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RECRUITING
NCT06092281
NA

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

Sponsor: Xijing Hospital of Digestive Diseases

View on ClinicalTrials.gov

Summary

Endoscopic submucosal dissection (ESD) is now considered the standard treatment for early gastrointestinal neoplasms. However, there is still a possibility of developing local recurrence or metachronous neoplasia after ESD. Regular endoscopic surveillance after ESD can identify and remove local recurrences and metachronous lesions early, improving patient prognosis. However, the patient compliance with post-ESD endoscopic surveillance is currently unclear, and many patients fail to adhere to the scheduled follow-up. A prospective, randomized controlled, superiority trial was designed to evaluate whether completing a questionnaire and receiving feedback on compliance-related education can improve patient compliance with post-ESD endoscopic surveillance, in comparison to those who did not complete the compliance-related education questionnaire. Additionally, the investigators intend to investigate the factors that influence patient compliance. This study will consist of two parts. Part 1 will assess whether the completion of questionnaire and feedback on compliance-related education can improve short-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing short-term patient compliance. Part 2 will assess whether the completion of questionnaire and feedback on compliance-related education can improve long-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing patient compliance.

Official title: Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After Endoscopic Submucosal Dissection: a Prospective, Randomized Controlled, Superiority Trial.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2023-10-01

Completion Date

2029-12

Last Updated

2025-04-08

Healthy Volunteers

No

Interventions

BEHAVIORAL

Questionnaire

Patients after ESD need to complete a questionnaire on compliance-related education before discharge. The questionnaire includes the following information: 1. General information about the patient (e.g., education level, place of residence, economic status, employment status, family history of neoplasms, whether the patient or immediate family member has a medical background, number of previous endoscopic examinations, etc.) 2. Awareness of follow-up examinations (e.g., knowledge about the timing of the first follow-up, the process of follow-up examinations, related educational issues about follow-up, etc.) 3. Awareness of the disease (self-perceived tumor is benign or malignant, whether lifestyle changes are required, etc.)

BEHAVIORAL

Questionnaire without compliance-related education

Patients after ESD need to complete a questionnaire without compliance-related education before discharge. The questionnaire includes only general information about the patient (e.g., education level, place of residence, economic status, employment status, family history of neoplasms, whether the patient or immediate family member has a medical background, number of previous endoscopic examinations, etc.)

Locations (1)

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, China