Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06092281

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

Led by Xijing Hospital of Digestive Diseases · Updated on 2025-04-08

500

Participants Needed

1

Research Sites

321 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients (≥18 years) after ESD for mucosal lesions.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Xijing Hospital of Digestive Disease

Xi'an, Shaanxi, China, 710032

Actively Recruiting

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Research Team

Z

Zhiguo Liu

CONTACT

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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