Effectiveness of a Modified Enhanced Recovery After Surgery (mERAS) Protocol in Reducing Surgical Site Infection After Emergency Cesarean Delivery: A Randomized Controlled Trial.”
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
研究概览
简要总结
Enhanced Recovery After Surgery (ERAS) is a comprehensive, evidence-based approach designed to minimize the physiological stress associated with surgical procedures, facilitate functional recovery, reduce complications, and shorten hospital stays. Initially developed for colorectal and significant abdominal surgeries, the ERAS principles have since been adapted to obstetric care, particularly in cesarean deliveries. These guidelines focus on optimizing various aspects of post-surgical care, such as pain management, early mobilization, fluid management, nutritional support, and encouraging early contact between mother and infant. Guidelines from the ERAS Society delineate specific recommendations tailored for peri-cesarean care, which can be applied in both elective and emergency contexts. Research has led to the establishment of a modified ERAS (mERAS) protocol that prioritizes certain postoperative factors—such as facilitating early oral intake, implementing multimodal analgesia, promoting early movement, and ensuring prompt removal of urinary catheters—with evidence suggesting that these modifications can be safely employed in emergency situations, based on studies of emergent colorectal surgeries. However, emergency cesarean deliveries present unique challenges. These include the urgency of the procedure, variability in preoperative preparation, a heightened baseline risk of infection, and the limited time available for preparatory measures. Therefore, it is essential to investigate whether implementing modified ERAS protocols can yield benefits, such as a reduction in surgical site infections (SSIs), while ensuring the safety of both mothers and their newborns. Current evidence supporting the application of ERAS in emergency cesarean deliveries remains less robust compared to that for elective cesarean births.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women undergoing emergency cesarean delivery (any indication).
- •Willing to provide informed consent and comply with follow-up (up to 30 days post- surgery).
排除标准
- •Elective cesarean deliveries.
- •Known immunocompromised state (e.g. HIV with low CD4, long-term steroids, chemotherapy).
- •Severe comorbidities (e.g., uncontrolled diabetes, severe anaemia, chronic kidney or chronic liver disease, ICU admissions).
- •Pre-existing infection at or near the proposed incision site.
- •Ongoing systemic antibiotic therapy for other infections at the time of surgery (beyond routine prophylaxis).
- •Refusal to participate or inability to follow up (e.g. no reachable contact).
研究者
Dr Vibha Rani Pipal
All India Institute of Medical Sciences
