Impact of Implementation of an Enhanced Recovery After Surgery Program in Laparoscopic Roux-en-Y Gastric Bypass
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Postoperative pain
研究概览
简要总结
A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an ERAS program and those ones following a standard protocol.
Postoperative pain 24 hours after surgery and hospital stay will be assessed.
详细描述
A prospective randomized study of patients undergoing Roux-en-Y gastric bypass will be randomized in 2 groups: those following an Enhanced Recovery After Surgery (ERAS) program and those ones following a standard protocol. The ERAS program implies early liquids oral intake, early deambulation and multimodal analgesia (port sites infiltration with Bupivacain 0.5% associated with intravenous analgesia).
Postoperative pain 24 hours after surgery, as measured by Visual Analogic Scale, and hospital stay will be assessed.
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)
盲法说明
Nurse evaluating postoperative pain is blinded to the protocol applied
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index (BMI) >40 Kg/m2
- •BMI >35 Kg/m2 with obesity-associated comorbidities
排除标准
- •Patients undergoing other bariatric procedures
- •Patients undergoing bariatric revisional surgery
结局指标
主要结局
Postoperative pain
时间窗: 24 hours after surgery
Evaluated by Visual Analogic Scale
次要结局
- Hospital stay(Days until patients´discharge: 2 days or more than 2 days)
研究者
Jaime Ruiz-Tovar, MD, PhD
Research Department
Hospital General Universitario Elche