Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After ESD
Recruiting now · Not applicable
Conditions studied: Patient Compliance
In brief
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.
Key facts
- Study ID
- NCT06092281
- Run by
- Xijing Hospital of Digestive Diseases
- People needed
- 500
- Starts
- 2023-10-01
- Expected to finish
- 2029-12-01
- Last updated by the study team
- 2025-04-08
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult patients (≥18 years) after ESD for mucosal lesions.
You may not qualify if…
- Patients after ESD for submucosal tumors, e.g. stromal tumors, neuroendocrine tumors;
- Additional radical surgery after ESD procedure;
- Past history of ESD procedure or local recurrence;
- Severe comorbidities with a life expectancy of <6 months as judged by the investigator;
- Unable to cooperate with information collection due to mental disorders, severe neurosis, or dysgnosia;
- Unable to understand or unwilling to sign a written informed consent.
Where it is running
- Xijing Hospital of Digestive Disease — Xi'an, Shaanxi, China (enrolling)
Full record on ClinicalTrials.gov
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