Abstract

Aim The aim of this study was to evaluate the effectiveness of a combined treatment strategy involving the use of a light convex ostomy appliance (Easifiex Confort Convex Light) and a fiexible ring (Brava moldable) in reducing the number of leak episodes and improving self-reported satisfaction in patients with digestive ostomies and early effiuent leakage. Methods A multicenter prospective study was conducted across 54 stoma units in Spain, with 257 patients screened and 244 completing the study. Clinical data were collected at baseline (V1) and 2–3 weeks after discharge (V2) by specialist stoma care nurses. The primary outcome was a reduction in the mean number of leak episodes per day. The secondary outcome was a change in self-reported satisfaction on a scale of 0–10. A multivariate analysis was conducted to identify the patient profile that benefited the most from the treatment strategy. Results The results showed a significant reduction in the mean number of leak episodes from 3.4±5.2 at baseline to 1.3±2.3 at the end of the study (P<0.0001). Additionally, the mean self-reported satisfaction with the device increased from 5.1±2 at baseline to 7.2±1.7 at the end of the study (P<.00001). A predictive model with an area under the curve of 0.74 was developed to identify the patient profile that benefited the most from the treatment strategy. Conclusions The study confirmed that patients with ostomy and early effiuent leakage benefit from convex light ostomy appliances and fiexible rings. To improve satisfaction, those with worse outcomes and higher needs should be treated early with the CONAN strategy (convex system and a seal) if they exhibit leakage, longer hospital stays, emergency surgery and previous use of open system and single-piece appliances. This combined treatment strategy can improve outcomes and satisfaction in patients with digestive ostomies and early effiuent leakage.

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