Management Of Stoma In Patients Younger Than 3 Months Old (STOMP)

June 12, 2024 updated by: University Hospital, Clermont-Ferrand

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

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

82

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63000
        • Clermont-Ferrand University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative medical complications
Time Frame: through study completion, an average of 1 year
infections, sepsis, dehydration, hydroelectrolytic disorders
through study completion, an average of 1 year
Postoperative surgical complications
Time Frame: through study completion, an average of 1 year
disunion, surgical scar,
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of stay
Time Frame: through study completion, an average of 1 year
time of hospitalization
through study completion, an average of 1 year
Hospitalization costs
Time Frame: through study completion, an average of 1 year
costs by department and overall costs
through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Redo
Time Frame: through study completion, an average of 1 year
Necessity to remake the stoma
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Study Director: Christelle Destinval, MD, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

July 15, 2024

Study Registration Dates

First Submitted

June 5, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-CF-265

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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