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临床试验/NCT04072419
NCT04072419Unknown不适用

Application of Enhanced Recovery After Surgery for Congenital Esophageal Atresia During Perioperative Period

Guangzhou Women and Children's Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年9月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Number of participants with post-operative anastomotic leak

研究概览

简要总结

The purpose of this prospective cohort study is to evaluate the safety and effectiveness of enhanced recovery after surgery (ERAS) to perform routine thoracoscopic repair for elective esophageal atresia type C

详细描述

The concept of enhanced recovery after surgery was introduced by Kelhet et al. in the 1990s for colorectal surgery, and it referred to a group of measures performed during a patient's treatment course to improve operative outcomes, reduce complications, and speed up patient recovery. It is now widely applied in many surgical fields, such as thoracic surgery The esophageal atresia is a group of birth defects including a break in continuity of the esophagus with or without persistent communication with the trachea (tracheoesophageal fistula), and occurs in approximately 1 in 3500-4500 births. Refinements in surgical technique and perioperative care have dramatically decreased mortality rates of infants with EA/TEF, such that mortality is generally related to associated anomalies. Accordingly, the current focus in optimizing patient outcomes has shifted toward decreasing morbidity, including minimizing postoperative complications, speeding up recovery. One of the milestones in recent years is the introduction and rapid development of video-assisted thoracoscopic surgery (VATS). This surgical method has beneficial effects on patient's post-operative recovery and functional status without compromising surgical resection. A range of operations can now be safely performed via VATS.

Although the survival rate of EA is more than 90 percent, there are still many postoperative complications, including anastomotic leakage, recurrence of esophagotracheal fistula, esophageal stenosis, gastroesophageal reflux and other problems, which seriously affect the prognosis. For decades, in order to reduce the complications, post-operative muscle paralysis, mechanical ventilation and urinary catheterization were performed for at least 2 days as convention perioperative management. However, complications after general anesthesia and endotracheal intubation are not negligible, and urinary catheterization is associated with urethral trauma, discomfort, infection. The main reason for placement of chest tube is for post-operative monitoring. However, a chest drain is a recognized cause of post-operative pain and can affect patient's post-operative morbility as well as effective chest physiotherapy.

The current project aims to explored the possibility of ERAS approach (i.e. weaning mechanical ventilation after surgery (less than 48h), no post-operative chest tube and urinary catheterization) for specific Type C EA (the distance of blind end is less than 2.5cm, weight>2.4Kg, without related malformations (heart, kidney, for example), and without structural heart disease (excluding patent ductus arteriosus, patent foramen ovale, or atrial septal defect)).

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 Hour 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • congenital esophageal atresia with type C
  • the distance of blind end is less than 2.5cm
  • weight>2.4Kg
  • without related malformations (heart, kidney),
  • without structural heart disease (excluding patent ductus arteriosus, patent foramen ovale, or atrial septal defect)

排除标准

  • Type A/B/D/E esophageal atresia
  • the distance of blind end is more than 2.5cm
  • weight is less than 2.4Kg
  • with Inherited chromosomal related diseases
  • with congenital heart disease (excluding patent ductus arteriosus, patent foramen ovale, or atrial septal defect)
  • preoperative severe pneumonia need mechanical ventilation

结局指标

主要结局

Number of participants with post-operative anastomotic leak

时间窗: one month after surgery

Comparison of the morbidity of anastomotic leak between ERAS group and control group, including major and minor leaks

Number of participants with post-operative anastomotic strictures

时间窗: two years after surgery

Comparison of the morbidity of anastomotic strictures between ERAS group and control. Anastomotic strictures defined as there are symptoms which require intervention.

Number of participants with post-operative recurrent fistula

时间窗: two years after surgery

Comparison of the morbidity of recurrent fistula between ERAS group and control group

Total number of participants with post-operative complications

时间窗: two years after surgery

Vocal cord dysfunction, Surgical site infection, Chylothorax, Gastroesophageal reflux, pleural effusion and other complications

次要结局

  • length of stay(up to 24 weeks)
  • Length of nutritional support in hospital(up to 24 weeks)

研究者

发起方
Guangzhou Women and Children's Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

He Qiuming

Department of Neonatal Surgery of vice director doctor

Guangzhou Women and Children's Medical Center

研究点 (1)

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