Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.
试验速览
- 阶段
- 不适用
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Efficacy of a multimodal prehabilitation
研究概览
简要总结
Several studies in major abdominal surgery demonstrated that preoperative optimization of surgical patients through prehabilitation is associated with fewer postoperative complications. However, patients' response to preoperative optimization is unpredictable, and there are no studies confirming the real benefit in pancreatic surgery.
Aims: To assess the benefits of pre-rehabilitation in pancreatic surgery, and identify those factors associated with an effective optimization. Secondary aims: impact of prehabilitation on nutritional status, sarcopenia, quality of life, inflammation markers, postoperative complications and hospital stay compared to low-risk patients.
Design: An objective multimodal assessment will be performed on those patients who are candidates to pancreaticoduodenectomy (PD) to identify patients at high-risk of postoperative complications. These patients will undergo prehabilitation and response will be evaluated. Intervention:Multimodal Prehabilitation will include:
- Physical and cardiopulmonary training followed by a personalized program according to basal aerobic capacity, patient circumstances and compliance, community-based and remote-controlled with information and communication technology (ICT).
- Personalized nutrition program adapted to the underlying disease (exocrine insufficiency, cachexia and sarcopenia, diabetes).
- Treatment of anxiety and depression.
Subjects: 56 consecutive patients who are high-risk candidates (anaerobic threshold 11ml/kg/min at CPET) for PD recruited at Hospital Clinic of Barcelona. Postoperative variables will be compared to low-risk patients evaluated during the same study period.
Analysis:
The main variable will be aerobic capacity (VO2max, AT). Secondary variables (before and after the program) will be nutritional status, sarcopenia, quality of life, inflammation markers and immune response, hospital stay, complications, 90-days mortality and costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients eligible for pancreatic surgery (PD) who are considered high risk based on the findings of the CPET (anaerobic threshold, AU <11ml/kg/min) (Older P et al. Crit Care. 2004;8:369-72) and accepted as candidates for said surgery by the multidisciplinary committee of our Institution.
排除标准
- •Non-elective surgery;
- •Palliative surgery;
- •Unstable respiratory or cardiac disease;
- •Locomotor or cognitive limitations that prevent adherence to the program;
- •Refusal to participate in the study.
结局指标
主要结局
Efficacy of a multimodal prehabilitation
时间窗: 4 weeks
To evaluate the efficacy of a multimodal prehabilitation program in high risk surgical patients undergoing oncological resection of the pancreas in terms of improvement in aerobic capacity (peak oxygen consumption, anaerobic threshold) measured through a CPET.
次要结局
- Evaluation of the adherence to the program(30 days)
- Evaluation of sarcopenia after prehabilitation(4 weeks)
- Evaluation of the impact on the incidence of postoperative complications(30 days)
- Evaluation of the impact on perceived quality of life(4 weeks)
- Evaluation of the impact on the inflammatory response after the intervention(30 days)
- Evaluation of complications severity(30 days)