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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06458699
Other study ID # 2024-CF-265
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date May 30, 2024
Est. completion date July 15, 2024

Study information

Verified date April 2024
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

The investigators gathered the data of patients born between January 2009 and December 2023, who had an ostomy made during the first three months of their life. The investigators then analyzed the patients outcomes ( postoperative complications, length of stay, cost of hospitalization) depending on the etiology of their primary disease.


Recruitment information / eligibility

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

Study Design


Locations

Country Name City State
France Clermont-Ferrand University Hospital Clermont-Ferrand Auvergne

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

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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