Management Of Stoma In Patients Younger Than 3 Months Old

NCT06458699 | Active Not Recruiting

• 1 other identifier: 2024-CF-265
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Stoma Colostomy; Stoma Ileostomy; Neonatal Disease

Keywords

Ostomy; Neonate; Outcomes; Costs

Outcome Measures

Primary Outcomes (2)

• Postoperative medical complications

  infections, sepsis, dehydration, hydroelectrolytic disorders

  through study completion, an average of 1 year

• Postoperative surgical complications

  disunion, surgical scar,

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Length of stay

  through study completion, an average of 1 year

• Hospitalization costs

  through study completion, an average of 1 year

Other Outcomes (1)

• Redo

  through study completion, an average of 1 year

Study Arms (5)

Hirschsprung's Disease

Patients with Hirschsprung's Disease who had a stoma in the first 3 months of life

Anorectal MAlformations

Patients with Anorectal MAlformations who had a stoma in the first 3 months of life

Intestinal Atresia

Patients with Intestinal Atresia who had a stoma in the first 3 months of life

Necrotizing Enterocolitis

Patients with Necrotizing Enterocolitis who had a stoma in the first 3 months of life

Intestinal Perforations

Patients with Intestinal Perforations who had a stoma in the first 3 months of life

Eligibility Criteria

• Age: 1 Minute - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Neonates whose disease require a stoma during the first 3 months of life, from January 2009 to December 2023

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, 63000, France

Location

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christelle Destinval, MD

  University Hospital, Clermont-Ferrand

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2024
• First Posted: June 14, 2024
• Study Start: May 30, 2024
• Primary Completion: June 30, 2024
• Study Completion: July 15, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-04

Locations

FR (1)