Supervised Home-based Multimodal Prehabilitation to Improve the Clinical Outcomes of Frail Elderly Patients With Gastric Cancer: Multicenter Randomized Controlled Trial (GISSG+2201)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- The incidence and severity of postoperative complications
研究概览
简要总结
The GISSG+2201 study was launched by Shandong Gastrointestinal Surgery Study Group (GISSG). The intention is to establish a multimodal prehabilitation protocol in frail elderly patients who undergo gastric cancer radical surgery, explore the feasibility and effectiveness of the measures and evaluate the effect of program on short-term clinical outcome, recovery index and the long-term tumor-related outcome.
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 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 65-85 years;
- •Karnofsky performance score ≥70 or Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
- •G8 score ≤14;
- •Endoscopic biopsies were pathologically confirmed as gastric adenocarcinoma;
- •Patients with cT1-4aN0-3M0 by endoscopy, imaging evaluations of CT and MRI, and possibility of gastric resection;
- •Received general anesthesia or combined spinal-epidural anesthesia (Surgery was performed by either laparotomy, laparoscopy or robotic-assisted laparoscopic);
- •Date of surgery ≥2 weeks from baseline (T0) assessment;
- •Physical conditions could meet the requirements of exercise training, and no severe concomitant disease;
- •All subjects had to be willing and able to comply with study protocol and were informed adequately that they maintained the right to drop out of the study at any time.
排除标准
- •Patients with uncontrolled seizure disorders, central nervous system diseases and mental disorders;
- •End-stage cardiac insufficiency (LVEF<30% or NYHA class IV), liver cirrhosis (Child-Pugh classification C), End-stage renal failure (receives chronic dialysis), or ASA grade IV;
- •Cerebral bleeding or infarction (within 6 months);
- •Patients with recurrent infection diseases or serious concomitant disease;
- •Patients who require synchronous surgery due to other illness;
- •Patients who required emergency surgery within an emergency setting (obstruction, bleeding, perforation);
- •Patients who are participating in any other clinical trials.
结局指标
主要结局
The incidence and severity of postoperative complications
时间窗: Postoperative (≤30 days after surgery)
Major postoperative complications of patients with Gastrointestinal malignancy included gastrointestinal complication, surgical site complication, respiratory complication, cardiovascular complication, thromboembolic complication, urinary complication and other complications. The severity of complications was recorded and classified according to Clavien-Dindo classification score.
次要结局
- Oncological outcomes(3 years)
- Cardio-pulmonary function and physical capacity(Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）)
- Quality of life (QoL).(Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）)
- Detection of immune and inflammatory indicators(Baseline (T0), Post-intervention (up to 2 weeks), and POD 30（30 days after surgery）)
- The postoperative other observation parameters(Postoperative (≤30 days after surgery))