Management Of Stoma In Patients Younger Than 3 Months Old

NCT ID: NCT06458699

Last Updated: 2024-06-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-30

Study Completion Date

2024-07-15

Brief Summary

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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

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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.

Conditions

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Stoma Colostomy Stoma Ileostomy Neonatal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Hirschsprung's Disease

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

No interventions assigned to this group

Anorectal MAlformations

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

No interventions assigned to this group

Intestinal Atresia

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

No interventions assigned to this group

Necrotizing Enterocolitis

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

No interventions assigned to this group

Intestinal Perforations

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christelle Destinval, MD

Role: STUDY_DIRECTOR

University Hospital, Clermont-Ferrand

Locations

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Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, France

Site Status

Countries

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France

Other Identifiers

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2024-CF-265

Identifier Type: -

Identifier Source: org_study_id

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