Study of newborn infants with stomas. To assess complications and death rates after stoma formation as well as the reasons for stoma formation and the timing of stoma closure.
Rates of Morbidity and Mortality Associated with Neonatal Stomas. A prospective observational study to assess morbidity and mortality after neonatal stoma formation, in addition to indications and timing of closure.
Timothy Little
50 participants
Aug 30, 2022
Observational
Conditions
Summary
Stoma formation in the neonatal period is necessary in many surgical conditions. There remains debate surrounding a number of factors (such as indications, type, timing of closure) and a paucity of quality literature to inform these decisions. The study aims to give an accurate reflection of practice and outcomes in Australia and New Zealand. Results will be used to aid and improve decision-making for this vulnerable group of patients
Eligibility
Inclusion Criteria1
- All new neonatal gastrointestinal stomas (gastrostomies, small bowel enterostomies, colostomies) undertaken during the minimum 3-month recruitment period
Exclusion Criteria1
- >30 days' corrected gestational age and infants without stomas
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Interventions
Exposure group = infants </=30 days corrected gestational age undergoing surgery and formation of a gastrointestinal stomas (gastrostomies, small bowel enterostomies, colostomies) undertaken during the minimum 3-month recruitment period). Information collected includes demographics, clinical status, operation performed and any complications. No active involvement of participants: all data collected from medical records. Period of observation is 3-month period September-November 2022, with a 3-month follow-up period December 2022 – February 2023
Locations(9)
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ACTRN12622001307796