Efficacy of Transumbilical Versus Standard Laparoscopic Cholecystectomy on Postoperative Pain
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Pain scores on the Visual Analog Scale before surgery
研究概览
简要总结
This is a trial to evaluate if single port laparoscopic cholecystectomy causes less pain than conventional laparoscopic cholecystectomy.
详细描述
This study is a randomized, two-arm, double-blinded three-center trial to compare single-port transumbilical laparoscopic cholecystectomy with conventional 4-port laparoscopic cholecystectomy. 120 patients are included with a 1:1 randomization. Three centers participate in the trial.
Inclusion criteria: Female patients, ASA I-III, age between 18 and 75 years, elective laparoscopic cholecystectomy because of biliary pain or recent uncomplicated biliary pancreatitis.
Exclusion criteria: Expected poor compliance, history of cholecystitis or severe pancreatitis, previous open upper abdominal surgery, pregnancy or lactation, preoperative chronic pain or conversion from laparoscopic to open surgery.
Pain and nausea is measured on VAS before the operation and 3 hrs, 1 day, 2 days and 3 days after the operation.
Cosmesis is evaluated after 28 days.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •Planned elective laparoscopic cholecystectomy because of biliary pain or uncomplicated biliary pancreatitis
排除标准
- •Expected poor compliance
- •History of cholecystitis or severe pancreatitis
- •Earlier open upper abdominal surgery, pregnancy or lactation, chronic pain or conversion to open surgery
结局指标
主要结局
Pain scores on the Visual Analog Scale before surgery
时间窗: Before surgery
Pain scores on the Visual Analog Scale 3 hours after surgery
时间窗: 3 hrs after surgery
Pain scores on the Visual Analog Scale 1 day after surgery
时间窗: 1 day after surgery
Pain scores on the Visual Analog Scale 2 days after surgery
时间窗: 2 days after surgery
Pain scores on the Visual Analog Scale 3 days after surgery
时间窗: 3 days after surgery
次要结局
- Nausea scores on a 4 point scale before surgery(Before surgery)
- Nausea scores on a 4 point scale 3 hours after surgery(3 hours after surgery)
- Nausea scores on a 4 point scale 1 day surgery(1 day after surgery)
- Nausea scores on a 4 point scale 2 days after surgery(2 days after surgery)
- Nausea scores on a 4 point scale 3 days after surgery(3 days after surgery)
- Well being scores on the Visual Analog Scale before surgery(Before surgery)
- Well being scores on the Visual Analog Scale 3 hours after surgery(3 hours after surgery)
- Well being scores on the Visual Analog Scale 1 day after surgery(1 day after surgery)
- Well being scores on the Visual Analog Scale 2 days after surgery(2 days after surgery)
- Well being scores on the Visual Analog Scale 3 days after surgery(3 days after surgery)
- Number of participants with adverse events as a measure of safety and tolerability(Within 30 days after surgery)
- Patient-assessed cosmesis on the Visual Analog Scale 30 days after surgery(30 days after surgery)