Randomized Controlled Trial Comparing Single Incision Laparoscopic Appendectomy Versus Standard Three Port Appendectomy in a Selected Cohort of Patients
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Morbidity and mortality
研究概览
简要总结
Laparoscopic appendectomy (LA) is nowadays considered the gold standard in fertile women affected by uncomplicated appendicitis. The level of evidence for benefits from LA in this subgroup is high. Since the dissemination of single access surgery (no-scars surgery) ameliorated outcome has been supposed in these patients regarding post-operative pain, hospital stay and cosmetics results, and keeping the same safety as LA. This randomized controlled study is supposed to give answers to these questions.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age: 14-60
- •American Society of Anesthesiologists (ASA) score: I-III
- •absence of non-correctable coagulopathy (international normalized ratio >1,5, or platelet count <90 × 109/l).
- •diagnosis: acute appendicitis with surgical indication
排除标准
- •Complicated appendicitis after exploration or previously diagnosed (CT)
- •Psychical inability
- •Pregnancy
研究组 & 干预措施
Single incision laparoscopic appendectomy
Acute appendicitis with surgical indication
干预措施: Single incision laparoscopic appendectomy (Procedure)
Multiport Laparoscopic appendectomy
Acute appendicitis with surgical indication
干预措施: Multiport laparoscopic appendectomy (Procedure)
结局指标
主要结局
Morbidity and mortality
时间窗: 30 days
次要结局
- Incision related morbidity(6 months)
- Quality of life(6 months)
- Post-operative pain score(3 days)
- Operative time(1 day)
- Cosmetic result(6 months)
- Post-operative hospital stay(7 days)
研究者
Nereo Vettoretto
MD
Associazione Chirurghi Ospedalieri Italiani