Clinical outcome of tracheoesophageal fistula repair with or without the use of trans-anastomotic feeding tube: a pilot randomised control trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the rate of an anastomotic leak following primary repair of EA/TEF with and without TAFT
研究概览
简要总结
The patients being operated on for tracheo-oesophagal fistula and undergoing primary oesophagal anastomosis will be randomised into 2 groups.
1. with TAFT- 6 Fr Nasogastric tube will be placed across the oesophagal anastomosis intraoperatively and will be used for giving tube feeds and removed once the child is stable postoperatively and is tolerating full oral feeds
2. without TAFT- NO Nasogastric tube will be placed across the oesophagal anastomosis intraoperatively and the child will be started on oral feeds in the postoperative period.
Both the groups will be followed up at various time points such as at discharge, 2 weeks, 1 month, 3 months and 6 months with respect to outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 0.00 Month(s) 至 1.00 Month(s)（—）
- 性别
- All
入选标准
- •Weight > 1.8KG
- •SNAPPE II Score < 7.
排除标准
- •Major symptomatic cardiac anomalies are defined as the presence of cyanosis, murmur, and difference in pre and post-ductal saturation.
- •(Tetralogy of Fallot with Pulmonary stenosis, Single ventricle, Tricuspid atresia and Truncus arteriosus)
- •Parents not willing to participate in the study
- •Babies who were operated outside and referred for complications •Babies who were diverted (oesophagostomy + gastrostomy) on the table in case of long gap (>3 vertebral bodies) •Presence of major associated congenital anomalies (e.g., duodenal atresia, anorectal malformations, etc.) requiring second surgery in the same setting or within the immediate postoperative period.
- •â€¢TEF types other than EA/TEF (e.g., pure oesophageal atresia and H-type tracheoesophageal fistula).
结局指标
主要结局
To compare the rate of an anastomotic leak following primary repair of EA/TEF with and without TAFT
时间窗: post operative period : follow up upto 6 months after surgery.
次要结局
- Time to start feed(post operative period)
- Anastomotic stricture(2 weeks, 1 month, 3 months, 6 months)
- Time to reach full feed(post operative period)
- Incidence of BRUE/ALTE(2 weeks, 1 month, 3 months, 6 months)
- Incidence of GERD(2 weeks, 1 month, 3 months, 6 months)
- Somatic growth(2 weeks, 1 month, 3 months, 6 months)
- All-cause mortality at 30 days(30 days)