The Comparison of Single Incision Laparoscopic Appendectomy and Three Port Laparoscopic Appendectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 主要终点
- Pain score
研究概览
简要总结
Laparoscopic techniques have allowed surgeons to perform complicated intrabdominal surgery with minimal trauma. In numerous studies, when conventional laparoscopic appendectomy using 3 ports is compared with open appendectomy, it has advantages of reduced pain, reduced hospital stay, and enhanced cosmetic effects. Single incision laparoscopic surgery (SILS) was developed with the aim of reducing the invasiveness of conventional laparoscopy. In this study the investigators aimed to compare results of SILS appendectomy and three port conventional laparoscopic appendectomy prospectively.
详细描述
Total of 50 patients who undergoing laparoscopic appendectomy for acute appendicitis will randomly assign to undergo SILS appendectomy group (n = 25) or Three port laparoscopic appendectomy group (n= 25) according to a computer-generated table of random numbers. Demographics (ie, age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, need for conversion to a standard or three port laparoscopic appendectomy, need for conversion to an open appendectomy will be recorded. Outcome measures include operative morbidity, operative time, pain score, hospital stay. Morbidity will be evaluated by rates of colonic leak, wound infection, intrabdominal abscess hospital readmission, and hernia.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Required laparoscopic cholecystectomy for gallbladder disease.
排除标准
- •American Society of Anesthesiologists score (ASA) more than III,
- •Patients had prior abdominal surgery,
- •Pregnancy,
- •Ongoing peritoneal dialysis,
- •Lack of written informed consent.
结局指标
主要结局
Pain score
时间窗: Postoperative first 24 hours
Postoperative pain will be assessed according Visual analog scale from 0 (no pain) to 10 (worst pain imaginable. Postoperative six hour VAS (POSH-VAS) and postoperative first day VAS (POFD-VAS) will be recorded and compared.
次要结局
- Intraoperative complications(Average of 50 minutes)
- Operating time(Average of 50 minutes)
- Postoperative complications(24th hour, 2nd day, 3rd day, 7th day, 1st month, 3rd month, 6th month, 1st year)
研究者
manuk norayk manukyan
Assoc.Prof.
Maltepe University