Laryngeal Disorders After Childhood Cardiac Surgery (RECUP-TML)

November 25, 2022 updated by: Hospices Civils de Lyon

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France
        • Hopital Femme Mere Enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 10 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children between 5 and 10 years old, having undergone a nasofibroscopy following cardiac surgery performed before their first year of life (between 01/01/2010 and 12/31/2015).

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No laryngeal mobility disorder post cardiac surgery
No Follow up, no questionnaires and no nasofibroscopic control.
Laryngeal mobility disorder post cardiac surgery
During a follow-up consultation, questionnaires will be offered to assess the child's quality of life.
Other: Questionnaires
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sonia AYARI-KHALFALLAH, MD, Hôpital Femme Mère Enfant - Department of ENT Pediatric surgery,

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2021

Primary Completion (Actual)

September 17, 2021

Study Completion (Actual)

September 17, 2021

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

November 19, 2020

First Posted (Actual)

November 20, 2020

Study Record Updates

Last Update Posted (Actual)

November 28, 2022

Last Update Submitted That Met QC Criteria

November 25, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL20_0505
  • 2020-A01701-38 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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