Randomised Controlled Trial of Fluorescent Urography Using Intravenous Methylene Blue Compared to White Light Alone in Left-sided Colorectal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Time to identification of the left ureter
研究概览
简要总结
This study will see if a blue dye (methylene blue) given into a vein, together with a special camera light, helps surgeons find the left ureter (the tube from the kidney to the bladder) faster during left-sided bowel surgery. Adults having open, laparoscopic, or robotic left-sided colorectal surgery will be randomly assigned to either the blue dye with special light or standard white light alone. The main question is whether the blue dye method finds the ureter more quickly, which could make the operation safer.
详细描述
This randomised controlled trial will test whether intravenous methylene blue, viewed with a special fluorescence camera, helps surgeons identify the left ureter (the tube that carries urine from the kidney to the bladder) more quickly during left-sided colorectal (bowel) surgery. Ureter injury is a rare but serious complication, and in some patients the ureter is hard to see under standard white light. Adults having open, laparoscopic, or robotic left-sided colorectal surgery at Prince of Wales Hospital (Hong Kong) will be screened; if the left ureter cannot be clearly seen before dissection, they will be randomly assigned to either fluorescence imaging with methylene blue or standard white-light vision alone.
The main outcome is the time from starting dissection to first seeing the left ureter. The study will also record how often the ureter is seen at set time points, operating times, surgeon-rated ease and confidence, any changes to the surgical plan, complications, and ureteric injuries. The goal is to find out whether the fluorescence method can make ureter identification faster and easier, potentially improving safety without needing invasive preoperative ureteric stents.
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
- 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
- •Aged ≥18 years
- •Scheduled to undergo open, laparoscopic or robotic left-sided colorectal surgery, including left colectomy, high anterior resection, low anterior resection, abdominoperineal resection, subtotal colectomy and total colectomy.
排除标准
- •Unable to understand the aims and objectives of this study and unable to give consent for participation
- •Known allergy to methylene blue
- •Taking selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, monoamine oxidase inhibitors, or tricyclic antidepressants (risk of serotonin syndrome)
- •Significant renal or hepatic impairment
- •Presence of renal or ureteric obstruction
- •History of G6PD deficiency (risk of hemolytic anemia)
研究组 & 干预措施
White Light Visualisation Alone
White Light Visualisation Alone
Fluorescence Imaging with Intravenous Methylene Blue
Fluorescence Imaging with Intravenous Methylene Blue
干预措施: Intravenous Methylene blue (Drug)
Fluorescence Imaging with Intravenous Methylene Blue
Fluorescence Imaging with Intravenous Methylene Blue
干预措施: Fluorescence Imaging Device for Methylene Blue (Device)
结局指标
主要结局
Time to identification of the left ureter
时间窗: Intraoperative, from peritoneal incision until the ureter is first seen
Time (in minutes) from peritoneal incision to first visualisation of the left ureter during left-sided colorectal surgery.
次要结局
未报告次要终点
研究者
Trevor Yeung
Assistant Professor
Chinese University of Hong Kong
