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A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia

NCT06286826 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2024-03-04

No results posted yet for this study

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

Conditions

  • Atresia Esophagus

Interventions

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

PROCEDURE

Minithoracotomy

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

Sponsors & Collaborators

  • Meyer Children's Hospital IRCCS

    lead OTHER

Principal Investigators

  • Elisa Severi · Meyer Children's Hospital IRCCS

Eligibility

Min Age
1 Day
Max Age
13 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-12
Primary Completion
2024-10-12
Completion
2026-01-12

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06286826 on ClinicalTrials.gov