Adherence and Compliance to ERAS in Gynecological Surgery as Predictor of Postoperative Complications
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Early non-compliance to ERAS
研究概览
简要总结
The aim of the study is to investigate the association between early non-compliance to ERAS in postoperative day 2 (POD2) with the rate of postoperative complications.
详细描述
The aim of this prospective multicenter observational study is to investigate the association between the early non-compliance to ERAS in postoperative day 2 (POD2) with the rate of postoperative complications, in women undergoing open surgery for gynecological cancer.
Every POD is defined from 8.00 AM of the same day until 8.00 AM of the day after. Namely, POD0 is the day of surgery, while POD1 is the first day after surgery and so on.
According to the ERAS protocol the same day of surgery (POD0) the patients should be mobilized out of bed and allowed to take liquids by mouth at will. Removal of urinary catheter and starting of oral feeding is planned on POD1. Intravenous fluid infusion is stopped as early as possible according to oral feeding recovery at POD1.
POD2 is considered more adequated to measure the early ERAS compliance compared to POD1. In fact, according to previous published data in colonic surgery, a small delay in recovery within an ERAS pathway in POD1, can be the reflection of inadvertent intraoperative fluid overload, inadequate control pain and missing nausea and vomiting prophylasis. Moreover, late end time of surgery can further impair the full application of ERAS during POD1.
The compliance of the participants will be assessed in POD2 using the following 5 indicators derived from ERAS items.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Early non-compliance to ERAS
时间窗: Postoperative day 2 (POD2)
Association between the early non-compliance to ERAS with the rate of postoperative complications.
次要结局
- Early non-compliance to ERAS in tubo-ovarian cancer(Postoperative day 2 (POD2))
研究者
Federico Ferrari
Consultant and Assistant Professor at Spedali Civili of Brescia and University of Brescia
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
