References
Novel digital leakage notification system can promote better stoma management routines: a multicentre clinical trial
Abstract
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 (
Conclusion:
The use of a digital leakage notification system reduced leakage-related worry and improved stoma self-care.
An operation that results in the creation of a stoma is a life-changing intervention that may negatively impact patients' physical and psychosocial wellbeing (Richbourg et al, 2007; Pearson et al, 2020; Jeppesen et al, 2022). Living with a stoma necessitates use of pouching systems for the collection of stomal efluent. Although these systems have gradually evolved since their inception, many people living with a stoma continue to struggle with leakages that progress beyond the baseplate, soiling clothes or bed sheets (Martins et al, 2022).
Experiencing leakage is inconvenient and emotionally distressing, and more than 90% of people with a stoma worry about it (Claessens et al, 2015; Jeppesen et al, 2022). Leakage of stomal efluent is associated with significant reductions in quality of life (QoL), with negative effects on people's emotional wellbeing and individual willingness to participate in social activities (Jeppesen et al, 2022). Indeed, the mental burden of leakage has been reported to last up to 1 year after a single incident (Jeppesen et al, 2022).
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