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临床试验/NCT04504656
NCT04504656Unknown不适用

Comparison of Early Outcomes of Minimally Invasive Surgery for Oesophageal Replacement Versus Open Surgery in Children

Assiut University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Anastamotic leaks

研究概览

简要总结

a comparative prospective study of postoperative between minimally invasive and open surgery complications for esophageal replacement in children

详细描述

Esophageal replacement in childhood is indicated in esophageal atresia patients with long-gap defects or following complications of primary esophageal anastomosis, as well as in patients with trauma and scarring to the esophagus following caustic ingestion. It is widely accepted that the ideal esophageal replacement is one that resembles the function of the native esophagus with minimal deterioration over time. Several techniques of esophageal replacement have been developed. These have focused mainly on the use of native tissues (including the stomach, jejunum, and colon) as conduits (1), attempts to use a synthetic prosthesis have been largely unsuccessful. In an attempt to reduce the trauma and morbidity associated with laparotomy and thoracotomy incisions, minimally invasive techniques are increasingly used. (2-4). Meta-analyses of adult esophagectomy for the treatment of esophageal cancer support the use of minimally invasive surgery (5) however, equivalent comparative studies in the pediatric population are lacking. As such, it is unclear whether minimally esophageal replacement is as safe as the open procedure in children. The present study aims to address this question by comparing the postoperative outcomes of children who underwent minimally invasive versus open esophageal replacement procedures at single-center and multicenter levels.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • All children undergoing oesophageal replacement aged one to 18 years. Due to
  • long gap esophageal atresia
  • caustic ingestion
  • congenital esophageal stenosis or strictures

排除标准

  • patient who underwent previous esophageal replacement operations.

结局指标

主要结局

Anastamotic leaks

时间窗: 2 years

Incidence of anastamotic leak which is identified clinically in both groups

次要结局

  • Mortality(2 years)
  • Anastamotic stricture(2 years)

研究者

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

A maher

Assistant lecturer of surgery

Assiut University

研究点 (1)

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