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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorXijing Hospital of Digestive Diseases

About this trial

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.

Eligibility criteria

Qualifiers

Adult patients (≥18 years) after ESD for mucosal lesions.

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Questionnaire
  • Questionnaire without compliance-related education

Treatment groups

500 Participants
are divided into 2 treatment groups