跳至主要内容
临床试验/NCT06208449
NCT06208449进行中(未招募)不适用

Comparison of Robotic Versus Thoracoscopy Versus Thoracotomy Repair for Congenital Esophageal Atresia

Zunyi Medical College1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
150
试验地点
1
主要终点
anastomotic leak

研究概览

简要总结

Thoracotomy repair has long been considered the gold standard for the repair of esophageal atresia but is associated with potential musculoskeletal complications which may result in long term morbidity for the patient. thoracoscopy repair offers better visualization of the posterior mediastinal structures, while limiting the surgical trauma. However, studies have shown that the incidence of anastomotic leakage and anastomotic stricture in thoracoscopic repair is not significantly lower than thoracostomy repair. Robotic repair had shorter anastomotic time, lower incidence of anastomotic leakage and stricture, and lower unplanned readmission rate than the thoracotomy repair. However, there were no randomized controlled trials to verify the effectiveness of three procedures. The objection was to compare the difference between robotic repair and thoracoscopic repair, and thoracotomy repair in intraoperative parameters and postoperative complications in EA neonates.

详细描述

Esophageal atresia (EA) and tracheoesophageal fistula (TEF) is one of the most common congenital malformations of esophagus, with an incidence of 1/2500~1/4500. The condition can be an isolated malformation or may be associated with other congenital anomalies. Since Dr Cameron Height performed the first successful primary repair of a neonate with EA/ TEF in 1941, many advances in surgical technique and neonatal care have steadily improved survival rates of babies within the EA/TEF spectrum. Survival of infants with esophageal atresia has increased over time since the first successful repair and the overall survival exceeds 90%. Commonly, esophageal atresia is repaired via a right posterolateral thoracotomy and more recently muscle sparing thoracotomy has become an alternative to the traditional muscle cutting approach. Open repair has long been considered the gold standard for the repair of esophageal atresia but is associated with potential musculoskeletal complications which may result in long term morbidity for the patient.

The first successful thoracoscopic surgery of a child with EA was reported in 1999. Compared to thoracotomy repair the proposed main advantage of thoracoscopic repair is that it offers better visualization of the posterior mediastinal structures, while limiting the surgical trauma. However, studies have shown that the incidence of anastomotic leakage and anastomotic stricture in thoracoscopic repair is not significantly lower than thoracostomy repair, thoracoscopic repair also offers concerns with more complicated anesthesia, limited workspace, and difficultly controlling the vascular structures. Especially, suturing within such a small, closed space has been considered a major technical difficulty.

Robotic repair was first reported by Meehan in 2009, followed by several case reports. The reported reasons for conversion mainly focused on the incompatibility between the robotic trocar's size and the intercostal space's width, and the technical challenges due to instrument collisions in the extremely limited thoracoscopic space. The intercostal space of neonates is highly narrow, and the thoracic diameter is only 8 cm. These are the two key technical issues to be addressed in this study. According to the existing robotic system setup standard for adults, the distance required between trocar ports in robots is usually at least 8 cm to ensure sufficient operating space and avoid instrument collisions. Even for the new generation of robots, this minimum distance requires 5-6 cm. Huge robotic trocars used in EA neonates fail to meet the standard for conventional operating port distances. There have study designed an asymmetric port distribution technique in which the third and eighth intercostal ports are 3 cm and 5 cm away from the camera port. The surgeons primarily manipulated the inner-articulating part of the robotic arms within the thoracic cavity, avoiding instrument collisions outside. Moreover, the setup of the trocars ensures that the robotic arms can reach the main operating area. When combined with instruments of 7 degrees of freedom, the mobilization and anastomosis of the esophagus could be completed easily, breaking through the narrow space restriction of thoracic cavity. Inserting 8-12 cm trocars into tiny intercostal space was another technical challenge. The results shown the robotic repair had shorter anastomotic time, lower incidence of anastomotic leakage and stricture, and lower unplanned readmission rate than the thoracotomy repair.

An international survey from 2014 highlighted the need for consensus on the optimal surgical treatment of EA. However, a detailed understanding of whether thoracoscopic repair or robotic repair offers advantages in terms of health outcomes, safety, and efficacy for providers compared to thoracotomy repair is still lacking. Several reviews are opinion-based or obscured by institutional/personal experiences. Herewith, we designed a comprehensive study and focused on evaluating the difference between robotic repair and thoracoscopic repair, and thoracotomy repair in intraoperative parameters and postoperative complications in EA neonates.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
— 至 1 Month(Child)
性别
All
接受健康志愿者

入选标准

  • Type C EA neonates with short esophageal gap length (less than 3 vertebral bodies), mini-invasive repair, and a successful one-stage anastomosis were included.

排除标准

  • Patients with respiratory distress requiring assisted ventilation, long esophageal gap length, multistage surgery, other types EA (type A/B/D/E) or surgical contraindications were excluded.
  • Gestational age less than 35 weeks and birth weight less than 2kg were excluded.

结局指标

主要结局

anastomotic leak

时间窗: 1 year

anastomotic leak within 30-days postoperative

anastomotic stricture

时间窗: 1 year

stricture requiring dilation within 1 year

次要结局

  • The use of vasopressors(1 year)
  • Time to extubation(1 year)
  • number of dilations in 1 year(1 year)
  • esophageal dehiscence(1 year)
  • surgical site infection(1 year)
  • sepsis(2 year)
  • Ventilation time(1 year)
  • Time to full enteral feeds(1 year)
  • vocal cord paresis/paralysis at discharge(1 year)
  • time to anastomotic stricture(2 years)
  • Postoperative length of stay(1 year)
  • mortality(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

zebing Zheng

prof.

Zunyi Medical College

研究点 (1)

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