Trial reportPediatric surgery international2026
An interim analysis of the standard care (stoma bags) and double-diapers in pediatric patients with stomas at a tertiary hospital in South Africa.
Trial report in Pediatric surgery international, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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12 authors.
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Abstract
purposeIn 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.
methodsA 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.
resultsOf 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).
conclusionDiapers are an accessible alternative to commercial stoma bags for patients with colostomies.
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