Patient Empowerment for Major Surgery Preparation @ Home: Multimodal Prehabilitation in Major Elective Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Rate of postoperative complications at Day-30
研究概览
简要总结
Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program (based on physical activity, nutritional support and mental preparation) for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery
详细描述
Prehabilitation programs essentially based on physical activity improvement may reduce postoperative complications after major surgery. We hypothesize that a multimodal program based on physical activity, nutritional support and mental preparation may not only improve postoperative recovery and reduce costs but also improve health status beyond postoperative period.
Non-randomized monocentric open cohort study vs historical comparative group testing the efficacy of a multimodal prehabilitation program for unfit patients based on nutrition, physical activity and mental preparation in reducing postoperative complications in elective major surgery.
Other outcomes will be measured : length of hospital stay, hospital readmissions, direct costs, health status at 1 and 6 months.
Moreover, the feasibility and adherence of Paprika program will be evaluated. Inter-data centres relating to the implementation of the same prehabilitation program will be compared with the consortium Paprika (Hospital Clinic of Barcelona, University of Cologne, University of Gdansk)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Paprika program will be proposed to all eligible patients.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient eligible to elective major surgery (digestive, orthopedic, vascular-thoracic, urologic)
- •Age > 70 years and/or American Society of Anesthesiologists (ASA) score 3-4
- •or Unfit patient according to appropriate scores (Two among 3 scores (HAD, Physical activity score, nutritional score) below threshold). Unfit patients will be defined by at least 2 criteria if 'YES' answers: Physical activity: Less than 50% of WHO recommendations = less than 5000 steps/day or less than 75 min moderate activity/week or less than 12 min moderate activity/day Yes/No Malnutrition: BMI < 20 kg/m2 if < 70 years (or <22 if >70y) = undernutrition Yes/No or BMI>25 kg/m2 (= overweight to obesity) or Loss of appetite? Mental evaluation HAD (Hospital Anxiety and Depression) >8 for A or D score Yes/No
- •Diagnosis:
- •Elective major surgery (digestive, orthopedic, vascular-thoracic, urologic)
- •Regulatory aspects: Be legally able to give consent Patient affiliated to social security
排除标准
- •Planned surgery (less than 4 weeks at inclusion)
- •Urgent surgery
- •Patient with, at baseline, good to excellent physical, nutritional, mental status as defined by appropriate scores.
- •Patient considered not eligible to this program for physical or psychological reasons by the surgeon or the anesthetist
- •Persons referred in Articles L1121-5 to L1121-8 of the French code of public health (this corresponds to all persons protected: pregnant or parturient women, breastfeeding mothers, persons deprived of liberty by judicial or administrative decision, persons subject to a legal protection measure).
研究组 & 干预措施
Paprika group
Patients coming for elective major surgery will participate to Paprika program
干预措施: multimodal prehabilitation (Other)
Historical group
Patients previously operated with same characteristics
结局指标
主要结局
Rate of postoperative complications at Day-30
时间窗: at Day-30 post surgery
Rate of postoperative complications at Day-30 classified following the standards of the European Society of Anaesthesiology and European Society of intensive Care Medicine.
次要结局
- Physical activity health status(a baseline, presurgery and 6 months post surgery)
- Nutritional health status(at baseline, 1 month and 6 months)
- Psychological health status(at baseline, 1 month and 6 months)
- Direct cost(interventional group: 1 month-cost before surgery+1 month-post surgery / Control group: 1 month-cost post-surgery)
- Hospital readmission(within 30 days post surgery)
- Number of patient participation to program in relation to the number of eligible patients(During Paprika inclusion period)
- Ratio patient participation to each session(During Paprika 1 month-sessions)
- Comparison with other centers(through study completion, an average of 1 year)
- Number and severity of postoperative complications(within 30 days post surgery)
- Length of stay (ICU and Hospital)(within 30 days post surgery)