ClinicalTrials.gg
CompletedNCT06461325LAPSUpdated Aug 28, 2024

Surgical Management Of Gastroschisis

An observational study in Gastroschisis, Neonatal Disease and Hernia, Umbilical, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 1 Minute to 17 Years. Per ClinicalTrials.gov, last updated 2024-08-28.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
30
Ages
1 Minute to 17 Years
Sex
All
01

Study summary

The investigators aim to analyze the management of children born with gastroschisis between January 2009 and December 2023, i.e. to evaluate post-operative follow-up, hospitalization costs, the risk of post-operative umbilical hernia, and the parents' and the child's appreciation of the scar.

Read the detailed description

Gastroschisis is an abdominal wall anomaly that affects 3 in 10,000 live births, and in over 90% of cases is diagnosed before birth. In fetuses with gastroschisis, the intestine protrudes through a defect in the abdominal wall, usually to the right of the umbilical cord. Although the survival rate of live newborns with gastroschisis is over 90%, the risk of intrauterine fetal death is still 7.5 times higher than in the normal population, and gastroschisis can cause significant morbidity during the neonatal period.

The scientific literature suggests multiple options for each stage in the care of children with gastroschisis, both pre- and postnatally. Heterogeneity of practice exists even within the same geographical area, and deserves to be analyzed.

In this context, the investigators wish to analyze the management of children born with gastroschisis between January 2009 and December 2023, i.e. to evaluate post-operative follow-up, hospitalization costs, the risk of post-operative umbilical hernia, and the parents' and the child's appreciation of the scar.

02

Conditions studied

  • Gastroschisis
  • Neonatal Disease
  • Hernia, Umbilical
  • Complication,Postoperative

Keywords

  • Gastroschisis
  • Hospitalization Costs
  • Neonate
  • Management
03

In context

Gastroschisis

42 studies on the registry are indexed under Gastroschisis; 6 are open to participants now.

This study's enrollment of 30 is below the median of 53 across 14 observational studies indexed under Gastroschisis.

Browse Gastroschisis studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Minute to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients born with gastroschisis between January 2009 and December 2023

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients born with gastroschisis between January 2009 and December 2023

Exclusion criteria

Exclusion Criteria:

  • Patients born with gastroschisis before January 2009 or after December 2023 Patients without gastroschisis
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
30 participants (actual)
Patient registry
No

Groups and cohorts

  • Bianchi

    Gastroschisis treated by the Bianchi procedure

  • Schuster

    Gastroschisis treated by the Schuster procedure

  • Sutureless

    Gastroschisis treated by the Sutureless procedure

  • Vacuum Assisted Closure

    Gastroschisis treated by Vacuum Assisted Closure

06

What researchers measure

Primary outcomes

  1. Number of patients with medical complications

    sepsis, infections,

    Time frame: through study completion, an average of 1 year

  2. Number of patients with surgical complications

    disunion, hernia scar

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Length of stay

    Length of stay

    Time frame: through study completion, an average of 1 year

  2. Rate of Hospitalization Cost by patient

    Costs by department, overall costs

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Clermont-Ferrand University Hospital
    Clermont-Ferrand, Auvergne 63000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06461325
Responsible party
Sponsor
First posted
Jun 17, 2024
Start date
May 1, 2024
Primary completion
Aug 27, 2024
Completion
Aug 28, 2024
Last update
Aug 28, 2024

Study contacts

Christelle Destinval
study director · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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