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

NCT06860919 | Recruiting

• 1 other identifier: APHP240714
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Atresia

Keywords

Esophageal Atresia

Outcome Measures

Primary Outcomes (1)

• Prevalence of Post Traumatic Stress Disorder

  At day 0

Secondary Outcomes (18)

• Hospital Anxiety and Depression score

  At day 0

• Hospital Anxiety and Depression score

  At 3 years

• Quality of life evaluation

  At day 0

• Quality of life evaluation

  At 3 years

• Eating assessment

  At day 0

Study Arms (1)

Young adults with esophageal atresia

Other: Follow-up of the patients during 3 years

Interventions

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.

Young adults with esophageal atresia

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Young adults with esophageal atresia

You may qualify if:

• 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

You may not qualify if:

• Inability to answer questionnaires
• Patients under guardianship
• Patients under AME (Aide Médicale d'Etat in France)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital Saint Louis

Paris, France

RECRUITING

MeSH Terms

Conditions

Esophageal Atresia

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Pierre Cattan, MD PhD

CONTACT

142499381; pierre.cattan@aphp.fr

Jérôme Lambert, MD PhD

CONTACT

142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: March 6, 2025
• Study Start: December 19, 2024
• Primary Completion (Estimated): December 19, 2030
• Study Completion (Estimated): December 19, 2030
• Last Updated: March 6, 2025

Record last verified: 2025-01

Locations

FR (1)