A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia

Recruiting

• Conditions: Atresia Esophagus
• Interventions: Procedure: Postero-lateral thoracotomy; Procedure: Minithoracotomy

• Registration Number: NCT06286826
• Lead Sponsor: Meyer Children's Hospital IRCCS

Brief 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).

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-12
• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-27
• Study First Posted: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-01
• Last Update Posted: 2024-03-04
• Primary Completion: 2024-10-12
• Study Completion: 2026-01-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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.

Exclusion Criteria

• Not signature of written informed consent and consent to the study and privacy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with oesophageal atresia postero-lateral thoracotomy	Postero-lateral thoracotomy	Patients with oesophageal atresia who underwent a postero-lateral thoracotomy between 2011-2021
Patients with oesophageal atresia minithoracotomy	Minithoracotomy	Patients with oesophageal atresia who underwent a minithoracotomy between 2011-2021

Primary Outcome Measures

Name	Time	Method
incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of severity of outcomes in the medium, short and long term	One year after the Beginning of the study	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.
incidence of musculoskeletal abnormalities in the short term	Six months after surgery	assess the incidence of musculoskeletal abnormalities in the short term (6 months after surgery);
Predective Facotrs evaluation	One year after the Beginning of the study	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).
incidence of musculoskeletal abnormalities in the medium term	Twentyfour months after surgery	to assess the incidence of musculo-skeletal abnormalities in the medium term (24 months after surgery);

Trial Locations

Locations (3)

Meyer Children's Hospital IRCCS; 🇮🇹 Florence, Italy

Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Ospedale Bambino Gesù di Roma; 🇮🇹 Roma, Italy