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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Intravenous Methylene Blue

    Drug

    Intravenous Methylene Blue

  • Methylene Blue Fluorescence Imaging System

    Device

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

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Methylene Blue Fluorescence Imaging ArmExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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)

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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