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NOT YET RECRUITING
NCT07861815
PHASE4

Assessing the Feasibility of Using Methylene Blue in Identifying Ureters During Colorectal Surgery

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-10-01

Completion Date

2028-10-01

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

DRUG

Intravenous Methylene Blue

Intravenous Methylene Blue

DEVICE

Methylene Blue Fluorescence Imaging System

Methylene Blue Fluorescence Imaging with Custom Optical Filter (Stryker 1688)