Clinical trial NCT06286826: A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia
Official title: Observational Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia: Comparison Between Posterolateral Thoracotomy and Axillary Muscle-sparing Minithoracotomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atresia Esophagus
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
First posted: 2024-02-29
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with oesophageal atresia (type III according to Ladd's classification).

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


Eligibility criteria: 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:

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

Primary outcomes:
measure: incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically
timeFrame: Four years after the beginning of the study
Secondary outcomes:
measure: incidence of musculoskeletal abnormalities in the short term
timeFrame: Six months after surgery
measure: incidence of musculoskeletal abnormalities in the medium term
timeFrame: Twentyfour months after surgery
measure: Evaluation of severity of outcomes in the medium, short and long term
timeFrame: One year after the Beginning of the study
measure: Predective Facotrs evaluation
timeFrame: One year after the Beginning of the study
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
city: Florence
country: Italy
facility: Meyer Children's Hospital IRCCS
city: Roma
country: Italy
facility: Ospedale Bambino Gesù di Roma
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Elisa Severi
role: PRINCIPAL_INVESTIGATOR
References: