A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia

Last updated: March 1, 2024
Sponsor: Meyer Children's Hospital IRCCS
Overall Status: Active - Recruiting

Phase

N/A

Condition

Esophageal Disorders

Treatment

Minithoracotomy

Postero-lateral thoracotomy

Clinical Study ID

NCT06286826
ATRESO
  • Ages 1-13
  • All Genders

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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

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

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Minithoracotomy
Phase:
Study Start date:
October 12, 2023
Estimated Completion Date:
January 12, 2026

Connect with a study center

  • Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • Meyer Children's Hospital IRCCS

    Florence, 50139
    Italy

    Active - Recruiting

  • Ospedale Bambino Gesù di Roma

    Roma, 00165
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.