NCT06461325

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2024

Completed
Last Updated

August 28, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

June 5, 2024

Last Update Submit

August 27, 2024

Conditions

GastroschisisNeonatal DiseaseHernia, UmbilicalComplication,Postoperative

Keywords

GastroschisisHospitalization CostsNeonateManagement

Outcome Measures

Primary Outcomes (2)

  • Number of patients with medical complications

    sepsis, infections,

    through study completion, an average of 1 year

  • Number of patients with surgical complications

    disunion, hernia scar

    through study completion, an average of 1 year

Secondary Outcomes (2)

  • Length of stay

    through study completion, an average of 1 year

  • Rate of Hospitalization Cost by patient

    through study completion, an average of 1 year

Study Arms (4)

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

Eligibility Criteria

Age1 Minute - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients born with gastroschisis between January 2009 and December 2023

You may qualify if:

  • Patients born with gastroschisis between January 2009 and December 2023

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, 63000, France

Location

MeSH Terms

Conditions

GastroschisisInfant, Newborn, DiseasesHernia, UmbilicalPostoperative Complications

Condition Hierarchy (Ancestors)

Musculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsHernia, VentralPathologic Processes

Study Officials

  • Christelle Destinval

    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 17, 2024

Study Start

May 1, 2024

Primary Completion

August 27, 2024

Study Completion

August 28, 2024

Last Updated

August 28, 2024

Record last verified: 2024-05

Locations

FR(1)