The Role of Indocyanine Green (ICG) Fluorescence Imaging on Anastomotic Leak and Short-term Outcomes in Robotic Colorectal Surgery: A Prospective Randomized Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Anastomotic leak rate
研究概览
简要总结
In colorectal surgery, anastomotic leak and its septic consequences still remain as the most concerning complications resulting in substantial morbidity and mortality. A common determining factor for assessing the viability of a bowel anastomosis is adequate arterial perfusion to ensure sufficient local tissue oxygenation. Intraoperative near-infrared fluorescence (INIF) imaging using indocyanine green (ICG) dye is a novel technique which allows the surgeon to choose the point of transection at an optimally perfused area before creating a bowel anastomosis. Recently, the INIF imaging system has been installed on the robotic systems and this helps identify intravascular NIF signals in real time.
Although reports from several case series and retrospective cohorts have described the feasibility and safety of this imaging system during robotic colorectal surgery, to date, no studies have addressed more systematically the outcomes of this technique in robotic surgery. Considering the limitations of these reports, investigators aim to conduct a prospective randomized trial to compare robotic procedures with or without INIF imaging in patients undergoing colorectal surgery.
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
- •Subject is able to give informed consent for participation in the study
- •Subject is willing and able to comply with the study procedures
- •Subject is diagnosed with colon/rectal neoplasia, inflammatory bowel disease, diverticular disease requiring surgical excision
- •Subject is scheduled for robotic colon or rectal resection
- •A negative pregnancy test for women of childbearing potential prior to surgery
排除标准
- •Subjects present with bowel obstruction or perforation
- •Subject undergo emergency surgery
- •Subject with ASA IV, V
- •History of allergy or hypersensitivity against indocyanine green
- •Pregnant or breast-feeding women
- •Subject has uremia (serum creatinine >2.5 mg/dl)
- •Subject is undergoing palliative surgery or who is terminally ill
- •Subject who is unable to discontinue warfarin anticoagulation 5 days before surgery
- •Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid
结局指标
主要结局
Anastomotic leak rate
时间窗: Postoperative 30 days
Anastomotic leak rate within 30 post operative days
次要结局
- Complication rate(Postoperative 30 days)
- Mortality(Postoperative 30 days)
