Multimodal Prehabilitation for Patients With Resectable Gastric Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Duke Activity Status Index before surgery
研究概览
简要总结
Surgical resection is the mainstay for gastric cancer. Surgical stress response, like insulin resistance and catabolism, is inevitable and is a risk factor for postoperative outcome. To cope with this stress, the enhanced recovery protocol has been proposed and successfully implemented in clinical practice. Recently, prehabilitation have attracted increasingly attention, which is the preoperative part of enhanced recovery pathway. Prehabtilitation are bundles of evidenced elements in order to improve patient's functional capacity. Patients with gastric cancer are usually suffered from nutritional risk, anxiety and frailty. In this trial, we investigate whether multimodal prehabilitation (exercise, nutrition and psychological support) could improve patient's functional status to better tolerate surgical trauma.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed gastric cancer, clinical I-III TNM stage (AJCC 8th edition);
- •Will receive curative-intent surgery;
- •Life expectance > 6 months;
排除标准
- •Gastric stump cancer or combined with other malignances;
- •NYHA III, NYHA IV;
- •Inability to swallow, with gastrostomy, or inability to move because of orthopedic disease or neuromuscular disease;
- •Psychiatric disorders, COPD, end-stage hepatic or renal disease, uncontrolled cardiac arhythmia or uncontrolled hypertention;
- •Receiving immunosuppressive therapy;
- •Emergency surgery because of tumor bleeding or tumor perforation;
结局指标
主要结局
Duke Activity Status Index before surgery
时间窗: Duke Activity Status Index score on the day before surgery
Duke Activity Status Index score is a 12-item self-reported questionnaire that assesses daily activities such as personal care, ambulation, household tasks, and recreation with respective metabolic costs. Duke Activity Status Index score ranges from 0 to 58.2. The higher score indicates the better functional status. Duke Activity Status Index has been recommended by European Society of Cardiology guidelines for functional assessment of patients undergoing non-cardiac surgery.
次要结局
- Postoperative hospital stay(During the postoperative 30 day period)
- 30-day readmission rate(During the postoperative 30 day period)
- Morbidity(In postoperative 30 day after gastrectomy)
研究者
Kecheng Zhang
Principal Investigator
Chinese PLA General Hospital