Effect of Indocyanine Green Fluorescence Angiography on Anastomotic Leak After Elective Laparoscopic Colorectal Resection: A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of clinically significant anastomotic leakage
研究概览
简要总结
This prospective randomized controlled trial evaluates whether intraoperative indocyanine green (ICG) fluorescence angiography reduces clinically significant anastomotic leakage after elective laparoscopic colorectal resection with primary anastomosis. A total of 120 adults were allocated in a 1:1 ratio to ICG-guided perfusion assessment or standard visual perfusion assessment, with 60 participants in each group. In the ICG arm, ICG 0.2 mg/kg was administered intravenously after bowel mobilization and before transection, and near-infrared imaging guided selection of a well-perfused transection margin. Participants were followed for 90 days after surgery for grade B or C anastomotic leakage.
详细描述
Adequate perfusion is essential for colorectal anastomotic healing. Standard intraoperative assessment relies on bowel color, mesenteric pulsation, and bleeding from the cut edge. ICG fluorescence angiography provides real-time near-infrared visualization of bowel perfusion and may identify inadequately perfused segments before anastomosis.
Eligible participants undergoing elective laparoscopic colorectal resection with planned primary anastomosis were randomized using closed-envelope allocation. In the experimental arm, fluorescence was evaluated using a standardized ordinal score: 0, no fluorescence within 60 seconds; 1, delayed or patchy fluorescence at 60 seconds; 2, reduced but homogeneous fluorescence within 30-60 seconds; and 3, rapid homogeneous fluorescence within 30 seconds. Time to fluorescence was recorded at a defined region of interest, and transection was performed at an area showing grade 3 perfusion. In the comparator arm, transection and anastomosis proceeded using standard visual assessment without ICG.
Postoperative evaluation included clinical surveillance. Contrast-enhanced computed tomography of the abdomen and pelvis was obtained when clinically indicated. Clinically significant anastomotic leakage was defined as grade B or C leakage within 90 days and confirmed by clinical findings, contrast imaging, or reoperation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Adults aged 18 years or older.
- •Undergoing elective laparoscopic colorectal resection.
- •Planned primary colorectal anastomosis.
- •Able and willing to provide written informed consent.
排除标准
- •Known allergy to iodine or indocyanine green.
- •Severe hepatic dysfunction.
- •Severe renal dysfunction.
- •Emergency colorectal resection.
- •Inflammatory bowel disease requiring extensive resection.
- •Previous colorectal surgery involving the planned anastomotic site.
研究组 & 干预措施
ICG Fluorescence Angiography
Assess the blood supply using icg
干预措施: Visual assessment (Other)
Standard Visual Perfusion Assessment
Immediate visual assessment for colon blood supply
干预措施: ICG visuals assessment (Diagnostic Test)
结局指标
主要结局
Incidence of clinically significant anastomotic leakage
时间窗: 90 days after surgery
Incidence of clinically significant anastomotic leakage, defined as Grade B or Grade C leak, .
次要结局
- Change in the planned bowel transection margin after ICG assessment(One hour intraoperative)
- Operative time(Hours in the operative theater)
- ICG-related adverse reactions, such as hypotension or allergic reaction(4 Hours intraoperative)
