Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2016-05-09
2017-05-02
Brief Summary
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Methylene blue has been safely given to patients for many years and it is fluorescent. It is removed by the kidney and will therefore travel through the ureters. Methylene blue shines brightly (becomes fluorescent) when viewed under red light.
This study aims to compare the ability of methylene blue with white light to identify the location of the ureters during colorectal surgery. Recruitment will include 50 patients undergoing colorectal surgery (25 for keyhole/laparoscopic, 25 for open procedures). Each patient will act as their own control.
To detect the fluorescence, a special fluorescent laparoscope for keyhole surgery will be utilised, and a wide-field camera will be used for open surgery.
The potential benefits of this procedure are to identify the ureters during surgery and therefore prevent inadvertent damage to them
It is hoped that near infra-red light emitting from the ureters will be detected. This will allow the surgeon to determine the anatomy of the ureters during the operation and avoid inadvertent injury.
Funding source: Nuffield Department of Surgical Sciences, University of Oxford Recruitment sites: Oxford University Hospitals NHS Trust.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Methylene Blue
Intravenous administration of methylene blue and assessment of ureteric fluorescence intraoperatively.
Methylene Blue
As described above. Intravenous injection with visualisation via fluorescence enabled laparoscope.
Interventions
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Methylene Blue
As described above. Intravenous injection with visualisation via fluorescence enabled laparoscope.
Eligibility Criteria
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Inclusion Criteria
* Male or Female, aged 18 years or above.
* Patients undergoing laparoscopic or open colorectal surgery
* In the Investigator's opinion, is able and willing to comply with all study requirements.
Exclusion Criteria
* Patient who is unable or unwilling to give informed consent
* Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
* Significant renal or hepatic impairment.
* Any patients with previous allergies to Methylene Blue
* Any patients at risk of serotonin syndrome, including those taking serotonin reuptake inhibitors (SSRIs) or serotonin reuptake inhibitors (e.g. duloxetine, sibutramine, venlafaxine, clomipramine, imipramine)
* Patients with glucose-6-phosphate dehydrogenase (G6PD deficiency)
18 Years
ALL
Yes
Sponsors
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University of Oxford
OTHER
Responsible Party
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Principal Investigators
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Trevor Yeung, MBChB
Role: PRINCIPAL_INVESTIGATOR
University of Oxford
Locations
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Oxford University Hospitals NHS Foundation Trust
Oxford, Oxfordshire, United Kingdom
Countries
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Other Identifiers
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10871
Identifier Type: -
Identifier Source: org_study_id
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