ONIS-STOMA: An observational multicentre prospective protocol study of stoma patients

Approximately 70,000 Italians live with urinary or intestinal stomas, primarily due to cancer, chronic inflammatory intestinal diseases, and trauma. These individuals face physical, psychological, and social challenges, reducing their quality of life. No study has yet mapped this situation in Italy. The ONIS-STOMA study aims to collect sociodemographic, clinical, health status, and quality of life data from patients with stomas to identify pathways and interventions for improving clinical outcomes and overall quality of life. This multicenter observational prospective study will involve at least four centers and adhere to the Strengthening the Reporting of Observational Studies in Epidemiology Checklist. Eligible participants are adults with temporary or permanent intestinal or urinary stomas attending specialized outpatient clinics. Data will be collected via ONIS, a dedicated online platform. Descriptive and correlation analyses will be conducted, targeting a sample size of 3,000–6,000 patients. • The study will provide valuable insights into the lives of patients with stomas in Italy, guiding personalized interventions. • The number of patients with stomas is expected to increase due to the aging population and rising prevalence of chronic conditions. • The registry could enroll patients to monitor their progress and provide decision-makers with information on the overall health status of this population.