跳至主要内容
临床试验/NCT05738902
NCT05738902招募中不适用

Adherence and Compliance to ERAS in Gynecological Surgery as Predictor of Postoperative Complications

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2023年5月30日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Federico Ferrari

Consultant and Assistant Professor at Spedali Civili of Brescia and University of Brescia

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

研究点 (1)

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