Multi-dimensional developmental assessment of patients who underwent thoracoscopic repair of Esophageal atresia: A prospective comparison with thoracotomy cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- groups.
研究概览
简要总结
Study Summary
Setting Department of Pediatric Surgery PGIMER Chandigarh
Subjects Patients with TREAT repaired via thoracotomy or thoracoscopy
Inclusion Criteria
Patients with TREAT and expectant recovery postnatally
Thoracotomy or thoracoscopic repair performed for esophageal atresia
Minimum 2 years of completed follow-up
Conversions to open surgery included in open group
Patients undergoing esophageal dilatation under general anesthesia included
Gestational age more than 35 weeks
Exclusion Criteria
Less than 2 years of follow-up
Major surgeries for other systems such as cardiac surgery
Anastomotic leak requiring more than 3 weeks of ventilation or esophageal diversion
Syndromic patients with cognitive or neurological impairment
Lost to follow-up cases
Perinatal asphyxia defined by WHO or APGAR less than 7
Preterm neonates less than 35 weeks gestation
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2.00 Year(s) 至 30.00 Year(s)（—）
入选标准
- •Age: 2 years and above Gender: male and female informed consent taken All the patients who had tracheo-esophageal fistula with thoracoscopic repair of esophageal atresia All the patients who had thoracotomy for esophageal atresia repair minimum 2 years of follow up after surgery gestational age greater than 35 weeks.
排除标准
- 未提供
结局指标
主要结局
groups.
时间窗: After 2 years of follow up
1. Neurodevelopmental outcome assessment of neonates who underwent
时间窗: After 2 years of follow up
thoracoscopic repair of Esophageal atresia and repair via open thoracotomy at
时间窗: After 2 years of follow up
birth using defined assessment methods with comparison between the two
时间窗: After 2 years of follow up
2. Formulate a standard assessment methodology for neurodevelopmental
时间窗: After 2 years of follow up
assessment of surgical patients undergoing complex and major surgical
时间窗: After 2 years of follow up
procedures at birth
时间窗: After 2 years of follow up
次要结局
- 1. Make comparative assessment of musculoskeletal development and problems in(patients operated via thoracotomy and thoracoscopy)
研究者
Rudri Joshipura
Post graduate institute of medical education and research, Chandigarh