A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-12

Study Completion Date

2026-01-12

Brief Summary

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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

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Detailed Description

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Conditions

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Atresia Esophagus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with oesophageal atresia minithoracotomy

Patients with oesophageal atresia who underwent a minithoracotomy between 2011-2021

Minithoracotomy

Intervention Type PROCEDURE

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

Postero-lateral thoracotomy

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Minithoracotomy

Minithoracotomy aims to preserve the muscles of the rib cage by retracting or disconnecting them rather than sectioning them (muscle sparing technique)

Intervention Type PROCEDURE

Eligibility Criteria

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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.