Evaluating the Effect of a Novel Digital Ostomy Device on Leakage Incidents, Quality of Life, Mental Well-Being, and Patient Self-Care: An Interventional, Multicentre Clinical Trial.

ABSTRACT: Background: Most people with a stoma worry about leakage, and a quarter experience leakage of stomal effluent outside the baseplate on a monthly basis. Leakage has additional physical and psychosocial consequences, for instance, peristomal skin complications, feeling unable to cope, and self-isolation. Method: An interventional, single-arm, multi-centre study was undertaken in the United Kingdom to evaluate a novel digital leakage notification system for ostomy care, including a support service (=test product) for 12 weeks in patients with a recent stoma formation (≤9 months). Patients completed questionnaires at baseline and after 4, 6, 8, 10, and 12 weeks, evaluating leakage episodes, Ostomy Leak Impact (tool containing three domains), and patient self-management (by PAM-13

SUBMITTER: Brady RRW 

PROVIDER: S-EPMC11477101 | biostudies-literature | 2024 Sep

REPOSITORIES: biostudies-literature