The PREHAAAB Trial: Multimodal Prehabilitation for Patients Awaiting Open Abdominal Aortic Aneurysm Repair - An International Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 152
- 试验地点
- 2
- 主要终点
- Postoperative complications measured by the Comprehensive Complication Index (CCI)
研究概览
简要总结
An abdominal aortic aneurysm is a condition where the major artery in the abdomen becomes larger than usual. Over time, as it continues to grow, the wall of the artery weakens and there is a risk that the artery can burst causing internal bleeding and death. Aortic aneurysms are fixed when they reach a certain size to prevent that outcome. The surgery to fix them is a major, high-risk surgery that is associated with a lot of complications and a slow recovery back to normal. The time between diagnosis and surgery is called the pre-operative period and is a key time to optimize a patient's health in order to ensure the best possible outcomes following surgery. This study will look at whether a multidisciplinary pre-operative program that involves exercise training, nutritional advice and supplementation, and psychosocial support will reduce complications following surgery. This program should decrease complications and speed up a patient's recovery back to normal after surgery. It is also a way for patients to take ownership of their disease and play an active role in their health care journey. The benefits from this program will go beyond the pre-operative time frame, as the habits and knowledge gained will improve their health over their lifetime. This study will also assess the economic impact and cost of a program like this.
详细描述
Abdominal aortic aneurysms (AAA) are asymptomatic until they rupture, which carries an 80- 90% mortality. Therefore, AAA are surgically repaired when they reach 5.0 cm in women and 5.5cm in men. Despite advances to surgical technique and peri-operative care, open surgical repair still carries a high incidence of post-operative complications of 30-40%, and a long recovery period. This is largely because the surgery itself is major abdominal surgery, and these patients often have significant comorbidities and low functional status. Multimodal prehabilitation (MP) is a concept that uses the preoperative timeframe (between diagnosis and surgery) to optimize physical, nutritional, and emotional wellbeing to improve a patient's functional status and ability to withstand the stress of surgery. To date, there is no study evaluating the effect of MP on post-operative complications following open AAA repair.
The primary objective of this trial is to determine if MP will decrease complications as measured by the comprehensive complication index following open AAA repair compared to standard of care. This trial will also assess the effect of MP on functional capacity, hospital length of stay, 30-day mortality and health related quality of life, as well as to assess cost effectiveness, adherence, and fidelity to the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants older than 50 years of age awaiting elective open AAA repair with AAA diameter ≤6.9cm. Participants should have the ability to give informed consent.
排除标准
- •Participants undergoing thoracic, thoracoabdominal and/or perivisceral AAA repair.
- •Participants with ruptured or symptomatic AAA.
- •Participants with AAA maximal diameter ≥7cm.
- •Physical inability to exercise: severe osteoarthritis, musculoskeletal or neurological impairment that precludes exercise.
- •Contraindication to exercise: rest systolic blood pressure ≥ 180 mmHg and/or diastolic ≥ 100 mmHg, uncontrolled atrial or ventricular arrythmias or proven exercise induced arrhythmias, unstable angina, unstable or acute heart failure, severe symptomatic valvular stenosis, dynamic left ventricular outflow tract obstruction or other comorbidities that imply clinical instability.
- •Cognitive impairment that would impede understanding of study procedures, informed consent or study questionnaires or the inability to effectively communicate in English/French/Spanish/Catalan.
结局指标
主要结局
Postoperative complications measured by the Comprehensive Complication Index (CCI)
时间窗: CCI will be measured from admission to 6 weeks postoperatively
The CCI was developed to address some of the limitations of traditional surgical morbidity reporting, such as only reporting the most severe complication or only picking the most common types of complications. It is scored on a true linear interval scale from 0-100 and incorporates the totality of all complications and their severity experienced by a patient
次要结局
- Reinterventions(from surgery day to 6 week postoperatively)
- 6-Minute Walk Test(Measured at baseline, preoperatively and 6 weeks postoperatively)
- Anxiety(Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively)
- Hospital length of stay(From admission to 6 weeks postoperatively)
- Readmission(at 6 weeks and at 1 year postoperatively)
- VE/VCO2(Measured at baseline and preoperatively)
- SF36(Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively)
- Patient Generated Subjective Global Assessment (PG-SGA)(Measured at baseline, preoperatively)
- Height(Measured at baseline and preoperatively)
- Weight(Measured at baseline and preoperatively)
- Body Fat percentage(Measured at baseline and preoperatively)
- Muscle Mass(Measured at baseline and preoperatively)
- ICU Length of stay(From admission to 6 weeks postoperatively)
- VO2 peak(Measured at baseline and preoperatively)
- Yale physical activity survey (YPAS)(Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively)
- Compliance to intervention(Measured from baseline to preoperatively)
- Fidelity to exercise intervention(Measured from baseline to preoperatively)
- Body Mass Index (BMI)(Measured at baseline and preoperatively)
- Satisfaction and acceptability(Preoperative assessment)
- Quality adjusted life years(Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively)
- Emergency Room visits(at 6 weeks and at 1 year postoperatively)
- VO2 AT(Measured at baseline and preoperatively)
- Incidents of adverse events (prehabilitation safety and tolerability)(Measured from Baseline to Preoperatively)
- Depression(Measured at baseline, preoperatively, 6 weeks and 1 year postoperatively)
- Fat Free Mass (FFM)(Measured at baseline and preoperatively)
- Phase angle(Measured at baseline and preoperatively)
- Prehabilitation cost-effectiveness(Measured at 1 year postoperatively)
研究者
Heather Gill
Principal Investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre