NCT03347409已完成不适用
Validation of an ERAS Protocol in Gynecological Surgery: an Italian Randomized Controlled Trial
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia2 个研究点 分布在 1 个国家目标入组 166 人开始时间: 2017年6月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Shorter Length Of Hospitalization (LOH)
研究概览
简要总结
Validation of ERAS interventional measures in elective gynecological surgery, for benign either malignant pathology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >18 and <75 years old
- •Patients candidated for elective gynecological surgery for benign pathology
- •Patients with diagnosis of gynecological neoplasm and candidated for elective gynecological surgery
- •Signed consent form
- •Karnofsky Performance Status > 70
排除标准
- •ASA score > 3
- •Contraindication to loco-regional anaesthesia
- •Patients with ileus or subocclusive condition prior surgery
- •Coagulation disorders
- •Organ failure or severe disfunction (heart, renal, pulmonary, hepatic)
- •Uncontrolled hypertension (>180/95)
- •Alcohol or drug abuser (current or previous)
- •Unability to self-care (PFS < 70)
- •Comorbidity-Polypharmacy Score > 22
- •Psychiatric condition or language barriers
- •Planned Intensive Care Recovery
结局指标
主要结局
Shorter Length Of Hospitalization (LOH)
时间窗: Up to 4 weeks after surgery
Total amount of days spent in hospital
次要结局
- Time to flatus(Up to 4 weeks after surgery)
- Time to eating(Up to 4 weeks after surgery)
- Time to walking(Up to 4 weeks after surgery)
- Postoperative complications(Up to 9 weeks after surgery)
- Presence/Absence of vomiting(At moment 0, 3, 6, 12 and 24 hours after surgery)
- Anesthesiological complications(Up to 1 weeks after surgery)
- Time to drink(Up to 4 weeks after surgery)
- Validated questionnaires(Administered 24 hours after surgery and up to 4 weeks after surgery)
- Presence/Absence of nausea(At moment 0, 3, 6, 12 and 24 hours after surgery)
- Time to bowel movement(Up to 4 weeks after surgery)
- Assessment of postoperative pain(At moment 0, 3, 6, 12 and 24 hours after surgery)
- Time to hunger(Up to 4 weeks after surgery)
- Compliance to ERAS protocol(Up to 4 weeks after surgery)
研究者
Federico Ferrari
MD
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
研究点 (2)
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