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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06860919
Acronym
TAO
Enrollment
50
Registered
2025-03-06
Start date
2024-12-19
Completion date
2030-12-19
Last updated
2025-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Atresia

Keywords

Esophageal Atresia

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.

Interventions

OTHERFollow-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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Prevalence of Post Traumatic Stress DisorderAt day 0

Secondary

MeasureTime frameDescription
Quality of life evaluationAt day 0EA 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 assessmentAt day 0EAT-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 assessmentAt day 0It 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.
WeightAt day 0
Hospital Anxiety and Depression scoreAt day 0The 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.
Body Mass IndexAt day 0
thoracic CT scanAt day 0
respiratory function testAt day 0
HeightAt day 0

Countries

France

Contacts

Primary ContactPierre Cattan, MD PhD
pierre.cattan@aphp.fr142499381
Backup ContactJérôme Lambert, MD PhD
jerome.lambert@u-paris.fr142499742

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026