PURPOSE: The purpose of this study was to evaluate clinical and economic outcomes during the first year following ostomy formation. DESIGN: Single-center retrospective audit. SUBJECTS AND SETTING: The sample comprised 200 patients who underwent surgery leading to ileostomy or colostomy at a large English National Health Service (NHS) Trust. METHODS: Clinical complications, medicine prescriptions, and interactions with healthcare services were reported over 12 months postsurgery, and interactions with the NHS were matched to the closest NHS unit cost to determine mean patient cost. RESULTS: The most common ostomy-related surgical site complications were high output (35.0%; n = 70), followed by moderate/severe peristomal skin complications (24.5%; n = 49) and bleeding (23.5%; n = 47). Ostomy management–related complications included general difficulties with ostomy management (50.0%; n = 100) and leakage-related mild peristomal skin issues (48.5%; n = 97). Clinical complication rates were highest in the first quarter following ostomy formation, except parastomal hernia, which increased in incidence over time. Ileostomy patients more frequently experienced high output, acute renal failure, and ostomy management–related complications and had increased length of inpatient admission. However, healthcare resource use was high in both groups, with a median of 13 inpatient admission days and 12 outpatient contacts overall within the first year. Mean cost per patient was £20,444.60 (US $26,018.41); 90.5% of these costs were attributed to ostomy-related factors. CONCLUSIONS: Patients are likely to experience at least one clinical complication following intestinal ostomy formation and have multiple interactions with the NHS. While a number of complications are more frequent in patients with ileostomies, both groups experienced considerable costs within the first year following surgery associated with ostomy management and recovery.

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.

Stoma bag filter-related issues, such as ballooning (the bag filling with gas), remain highly prevalent among users. The full-circle filter was purposely designed to reduce ballooning through the inclusion of a unique, full-circle pre-filter. Two similar randomized crossover trials were conducted to compare the performance of the full-circle filter with a dual filter in adults with a colostomy (n = 20) or an ileostomy (n = 20). The frequency of ballooning was significantly lower with the full-circle filter versus the dual filter in participants with a colostomy (p < 0.0007) and in participants with an ileostomy (p < 0.0001). No significant differences were observed in the frequency of other issues (pancaking, odor problems, and ostomy solution discretion) between the filters. On average, participants with an ileostomy wore ostomy solutions with the full-circle filter for 3.3 h longer than ostomy solutions with the dual filter (p < 0.0001); wear-time in users with a colostomy was comparable between the filters. Considering the lack of published research on stoma bag filters and the high prevalence of filter-related issues, these data provide important information for health care practitioners who support people living with a stoma.

Background People with stomas report a substantial negative impact of stomal effluent leaking outside the ostomy baseplate and subsequent complications in their professional and social lives, causing immense worry. However, many patients are not able to recognize leakages in a timely manner. We conducted a cost-effectiveness study to evaluate the impact of a digital leakage notification system (DLNS) to reduce leakages outside the baseplate (LOB) and worry about leakage for people with intestinal stomas from a UK National Health Service and Personal Social Services perspective. Methods A Markov model for ostomy care was used to compare health-related quality of life and costs for adults with ileostomies or colostomies using UK standard of care ostomy products with the DLNS (intervention) or without the DLNS (comparator). The base case model used a 3-year time horizon with 1-week cycles and an annual 3.5% discounting of utilities and costs. Patients in all health states experience LOB events and/or worry about leakage as events associated with one-time utility decrements and costs of additional healthcare provider visits and ostomy product use. Probabilities of LOB (DLNS, 46.5%; comparator, 78.6%) and worry about leakage (DLNS, 39.1%; comparator, 78.6%) were based on clinical trial results. Peristomal skin complications were included in the model with the same probabilities of occurrence in the intervention and comparator arms. Sensitivity and scenario analyses were performed to test the robustness of the base case model assumptions. Results In the base case analysis, the DLNS arm had 49.81 fewer LOB events per person than the comparator arm, resulting in 0.309 incremental quality-adjusted life-years (QALYs) and cost savings of British Pound Sterling (GBP) £1703 per person over 3 years (2023/2024 costing year). The DLNS arm had 56.98 fewer worry about leakage events per person, resulting in cost savings of £403 per person. Total costs and QALYs were £18,600 and 1.818 for the intervention arm, respectively, and £18,566 and 1.509 for the comparator arm. Overall, the DLNS provided 0.309 incremental QALYs at an incremental cost of £34 versus the comparator arm for an incremental cost-effectiveness ratio of £110/QALY gained, well below a willingness-to-pay threshold of £20,000/QALY. Sensitivity analyses showed the DLNS was cost-effective in 97.6% of simulations. Conclusions This analysis suggests that the DLNS added to standard of care ostomy products is a cost-effective intervention to help prevent LOB events and reduce worry about leakage for people with stomas in the UK. Results of the present study suggest that timely awareness of leakage has a positive impact on the health-related quality of life of people with stomas and on the direct costs of stoma management in the UK.

Background/Objectives: Leakage of stomal effluent adversely affects the quality of life for people living with a stoma and increases healthcare resource utilisation and costs. The Heylo™ digital leakage notification system (DLNS) detects early signs of leakage under the baseplate, enabling proactive stoma management. We evaluated the impact of the DLNS on stoma-related costs in a real-world UK setting. Methods: This costing analysis used data from the first 100 DLNS users with 6 months of follow-up in an ongoing longitudinal observational study (NCT06554015). Costs were calculated as 3-month totals before DLNS (baseline): Month 3, and Month 6 for stoma-related healthcare provider consultations, hospitalisations, and ostomy solution components (pouching systems, supporting products, and DLNS sensor layers). Least squares (LS) means were estimated using a mixed model. Results: Total LS mean costs for stoma-related consultations plus ostomy solution use decreased significantly from baseline by 21.9% at Month 3 (−£304 [95% CI: −£456, −£153]; p = 0.001) and 24.5% at Month 6 (−£340 [95% CI: −£504, −£175]; p < 0.001). Stoma-related consultation costs decreased by 50.7% at Month 3 (−£309 [95% CI: −£447, 171]; p < 0.001) and 57.9% at Month 6 (−£353 [95% CI: −£493, −£213]; p < 0.001), driven by fewer physician and stoma care nurse consultations. Mean ostomy solution costs remained similar from baseline (£784/person) to Month 6 (£782/person; p = 0.955) as DLNS sensor layer costs were offset by less use of other ostomy products. Conclusions: Initiation of the Heylo™ DLNS was associated with significant cost savings from reduced stoma-related consultations, pouching systems, and supporting product use.