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临床试验/NCT04175782
NCT04175782已完成不适用

Comparison of Enhanced Recovery Protocol With Conventional Care in Patients Undergoing Urogynecologic Surgery

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 125 人开始时间: 2019年7月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
125
试验地点
1
主要终点
Time to ambulation

研究概览

简要总结

Enhanced recovery after surgery (ERAS) has been shown to improve postoperative outcomes in a variety of surgical conditions. However, data regarding its role in urogynecologic surgery is limited. This study aimed to investigate the role of the ERAS protocol on postoperative outcomes in patients undergoing urogynecologic surgery.

详细描述

Enhanced recovery after surgery (ERAS) or in other words "fast-track" protocol roughly purposes to improve patient satisfaction, reduce complications and shorten the hospital stay. Chronic diseases, nutrition, and any volume depletion are corrected prior to surgery and less invasive surgical techniques are utilized to this end The impact of ERAS protocols in decreasing length of stay (LOS), reducing postoperative pain, improving early ambulation and decreasing the rate of potentially serious medical complications have been studied in patients undergoing colorectal, urologic, gastric and pancreatic surgery previously. However, data regarding the role of ERAS protocol in improving postoperative outcomes and postoperative compliance in patients undergoing urogynecological surgery is limited.

The present study purposes to clarify the role of the ERAS protocol on postoperative outcomes in patients undergoing urogynecologic surgery.

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
Double (Investigator, Outcomes Assessor)

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 must be > 18 years
  • •Must be scheduled for urogynecologic surgery

排除标准

  • •Emergency surgery
  • •Presence of preoperative sepsis
  • •Presence of advanced liver or kidney disease

研究组 & 干预措施

ERAS group

Experimental

A standardized ERAS protocol is applied to the ERAS group based on the latest guidelines. Smoking and alcohol consumption is stopped 4 weeks before the surgery. Preoperative anemia is corrected with intravenous iron supplementation. Prolonged fasting, bowel preparation, and premedication are avoided in this group. Clear fluids are allowed up to 2 h and solids rich in carbohydrate up to 6 h hours prior to induction of anesthesia. Warmed up intravenous fluids are administered to maintain normothermia intraoperatively. This group of subjects receives general anesthesia. Volume and salt overload and drain usage are avoided to the utmost. Intravenous paracetamol is administered for postoperative analgesia before the completion of the surgical procedure. Nasogastric tube placement is avoided and catheters are removed as soon as possible. Nonopioid oral analgesics and NSAIDs are utilized for postoperative pain medication.

干预措施: Enhanced recovery after surgery (ERAS) protocol (Procedure)

Control

No Intervention

This group will receive conventional pre-and postoperative care.

结局指标

主要结局

Time to ambulation

时间窗: Up to 1 week

Hours

次要结局

未报告次要终点

研究者

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

Gulseren Yilmaz

Principal Investigator, M.D.

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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