Leakage and ostomy appliances: results from a large-scale, open-label study in clinical practice

Abstract

Leakage from an ostomy appliance impairs peristomal skin integrity and quality of life (QoL). The proportion of participants who reported that they ‘never’ had leakage increased from 13% at visit 1 (i.e. with their pre-study appliance) to 36% at visit 2 (i.e. after using the double-layer adhesive appliance, SenSura (Coloplast A/S)) (P<0.0001). The proportion of participants reporting that they ‘never’ had unplanned changes increased from 12% at Visit 1 to 34% at visit 2 (P<0.0001). The double-layer adhesive appliance, SenSura, in conjunction with advice/intervention from a stoma care nurse (SCN), was superior to the pre-study appliance across all performance parameters (P<0.0001), including adhesion, flexibility and erosion. Higher leakage frequency at baseline correlated with worse peristomal skin (P<0.0001). Peristomal skin improved from visit 1 to visit 2, across all leakage frequencies. The use of an appropriate double-layer adhesive appliance in conjunction with SCN intervention, reduced leakage and improved peristomal skin conditions.

Peristomal Skin Complications Are Common, Expensive, and Difficult to Manage: A Population Based Cost Modeling Study

“…The absence of colonic function in patients with an ileostomy leads to more frequent stool, thus resulting in a greater risk of skin irritation compared with individuals with a colostomy [19]. Unsurprisingly, peristomal leakage, PSCs and overall QoL are interconnected [6], [20] and the global results from the DS confirmed that leakage is a critical factor in the development of PSC [21]. Testing the influence of several co-variables on PSC costs, leakage turned out to have the highest impact in the present study.…”

The Ostomy Life Study: the everyday challenges faced by people living with a stoma in a snapshot

“…The experience of leakage, and how it affects people with a stoma, emotionally and physically, has been of focus in other studies. In a large multinational post-marketing study (Porrett et al, 2011), which included more than 3000 ostomates, it was shown that the frequency of leakage had a significant correlation with the severity of the peristomal skin condition as well as the stomarelated quality of life. The study also showed that those experiencing leakage carried out more unplanned appliance changes (Porrett et al, 2011).…”

The ostomy leak impact tool: development and validation of a new patient-reported tool to measure the burden of leakage in ostomy device users

“…Leakage can affect a person’s physical and emotional well-being. Studies have shown that frequency of leakage is significantly correlated with the severity of peristomal skin complications [5] and that many people with a stoma do not recognize that they have a skin disorder [6, 7]. The emotional burden of leakage and its impact has also been reported as significant whereby the sudden experience of leakage can be a significant concern for people with a stoma.…”

“…Most studies refer to the frequency and severity of self-reported leakage but there is no validated or standardized tool for assessing the subjective and emotional burden of leakage. Currently, two scales are being used to measure leakage: the Dialogue Study Ostomy Appliance Questionnaire [5] and the City of Hope – Quality of Life – Ostomy Questionnaire [8], as well as Likert scales. These measures are not psychometrically validated and do not provide a clear definition of leakage.…”