POWER AUDIT, Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol After Gastric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 350
- 试验地点
- 22
- 主要终点
- Disease-free surviva
研究概览
简要总结
The main objective of this study is to analyze the impact on three years survival of an enhanced recovery program (PRI) after radical surgert for adenocarcinoma gastric cancer. As secondaries objectives, we propose to analyze comparing survival distributions between patient groups (ERAS/no ERAS) and the relationship between the ERAS program and early incorporation into oncology therapies (RIOT).
It is proposed to review the medical records of oncology patients included in POWER 4 (as already foreseen in that study), with the aim of performing a 3-year follow-up.
To create comparable treatment and control groups, the Propensity Index method will be used. To study each variable, multivariate regression will be used. Kaplan-Meier will be used for survival and the log-rank test for comparisons. Significance will be considered if p <0.05 (two tails).
详细描述
Study Data three-year data will be collected from all eligible patients who have undergone elective colorectal surgery within the POWER4 protocol.
Only routine clinical data will be included and, when not available, the field will be left blank, e.g., patients lost to follow-up. Regional groups may supplement their basic data set with a very limited number of additional variables.
Data collection The data will be collected from CRFs collected in POWER4. The list of pseudo-anomized patients delivered at the time will be provided with the new variables to be completed by the centers.
Variables Overall mortality: The number and percentage of deaths occurred since the intervention until the end of the follow-up period.
Overall survival: patients alive from surgery to the last control. Disease-free survival: number of patients alive and without cancer recurrence from the intervention period until the end of follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •All patients over 18 years of age who underwent elective gastric cancer surgery in POWER4
排除标准
- •Non oncological surgery, refusal of the centers to participate.
结局指标
主要结局
Disease-free surviva
时间窗: 3 years
Number of patients alive and without cancer recurrence from the intervention period until the end of follow-up
Overall Survival
时间窗: 3 years
Patients alive from surgery to the last control
Time to disease recurrence
时间窗: 3 years
Detected from the day of the intervention until the end of follow-up
Time to return to intended oncologic treatment (RIOT)
时间窗: 3 years
Date between discharged and adjuvant treatment
次要结局
未报告次要终点