Prospective, Randomized Study of Single Port and Conventional Laparoscopic Appendectomy in Acute Appendicitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
The aim of this study is to investigate the safety and efficacy of single port laparoscopic appendectomy compared with conventional laparoscopic appendectomy in adults with acute appendicitis.
详细描述
Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic appendectomy, single port laparoscopic appendectomy was expected to be less painful, more rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial, we tried to investigate the superiority of this new technique in adult patients with acute appendectomy.
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
- 7 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed acute appendicitis
排除标准
- •Age less than 7 or more than 75 years old
- •Gangrenous appendicitis
- •Combined generalized peritonitis
- •ASA score more than 3 point
- •Pregnant women
- •Cases requiring draining tube
研究组 & 干预措施
Single port
Single port through the transumbilical incision was made by wound retractor combined with surgical glove and then 3 trocal was inserted to the finger part of the surgical glove. Laparoscopic instrument was working through the single port and resected appendix removed through it.
干预措施: Single port laparoscopic appendectomy (Procedure)
3 port
3 port laparoscopic appendectomy was done by conventional method
干预措施: 3 port laparoscopic appendectomy (Procedure)
结局指标
主要结局
Safety
时间窗: 1 month
30 day morbidity and mortality
次要结局
- Efficacy(7 days)
- Efficacy(1 day)
- Efficacy(2 days)
研究者
Byung Mo Kang
Professor
Kyunghee University Medical Center