Observational Study of Patients Undergoing Surgical Treatment for Oesophageal Atresia: Comparison Between Posterolateral Thoracotomy and Axillary Muscle-sparing Minithoracotomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically
研究概览
简要总结
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Not signature of written informed consent and consent to the study and privacy.
结局指标
主要结局
incidence of musculoskeletal abnormalities patients with oesophageal atresia treated surgically
时间窗: Four years after the beginning of the study
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.
次要结局
- Evaluation of severity of outcomes in the medium, short and long term(One year after the Beginning of the study)
- incidence of musculoskeletal abnormalities in the short term(Six months after surgery)
- Predective Facotrs evaluation(One year after the Beginning of the study)
- incidence of musculoskeletal abnormalities in the medium term(Twentyfour months after surgery)
研究者
Elisa Severi
Principal Investigator
Meyer Children's Hospital IRCCS