Stoma Ileostomy Clinical Trial
— STOMPOfficial title:
Management of Ostomy in Neonates: A Retrospective Single-Center Study
Verified date | April 2024 |
Source | University Hospital, Clermont-Ferrand |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Indications for jejunostomy, ileostomy or colostomy vary in the neonatal population. The most common etiologies are congenital anomalies, such as anorectal malformations, intestinal atresia or Hirschsprung's disease, but also acquired conditions, such as enterocolitis or intestinal perforation. The aim of these stomas is to divert stool in the event of intestinal obstruction or risk of fecal contamination. Depending on the indication and the type of stoma used, the post-operative follow-up, such as resumption of intestinal transit and feeding, secondary closure of the stoma or not, and the duration and cost of hospitalization differ. The aim of this study is to compare these differences in order to extract an optimal management strategy, in the light of what is reported in the international scientific literature.
Status | Active, not recruiting |
Enrollment | 82 |
Est. completion date | July 15, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Minute to 3 Months |
Eligibility | Inclusion Criteria: - Patients who had a stoma during the first 3 months of life, from January 2009 to December 2023 Exclusion Criteria: - Patients who had a stoma after the first 3 months of life, from January 2009 to December 2023 - Patients without a stoma |
Country | Name | City | State |
---|---|---|---|
France | Clermont-Ferrand University Hospital | Clermont-Ferrand | Auvergne |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Redo | Necessity to remake the stoma | through study completion, an average of 1 year | |
Primary | Postoperative medical complications | infections, sepsis, dehydration, hydroelectrolytic disorders | through study completion, an average of 1 year | |
Primary | Postoperative surgical complications | disunion, surgical scar, | through study completion, an average of 1 year | |
Secondary | Length of stay | time of hospitalization | through study completion, an average of 1 year | |
Secondary | Hospitalization costs | costs by department and overall costs | through study completion, an average of 1 year |
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