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

NCT07337694 | Not Yet Recruiting

• 1 other identifier: 2025ZSLYEC-747
• Study Type: interventional
• Target: 524
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bowel Preparation for Colonoscopy; Colonoscopy

Keywords

Bowel preparation; Colonoscopy; Artificial intelligence

Outcome Measures

Primary Outcomes (1)

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

  The rate of adequate and excellent bowel preparation.

  Periprocedural

Secondary Outcomes (10)

• Evaluate the diagnostic performance of the app-based assessment.

  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

Study Arms (2)

The App group

EXPERIMENTAL

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

The control group

NO INTERVENTION

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.

Interventions

The app group OTHER

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.

The App group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willing to participate voluntarily

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 13, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share