Randomized Controlled Trial Of Transumbilical Laparoendoscopic Single Site Cholecystectomy Versus Conventional Laparoscopic Cholecystectomy
试验速览
- 阶段
- 2 期
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- the incidence of surgical complications
研究概览
简要总结
The purpose of this study is to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site cholecystectomy.
详细描述
As the natural orifice during embryonic, the transumbilical surgery not only can mask the abdominal scar and avoid infection produced by puncturing stomach, vagina or rectum in NOTES,but also can be played by the conventional laparoscopic instruments. TU-LESS (transumbilical laparoendoscopic single site surgery), is considered to be the most feasible NOTES(natural orifice transluminal endoscopic surgery)technology at present. Researches about TU-LESS mostly are case reports and small samples or the control experiments up to now,there are not persuasive randomized controlled trail between TU-LESS and conventional laparoscopic cholecystectomy. So the investigators design this prospective randomized controlled trail to scientifically evaluate the safety, efficacy and cosmetic results of transumbilical laparoendoscopic single site 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 (Investigator, Outcomes Assessor)
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
- •18 Years to 5 Years
- •Benign gallbladder diseases
- •informed consent
排除标准
- •Obstructive jaundice
- •Broadening of the common bile duct
- •Gallstone pancreatitis
- •Serious heart,brain,lung, metabolic diseases history
- •History of upper abdominal surgery
- •Pregnancy or breast-feeding women
- •Refuse TU-LESSC
- •BMI(Body Mass Index)≥ 30
研究组 & 干预措施
Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.
干预措施: CLC (Procedure)
TU-LESSC
TU-LESSC will be performed in a routine fashion which is same to CLC（conventional laparoscopic cholecystetomy）by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments.
干预措施: TU-LESSC (Procedure)
结局指标
主要结局
the incidence of surgical complications
时间窗: up to 12 weeks
The primary outcome messures are the incidence of surgical complications caused by the two surgeries.Bleeding,bile duct injury and bile leakage during operation.Wound infection，umbilical hernia，poke holes hernia and biliary fistula after operation.
次要结局
- transfer rate(participants will be followed for the duration of hospital stay, an expected average of 5 days)
- quality of life scores(up to 12 weeks)
- pain scores(up to 12 weeks)
- length of hospital stay(participants will be followed for the duration of hospital stay, an expected average of 5 days)
- total cost of hospitalization(participants will be followed for the duration of hospital stay, an expected average of 5 days)
- Cosmetic results(1 month)
- The incidence of adverse events(up to 12 weeks)