ERAS (Enhanced Recovery After Surgery) Protocol Implementation in Piedmont Region for Hysterectomy of Benign or Malignant Tumors of the Uterus. A Stepped-wedge Cluster Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- Length of stay
研究概览
简要总结
The study assesses the impact on quality of care of implementing the ERAS (Enhanced Recovery After Surgery) protocol for hysterectomy of benign or malignant tumors of the uterus in the network of public hospitals in the Regione Piemonte (North-West Italy). Every hospital is a cluster entering the study treating patients according to its current clinical practice. On the basis of a randomized order, each hospital switches from current clinical practice to the adoption of the ERAS protocol.
详细描述
ERAS (Enhanced Recovery After Surgery) protocol is a multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. Even if efficacy and safety of ERAS protocol in gynaecological surgery is well-established in the literature, its implementation is limited to few selected centres in Piemonte. The aim of the study is to extend the implementation of the ERAS protocol to whole regional network of hospitals. Specific objectives are to estimate its impact on different dimensions of quality of care, including length of stay, complications and patient satisfaction, and to identify possible barriers or facilitating factors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All the hospital wards within the Piemonte Region performing hysterectomy.
- •All the patients receiving an elective hysterectomy for benign or malignant tumors of the uterus.
排除标准
- •Hospital wards performing less than 20 expected cases per year
- •Emergency hysterectomy
- •Hysterectomy for pelvic floor disorders
- •High severity cases not allowing ERAS protocol implementation (i.e. American Society of Anesthesiologists score: ASA V).
结局指标
主要结局
Length of stay
时间窗: 12 days after admission
Mean length of stay calculated as difference between date of discharge and date of admission of the hospitalization for surgery, excluding length of stay \>12 days (98th percentile of the expected distribution).
次要结局
- Length of stay >12 days(30 days after admission)
- Recovery after surgery(24 hours after surgery)
- Complications(30 days after discharge)
- Emergency visits after discharge(30 days after discharge)
- Transfer to intensive care unit(30 days after surgery)
- Hospital admissions after discharge(30 days after discharge)
- Reintervention(30 days after surgery)
- Healthcare costs(30 days after discharge)
- Patients' satisfaction(15 days after discharge)
研究者
Dr. Andrea Puppo
Gynecologists
Ospedale Regina Montis Regalis