A Prospective, Single-Center Investigation of the Safety and Performance of the da Vinci SP® Surgical System in Colorectal Procedures
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Success rate (%)
研究概览
简要总结
The study is a prospective, single-center, single-arm unblinded clinical investigation. The aim of this study is to evaluate the performance and safety of da Vinci SP system. This study will entail a collection of demographics, preoperative, perioperative and postoperative outcomes of the patients into a database to follow this report on the outcomes, and notably answer questions to demonstrate the performance and safety of this surgical option.
All patients being considered for minimally invasive colorectal surgery will be evaluated for participation in the above study. All of these patients will undergo a standard minimally invasive resection in the same fashion as would be carried out with multiport laparoscopic or robotic surgery
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥18 years
- •Pathological confirm of colon or rectal cancer
- •Clinical stage I-III
- •Patient is a candidate for minimally invasive right hemicolectomy or anterior resection.
- •Performance status: ECOG 0-1
排除标准
- •Emergency surgery
- •Patient has metastatic disease
- •Patient has a bleeding or clotting disorder
- •Uncontrolled illness, including active infection, symptomatic heart failure, unstable angina or cardiac arrhythmias, or psychiatric illness that would limit compliance with study requirements
- •Previous laparotomy history
- •Patient unable to provide informed consent
- •Patient is pregnant
- •BMI 35.0 or higher
结局指标
主要结局
Success rate (%)
时间窗: immediately after the surgery
Calculating the percentage of cases successfully performed using the da Vinci SP system via the SP access port with or without an additional 12mm assistant port. Conversion to laparoscopy or laparotomy will be considered as failure.
次要结局
- Perioperative Parameters:Incision length(immediately after the surgery)
- Postoperative Parameters:Readmission and reoperation rate(Within 30days after the surgery)
- Postoperative Parameters:Time to discharge(Within 30days after the surgery)
- Perioperative Parameters:Time of surgery(immediately after the surgery)
- Perioperative Parameters: Estimated blood loss(immediately after the surgery)
- Perioperative Parameters:Robotic console time(immediately after the surgery)
- Perioperative Parameters: Type of anastomosis(immediately after the surgery)
- Postoperative Parameters:pain requirements(Within 30days after the surgery)
- Postoperative Parameters:Time to tolerate diets(Within 30days after the surgery)
- Postoperative Parameters:Time to flatus(Within 30days after the surgery)
- Perioperative Parameters: Blood transfusions(immediately after the surgery)
- Perioperative Parameters: Intra-operative Complications(immediately after the surgery)
- Postoperative Parameters:Pain score(Within 30days after the surgery)
- Perioperative Parameters:Total operative time(immediately after the surgery)
- Perioperative Parameters: Urine output(immediately after the surgery)
- Postoperative Parameters:Complications(Within 30days after the surgery)