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

NCTNCT07835932Other idUreter MB RCT

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Overview

Status: Not yet recruiting
Phase: Phase 4
Enrollment: 108 participants (estimated)
Sponsor: Chinese University of Hong Kong · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
Hong Kong
Start: 1 Oct 2026 (estimated)
Primary completion: 1 Oct 2028 (estimated)
Completion: 1 Oct 2029 (estimated)
First posted: 23 Sept 2026
Last update posted: 23 Sept 2026
Conditions: Colorectal Surgery · Ureter

Timeline

1 trial · 1 not yet recruiting

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20262027202820292030

Ph 4
Randomised Controlled Trial of Fluorescent Urography Using Intravenous Methylene Blue Compared to White Light Alone in Left-sided Colorectal Surgery
NCT07835932
est. 1 Oct 2026 to est. 1 Oct 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Intravenous Methylene blueDrug
Fluorescence Imaging Device for Methylene BlueDevice

Arms2

Experimental
Fluorescence Imaging with Intravenous Methylene Blue
Fluorescence Imaging with Intravenous Methylene Blue
No intervention
White Light Visualisation Alone
White Light Visualisation Alone

Primary outcomes1

Outcomes the sponsor listed as primary.

Time to identification of the left ureter
Time frame · Intraoperative, from peritoneal incision until the ureter is first seen
Registry description
Time (in minutes) from peritoneal incision to first visualisation of the left ureter during left-sided colorectal surgery.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * 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. Exclusion Criteria: * 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) * Significant renal or hepatic impairment * Presence of renal or ureteric obstruction * History of G6PD deficiency (risk of hemolytic anemia)

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