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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-30
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with esophageal atresia

Aged 18 to 30

Followed at Hôpital Saint Louis

Informed and not opposed to the study

Disqualifiers

Inability to answer questionnaires

Patients under guardianship

Patients under AME (Aide Médicale d'Etat in France)

Trial population

Young adults with esophageal atresia

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Follow-up of the patients during 3 years

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Young adults with esophageal atresia1 intervention

Trial outcomes

Primary outcomes

1

Prevalence of Post Traumatic Stress Disorder

Time frame
At day 0

Secondary outcomes

1

Hospital Anxiety and Depression score

The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. HAD scale is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). A higher score indicates worse outcome.

Time frame
At day 0
2

Hospital Anxiety and Depression score

The HAD scale is a self-assessment scale for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. HAD scale is a self-administered scale of 14 items which assessed levels of depression and anxiety, divided into 2 subscales of 7 items (Anxiety or HADS-A, Depression or HADS-D). Each item is scored on a scale of 0 to 3. A score is generated for each of the two sub-scales (sum of the 7 items, ranging from 0 to 21). A higher score indicates worse outcome.

Time frame
At 3 years
3

Quality of life evaluation

EA QOL questionnaire The score includes 4 domains : eating, social relationships, body perception, and health and well-being. The score varies between 0 to 100, the higher score the higher the quality of life.

Time frame
At day 0
4

Quality of life evaluation

EA QOL questionnaire The score includes 4 domains : eating, social relationships, body perception, and health and well-being. The score varies between 0 to 100, the higher score the higher the quality of life.

Time frame
At 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.