Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-10-20
2022-10-20
Brief Summary
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Ingestion of FB involves very different mechanisms in children and adult patients. Unlike adults, 98% of FB ingestions in children are accidental and involve common objects found at home environment. Ingested FBs are of many types and vary depending on the object composition of the child's environment and supervision. The lockdown for COVID-19 pandemic highly modified children environment and parent supervision. Children remained at home and parents lived at home for teleworking.
In this study, the modifications of children environment that could affect epidemiology of FB ingestion will be evaluated. This is a retrospective study with a sample of around \> 100 children of Louis Mourier hospital from January 1 to December 31, 2019 and from March 1 to May 31, 2020. The total duration of the study is planned for 10 months.
Primary outcomes:
• To determine the role of COVID-19 pandemic linked containment on the prevalence of FB ingestions in children.
Secondary outcomes:
* Describe the epidemiological-clinical, radiological, therapeutic and evolutionary characteristics of the FB consultant's ingestions in the emergency department
* Determine the frequency of endoscopy or surgery
* Determine the factors favoring the use of endoscopic extraction From March 16 to May 10, 2020.
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Detailed Description
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The variables of interest will include: sex, age at the time of ingestion, type of the FB, single or multiple ingestion, annual period of ingestion, ingestion schedule, existence of a witness, time of arrival at the emergency room, presence and nature of clinical symptoms of ingestion, position of the FB in the digestive tract, complications of this ingestion, x-ray exams used to locate FB need for an extraction gesture, nature of this gesture, completion time, successes and complications of extraction.
The population should have an estimated number of between 100-150 children. Descriptive statistics. The quantitative variables will be described as mean and standard deviation or as median, quartiles, minimum and maximum depending on whether their distribution is Gaussian or not. The qualitative variables will be described in numbers (percentage).
Comparison tests. Qualitative data will be analyzed using Chi2 or Fischer's exact test.
The study was approved by hospital's ethics committee.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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No intervention
No intervention (retrospective study)
Eligibility Criteria
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Inclusion Criteria
* Child who consulted in the pediatric emergency department of Louis-Mourier University Hospital.
* For ingestion of foreign bodies coded in Urqual software.
Exclusion Criteria
* unusable files (\> 20% missing data out of a total of 40 major items),
* Ingestion of CE was suspected but not confirmed,
* Ingestion of caustics or other chemicals,
* Introduced from an FB into the digestive tract by a route other than the oral cavity.
1 Day
15 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Jerôme VIALA, MD, PhD
Role: STUDY_CHAIR
Assistance Publique - Hôpitaux de Paris
Locations
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Louis Mourier Hospital - Assistance Publique Hopitaux de Paris
Colombes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APHP-COCE
Identifier Type: -
Identifier Source: org_study_id
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