Management Of Stoma In Patients Younger Than 3 Months Old

Active, not recruiting

• Conditions: Stoma Colostomy; Neonatal Disease; Stoma Ileostomy

• Registration Number: NCT06458699
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-05-30
• Study First Submitted: 2024-06-05
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Primary Completion: 2024-06-30
• Study Completion: 2024-07-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Patients who had a stoma during the first 3 months of life, from January 2009 to December 2023

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Exclusion Criteria

• Patients who had a stoma after the first 3 months of life, from January 2009 to December 2023
• Patients without a stoma

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative medical complications	through study completion, an average of 1 year	infections, sepsis, dehydration, hydroelectrolytic disorders
Postoperative surgical complications	through study completion, an average of 1 year	disunion, surgical scar,

Secondary Outcome Measures

Name	Time	Method
Hospitalization costs	through study completion, an average of 1 year	costs by department and overall costs
Length of stay	through study completion, an average of 1 year	time of hospitalization

Trial Locations

Locations (1)

Clermont-Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, Auvergne, France