NCT01348464已完成不适用
Transumbilical Single Port Laparoscopic Appendectomy Versus Conventional Laparoscopic Appendectomy in Adult Patients: A Prospective Randomized Control Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Complication rate
研究概览
简要总结
The aim of this study is to compare patients who undergone single-port access laparoscopic appendectomy to those who underwent conventional three-port laparoscopic appendectomy (TPLA) in a prospective randomized trial
详细描述
- primary objective
- complication rate
- secondary objectives
- satisfaction rate
- pain scale difference
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 5~85 years
- •any patient diagnosed with acute appendicitis on appendix sonography or abdominopelvic CT
- •Patient performance status(PS) with greater than 80 or more on Karnofsky PS
- •Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
排除标准
- •Pregnant or lactating
- •Serious uncontrolled intercurrent infections, or other serious uncontrolled concomitant disease
- •History of Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently treated cancer
- •Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
结局指标
主要结局
Complication rate
时间窗: participants will be followed for the duration of hospital stay, an expected average of 24 weeks
observe complication caused by both procedures
次要结局
- patient satisfaction(participants will be followed for the duration of hospital stay, an expected average of 24 weeks)
研究者
Won-Suk Lee
Assistant prof
Gachon University Gil Medical Center
研究点 (1)
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