A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia

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.

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 Overview

• Status: Recruiting
• Conditions: Atresia Esophagus
• Intervention / Treatment: Procedure: Minithoracotomy; Procedure: Postero-lateral thoracotomy

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Elisa Sieri; Phone Number: 055 5662900; Email: elisa.sieri@meyer.it

Study Locations

• Italy
  • Brescia, Italy, 25123
    • Recruiting
    • Spedali Civili di Brescia
    • Contact: Daniele Alberti; Email: daniele.alberti@unibs.it
  • Florence, Italy, 50139
    • Recruiting
    • Meyer Children's Hospital IRCCS
    • Contact: Elisa Severi; Phone Number: 0555662900; Email: elisa.severi@meyer.it
  • Roma, Italy, 00165
    • Recruiting
    • Ospedale Bambino Gesù di Roma
    • Contact: Andrea Conforti, MD; Email: andrea.conforti@opbg.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with oesophageal atresia (type III according to Ladd's classification).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with oesophageal atresia minithoracotomy; Patients with oesophageal atresia who underwent a minithoracotomy between 2011-2021	Procedure: Minithoracotomy; Minithoracotomy aims to preserve the muscles of the rib cage by retracting or disconnecting them rather than sectioning them (muscle sparing technique)
Patients with oesophageal atresia postero-lateral thoracotomy; Patients with oesophageal atresia who underwent a postero-lateral thoracotomy between 2011-2021	Procedure: Postero-lateral thoracotomy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Four years after the beginning of the study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of musculoskeletal abnormalities in the short term	assess the incidence of musculoskeletal abnormalities in the short term (6 months after surgery);	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);	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.	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).	One year after the Beginning of the study

Collaborators and Investigators

• Sponsor: Meyer Children's Hospital IRCCS
• Investigators: Principal Investigator: Elisa Severi, Meyer Children's Hospital IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): October 12, 2024
• Study Completion (Estimated): January 12, 2026

Study Registration Dates

• First Submitted: February 19, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): March 4, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Esophageal Diseases; Digestive System Abnormalities; Esophageal Atresia
• Other Study ID Numbers: ATRESO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No