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临床试验/NCT03216694
NCT03216694已完成不适用

The Association Between Preoperative Cardiopulmonary Exercise Test Variables and Short-term Postoperative Morbidity Following Oesophagectomy: a Hospital-based Cohort Study

University of East Anglia1 个研究点 分布在 1 个国家目标入组 254 人开始时间: 2017年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
254
试验地点
1
主要终点
All cause postoperative morbidity

研究概览

简要总结

A retrospective hospital-based cohort study of the association between preoperative cardiopulmonary exercise test (CPEX) variables and short-term postoperative morbidity following oesophagectomy.

详细描述

The aim of this study is to examine the correlations between preoperative CPEX variables (VO2max and Anaerobic Threshold) and 30 day postoperative all cause morbidity in a sample large enough to allow (should significant associations exist) calculation of a threshold value. Secondary aims are to examine associations between the VO2max, AT and cardiopulmonary, non-cardiopulmonary complications as well as specific complications (atrial fibrillation, pneumonia, and anastomotic leak) as well as 30 and 90 day mortality.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • i. male and female ii. underwent an oesophagectomy iii. completed a pre-operative CPEX test

排除标准

  • i. patients that were unable to complete a full CPEX test ii. emergency or palliative surgery iii. pharyngolaryngo-oesophagectomy iv. oesophagectomy and gastrectomy

结局指标

主要结局

All cause postoperative morbidity

时间窗: 30 days

Classified using Esophageal Complications Consensus Group (ECCG) definitions \[1\] and graded using Clavien-Dindo severity classification \[2\].

次要结局

  • Cardiopulmonary complications(30 days)
  • Non-cardiopulmonary complications(30 days)
  • Mortality(90 days)
  • Pneumonia(30 days)
  • Anastomotic leak(30 days)
  • Atrial fibrillation(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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