Has High Compliance With Enhanced Recovery After Surgery (ERAS) Protocol Improved 5-Year Survival? - A Cohort Study of 468 Non-Metastatic Colorectal Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- Post operative 5 year survival rate
研究概览
简要总结
The Enhanced Recovery after Surgery (ERAS) protocol has transformed perioperative care, representing a significant paradigm shift in managing colorectal cancer patients. While the immediate benefits of Enhanced Recovery After Surgery (ERAS) in expediting postoperative recovery are well-documented and widely acknowledged, it is essential to investigate its long-term implications, particularly its influence on survival rates. The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection.
详细描述
The aim of this study will be to analyse the impact of compliance with the ERAS protocol on long- term outcomes after laparoscopic colorectal resection.
The study will be designed as a prospective observational study to compare the long-term effects of surgical treatment of colorectal cancer in two groups of patients: those with high compliance with the ERAS protocol (≥80%) and those with low compliance with the ERAS protocol (<80%).
The primary outcome of the study will be the 5-year survival rate. The inclusion criteria for Group 1 will involve 128 patients with ERAS compliance below 80%. Conversely, Group 2 will consist of 340 patients, all of whom achieved a compliance rate of at least 80%.
The correlation between compliance with the ERAS protocol and 5-year survival will be assessed using the Kaplan-Meier method with log-rank tests. Additionally, survival analysis will be conducted separately for groups with varying cancer stages.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •patients undergoing treatment for colorectal cancer
排除标准
- •primary open or emergency surgery,
- •transanal endoscopic microsurgery (TEM),
- •stage IV of the disease according to the American Joint Committee on Cancer (AJCC) classification,
- •multivisceral resection,
- •concomitant inflammatory bowel diseases,
- •intensive care unit stay immediately after surgery
- •lost-to-follow-up patients.
结局指标
主要结局
Post operative 5 year survival rate
时间窗: 5 years
次要结局
未报告次要终点
研究者
Mateusz Rubinkiewicz
MD PhD
Jagiellonian University