	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
post-procedural adverse events		From enrollment to 30 days after the procedure.
Evaluate the diagnostic performance of the app-based assessment.	Sensitivity, specificity, negative predictive value, positive predictive value	Periprocedural
cecal intubation rate		Periprocedural
cecal intubation time		Periprocedural
withdrawal time (excluding polypectomy and biopsy)		Periprocedural
polyp-detection rate (PDR), adenoma-detection rate (ADR), advanced-adenoma-detection rate (aADR)		Periprocedural
rate of rescue preparation due to inadequate preparation		Periprocedural
clinical staffs' assessment time		Periprocedural
User satisfaction score	From 0 to 10, 0 stands for the least satisfaction, and 10 stands for the most satisfaction.	Periprocedural
rate of rescheduled examinations due to inadequate preparation		Periprocedural

Collaborators and Investigators

• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
• Collaborators: Cangzhou Central Hospital; Guangdong Second Provincial General Hospital; Tianjin Haihe Hospital; Dongguan Humen Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 4, 2026
• First Submitted That Met QC Criteria: January 4, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Colonoscopy; Artificial intelligence; Bowel preparation
• Other Study ID Numbers: 2025ZSLYEC-747

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No