Effectiveness of Enhanced Recovery After Surgery (ERAS) Protocols in Hysterectomy Patients. A Prospective,Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- length of hospital stay (LOS)
研究概览
简要总结
This prospective randomized controlled clinical trial aims to evaluate the effectiveness of Enhanced Recovery After Surgery (ERAS) protocols in patients undergoing elective hysterectomy. ERAS is an evidence-based perioperative approach designed to reduce surgical stress, accelerate recovery, and improve clinical outcomes. Participants will be randomized to receive either ERAS-based care or conventional perioperative management. The study will assess whether ERAS implementation reduces hospital stay and improves postoperative recovery without increasing complications.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •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.
排除标准
- •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
研究组 & 干预措施
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
干预措施: dextrose (5%) (Drug)
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
干预措施: ERAS protocols (Procedure)
Conventional care
Overnight fasting Delayed postoperative feeding Opioid-based analgesia Delayed mobilization Routine prolonged use of drains/catheters
结局指标
主要结局
length of hospital stay (LOS)
时间窗: From day of surgery up to 7 postoperative days
Time from completion of surgery to hospital discharge readiness, measured in days.
次要结局
- postoperative pain score(At 12 and 24 hours postoperatively)
- time to first bowel movement(Up to 5 postoperative days)