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

Обзор

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.

Вмешательства

• Другое 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 additi

Первичные конечные точки

• Compare the bowel preparation quality between the app group and the control group. [Срок оценки: Periprocedural]

Вторичные конечные точки (10)

• Evaluate the diagnostic performance of the app-based assessment. [Срок оценки: Periprocedural]
• cecal intubation rate [Срок оценки: Periprocedural]
• cecal intubation time [Срок оценки: Periprocedural]
• withdrawal time (excluding polypectomy and biopsy) [Срок оценки: Periprocedural]
• polyp-detection rate (PDR), adenoma-detection rate (ADR), advanced-adenoma-detection rate (aADR) [Срок оценки: Periprocedural]
• rate of rescue preparation due to inadequate preparation [Срок оценки: Periprocedural]
• clinical staffs' assessment time [Срок оценки: Periprocedural]
• User satisfaction score [Срок оценки: Periprocedural]
• post-procedural adverse events [Срок оценки: From enrollment to 30 days after the procedure.]
• rate of rescheduled examinations due to inadequate preparation [Срок оценки: Periprocedural]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07337694 · 2025ZSLYEC-747

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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