Effect of Prehabilitation on the Lean Mass Index (IMM) in Patients Operated on for Colon Cancer in ERAS Programm.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 130
- 主要终点
- Effect of prehabilitation on the change from lean mass index
研究概览
简要总结
The implementation of prehabilitation in patients operated on for colon cancer in a multimodal rehabilitation regimen improves the values of the "lean body mass" or lean mass index, positively influencing the results of clinical, analytical and radiological nutritional values pre- and postoperatively and in morbi-mortality, recovery, average stay and re-entry rates.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It is considered that the subject suffers a confirmed diagnosis of colon cancer and is going to undergo surgery on a scheduled basis under a RHMM program.
- •The subject is ≥ 18 years of age.
- •The subject can perform any of the two proposed treatments.
- •Preoperative staging TxNxM
- •The patient has voluntarily signed and dated an informed consent document (IC), approved by an independent Ethics Committee (CEIC) before participating in the study.
排除标准
- •Patients with rectal cancer.
- •The study doctor determines that the subject is not eligible to participate.
- •The subject can not give informed consent to participate in the study.
- •The subject can not perform the pre-habilitation.
- •Non-acceptance or impossibility of following rehabilitation protocol multimodal
- •The subject was previously scheduled at the time of the inclusion of the nutritional supplement study, whether it is different or the same that would be scheduled at this time
- •Subjects who have received previous radiochemotherapy, HIV, gestational stage, psychiatric, with CRF who are undergoing renal replacement techniques, urgent surgery, with intestinal obstructions, with uncontrolled infections, urgent surgery, distant metastasis, ASA IV, advanced liver failure, severe coagulation disorder, severe hyperlipidemia and hyperglycemia or difficult to control.
- •Subject has renal or hepatic impairment (GFR <60ml / m or AST / ALT 3 x upper limit of normal).
研究组 & 干预措施
Prehabilitation
exercise, nutrition and anxiety reduction in the preoperative period
干预措施: Prehabilitation (Other)
No Prehabilitation
Not: exercise, nutrition and anxiety reduction in the preoperative period
结局指标
主要结局
Effect of prehabilitation on the change from lean mass index
时间窗: preoperative and 1-month postoperative
Effect of prehabilitation on the lean mass index
次要结局
未报告次要终点
研究者
Antonio Arroyo Sebastian
Prof
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana