Effect of multimodal home based prehabilitation programme on overall complications in patient undergoes surgery for esophagogastric cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall complications as per Clavien Dindo classification
研究概览
简要总结
Patients scheduled for esophago-gastric cancer surgery at Medanta Hospital will be enrolled in a multimodal prehabilitation program after randomization. This program will commence at least 2 weeks prior to the surgery and will encompass various components including structured physical exercise, nutritional support, psychological counselling, and cessation of smoking and alcohol intake.
Patients will be provided with booklets to record daily self-assessments, and weekly assessments will be conducted by medical professionals. Adherence to the prehabilitation protocol for a minimum of two weeks will be mandatory. The leaflets will be collected from patients upon admission before surgery.
The analysis will include profiling of patients on different demographic, clinical and laboratory parameters. Descriptive analysis of quantitative parameters will be expressed as means and standard deviation. Categorical data will be expressed as absolute number and percentage. Independent Student t – test will be used for testing of mean between independent groups. Cross tables will be generated and Chi square test will be used for testing of associations. P-value < 0.05 will be considered statistically significant.
Patients will be followed up until discharge and up to 30 days following surgery. In case of readmission for the surgical complications within 30 days and surgical complications related mortality, the necessary data will be collected.
Clearer evidence that will most likely emerge from the analysis of the data will serve as useful reference for upper GI surgeons in India and around the world about effect of prehabilitation on postoperative complication in patients undergoing surgery for esophagogastric cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All esophago-gastric cancer patient undergoing curative surgical resection –esophageal carcinoma, gastroesophageal junction carcinoma, and gastric carcinoma
- •Age ≥18 year
- •Willing to participate in the study
- •American Society of Anaesthesiologists physical status classes (ASA) score of ≤ 3.
排除标准
- •Patients not giving informed consent
- •Patients found to have unresectable disease (locally advanced/ metastatic)
- •Inability to perform prescribed exercises
- •American Society of Anaesthesiologists physical status classes 4 and 5,.
结局指标
主要结局
Overall complications as per Clavien Dindo classification
时间窗: 30 days after surgery
次要结局
- Incidence of postoperative pneumonia(30 days)
- Hours of postoperative mechanical ventilation(30 days)
- Postoperative hours of ICU stay(30 days)
- Postoperative days of hospital stay(30 days)
研究者
Dr Sachin Jivani
Medanta- The Medicity