Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Postoperative length of stay (pLOS)
研究概览
简要总结
The study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis.
详细描述
Laparoscopic cholecystectomy (LC) is the most common surgical procedures in the world. Elective LC is commonly performed as one-day surgery, while in an emergency setting of acute cholecystitis the in-hospital stay averages 4.5 days. Causes of prolonged rehabilitation period are often associated with severe pain syndrome, dyspepsia and postoperative complications. The complications rate after LC is about 6% and has no tendency to decrease. The implementation of enhanced recovery after surgery (ERAS) programs may potentially reduce stress-associated complications and improve the quality of rehabilitation. A few retrospective studies examined their advantages and setbacks in the treatment of acute cholecystitis with encouraging results. The aim of this randomized control study is to evaluate the modified ERAS program for patients with acute cholecystitis.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Grade I and II acute cholecystitis according to Tokyo Guidelines 2013 classification (TG13)
- •ASA I and II.
排除标准
- •Severe acute cholecystitis (Grade III on TG13);
- •Patient's refusal to participate;
- •The language barrier;
- •Transfer to the intensive care unit after surgery;
- •ASA class ≥ III;
- •Conversion to open procedure;
- •Biliary hypertension detected during preoperative examination or intraoperatively.
结局指标
主要结局
Postoperative length of stay (pLOS)
时间窗: 30 days
Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days
次要结局
- Readmission rate(30 days)
- Shoulder pain incidence(24 hours)
- Complication rate(30 days)
- Postoperative pain(24 hours)
- Shoulder pain level(24 hours)