Effects of Pre-operative Prehabilitation on the Clinical Outcomes of Gastric Cancer Patients With Metabolic Syndrome Who Undergo Laparoscopic Radical Gastrectomies: A Polit Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- The proportion of postoperative complications
研究概览
简要总结
A prospective randomised controlled trial to investigate the effects of a pre-operative prehabilitation protocol on clinical outcomes of gastric cancer patients with metabolic syndrome who undergo laparoscopic radical gastrectomies and to determine the underlying mechanisms.
详细描述
To investigate the effects of a pre-operative prehabilitation protocol on clinical outcomes of gastric cancer patients with metabolic syndrome who undergo laparoscopic radical gastrectomies and to determine the underlying mechanisms.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically-proven pre-operative stage I-III gastric cancer
- •Combined with metabolic syndrome
- •Age limits from 18 to 80 years old
- •Classified into American Society of Anesthesiology (ASA) II or III surgical risk
- •no history of abdominal surgery on organs located at the abdominal supramesocolic level
排除标准
- •Combined with severe cardiac or pulmonary disease or other organ dysfunction
- •The history of abdominal surgery
- •Conversion to open surgery
- •The presence of gastrointestinal obstruction, perforation or necrosis;
- •Declined to participate in this study
研究组 & 干预措施
pre-operative prehabilitation
Patients in the pre-operative prehabilitation group required the exercise intervention protocol, which included climbing six flights of stairs at least 6 times as a daily routine and adaptive simulated training of restrictive ventilation dysfunction following abdominal surgery by using a full elastic breathable abdominal bandage.
干预措施: pre-operative prehabilitation (Behavioral)
Comparator
Patients in the control group did not need to undergo this pre-rehabilitation protocol and prepared conventionally.
结局指标
主要结局
The proportion of postoperative complications
时间窗: up to six months
次要结局
未报告次要终点
研究者
Yanbing Zhou
Professor
Qingdao University