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临床试验/ACTRN12619001094167
ACTRN12619001094167撤回未知

Multicentre Pre-operative Prehabilitation to Reduce Surgical Complications in Patients undergoing Major Upper GI Resections.

Hunter New England Local Health District0 个研究点目标入组 200 人开始时间: 2019年8月9日最近更新:

试验速览

阶段
未知
状态
撤回
入组人数
200

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Aged 18 years and over
  • - Written informed consent
  • - Operative procedure planned at least 4 weeks from randomisation date
  • Patient must be assessed as fit for surgery by the treating Surgeon based on past medical history and CPET testing.
  • - Patient must be undergoing a major upper gastrointestinal surgical procedure with neoadjuvant therapy including the following:
  • * Oesophagectomy
  • * Total/ Subtotal Gastrectomy
  • * Pancreaticoduodenectomy
  • * Major Liver Resection( >2 segments)

排除标准

  • Unresectable/ metastatic disease at any point within the study
  • - Progressive disease during neoadjuvant chemotherapy
  • - Known Class III/IV heart failure or moderate to severe pulmonary hypertension
  • - Poorly controlled cardiac arrhythmia/ excluded by an anaesthetist or a cardiologist
  • - Uncontrolled hypertension >180/100
  • - Claudication
  • - Vascular aneurysm
  • - Severe COPD with FEV1<50% predicted
  • - For safety reasons, the study cannot enrol people who don’t speak basic English as in a maximal intensity exercise program we cannot provide a safe environment without a trained, NSW Health registered translator for every exercise session.
  • - Clinical decision by treating Surgeon that operative procedure will be scheduled less than 4 weeks

研究者

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