An interim analysis of the standard care (stoma bags) and double-diapers in pediatric patients with stomas at a tertiary hospital in South Africa

Abstract

PURPOSE: In resource-limited settings, commercial stoma bags are often unavailable for pediatric colostomy patients, necessitating affordable and accessible alternatives for colostomy care. This is an interim analysis of a study comparing standard of care (stoma bags (SB)) with double-diaper (DD) in patients with colostomies at the Johannesburg Pediatric Colorectal Clinic (JPCC) at Chris Hani Baragwanath Academic Hospital, South Africa. METHODS: A prospective, randomized descriptive study enrolled children < 3 years with newly created colostomies whose caregivers consented; participants were randomized via REDCap to SB or DD and followed up at routine visits until colostomy closure. RESULTS: Of 45 screened patients, 40 were enrolled; 22 (55%) were female, with a mean (SD) age of 110.15 (151.22) days and weight of 4.57 (1.51) kg. Most had anorectal malformations (30, 75%), end colostomies (24, 60%), and 29 (72.5%) had sigmoid colostomies. At analysis, 23 (58.97%) underwent closure. At enrolment, 19 (47.50%) were randomized to SB and 21 (52.50%) to DD; 28 (71.79%) remained in their assigned group, while 12 (29.27%) crossed over due to guardian preference (7, 38.89%) or healthcare provider recommendation (11, 61.11%). Baseline mean (SD) peristomal skin scores (using the OST scoring system) were 0.83 (1.99) for the SB group compared to 2.31 (3.61) (worse) for the DD group (p = 0.402). Follow-up scores among those remaining in their groups were: SB group 0.55 (1.54) and DD group 1.7 (2.51) (p = 0.002). Patients who crossed over had mean (SD) scores of 1.42 (2.46) at enrollment and 2.05 (2.63) at follow-up. Mean (SD) clinic visits were 3.92 (2.47) for the SB group, 5.73 (3.87) for the DD group, and 7.75 (2.83) for the mixed group (p = 0.01). When supplies were depleted, 12 (28.57%) returned for more of their respective product, while 29 (69.05%) purchased diapers. Care givers out-of-pocket expenditure as lower in SB 1 (6.7%) and 5 (29.4%) in DD group (p = 0.01). Patients who remained in the SB group reported satisfaction with bag quality 10 (66.7%), compared to those who crossed over 4 (26.7%) (p = 0.02). CONCLUSION: Diapers are an accessible alternative to commercial stoma bags for patients with colostomies.