Laryngeal Disorders After Childhood Cardiac Surgery

Laryngeal disorders after childhood cardiac surgery is a complication well described in the literature. However, the long term progression of the affected children has never been studied (all the studies stopped before 2 years of follow up).

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Key information

Conditions

Laryngeal Injury Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Surgery--Complications Swallowing Disorder Voice Disorders in Children

Age range

5 year–10 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Femme Mère Enfant

Bron, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

No opposition from children and parents
Patient or parents able to understand the ins and outs of the study

Exclusion criteria

None

Treatment and study plan

questionnaires

Other

To explore the quality of life, two questionnaires will be submitted to the parents and the child. The first one is the pediatric version of the VHI (Voice Handicap Index), which explore, using 23 items, the functional, physical and emotional aspects of the dysphonia. The second one is the PEDI-EAT-10 (Pediatric Voice Handicap Index - Eating Assessment Tool), which explore, through 10 items (ranging from 0 to 4), the risk of aspiration and assess the impact of possible dysphagia on quality of life.

Primary outcomes

Prevalence of a laryngeal mobility disorder after childhood cardiac surgery

Time frame: One day

The prevalence will be evaluated on the respiratory, food or phonatory difficulties reported after surgery as well as on the result of early postoperative nasofibroscopy.

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Prevalence of Laryngeal Disorders After Childhood Cardiac Surgery and Evaluation of Their Long-term Recovery

Acronym: RECUP-TML

Important dates

Study start: 2021
Primary completion: 2021
Study completion: 2021
First posted: Nov 20, 2020
Registry last updated: Nov 28, 2022

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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