A Prospective Multicenter Randomized Controlled Study for The Safety of Single Incision Laparoscopic Cholecystectomy With a Camera Holder Versus With a Camera Operator
试验速览
- 阶段
- 不适用
- 入组人数
- 272
- 主要终点
- Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC)
研究概览
简要总结
The purpose of this study is to determine safety of solo surgery in single incision laparoscopic cholecystectomy (SILC) with a camera holder comparing to a camera operator assisted SILC
详细描述
This study is a multicenter randomized controlled study. The primary outcome based on non-inferior study design(α=0.05, power (1-β)=0.90); comparing a complications rate between Solo-SILC group and conventional cholecystectomy group (Ca-SILC).
Total of 272 patients who were undergoing laparoscopic cholecystectomy for gallbladder disorders will randomly assign to two groups according to a computer-generated table of random numbers Solo-SILC group using a laparoscopic camera holder (n=136) or Ca-SILC group in which a camera operator joins (n=136). .
Demographics (i.e., age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, indication for operation, need for conversion to open surgery or additional port will be recorded. Outcome including pain, hernia, complication rates, post-cholecystectomy diarrhea, operator's workload will be investigated
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all patient need laparoscopic cholecystectomy (check the possibility of routine application of Solo-SILC in clinical practice)
排除标准
- •Mirizzi syndrome
- •unstable vital sign
- •no compliance
- •no consent
研究组 & 干预措施
Solo-SILC
Solo surgery using a laparoscopic camera holder instead of a camera operator in SILC
干预措施: Solo surgery (Procedure)
Ca-SILC
No solo surgery, operation with a camera operator in SILC
干预措施: operation with a camera operator in SILC (Procedure)
结局指标
主要结局
Complication rate in Solo-Single Incision Laparoscopic Cholecystectomy (SILC)
时间窗: average 2 weeks
intraoperative and immediate postoperative complications in Solo-SILC comparing with that in laparoscopic cholecystectomy
次要结局
- Postoperative adverse symptoms after SILC(average 2weeks after discharge)
- number of participant with abnormal laboratory values(average 2weeks after discharge)
- Wound, back, and shoulder pain(postoperative 6 hr, 24 hr, 2 weeks after the operation)
- Operator's workload(intraoperative)
- complications in both groups(average 2 weeks)
- Conversion rate(intraoperative)
- Incisional hernia(average 6 months)
研究者
YoungRok Choi
Professor
Seoul National University Hospital