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

NCT07835932 | Not Yet Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: Ureter MB RCT
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Surgery; Ureter

Keywords

Methylene Blue; Fluorescence imaging; Ureter identification; Colorectal surgery; Image-guided surgery

Outcome Measures

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.

  Intraoperative, from peritoneal incision until the ureter is first seen

Study Arms (2)

Fluorescence Imaging with Intravenous Methylene Blue

EXPERIMENTAL

Fluorescence Imaging with Intravenous Methylene Blue

Drug: Intravenous Methylene blue; Device: Fluorescence Imaging Device for Methylene Blue

White Light Visualisation Alone

NO INTERVENTION

White Light Visualisation Alone

Interventions

Intravenous Methylene blue DRUG

Intravenous methylene blue 0.5-1.0 mg/kg administered intraoperatively for fluorescence ureter identification.

Fluorescence Imaging with Intravenous Methylene Blue

Fluorescence Imaging Device for Methylene Blue DEVICE

Modified Stryker 1688 Fluorescence Laparoscopic System with additional filter

Fluorescence Imaging with Intravenous Methylene Blue

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Central Study Contacts

Trevor Yeung, MA, MBBChir, DPhil, FRCS

CONTACT

+852 3505 1495; uretertrial@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 17, 2026
• First Posted: September 23, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)