NCT00832767已完成不适用
Prospective Randomized Controlled Trial of Traditional Laparoscopic Cholecystectomy Versus SILS™ Port Laparoscopic Cholecystectomy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 18
- 主要终点
- Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC
研究概览
简要总结
The objectives of this trial are:
- to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy
- monitor and compare the outcomes of SILS™ Port Laparoscopic Cholecystectomy versus 4PLC to objectively document the scientific merit and the perceived advantages of SILS™ 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
- Single (Participant)
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
- •Between 18 and 85 years old.
- •Patient has a diagnosis of biliary colic with documented gallstones or polyps by imaging or Biliary dyskinesia with documented EF < 30%.
- •Body Mass Index (BMI) < 45 kg/m2.
排除标准
- •Any female patient, who is pregnant, suspected pregnant, or nursing.
- •Any patient with acute calculus or acalculous cholecystitis.
- •Any patient who has had an upper midline or right sub costal incision.
- •Any patient with pre-operative indication for a cholangiogram.
- •Any patient with ASA > 3 with normal liver function.
- •Any patient who is undergoing Peritoneal Dialysis (PD).
- •Any patient who has an unrepaired umbilical hernia or has had prior umbilical hernia repair.
研究组 & 干预措施
SILS Port
Active Comparator
SILS™ Port Laparoscopic Cholecystectomy
干预措施: SILS™ port laparoscopic cholecystectomy (Procedure)
Four Port
Active Comparator
Four Port Laparoscopic Cholecystectomy
干预措施: Four Port Laparoscopic Cholecystectomy (Procedure)
结局指标
主要结局
Feasibility and Safety of SILS™ Port Cholecystectomy Versus 4PLC
时间窗: One year
Feasibility and safety as determined by intraoperative and postoperative adverse events.
Operative Time
时间窗: Day 0
Duration of surgical procedure in minutes.
Estimated Blood Loss
时间窗: Day 0
Blood loss from surgical procedure in cc.
次要结局
- Average Pain Experienced in the Last 24 Hours at Various Time Frames(Various (Pre-operative, Day 0, 1,3, 5, 1 Week, 2 Week and 1 Month))
- Body Image Scale(Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year))
- Cosmetic Scale(Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year))
- Confidence Scale Change From Baseline(Change from Baseline (Pre-Op) at 1 Week, 2 Week, 1 Month, 3 Month and 1 Year)
- Mental Quality of Life(Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week))
- Time to Cannulization(Day 0)
- Normalized Scar Scores(Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year))
- Modified Hollander(Various (1 Week, 2 Week, 1 Month, 3 Month and 1 Year))
- Physical Quality of Life(Various (Baseline (Pre-Op), Day 1, 3, 5 and 1 Week))
研究者
研究点 (18)
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