Improving Outcomes in Patients With Hepatobiliary Cancers With a Nutritional and Physical Conditioning Pre-habilitation Program
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Change in six minute walk test
研究概览
简要总结
- To determine whether a combined nutritional support program and exercise-based prehabilitation is superior to nutritional support alone in increasing functional recovery and reducing post-operative morbidity after surgery for HPB malignancy.
- To understand which measures of immediate surgical recovery are sensitive to prehabilitation interventions and predict change in later outcome measures.
详细描述
Patients scheduled for elective liver resection be will be approached andrandomized to one of two groups using a computer generated block randomisation scheme. The first group (pre-hab) will receive both nutritional supplementation and a prehabilitation program as outlined below. The second group (nutrition) will receive only nutritional supplementation. Both groups will be given a post-operative exercise program.
Once randomized, the subjects will be called by the research co-ordinator and an appointment will be made for the initial assessment. After the study is explained and consent obtained, subjects will be tested on 6MWT, followed by a 30 minute rest period during which various questionnaires assessing physical activity, quality of life, fatigue and nutritional status will be completed with the aid of the coordinator.
The prehabilitation program will last a minimum of four weeks and a maximum of 8 weeks.
Surgery will be performed by one of the HPB surgeons at the McGill University Health Center. Surgical approach, including laparoscopic or open surgery will be at the discretion of the surgeon. Perioperative care will follow an Enhanced Recovery After Surgery (ERAS)-based clinical care pathway27, 28, a fast-track care plan including patient education, afferent neural blockade, multimodal analgesia, early oral intake and mobilization, early removal of catheters and drains, and a planned 6-8 day hospital admission. This pathway has already been implemented at the Royal Victoria Hospital as part of standard patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects eligible to enter the prehabilitation program will include those aged 18 and above and referred electively for resection of malignancies.
排除标准
- •Excluded will be persons with American Society of Anesthesiologists (ASA) health status class 4-5 or co-morbid medical, physical and mental conditions (e.g. dementia, disabling orthopedic and neuromuscular disease, psychosis), cardiac abnormalities, severe end-organ disease such as cardiac failure, COPD, and hepatic failure (ALT and AST >50% over the normal range), and sepsis), morbid obesity (BMI >40), anemia (hematocrit < 30 %) and other conditions interfering with the ability to perform exercise at home or to complete the testing procedures.
- •Patients will be excluded if they have poor English or French comprehension.
结局指标
主要结局
Change in six minute walk test
时间窗: 8 weeks pre-op and 1 week pre-op
The primary outcome is patient-relevant, functional walking capacity as measured by the six-minute walk test (6MWT). The 6MWT evaluates the ability of an individual to maintain a moderate level of physical activity over a time period reflective of the activities of daily living
次要结局
- post-operative complications(30 days)
- Health-related quality of life (HRQL)(8 and 1 week pre-operatively, 4 and 8 weeks post-operatively)
- Physical activity level(8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively)
- Depression and anxiety(8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively)
- Fatigue(8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively)
- Nutritional status(8 and 1 weeks pre-operatively, 4 and 8 weeks post-operatively)
研究者
Prosanto Chaudhury
HPB and Transplant Surgeon
McGill University Health Centre/Research Institute of the McGill University Health Centre