Novel digital leakage notification system can promote better stoma management routines: a multicentre clinical trial

Background: Most people with a stoma are anxious about stoma-related leakage. Aims: To investigate the impact of a novel digital leakage notification system on worry related to stoma leakage, and to evaluate the effect on overall stoma care management. Method: A 12-week interventional, single-arm, multicentre study was conducted in the UK to evaluate the novel digital leakage notification system, including a telemedicine-based support service (=test product), as part of routine stoma care in patients with a recent stoma formation (ClinicalTrials.gov: NCT05135754). Patients completed questionnaires at baseline and at other time points throughout the study period. Study nurses evaluated the test product on individual patient completion of the trial. Findings: The intention-to-treat-population consisted of 92 patients. At baseline, 39% of patients worried to a high or very high degree about leakage, which fell to 14% at the final evaluation (P<0.001), at which point patients also reported significantly fewer baseplate changes due to leakage-related worry (P<0.001). The vast majority of nurses reported that the test product helped patients (82%) improve their stoma-care routines (P<0.0001). Conclusion: The use of a digital leakage notification system reduced leakage-related worry and improved stoma self-care.