Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06286826
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-02-19
Brief Title:
A Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia
Sponsor:
Meyer Childrens Hospital IRCCS
Organization:
Meyer Childrens Hospital IRCCS
Study Overview
Official Title:
Observational Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia Comparison Between Posterolateral Thoracotomy and Axillary Muscle-sparing Minithoracotomy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None