Objective: It is well established that having a stoma can negatively impact health-related quality of life (HRQoL), but there is a paucity of research describing the natural history of certain complications associated with living with a stoma, such as leakage and peristomal skin complications (PSCs), and whether these affect QoL within the first year of stoma surgery. The objective of this study was to investigate the pattern of such complications and impact on QoL in individuals who had stoma surgery within the preceding year. Methods: A cross-sectional study was conducted at three hospital sites in the United Kingdom to evaluate the burden of disease in those who had undergone intestinal stoma formation surgery within the preceding year. The study consisted of a one-to-one consultation with a study nurse and the completion of an online questionnaire by the patient (ISRCTN-registry: 23080097). The nurse-led interview directly evaluated peristomal skin health, whilst the online questionnaire evaluated the impact of leakage (using the Ostomy Leak Impact tool), generic mental well-being (by WHO-5) and wider HRQoL (by EQ-5D-5L). Results: A total of 114 individuals with an intestinal stoma completed the evaluations. The participants had a mean age of 55.8 years (range 18–87 years) and 58% were male. Forty-three percent of the participants had experienced leakage of stomal effluent outside the baseplate (e.g., onto clothes) in the preceding two weeks and 85% suffered from PSCs ranging from mild (35%), to moderate (18%), and severe (32%). Leakage and PSCs were associated with lower mental well-being and HRQoL (p < 0.05). Leakage events, HRQoL, mental well-being and peristomal skin health were similar for individuals across different timepoints from the time of surgery within the first year. Conclusions: This study reported a high disease burden in people with a new intestinal stoma. Experiencing frequent leakage incidents and/or living with severe PSCs were associated with reduced HRQoL and mental well-being.

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). Additionally, mental well-being (by WHO-5) and health-related quality of life (QoL) (by EQ-5D-5L) were assessed. Outcomes between baseline and final evaluation were compared by generalised linear and linear mixed models. Results: 92 patients (ITT population) with a mean age of 49.4 years (range 18–81 years) were recruited. Of these, 80% had an ileostomy, and 53% were female. After 12 weeks of using the test product, a significant decrease in mean episodes of leakage outside the baseplate (1.57 versus 0.93, p < 0.046) was observed. Ostomy Leak Impact scores improved across all three domains (p < 0.001), indicating less embarrassment, increased engagement in social activities, and increased control. Patient self-management also improved significantly (PAM-13 score: ∆6.6, p < 0.001), as did the WHO-5 well-being index (∆8.0, p < 0.001). Lastly, EQ-5D-5L profile scores tended to improve (p = 0.075). Conclusions: A new digital leakage notification system demonstrated strong improvements to patients’ stoma self-care, mental well-being, and QoL. Registration number on ClinicalTrials.gov: NCT05135754.

To investigate the effect of a novel digital leakage notification system (Heylo) on quality of life (QoL) and burden of living with an intestinal ostomy. A randomized, controlled, open-label, cross-over trial was conducted in Germany with people having intestinal ostomies, who were cared for by 13 ostomy care specialists. Participants with fecal leakage problems were randomized by a centralized system to either Heylo + Standard of Care (SoC) or SoC alone for 8 weeks, whereafter participants crossed over to the opposite treatment for an additional 8 weeks. Primary and secondary end points were: E motional impact domain score of the Ostomy Leak Impact tool and P articipation domain score of the WHO Disability Assessment Schedule 2.0, respectively. Primary comparisons between Heylo and SoC were evaluated using linear mixed models, taking time and study period into account. The trial is registered with ClinicalTrials.gov, NCT05200416. A total of 144 participants were allocated to a treatment sequence after giving informed consent (safety population). Analyses included randomized participants who had been exposed to at least 1 product and with information on at least 1 end point (intention-to-treat population, n=139). Both the E motional impact and P articipation domain scores improved significantly after 8 weeks use of Heylo compared with SoC (LS mean difference of 11.4; 95% CI, 7.8-15.0; P<.001 and −4.2; 95% CI, −6.7 to −1.6; P=.001, respectively). Few adverse events related to Heylo were reported (n=5, 3.5%; all related to skin irritation). Use of Heylo reported positive effects on quality of life and the overall burden of living with an intestinal ostomy.

Background: Most people with a stoma worry about leakage, and a quarter experience leakage of stomal effluent outside 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 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). Additionally, mental well-being (by WHO-5) and quality of life (QoL) (by EQ-5D-5L) were assessed. Outcomes between baseline and final evaluation were compared by generalised linear- and linear mixed models. Results: 92 patients (ITT population) were recruited with a mean age of 49.4-years (range 18-81 years). 80% had an ileostomy and 53% were female. After 12 weeks use of the Test Product, a significant decrease in mean episodes of leakage outside the baseplate (1.57 versus 0.93, P <0.046) was observed. Ostomy Leak Impact scores improved across all three domains ( P <0.001), indicating less embarrassment, increased engagement in social activities, and increased control. Patient self-management also improved significantly (PAM-13 score: Δ6.6, P <0.001), as did the WHO-5 well-being index (Δ8.0, P <0.001). Lastly, EQ-5D-5L-profile-scores tended to improve ( P =0.075). Conclusion: A new digital leakage notification system demonstrated strong improvements to patients’ stoma self-care, mental well-being, and QoL. What does this paper add to the literature?: Sensor technology embedded in supporting ostomy solutions can notify users about leakage seeping underneath the baseplate and thus secure a timely change of the baseplate before effluent may reach outside the baseplate soiling clothes or bedsheets. The technology showed potential in increasing quality of life for people with a stoma.

Background: Leakage is a major concern for individuals living with a stoma and may negatively impact quality of life (QoL). A digital leakage notification system (DLNS) recently launched in the UK provides timely notifications to users via their smartphone when faeces is detected underneath the baseplate. This provides predictability and enables users to take proactive measures to help avoid leakages outside the baseplate. Methods: A single-arm, observational, longitudinal study of the DLNS, including its associated support service, has been initiated to follow 300 users for a year in the UK to evaluate long-term health benefits of the DLNS and its implications for healthcare resource utilisation in a real-world setting. The DLNS is prescribed by healthcare professionals (HCPs), and all users were invited to participate in the study. Study participants complete questionnaires capturing data on QoL (using the Ostomy Leak Impact tool), number of leakages outside the baseplate, utilisation of ostomy products, interactions with HCPs, and work productivity (using the Work Productivity and Activity Impairment questionnaire) at baseline and then every third month for one year. Data from the planned interim analysis of the first 100 participants who had been in the study for 6 months is presented. Results: Use of the DLNS for 6 months together with the associated support service was associated with a 51% reduction in leakage episodes outside the baseplate (p < 0.001) and great improvements in QoL (p < 0.001). Use of the DLNS reduced the number of unplanned baseplate changes due to worry about leakage by 47% (p < 0.001) and overall was associated with a reduction in the number of baseplates used by 14% (p = 0.002). Total time spent with HCPs related to stoma care was reduced by 65% after 6 months compared with baseline (p < 0.001). Work absenteeism and presenteeism improved significantly with the use of the DLNS. Conclusions: The interim results of this prospective, longitudinal study provided first insights into the long-term benefits of the DLNS in a real-world setting. ClinicalTrials.gov ID: NCT06554015.