Improving patient compliance with endoscopic surveillance after ESD using questionnaires and feedback
Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After Endoscopic Submucosal Dissection: a Prospective, Randomized Controlled, Superiority Trial.
NA · Xijing Hospital of Digestive Diseases · NCT06092281
This study is trying to see if giving patients who had endoscopic surgery for mucosal lesions a questionnaire and feedback about their follow-up care can help them stick to their post-surgery check-ups better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases (other) |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06092281 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a questionnaire and feedback on compliance-related education to enhance patient adherence to post-endoscopic submucosal dissection (ESD) surveillance. It is a prospective, randomized controlled trial involving patients who have undergone ESD for mucosal lesions at Xijing Hospital. Participants will be divided into two groups: one receiving standard follow-up instructions and a questionnaire without education, and the other receiving the same instructions along with compliance-related education and feedback. The study aims to determine if this educational intervention can significantly improve compliance rates and identify factors influencing patient adherence.
Who should consider this trial
Good fit: Ideal candidates are adult patients aged 18 and older who have undergone ESD for mucosal lesions.
Not a fit: Patients who have had ESD for submucosal tumors or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved patient compliance with necessary surveillance, potentially reducing the risk of local recurrence and improving overall patient outcomes.
How similar studies have performed: While the specific approach of using questionnaires and feedback for compliance improvement is novel, similar educational interventions have shown promise in enhancing patient adherence in other medical contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (≥18 years) after ESD for mucosal lesions. Exclusion Criteria: * 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 this trial is running
Xi'an, Shaanxi
- Xijing Hospital of Digestive Disease — Xi'an, Shaanxi, China (RECRUITING)
Study contacts
- Principal investigator: Zhiguo Liu — Xijing Hospital of Digestive DIsease
- Study coordinator: Zhiguo Liu
- Email: liuzhiguo@fmmu.edu.cn
- Phone: 86-29-84771535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Patient Compliance, compliance, endoscopic submucosal dissection, surveillance, post-ESD