Atresia EsophagusNCT06286826
A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia
An observational study of Atresia Esophagus, run by Meyer Children's Hospital IRCCS at 3 sites in Italy.
Trial summary
Oesophageal atresia (EA) is a rare congenital anomaly whose prevalence varies between 1 and 2 per 5000 live births in Europe. This condition is characterised by an interruption of the oesophagus often associated with the presence of a tracheo-oesophageal fistula (FTE). Read more about this study
- Who is it for?
- Ages 1 day to 13 years
- Conditions the study is for
- Atresia Esophagus
- What is being tested?
- Postero-lateral thoracotomy and Minithoracotomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 3 sitesItaly
- Study dates
- 12 Oct 2023to 12 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 1 day to 13 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with oesophageal atresia (type III according to Ladd's classification).
Who may be able to join
- Patients with oesophageal atresia (type III according to Ladd's classification);
- Patients who underwent their first operation for oesophageal atresia in the period 2011-2021
- Signature of written informed consent and consent to the study and privacy.
Who cannot join
- Not signature of written informed consent and consent to the study and privacy.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites, 3 recruiting
- Recruiting
Spedali Civili di Brescia
Brescia, 25123
Daniele Alberti, daniele.alberti@unibs.it
- Recruiting
Meyer Children's Hospital IRCCS
Florence, 50139
Elisa Severi, 0555662900, elisa.severi@meyer.it
- Recruiting
Ospedale Bambino Gesù di Roma
Roma, 00165
Andrea Conforti, MD, andrea.conforti@opbg.net
About this study
Official title: Observational Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia: Comparison Between Posterolateral Thoracotomy and Axillary Muscle-sparing Minithoracotomy
Oesophageal atresia (EA) is a rare congenital anomaly whose prevalence varies between 1 and 2 per 5000 live births in Europe. This condition is characterised by an interruption of the oesophagus often associated with the presence of a tracheo-oesophageal fistula (FTE).
Although considerable progress has been made in the treatment of AE in recent years, the aetiology of this defect is still not fully understood and several theories have been put forward to explain this phenomenon. What they have in common is an abnormal separation of the primary oesophagus and trachea. The main goal of AE treatment is the closure of the FTE using surgical techniques.
Read more
This is a non-profit, multicentre longitudinal observational cohort study. This study will enrol patients who underwent surgery for oesophageal atresia during the period 2011-2021 and are still in follow-up at participating clinical centres.
The primary objective is to assess the incidence of musculoskeletal abnormalities, of any type, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically by two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation
- Conditions
- Atresia Esophagus
- Being tested
- Postero-lateral thoracotomy, Minithoracotomy
- Medical subject headings
- Esophageal Atresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postero-lateral thoracotomyProcedure or surgery
this incision extends from the anterior axillary line, goes posteriorly behind the scapula and includes the division of the fibres of the latissimus dorsi muscle and the serratus anterior muscle. The latter approach presents the risk of numerous long-term musculoskeletal complications such as costal abnormalities (costal hypoplasia, costal fusion), winged scapula, scoliotic spine posture
MinithoracotomyProcedure or surgery
Minithoracotomy aims to preserve the muscles of the rib cage by retracting or disconnecting them rather than sectioning them (muscle sparing technique)
| Study group | Role | What they receive |
|---|---|---|
| Patients with oesophageal atresia minithoracotomy | Patients with oesophageal atresia who underwent a minithoracotomy between 2011-2021 Receives: Procedure: Minithoracotomy | |
| Patients with oesophageal atresia postero-lateral thoracotomy | Patients with oesophageal atresia who underwent a postero-lateral thoracotomy between 2011-2021 Receives: Procedure: Postero-lateral thoracotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically
evaluate the incidence of musculoskeletal abnormalities, of all types, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically using two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation.
Measured: Four years after the beginning of the study
Secondary outcomes (4)
incidence of musculoskeletal abnormalities in the short term
assess the incidence of musculoskeletal abnormalities in the short term (6 months after surgery);
Measured: Six months after surgery
incidence of musculoskeletal abnormalities in the medium term
to assess the incidence of musculo-skeletal abnormalities in the medium term (24 months after surgery);
Measured: Twentyfour months after surgery
Evaluation of severity of outcomes in the medium, short and long term
evaluate the severity of outcomes (musculoskeletal abnormalities, respiratory pathologies, eating disorders) in the medium, short and long term. Musculoskeletal abnormalities will be evaluated using the "Trunk Aesthetic Clinical Evaluation (TRACE) Scale"; this scale involves evaluation of shoulder asimmetry (1-3), scapulae asimmetry (1-2), hemi-thorax asimmetry (1-2), waist asimmetry (1-4). Respiratory pathologies are defined as the presence or absence of asthma and recurrent respiratory infections that requires hospitalization (>3 per years). Eating disorders will be defined on the base of the consistence and the dimension of the pieces of food eaten by the child.
