Azygos Vein Preservation Revisited: Impact on Early Outcomes After Repair of Esophageal Atresia/ Tracheo-Esophageal Fistula in Newborns: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- gap between the pouches after mobilization
研究概览
简要总结
Azygos vein preservation revisited: impact on early outcomes after repair of Esophageal atresia/ Tracheo-Esophageal Fistula in newborns. A randomized controlled study.
详细描述
Since the first successful repair of esophageal atresia/tracheoesophageal fistula was performed approximately eight decades ago, surgeons have made considerable technical advances in solving intraoperative surgical challenges and reducing postoperative complications. According to some surgeons, the advantage of maintaining the Azygos vein makes this modification attractive. This study aimed to explore the benefits of retaining the Azygos vein during surgery for Esophageal Atresia with tracheoesophageal fistula, to emphasize its advantages in terms of reducing anastomotic leak, stricture, and other postoperative outcomes.
Patients and Methods: This prospective randomized study was conducted between April 2020 and April 2023. The study included all newborns with (EA & TEF) eligible for primary repair, patients were randomly assigned to either Group A or Group B. (Group A) patients who underwent Azygos vein preservation during TEF repair, whereas the remaining patients (Group B) had Azygos vein disconnection.
Statistical analysis
The Statistical Package for Social Sciences (SPSS) (version 23.0, IBM Corp IBM Corp., Armonk, NY, USA) was used for statistical analysis. The chi-square test (X2) was used to compare qualitative data in the groups, while an independent-sample t-test was used to compare quantitative data between groups. The degree of confidence was set at 95%. The p-value was considered significant at a level of 0.05.
Discussion: will focus on advantages of azygous vein preservation on intactness of esophageal anastomosis, retaining the venous drainage of the bronchial system, and chest wall. Points of discussion will include effects of Azygous vein preservation on incidence of postoperative pneumonitis, anastomotic leakage and stricture rate, and mortality rate. The results obtained from this study will be compared between both groups and with those reported in the literature.
Finally, the investigators will conclude the reconstructive technique that gives the better results and least morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
single (participants will choose from sealed closed envelopes)
入排标准
- 年龄范围
- 1 Day 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all neonates suitable for primary repair of Esophageal Atresia and tracheoesophageal fistula
排除标准
- •long gap esophageal atresia (> 3 cm)
- •esophageal atresia without tracheoesophageal fistula
结局指标
主要结局
gap between the pouches after mobilization
时间窗: 2 years
missed distance between the mobilized esophageal pouches in centimeters
mortality
时间窗: 35 months
mortality rate in number
early postoperative pneumonia
时间窗: 35 months
postoperative pneumonitis in number
operative time
时间窗: 2 years
operative time in minutes
early postoperative anastomotic leak
时间窗: 35 months
anastomotic leakage rate in number
early postoperative anastomotic stricture
时间窗: 35 months
anastomotic stricture rate in number
次要结局
- sex(2 years)
- associated congenital anomalies(2 years)
- gestational age(2 years)
- associated anomalies(2 years)
研究者
dr. Muhammad Abdelhafez Mahmoud, MD
Lecturer of pediatric surgery, Al-Azhar Faculty of Medicine
Al-Azhar University