Esophageal AtresiaTAONCT06860919
Prospective Evaluation of the Results of Multidisciplinary Follow-up After a Transitional Consultation for Esophageal Atresia
An observational study of Esophageal Atresia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Esophageal Atresia
- What is being tested?
- Follow-up of the patients during 3 years
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2024to 19 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Study population: Young adults with esophageal atresia
Who may be able to join
- 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
Who cannot join
- Inability to answer questionnaires
- Patients under guardianship
- Patients under AME (Aide Médicale d'Etat in France)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopital Saint Louis
Paris
Pierre Cattan, MD PhD, +33142499381 ext. +33, pierre.cattan@aphp.fr
About this study
Official title: 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.
- Conditions
- Esophageal Atresia
- Being tested
- Follow-up of the patients during 3 years
- Keywords
- Esophageal Atresia
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up of the patients during 3 yearsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Young adults with esophageal atresia | Not described Receives: Other: Follow-up of the patients during 3 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Post Traumatic Stress Disorder
Measured: At day 0
Secondary outcomes (18)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: At 3 years
Weight
Measured: At day 0
Weight
Measured: At 3 years
Height
Measured: At day 0
Height
Measured: At 3 years
Body Mass Index
Measured: At day 0
Body Mass Index
Measured: At 3 years
thoracic CT scan
Measured: At day 0
thoracic CT scan
Measured: At 3 years
respiratory function test
Measured: At day 0
respiratory function test
Measured: At 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start19 Dec 2024
- Primary completion19 Dec 2030 (estimated)
- Study completion19 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal AtresiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860919
- Sponsor's protocol ID
- APHP240714
- Acronym
- TAO
- Status last verified
- Jan 2025
- First submitted
- 16 Jan 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Prospective Des résultats du Suivi Pluridisciplinaire Mis en Place au décours d'Une Consultation de Transition Pour l'atrésie de l'œsophage
- ClinicalTrials.gov ID
- NCT06860919
- Acronym / sponsor ID
- TAO / APHP240714
- Conditions
- Esophageal Atresia
- Keywords
- Esophageal Atresia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 19 Dec 2030 (estimated)
- Study completion
- 19 Dec 2030 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young adults with esophageal atresia | – | Other: Follow-up of the patients during 3 years |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Young adults with esophageal atresia
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Inability to answer questionnaires
- Patients under guardianship
- Patients under AME (Aide Médicale d'Etat in France)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up of the patients during 3 yearsEvaluation 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. | Other | Young adults with esophageal atresia |
Primary outcome
Prevalence of Post Traumatic Stress Disorder
Time frame: At day 0
18 secondary outcomes
Hospital Anxiety and Depression score
Time frame: At day 0
Hospital Anxiety and Depression score
Time frame: At 3 years
Quality of life evaluation
Time frame: At day 0
Quality of life evaluation
Time frame: At 3 years
Eating assessment
Time frame: At day 0
Eating assessment
Time frame: At 3 years
Quality of life assessment
Time frame: At day 0
Quality of life assessment
Time frame: At 3 years
Weight
Time frame: At day 0
Weight
Time frame: At 3 years
Height
Time frame: At day 0
Height
Time frame: At 3 years
Body Mass Index
Time frame: At day 0
Body Mass Index
Time frame: At 3 years
thoracic CT scan
Time frame: At day 0
thoracic CT scan
Time frame: At 3 years
respiratory function test
Time frame: At day 0
respiratory function test
Time frame: At 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Atresia, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Cattan, MD PhD (142499381 ext. +33, pierre.cattan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Post Traumatic Stress Disorder (time frame: At day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.