Measured: One year after the Beginning of the study
Predective Facotrs evaluation
evaluate the effect of potential predictive factors (such as incision type, intercostal space opening, pleural approach) on abnormalities at different time-points. Musculoskeletal abnormalities will be evaluated using the "Trunk Aesthetic Clinical Evaluation (TRACE) Scale"; this scale involves evaluation of shoulder asimmetry (1-3), scapulae asimmetry (1-2), hemi-thorax asimmetry (1-2), waist asimmetry (1-4).
Measured: One year after the Beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start12 Oct 2023
- Primary completion12 Oct 2024 (estimated)
- Study completion12 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atresia EsophagusStudies of the same condition, open and under way.
- More trials run by Meyer Children's Hospital IRCCSThe 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
- Meyer Children's Hospital IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Severi, Meyer Children's Hospital IRCCS
- Investigators
- Elisa Severi, Principal investigator, Meyer Children's Hospital IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06286826
- Sponsor's protocol ID
- ATRESO
- Status last verified
- Mar 2024
- First submitted
- 19 Feb 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia: Comparison Between Posterolateral Thoracotomy and Axillary Muscle-sparing Minithoracotomy
- ClinicalTrials.gov ID
- NCT06286826
- Acronym / sponsor ID
- ATRESO
- Conditions
- Atresia Esophagus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Meyer Children's Hospital IRCCSUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 12 Oct 2024 (estimated)
- Study completion
- 12 Jan 2026 (estimated)
- First posted
- 29 Feb 2024 (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.
Oesophageal atresia (EA) is a rare congenital anomaly whose prevalence varies between 1 and 2 per 5000 live births in Europe. This condition is characterised by an interruption of the oesophagus often associated with the presence of a tracheo-oesophageal fistula (FTE).
Although considerable progress has been made in the treatment of AE in recent years, the aetiology of this defect is still not fully understood and several theories have been put forward to explain this phenomenon. What they have in common is an abnormal separation of the primary oesophagus and trachea. The main goal of AE treatment is the closure of the FTE using surgical techniques.
This is a non-profit, multicentre longitudinal observational cohort study. This study will enrol patients who underwent surgery for oesophageal atresia during the period 2011-2021 and are still in follow-up at participating clinical centres.
The primary objective is to assess the incidence of musculoskeletal abnormalities, of any type, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically by two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with oesophageal atresia minithoracotomy | – | Procedure: MinithoracotomyPatients with oesophageal atresia who underwent a minithoracotomy between 2011-2021 |
| Patients with oesophageal atresia postero-lateral thoracotomy | – | Procedure: Postero-lateral thoracotomyPatients with oesophageal atresia who underwent a postero-lateral thoracotomy between 2011-2021 |
Who may qualify
- Ages
- 1 day to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with oesophageal atresia (type III according to Ladd's classification).
Key inclusion criteria (3 listed)
- Patients with oesophageal atresia (type III according to Ladd's classification);
- Patients who underwent their first operation for oesophageal atresia in the period 2011-2021
- Signature of written informed consent and consent to the study and privacy.
Key exclusion criteria (1 listed)
- Not signature of written informed consent and consent to the study and privacy.
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 |
|---|---|---|
| Postero-lateral thoracotomythis incision extends from the anterior axillary line, goes posteriorly behind the scapula and includes the division of the fibres of the latissimus dorsi muscle and the serratus anterior muscle. The latter approach presents the risk of numerous long-term musculoskeletal complications such as costal abnormalities (costal hypoplasia, costal fusion), winged scapula, scoliotic spine posture | Procedure or surgery | Patients with oesophageal atresia postero-lateral thoracotomy |
| MinithoracotomyMinithoracotomy aims to preserve the muscles of the rib cage by retracting or disconnecting them rather than sectioning them (muscle sparing technique) | Procedure or surgery | Patients with oesophageal atresia minithoracotomy |
Primary outcome
incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically
Time frame: Four years after the beginning of the study
evaluate the incidence of musculoskeletal abnormalities, of all types, in the long term (4 years after surgery) in patients with oesophageal atresia treated surgically using two different approaches: postero-lateral thoracotomy and mini-thoracotomy with muscle preservation.
4 secondary outcomes
incidence of musculoskeletal abnormalities in the short term
Time frame: Six months after surgery
incidence of musculoskeletal abnormalities in the medium term
Time frame: Twentyfour months after surgery
Evaluation of severity of outcomes in the medium, short and long term
Time frame: One year after the Beginning of the study
Predective Facotrs evaluation
Time frame: One year after the Beginning of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
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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. This study is not recruiting at the moment.
Elisa Severi principal investigator
Meyer Children's Hospital IRCCS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atresia Esophagus, run by Meyer Children's Hospital IRCCS at 3 sites in Italy.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Sieri (055 5662900, elisa.sieri@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically (time frame: Four years after the beginning of the study). 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 4 Mar 2024.