Single Port Laparoscopic Cholecystectomy Versus Four Port Laparoscopic Cholecystectomy: Impact on Postoperative Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Post-operative pain scores (visual analogue pain scale from 0-10)
研究概览
简要总结
This is a single-institution, prospective, randomized controlled trial. Subjects determined to need a cholecystectomy will be consented for surgery and study participation prior to enrollment in this study. Patients will then be randomized to receive either a single port laparoscopic cholecystectomy or a four port laparoscopic cholecystectomy.
详细描述
The main advantages of laparoscopic surgery are reduced postoperative pain, shorter hospital stay and the cosmetic result. Although reduced, however, pain is still substantial and constitutes the main clinical problem after laparoscopic cholecystectomy, in particular for future daily planned procedures.
Recently, a new technique of laparoscopic cholecystectomy has been developed, in which all instruments are inserted through the same port placed in the umbilical incision. This technique for cholecystectomy has been proved to be feasible and safe by several studies.
The purpose of the study is to compare postoperative pain, operating time, cosmetic result, between one port and standard 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biliary cholic
- •Biliary dyskinesia
- •Gallbladder polyps
- •Other diagnosis at the discretion of the surgeon
排除标准
- •History of Acute cholecystitis
- •Choledocolithiasis
- •History of Pancreatitis
- •Severe comorbidity
- •BMI > 30
结局指标
主要结局
Post-operative pain scores (visual analogue pain scale from 0-10)
时间窗: Before surgery (baseline) and 2 hrs, 4 hrs, 6hrs, 12hrs, 24hrs and 48hrs after surgery
次要结局
- Patient-assessed cosmesis on the Visual Analogue Scale(30 days after surgery)