ACTRN12619001094167撤回未知
Multicentre Pre-operative Prehabilitation to Reduce Surgical Complications in Patients undergoing Major Upper GI Resections.
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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