Management Of Stoma In Patients Younger Than 3 Months Old

Stoma Ileostomy Clinical Trial

— STOMP  

Official title:

Management of Ostomy in Neonates: A Retrospective Single-Center Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06458699
• Other study ID #: 2024-CF-265
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Neonatal Disease
• Stoma Colostomy
• Stoma Ileostomy

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