A Prospective, Randomized Trial Comparing ERAS and Conventional Protocol for Perioperative Care of Patients After Gynecological Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Shorter Length Of Hospitalization (LOH)
研究概览
简要总结
Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.
详细描述
The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age >18 and <70 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
排除标准
- •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)
- •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
- Presence/Absence of nausea(At moment 0, 3, 6, 12 and 24 hours after surgery)
- Readmission rates(Up to 21 days post surgery)
- Time to flatus(Up to 4 weeks after surgery)
- Presence/Absence of vomiting(At moment 0, 3, 6, 12 and 24 hours after surgery)
- Foley catheter removal(From 1 to 14days post surgery)
- Time to drink(Up to 4 weeks after surgery)
- Time to eating(Up to 4 weeks after surgery)
- Time to bowel movement(Up to 4 weeks after surgery)
- Time to walking(Up to 4 weeks after surgery)
- Postoperative complications(Up to 2 weeks after surgery)
- Assessment of postoperative pain(At moment 24 hours after surgery)
- Time to adjuvant treatment(60 days)
研究者
Beihua Kong
Clinical Professor
Shandong University