NCT00872287已完成4 期
Randomized Controlled Study of Different Pain Scores in Single Transumbilical Incision Laparoscopic Cholecystectomy Versus Classic Laparoscopic Cholecystectomy
G. Hatzikosta General Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2008年9月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores
研究概览
简要总结
The attempt to further reduce the operative trauma in laparoscopic cholecystectomy led in new techniques, as Natural Orifice Transluminal Endoscopic Surgery (NOTES) and Single Incision Laparoscopic Surgery (SILS). These new techniques are considered as painless procedures, but there are not any publications to study a possible different pain score in new techniques versus classic laparoscopic cholecystectomy. In this randomized controlled study the researchers have investigated the pain scores, the incidence of nausea and vomiting and analgesics request after the procedure.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 28 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body Mass Index less than 30
- •Attacks of cholelithiasis
排除标准
- •Body Mass Index more than 30
- •Signs of acute cholecystitis
结局指标
主要结局
SILS cholecystectomy, except the invisible scar, has significantly less abdominal and shoulder pain scores
次要结局
未报告次要终点
研究者
研究点 (2)
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