Effect of Questionnaires and Feedback on Patient Compliance for Endoscopic Surveillance After Endoscopic Submucosal Dissection: A Prospective, Randomized Controlled Trial

What this Trial Is About

Researchers are evaluating whether completing a questionnaire and receiving feedback on compliance-related education can improve patient follow-up after endoscopic submucosal dissection (ESD) for early gastrointestinal mucosal lesions. This prospective, randomized controlled trial aims to compare patient compliance with post-ESD endoscopic surveillance between those who receive this educational intervention and those who do not. The study also investigates factors influencing patient compliance over short-term and long-term periods. Participants are divided into two groups: one group receives usual follow-up instructions and completes a questionnaire without compliance-related education, while the other group completes a questionnaire that includes compliance-related education and receives feedback and guidance from nurses based on their responses. The study consists of two parts, with part 1 focusing on short-term compliance from enrollment to the first endoscopic surveillance at 3 months, and part 2 assessing long-term compliance over 1 to 5 years. Both parts involve randomized allocation to the respective study arms. During the study, researchers will monitor patient adherence to scheduled endoscopic surveillance visits and assess related outcomes such as ulcer scar rates, incidence of metachronous lesions, local recurrence, and overall survival over 5 years. Patient information including education level, residence, economic status, and disease awareness will be collected via questionnaires. The trial includes double-blinding of patients and doctors to group assignments to objectively evaluate the impact of the questionnaire and feedback intervention on compliance.

Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After ESD