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NCT Number: NCT06860919

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

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.

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Key information

Conditions

Esophageal Atresia Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hopital Saint Louis

Paris, France

Location status: Recruiting

Location contact

Pierre Cattan, MD PhD

CONTACT

[email protected]

+33142499381 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Follow-up of the patients during 3 years

Other

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 outcomes

  1. Prevalence of Post Traumatic Stress Disorder

    Time frame: At day 0

Secondary outcomes

  1. Hospital Anxiety and Depression score

    Time frame: At day 0

    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.

  2. Hospital Anxiety and Depression score

    Time frame: 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.

  3. Quality of life evaluation

    Time frame: At day 0

    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.

  4. Quality of life evaluation

    Time frame: 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.

  5. Eating assessment

    Time frame: At day 0

    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)

  6. Eating assessment

    Time frame: 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)

  7. Quality of life assessment

    Time frame: At day 0

    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.

  8. Quality of life assessment

    Time frame: 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.

  9. Weight

    Time frame: At day 0

  10. Weight

    Time frame: At 3 years

  11. Height

    Time frame: At day 0

  12. Height

    Time frame: At 3 years

  13. Body Mass Index

    Time frame: At day 0

  14. Body Mass Index

    Time frame: At 3 years

  15. thoracic CT scan

    Time frame: At day 0

  16. thoracic CT scan

    Time frame: At 3 years

  17. respiratory function test

    Time frame: At day 0

  18. respiratory function test

    Time frame: At 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Lambert, MD PhD

CONTACT

[email protected]

142499742 ext. +33

Pierre Cattan, MD PhD

CONTACT

[email protected]

142499381 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: TAO

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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