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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.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12622001307796
Acronym
ROMANS
Enrollment
4
Registered
2022-10-10
Start date
2022-08-30
Completion date
Unknown
Last updated
2022-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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

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

Sponsors

Timothy Little
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
No minimum to 30 Days
Healthy volunteers
No

Inclusion criteria

All new neonatal gastrointestinal stomas (gastrostomies, small bowel enterostomies, colostomies) undertaken during the minimum 3-month recruitment period

Exclusion criteria

>30 days' corrected gestational age and infants without stomas

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026