About this trial
This study will assess whether methylene blue fluorescence imaging can help surgeons identify the ureters during colorectal surgery. Methylene blue, given through a vein during the operation, is taken up and excreted by the kidneys, allowing the ureters to appear under a special fluorescence camera system.
The study will include adults undergoing open, laparoscopic, or robotic colorectal surgery at Prince of Wales Hospital. The surgeons will compare ureter visibility using standard white light with visibility using fluorescence imaging at different stages of the operation. The study will also assess the best dose of methylene blue, the additional time required, the ease of using the imaging system, and whether the imaging findings affect the surgical plan.
The study's hypothesis is that methylene blue fluorescence imaging will make it easier or faster to identify the ureters than white light alone. The technique will be considered feasible if it is helpful in at least 20% of operations-for example, by identifying a ureter earlier or identifying it when it cannot be seen under white light. The findings will help determine whether a larger future study should be conducted.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged ≥18 years
Scheduled to undergo open, laparoscopic or robotic colorectal surgery, including right colectomy, extended right colectomy, left colectomy, high anterior resection, low anterior resection, abdominoperineal resection, subtotal colectomy and total colectomy.
Disqualifiers
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)
Trial design
Single group
Treatments tested in this trial
Intravenous Methylene Blue
DrugIntravenous Methylene Blue
Methylene Blue Fluorescence Imaging System
DeviceMethylene Blue Fluorescence Imaging with Custom Optical Filter (Stryker 1688)
Treatment groups
Trial outcomes
Primary outcomes
Proportion of cases in which fluorescence imaging with methylene blue is deemed helpful for identifying the index ureter
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: