A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia

NCT06286826 | Recruiting

• 1 other identifier: ATRESO
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• incidence of musculoskeletal abnormalities in the short term

  Six months after surgery

• incidence of musculoskeletal abnormalities in the medium term

  Twentyfour months after surgery

• Evaluation of severity of outcomes in the medium, short and long term

  One year after the Beginning of the study

• Predective Facotrs evaluation

  One year after the Beginning of the study

Study Arms (2)

Patients with oesophageal atresia minithoracotomy

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

Procedure: Minithoracotomy

Patients with oesophageal atresia postero-lateral thoracotomy

Patients with oesophageal atresia who underwent a postero-lateral thoracotomy between 2011-2021

Procedure: Postero-lateral thoracotomy

Interventions

Postero-lateral thoracotomy 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

Patients with oesophageal atresia postero-lateral thoracotomy

Minithoracotomy 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 minithoracotomy

Eligibility Criteria

• Age: 1 Day - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Meyer Children's Hospital IRCCS: lead

Study Sites (3)

Spedali Civili di Brescia

Brescia, 25123, Italy

RECRUITING

Meyer Children's Hospital IRCCS

Florence, 50139, Italy

RECRUITING

Ospedale Bambino Gesù di Roma

Roma, 00165, Italy

RECRUITING

MeSH Terms

Conditions

Esophageal Atresia

Condition Hierarchy (Ancestors)

Digestive System Abnormalities; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Elisa Severi

  Meyer Children's Hospital IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa Sieri

CONTACT

055 5662900; elisa.sieri@meyer.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 29, 2024
• Study Start: October 12, 2023
• Primary Completion: October 12, 2024
• Study Completion: January 12, 2026
• Last Updated: March 4, 2024

Record last verified: 2024-03

Locations

IT (3)