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NCT Number: NCT07835932

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Intravenous Methylene blue

Drug

Intravenous methylene blue 0.5-1.0 mg/kg administered intraoperatively for fluorescence ureter identification.

Fluorescence Imaging Device for Methylene Blue

Device

Modified Stryker 1688 Fluorescence Laparoscopic System with additional filter

Primary outcomes

  1. Time to identification of the left ureter

    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.

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Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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