Multimodal Prehabilitation for Major Surgery in Elderly Patients to Lower Complications and to Increase Cost Effectiveness: a Randomised, Prospective, Multicenter, Multidisciplinary Trial (PREHABIL Trial).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 466
- 试验地点
- 1
- 主要终点
- Comprehensive Complication Index (CCI)
研究概览
简要总结
This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, frail patients.
详细描述
Postoperative complications occur in up to 50% of patients and major surgery is associated with a 20 to 40% reduction in physiological and functional capacity. The elderly have surgery 4 times more often than the rest of the population, thus in the future a major proportion of patients presenting for surgery will be older than 65 years. Elderly patients have more postoperative complications, a longer convalescence and higher surgical morbidity and mortality. The number and severity of complications are closely related to preoperative functional capacity, nutritional state, psychological state, and smoking behavior. Another population most probably to benefit from such a program are cancer patients with decreased functional health after cancer treatment. Cancer prehabilitation affords an opportunity for the patient to improve functional status while waiting to begin treatment. This is a patient group expected to grow in the future.
This is a multicenter, multidisciplinary, 2 arms (standard, n=233 vs intervention i.e. prehabilitation, n=233), randomised controlled trial (RCT).
The prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation.
This multicentric, randomised controlled trial is to the investigators knowledge the first implementation of a multimodal, multidisciplinary prehabilitation approach using knowledge from different specialties to lower complications and to increase cost effectiveness after major surgery in elderly, morbid patients.
The primary outcome is measured by the comprehensive complication index (CCI). Secondary outcomes are physical parameters measured by cardio-pulmonary exercise testing (CPET), grip strengh, Nutritional Risk Score (NRS). Further outcomes are amongst others smoking behavior, haemoglobin concentration, days at home at 30 days (DAH30) and quality of recovery 15 (QoR15).
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •comorbid (≥ASA 3)
- •pre-existing fitness deficit: AT<11ml/kg/min respectively VO2peak<14ml/kg/min if AT unavailable or VE/VCO2 slope > 33
- •scheduled for major urologic, thoracic, visceral, orthopaedic or cardiovascular surgery
- •screening at least 2 weeks prior to surgery
排除标准
- •Paralysis or patients with mobility problems (who are unable to exercise),
- •Premorbid conditions or orthopaedic impairments that contraindicate exercise,
- •Cognitive disabilities,
- •Chronic renal failure (need for dialysis)
- •Emergency procedures.
研究组 & 干预措施
Control
Perioperative care of the control group will be based on standardized, multi-element, ERAS recommendations as already implemented in the different participating clinics.
Intervention
Patients that meet the inclusion criteria will be randomised and scheduled for surgery at least 2 weeks after the diagnosis/decision to proceed to surgery. This timeframe allows the implementation of a minimal 2 weeks (up to 4 weeks) multidisciplinary prehabilitation program. Prehabilitation program is composed of 4 elements: exercise training, nutritional intervention, correction of anaemia and smoking cessation. An individual treatment strategy will be proposed to the patient by a multidisciplinary team consisting of surgeon, anesthesiologist, dietitian and physiotherapist.
干预措施: Multimodal Prehabilitation (Procedure)
结局指标
主要结局
Comprehensive Complication Index (CCI)
时间窗: 30 days after surgery
The comprehensive complication index (value from 0 = no complication to 100 = death) is a valuable, validated index for the assessment of multiple postoperative complications. It has been developed based on Swiss hospital data and has been validated internationally.
次要结局
- Cardiovascular & Pulmonary(Before and after 2-4 weeks of prehabilitation, at 30 days)
- Nutrition & Bioimpendance(At the beginning of study, before and after surgery, at 30 days.)
- Anaemia(30 days after surgery)
- Smoking(At the beginning of study, before and after surgery, at 30 days.)
- Questionnaires for recovery, anxiety and cardiac risk(At the beginning of study, before and after surgery, at 30 days.)
研究者
Dominique Engel
Dr.med.
Insel Gruppe AG, University Hospital Bern