Randomised Controlled Trial of Fluorescent Urography Using Intravenous Methylene Blue Compared to White Light Alone in Left-sided Colorectal Surgery
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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Trevor Yeung, MA, MBBChir, DPhil, FRCS
- 电话号码:+852 3505 1495
- 邮箱:uretertrial@gmail.com
学习地点
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-
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Hong Kong、香港
- Prince of Wales Hospital, The Chinese University of Hong Kong
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接触:
- Trevor Yeung, MA, MBBChir, DPhil, FRCS
- 电话号码:+852 3505 1495
- 邮箱:uretertrial@gmail.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Unable to understand the aims and objectives of this study and unable to give consent for participation
- Known allergy to methylene blue
- Pregnant
- 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)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Fluorescence Imaging with Intravenous Methylene Blue
Fluorescence Imaging with Intravenous Methylene Blue |
Intravenous methylene blue 0.5-1.0 mg/kg administered intraoperatively for fluorescence ureter identification. Modified Stryker 1688 Fluorescence Laparoscopic System with additional filter |
|
无干预:White Light Visualisation Alone
White Light Visualisation Alone |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Time to identification of the left ureter
大体时间: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. |
Intraoperative, from peritoneal incision until the ureter is first seen
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- Ureter MB RCT
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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