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

Recruiting

• Conditions: Esophageal Atresia

• Registration Number: NCT06860919
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-19
• Status Verified: 2025-01
• Study First Submitted: 2025-01-16
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2030-12-19
• Study Completion: 2030-12-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of Post Traumatic Stress Disorder	At day 0

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression score	At 3 years	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.
Quality of life evaluation	At 3 years	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.
Eating assessment	At 3 years	EAT-10 is an auto-questionnaireto evaluate dysphagia. There are 10 items, with a result for each varying between 0 (no problem) and 4 (severe problems)
Quality of life assessment	At 3 years	It will be assessed by the SF36 scale. The Short Form (36) Health Survey is a 36-item measure if health status. The score obtained varies between 0 and 100. The higher the score the less disability.; Ware JE, Sherbourne CD. The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992;30:473-83.
Weight	At 3 years
Height	At 3 years
Body Mass Index	At 3 years
thoracic CT scan	At 3 years
respiratory function test	At 3 years

Trial Locations

Locations (1)

Hopital Saint Louis; 🇫🇷 Paris, France