Prospective Randomized Trial on the Assessment of Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy
试验速览
- 阶段
- 1 期
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- post-operative pain
研究概览
简要总结
Appendicitis is the most common benign inflammatory disease that requires an operation.
Laparoscopic appendectomy using three trocar is generally performed, and reveals good surgical outcomes incluing less pain, early recovey, cosmetic effect et al. However, with using three trocar, there are some problems including pain around trocar insertion sites(three portions), wound infecton and scar at trocar insertion sites. For these reasons, more minimal invasive appendectomy is required, with development of laparoscopic instrument,eventually one port sppectomy is developed. So, the investigators assess post-operative Outcomes according to the Number of Trocar.
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
- Single (Investigator)
入排标准
- 年龄范围
- 8 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Appendicitis (clinical or radilogical diagnosis)
排除标准
- •Appendicitis with palpable mass( clinical or radilogical diagnosis)
- •Patient has bleeding tendency
研究组 & 干预措施
one port
Patients undergo one port appectomy. Skin incision about 2cm size is made upon umbilicus and dissection is performed to make opening. Then, wound retractcor(Alexis) is iserted on opening site and wound is extended. Rubber glove built-in three 5mm trocars is applied over wound retractor. Pneumoperitoneum is achieved via trocar and appendectomy is performed. After appendectomy, wound is repaired.
干预措施: appendectomy (Procedure)
Three ports
Paitents will undergo three port appendectomy. 10 mm trocar is inserted on umbilicus, and two 5mm trocas is inserted low abdomen, left flank respectively.
Appendectomy is performed vis these trocas. After operation, wounds are repaired.
干预措施: appendectomy (Procedure)
结局指标
主要结局
post-operative pain
时间窗: For 7days
次要结局
- cosmetic effect(for 14days)