Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
NCT Number: NCT07835932
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Hong Kong
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous methylene blue 0.5-1.0 mg/kg administered intraoperatively for fluorescence ureter identification.
Modified Stryker 1688 Fluorescence Laparoscopic System with additional filter
Time frame: 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.
Trial opening soon.
Get NotifiedChinese University of Hong Kong
Other
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