NCT02499016Unknown不适用
Suprapubic Single-incision Laparoscopic Appendectomy Versus Conventional Multiport Appendectomy: a Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- incidence of complications
研究概览
简要总结
Conventional laparoscopic appendectomy(CLA) is the current standard treatment. To obtain additional benefits such as a better cosmetic outcome, the investigators developed a surgical option termed suprapubic single-incision laparoscopic appendectomy (SSILA), which creates a non-visible scar, that was preliminarily shown to be feasible and safe in our previous retrospective studies To further evaluate the feasibility, safety and cosmetic results of this innovative approach, the investigators compared the outcomes of SSILA and CLA by performing a randomized controlled trial.
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
- •acute appendicitis or interval appendicitis
- •informed consent
排除标准
- •diagnosis of appendicitis was not clinically established (symptoms attributable to urinary or gynecological problems)
- •history of cirrhosis and coagulation disorders
- •suspected or proven malignancy
- •contraindication to general anesthesia (severe cardiac and/or pulmonary disease)
- •inability to give informed consent(severe mental disease)
- •pregnancy
- •BMI>30kg/m2
- •generalized peritonitis
结局指标
主要结局
incidence of complications
时间窗: 30 days
The early morbidity rate is defined as the event observed during operation and within 30 days after surgery
次要结局
- operative time(intraoperative)
- time to recover(14 days)
- Pain score(14 days)
- mortality rate(30 days)
- cosmetic results(30 days)
研究者
研究点 (1)
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