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NCT Number: NCT07337694

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Periprocedural

    The rate of adequate and excellent bowel preparation.

Secondary outcomes

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

    Time frame: Periprocedural

    Sensitivity, specificity, negative predictive value, positive predictive value

  2. cecal intubation rate

    Time frame: Periprocedural

  3. cecal intubation time

    Time frame: Periprocedural

  4. withdrawal time (excluding polypectomy and biopsy)

    Time frame: Periprocedural

  5. polyp-detection rate (PDR), adenoma-detection rate (ADR), advanced-adenoma-detection rate (aADR)

    Time frame: Periprocedural

  6. rate of rescue preparation due to inadequate preparation

    Time frame: Periprocedural

  7. clinical staffs' assessment time

    Time frame: Periprocedural

  8. User satisfaction score

    Time frame: Periprocedural

    From 0 to 10, 0 stands for the least satisfaction, and 10 stands for the most satisfaction.

  9. post-procedural adverse events

    Time frame: From enrollment to 30 days after the procedure.

  10. rate of rescheduled examinations due to inadequate preparation

    Time frame: Periprocedural

Sponsors and collaborators

Lead sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Other

Collaborators

  • Cangzhou Central Hospital
  • Dongguan Hospital of Traditional Chinese Medicine
  • Guangdong Second Provincial General Hospital
  • Tianjin Haihe Hospital

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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