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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Atresia
• Intervention / Treatment: Other: Follow-up of the patients during 3 years

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Jérôme Lambert, MD PhD; Phone Number: +33 142499742; Email: jerome.lambert@u-paris.fr
• Study Contact Backup: Name: Pierre Cattan, MD PhD; Phone Number: +33 142499381; Email: pierre.cattan@aphp.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Hopital Saint Louis
    • Contact: Pierre Cattan, MD PhD; Phone Number: +33 +33142499381; Email: pierre.cattan@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Young adults with esophageal atresia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Young adults with esophageal atresia	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Prevalence of Post Traumatic Stress Disorder	At day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At day 0
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.	At 3 years
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.	At day 0
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.	At 3 years
Eating assessment	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)	At day 0
Eating assessment	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)	At 3 years
Quality of life assessment	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.	At day 0
Quality of life assessment	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.	At 3 years
Weight		At day 0
Weight		At 3 years
Height		At day 0
Height		At 3 years
Body Mass Index		At day 0
Body Mass Index		At 3 years
thoracic CT scan		At day 0
thoracic CT scan		At 3 years
respiratory function test		At day 0
respiratory function test		At 3 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2024
• Primary Completion (Estimated): December 19, 2030
• Study Completion (Estimated): December 19, 2030

Study Registration Dates

• First Submitted: January 16, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Esophageal Atresia
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Congenital Abnormalities; Digestive System Abnormalities; Esophageal Atresia
• Other Study ID Numbers: APHP240714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No