A Randomized Trial of Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test.
研究概览
简要总结
This is a single-institution, prospective, one-to-one randomized controlled research study. Subjects medically determined to need a cholecystectomy will be consented for surgery and study participation prior to enrolment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-operative diagnosis of one of the following:
- •Pancreatic cholecystitis
- •Biliary cholic
- •Biliary dyskinesia
- •Choledocholithiasis status post endoscopic retrograde cholangiopancreatography/sphincterotomy
- •Gallbladder polyps
- •Other diagnosis at the discretion of the surgeon
排除标准
- •Acute cholecystitis
- •Gallstones > 2.5cm in length on ultrasound
- •Suspected presence of common duct stones
- •History of jaundice
- •History of gallstone pancreatic
研究组 & 干预措施
1
Single port laparoscopic device
干预措施: Laparoscopic cholecystectomy surgery (Device)
2
Four-port laparoscopic device
干预措施: Laparoscopic cholecystectomy surgery (Device)
结局指标
主要结局
Post-operative pain scores (visual analogue pain scale from 0-10)assessed on post-operative day 1 and at the post-operative follow up visit in clinic. The mean pain scores will be compared using student's t-test.
时间窗: 3-6 weeks
次要结局
- The postoperative infection rate will be monitored and compared for patients undergoing single port laparoscopic cholecystectomy and four port laparoscopic cholecystectomy.(3-6 weeks)