Clinical Trial

Construction and Evaluation of a Flipped Discharge Model for Stomates With Colorectal Cancer

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Summary
This multicenter randomized controlled trial aims to develop and evaluate the effectiveness of a "Flipped Discharge" intervention for colorectal cancer patients with a new intestinal stoma. Guided by the Response to Transition Theory, the model addresses the care gap during the vulnerable post-discharge period by shifting critical support from the hospital to the patient's home. Approximately 200 eligible patients will be randomized into either the intervention or standard care control group. The core "Flipped Discharge" intervention occurs on the third day post-discharge, delivered either as an in-home visit by a specialist stoma nurse (via an "Internet + Nursing Service" platform) or as an intensive, standardized video follow-up with mailed instructional materials. The study's primary outcome is the incidence of stoma-related complications. Secondary outcomes include quality of life, self-care ability, self-efficacy, stoma adaptation, discharge readiness, healthcare costs, and satisfaction. The trial will also explore the mechanisms by which the intervention affects patient outcomes, ultimately seeking to provide evidence for a feasible, patient-centered model to improve care continuity.
Trial Details
NCT Number NCT07463690
Lead Sponsor Sun Yat-sen University
Conditions Colorectal Cancer, Stoma
Enrollment 200 participants
Start Date 2026-03-10
Primary Completion 2027-12-30 (estimated)
Study Completion 2027-12-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-11