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

Status

Not yet recruiting

Phase

Phase 4

Enrollment

20 participants (estimated)

Sponsor

Chinese University of Hong Kong · Other

Design

Allocation not applicable · Open label (no masking)

Countries

Not stated

Start

1 Oct 2026 (estimated)

Primary completion

1 Oct 2027 (estimated)

Completion

1 Oct 2028 (estimated)

First posted

6 Oct 2026

Last update posted

6 Oct 2026

Conditions

Colorectal Cancer · Colorectal Surgery · Ureteric Injury

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.

• Experimental

  Methylene Blue Fluorescence Imaging Arm

  Intravenous Methylene Blue with Fluorescence Imaging for Ureter Identification

1. Proportion of cases in which fluorescence imaging with methylene blue is deemed helpful for identifying the index ureter

   Time frame · Intraoperative - at three predefined stages of the index operation (before dissection, before division of critical structures, and after specimen removal)

No study cites this trial.