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Clinical Trials/NCT03708250
NCT03708250CompletedNot Applicable

PilBouTox® Project: Prospective and Descriptive Study About Button Battery Poisoning Performed on Data Collected by French Poison Control Centres (PCC)

University Hospital, Bordeaux1 site in 1 country510 target enrollmentStarted: June 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
510
Locations
1
Primary Endpoint
occurrence of a serious complication

Study Overview

Brief Summary

Button batteries are found in all householders and can be responsible for poisoning, in particular in children. Unexpected complications and death in children who have ingested button battery have been published for over twenty years in medical literature. There are many questions related to the treatment that remain unanswered, because some data are missing in previously published studies. The main objective of this study is to precisely describe poisoning cases by button battery in order to propose a better management

Detailed Description

Button batteries are found in all householders and can be responsible for poisoning, in particular in children. Unexpected complications and death in children who have ingested button battery have been published for over twenty years in medical literature. The most serious cases are those related to the ingestion of button cells, especially in children, when the battery gets stuck in the esophagus. Poison control centres, as well as addictovigilance centres, are regularly called upon for serious poisoning resulting in hospitalization, for which precisely description is most often missing or difficult to obtain and limits the efficiency of the management of these poisonings. So there are many questions related to the treatment that remain unanswered, because some data are missing in previously published studies. For example, in many cases, there is a lack of detail of initial symptoms, delays between symptoms and completion of further tests, follow-ups... A prospective and descriptive study about button battery poisoning performed on data collected by French PCC will be conducted between the 1st June of 2016 and the 31 May of 2018: any call in a PCC that occurred during the period studied and concerning an exposure to a button cell regardless of the route of exposure, the age of the patient, and its symptomatology will be included. The following data will be taken : severe complication, need for surgery, length of hospital stay, death, risk factors concerning the battery (size, voltage), abnormalities at the first fibroscopy.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Any call that occurred during the period studied in a Poison Control Centre and concerning an exposure to a button cell regardless of the route of exposure, the age of the patient, and its symptomatology.

Exclusion Criteria

  • •Animal cases

Outcomes

Primary Outcomes

occurrence of a serious complication

Time Frame: Baseline

occurrence of a serious complication

Secondary Outcomes

  • Death(baseline)
  • Battery Size(baseline)
  • Presence of Lying(baseline)
  • Length of hospital stay(baseline)
  • Need for surgery(baseline)
  • Battery Voltage(baseline)
  • Length of Insertion(baseline)
  • Abnormalities at First Fibroscopy(baseline)

Investigators

Sponsor
University Hospital, Bordeaux
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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