Improving Patient Compliance with Endoscopic Surveillance After Endoscopic Submucosal Dissection Through Questionnaires and Feedback
Led by Xijing Hospital of Digestive Diseases · Updated on 2025-04-08
500
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
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.
CONDITIONS
Brief Title
Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After ESD
Research Team
Z
Zhiguo Liu
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Adult patients (18 years or older) who have undergone ESD for mucosal lesions.
You will not qualify if you...
Patients who had ESD for submucosal tumors such as stromal or neuroendocrine tumors.
Patients who had additional radical surgery after ESD.
Patients with a past history of ESD or local recurrence.
Patients with severe comorbidities and a life expectancy less than 6 months.
Patients unable to cooperate due to mental disorders, severe neurosis, or cognitive impairment.
Patients unable to understand or unwilling to sign written informed consent.
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Until the first endoscopic surveillance (3 months)
Participants receive follow-up instructions before discharge and complete a questionnaire related to their follow-up compliance. In the questionnaire arm, nurses provide feedback and guidance based on questionnaire responses.
1 baseline visit before discharge
Long-term Monitoring
Duration - 1 to 5 years
Participants are monitored for their compliance with endoscopic surveillance over a long-term period, up to 5 years, to assess the incidence of metachronous lesions, local recurrence, and overall survival.
Periodic endoscopic surveillance visits as per follow-up schedule
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022.
Pedro Pimentel-Nunes, Diogo Libânio, Barbara A J Bastiaansen...