A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia

Meyer Children's Hospital IRCCS

Status

Enrolling

Conditions

Atresia Esophagus

Treatments

Procedure: Minithoracotomy

Procedure: Postero-lateral thoracotomy

Study type

Observational

Funder types

Other

Identifiers

NCT06286826

ATRESO

Details and patient eligibility

About

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

Enrollment

50 estimated patients

Sex

All

Ages

1 day to 13 years old

Volunteers

No Healthy Volunteers

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