A Novel Robotic Surgical System for Minimally Invasive Surgery: A Prospective, Single Center, Multi-speciality Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System
研究概览
简要总结
This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.
详细描述
This is a prospective single center cohort study on effect of a novel robotic surgical system for performance of minimally invasive surgery in multiple specialties. The targeted procedures include Urological, upper and lower GI robotic surgeries and the expected sample size will be 20 patients. The procedures will be standardized according to previously reported. The diseases for robotic surgical treatment will include prostate carcinoma, colorectal carcinoma, as well as esophageal hiatal diseases and gastric carcinoma. The clinical outcomes for assessment include background demographics, operative time, perioperative complications as well as completion rate of procedure, hospital stay and recovery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Body mass index <35 kg/m2
- •Suitable for the listed minimally invasive surgical procedures for treatment of respective diseases
- •Willingness to participate as demonstrated by giving informed consent
排除标准
- •Contraindication to general anesthesia
- •Severe concomitant illness that drastically shortens life expectancy or increases risk of therapeutic intervention
- •Untreated active infection
- •Noncorrectable coagulopathy
- •Presence of another malignancy or distant metastasis
- •Emergency surgery
- •Vulnerable population (e.g. mentally disabled, pregnancy)
结局指标
主要结局
Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System
时间窗: 30 days
Rate of conversion to ordinary laparoscopic surgery of robotic surgical procedures performed using the novel K2 Robotic Surgical System is defined as the need to change to laparoscopic surgery during the procedure.
次要结局
- intraoperative time(30 days)
- Blood Loss(30 days)
- Length of Hospital Stay(30 days)
- Rate of perioperative complications(30 days)
- Analgesic requirement(30 days)
- Pain scores on a visual analog scale(30 days)
研究者
Philip Wai Yan CHIU
Professor
Chinese University of Hong Kong