Enhanced Recovery After Surgery in Hysterectomy Patients (ERAS)
Effectiveness of Enhanced Recovery After Surgery (ERAS) Protocols in Hysterectomy Patients. A Prospective,Randomized Controlled Clinical Trial.
研究概览
详细说明
Enhanced Recovery After Surgery (ERAS) protocols are structured, multidisciplinary perioperative care pathways developed to optimize surgical outcomes by minimizing physiological stress and promoting early recovery. These protocols include preoperative counseling, shortened fasting with carbohydrate loading, opioid-sparing anesthesia, early feeding, and early mobilization.
Hysterectomy remains one of the most common gynecological procedures worldwide and is often associated with prolonged hospital stay and postoperative morbidity, particularly in resource-limited settings. While international evidence supports the benefits of ERAS in improving outcomes such as reduced length of hospital stay, improved pain control, and decreased complications, there is a need for locally generated data to validate its effectiveness in Egyptian tertiary healthcare settings.
This study will be conducted at Kasr Al-Ainy Hospital, Cairo University, and will include women undergoing elective hysterectomy for benign or early-stage malignant gynecological conditions. Participants will be randomly assigned to either the ERAS group or the conventional care group. Outcomes will be assessed during hospitalization and up to 30 days postoperatively.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Ehab H Sorour, MD
- 电话号码：+201112496821
- 邮箱：dr.ehabsorour@gmail.com
研究联系人备份
- 姓名：Mohamed E El Mahy, MD
- 电话号码：+201111831716
- 邮箱：mohammed.elmahy@kasralainy.edu.eg
学习地点
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-
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Cairo、埃及
- Faculty of Medicine-Cairo University
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Women aged 18-70 years.
- Undergoing elective total hysterectomy for benign or early stage malignant gynacological conditions .
- ASA ( American Society of Anesthesiologists ) physical status I-II.
- Able to provide informed consent.
Exclusion Criteria:
- Emergency hysterectomy
- Advanced malignant requiring extensive debulking
- Known bowel disease or previous bowel surgery ( crohn's disease , bowel obstruction )
- Significant cognitive impairment or psychiatric illness
- Inability to follow ERAS protocol (e.g., cognitive impairment)
- Refusal to participate
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：ERAS group
Preoperative counseling Reduced fasting and carbohydrate loading Standardized anesthesia with reduced opioid use Early oral feeding Early mobilization Multimodal analgesia IV dextrose infusion (5%) 500 ml once or apple juice( 200-400 mL) 2-3 hours before anesthesia
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IV dextrose infusion (5%) 500 ml once ,2-3 hours before anesthesia
Reduced fasting Early oral feeding Early mobilization
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无干预：Conventional care
Overnight fasting Delayed postoperative feeding Opioid-based analgesia Delayed mobilization Routine prolonged use of drains/catheters
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
length of hospital stay (LOS)
大体时间：From day of surgery up to 7 postoperative days
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Time from completion of surgery to hospital discharge readiness, measured in days.
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From day of surgery up to 7 postoperative days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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postoperative pain score
大体时间：At 12 and 24 hours postoperatively
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Postoperative pain intensity measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
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At 12 and 24 hours postoperatively
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time to first bowel movement
大体时间：Up to 5 postoperative days
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the interval (in hours) from completion of surgery to the first documented passage of stool."
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Up to 5 postoperative days
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合作者和调查者
调查人员
- 首席研究员：Ehab H Sorour, MD、Cairo University
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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