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Recruiting NCT06860919

Prospective Evaluation of the Results of Multidisciplinary Follow-up After a Transitional Consultation for Esophageal Atresia

Observational Esophageal Atresia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Follow-up of the patients during 3 years.
Who it may be relevant to
Registry conditions: Esophageal Atresia. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Evaluation Prospective Des résultats du Suivi Pluridisciplinaire Mis en Place au décours d'Une Consultation de Transition Pour l'atrésie de l'œsophage

Overview

A transition consultation for adult patients with esophageal atresia, involving medical and paramedical stakeholders, was set up at Hôpital Saint-Louis in 2020. The aim of this initiative is to: 1. initiate adult medical, psychological and social follow-up; 2. empower these adults in their future care; 3. establish a personalized follow-up schedule. This project is the first to focus on post-traumatic stress disorder (PTSD) in young adults with esophageal atresia. A 3-year analysis of the somatic and psychosocial variables analyzed will confirm the validity of this initiative, and define its optimal contours for improving these patients' quality of life as adults.

Interventions

  • Other Follow-up of the patients during 3 years
    Evaluation of PTSD prevalence, anxiety-depressive state, quality of life, look for a correlation between their clinical history and PTSD. Analysis of the nutritional, gastrointestinal and respiratory status.

Primary outcome measures

  • Prevalence of Post Traumatic Stress Disorder [Time frame: At day 0]
Secondary outcome measures (12)
  • Hospital Anxiety and Depression score [Time frame: At day 0]
  • Hospital Anxiety and Depression score [Time frame: At 3 years]
  • Quality of life evaluation [Time frame: At day 0]
  • Quality of life evaluation [Time frame: At 3 years]
  • Eating assessment [Time frame: At day 0]
  • Eating assessment [Time frame: At 3 years]
  • Quality of life assessment [Time frame: At day 0]
  • Quality of life assessment [Time frame: At 3 years]
  • Weight [Time frame: At day 0]
  • Weight [Time frame: At 3 years]
  • Height [Time frame: At day 0]
  • Height [Time frame: At 3 years]

Eligibility criteria

Inclusion criteria

  • Patients with esophageal atresia
  • Aged 18 to 30
  • Followed at Hôpital Saint Louis
  • Informed and not opposed to the study
  • Patients affiliated to a social security scheme

Exclusion criteria

  • Inability to answer questionnaires
  • Patients under guardianship
  • Patients under AME (Aide Médicale d'Etat in France)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Hopital Saint Louis — Paris

Identifiers

NCT: NCT06860919 · APHP240714

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