Surgical Management Of Gastroschisis

NCT06461325 — Completed, 30 participants, University Hospital, Clermont-Ferrand

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Surgical Management Of Gastroschisis With Analysis Of Health Costs And Satisfaction Questionnaire On The Quality Of The Scar: A Retrospective Single-Center Comparative Study

RegistryNCT06461325, acronym LAPS
StatusCompleted
Study typeObservational
Enrollment30 (Actual)
SponsorUniversity Hospital, Clermont-Ferrand (Other)
ConditionsGastroschisis, Neonatal Disease, Hernia, Umbilical, Complication,Postoperative
Datesstart 2024-05-01, primary completion 2024-08-27, completion 2024-08-28, first posted 2024-06-17, last updated 2024-08-28
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Gastroschisis All trials for Neonatal Disease

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
BianchiGastroschisis treated by the Bianchi procedure
SchusterGastroschisis treated by the Schuster procedure
SuturelessGastroschisis treated by the Sutureless procedure
Vacuum Assisted ClosureGastroschisis treated by Vacuum Assisted Closure

+Outcome measures

Primary outcomes

  • Number of patients with medical complications [through study completion, an average of 1 year]: sepsis, infections,
  • Number of patients with surgical complications [through study completion, an average of 1 year]: disunion, hernia scar

Secondary outcomes

  • Length of stay [through study completion, an average of 1 year]: Length of stay
  • Rate of Hospitalization Cost by patient [through study completion, an average of 1 year]: Costs by department, overall costs

+Eligibility

Sex: All, ages: 1 Minute to 17 Years

Inclusion Criteria:

* Patients born with gastroschisis between January 2009 and December 2023

Exclusion Criteria:

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

+Locations (1)

FacilityCityCountryStatus
Clermont-Ferrand University HospitalClermont-Ferrand, AuvergneFrance

+Investigators