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Novel digital leakage notification system can promote better stoma management routines: a multicentre clinical trial
Richard Rw Brady1, Diane Sheard2, Mandie Alty3
1Consultant Colorectal Surgeon and Lead, Newcastle Centre for Bowel Disease Research Hub, Newcastle Hospitals and Newcastle University, Newcastle upon Tyne.
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.
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