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Completed

NCT Number: NCT03708250

PilBouTox® Project: Button Battery Poisoning From Data Collected by French Poison Control Centres

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Anti Poison, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. occurrence of a serious complication

    Time frame: Baseline

    occurrence of a serious complication

Secondary outcomes

  1. Need for surgery

    Time frame: baseline

    Need for surgery

  2. Length of hospital stay

    Time frame: baseline

    Length of hospital stay

  3. Death

    Time frame: baseline

    Death

  4. Battery Size

    Time frame: baseline

    Battery Size

  5. Battery Voltage

    Time frame: baseline

    Battery Voltage

  6. Presence of Lying

    Time frame: baseline

    Presence of Lying

  7. Length of Insertion

    Time frame: baseline

    Length of Insertion

  8. Abnormalities at First Fibroscopy

    Time frame: baseline

    Abnormalities at First Fibroscopy

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: PILBOUTOX

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 17, 2018
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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