Randomised Controlled Trial of Fluorescent Urography Using Intravenous Methylene Blue Compared to White Light Alone in Left-sided 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 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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

Parallel

Treatments tested in this trial

  • 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

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: Fluorescence Imaging with Intravenous Methylene BlueExperimental treatment 2 interventions
Group B: White Light Visualisation AloneNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Time to identification of the left ureter

Time (in minutes) from peritoneal incision to first visualisation of the left ureter during left-sided colorectal surgery.

Time frame
Intraoperative, from peritoneal incision until the ureter is first seen

Secondary outcomes

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: