GastroschisisLAPSNCT06461325
Surgical Management Of Gastroschisis
An observational study of Gastroschisis and Neonatal Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 1 minute to 17 years
- Conditions the study is for
- Gastroschisis, Neonatal Disease, Hernia, Umbilical
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2024to 28 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients born with gastroschisis between January 2009 and December 2023
Who may be able to join
- Patients born with gastroschisis between January 2009 and December 2023
Who cannot join
- Patients born with gastroschisis before January 2009 or after December 2023 Patients without gastroschisis
Trial locations and contacts
1 site in 1 country.
France1 site
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, 63000
About this study
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
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.
- Keywords
- Gastroschisis, Hospitalization Costs, Neonate, Management
- Medical subject headings
- Gastroschisis, Infant, Newborn, Diseases, Hernia, Umbilical, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with medical complications
sepsis, infections,
Measured: through study completion, an average of 1 year
Number of patients with surgical complications
disunion, hernia scar
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Length of stay
Length of stay
Measured: through study completion, an average of 1 year
Rate of Hospitalization Cost by patient
Costs by department, overall costs
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start1 May 2024
- Primary completion27 Aug 2024
- Study completion28 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroschisisStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle Destinval, Study director, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461325
- Sponsor's protocol ID
- 2024-CF-264
- Acronym
- LAPS
- Status last verified
- May 2024
- First submitted
- 5 Jun 2024
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06461325
- Acronym / sponsor ID
- LAPS / 2024-CF-264
- Keywords
- Gastroschisis, Hospitalization Costs, Neonate, Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 27 Aug 2024 (actual)
- Study completion
- 28 Aug 2024 (actual)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 minute to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients born with gastroschisis between January 2009 and December 2023
Key inclusion criteria (1 listed)
- Patients born with gastroschisis between January 2009 and December 2023
Key exclusion criteria (1 listed)
- Patients born with gastroschisis before January 2009 or after December 2023 Patients without gastroschisis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with medical complications
Time frame: through study completion, an average of 1 year
sepsis, infections,
Number of patients with surgical complications
Time frame: through study completion, an average of 1 year
disunion, hernia scar
2 secondary outcomes
Length of stay
Time frame: through study completion, an average of 1 year
Rate of Hospitalization Cost by patient
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle Destinval study director
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroschisis and Neonatal Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with medical complications (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.