Surgical Management Of Gastroschisis

Complication,Postoperative Clinical Trial

— LAPS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06461325
• Other study ID #: 2024-CF-264
• Status: Active, not recruiting
• Start date: May 1, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: July 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Complication,Postoperative
• Gastroschisis
• Hernia, Umbilical
• Infant, Newborn, Diseases
• Neonatal Disease
• Postoperative Complications

Locations

Country	Name	City	State
France	Clermont-Ferrand University Hospital	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with medical complications	sepsis, infections,	through study completion, an average of 1 year
Primary	Number of patients with surgical complications	disunion, hernia scar	through study completion, an average of 1 year
Secondary	Length of stay	Length of stay	through study completion, an average of 1 year
Secondary	Rate of Hospitalization Cost by patient	Costs by department, overall costs	through study completion, an average of 1 year