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Real-time intraoperatieve detectie van ureters.


- candidate number12894
- NTR NumberNTR3481
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-jun-2012
- Secondary IDsP10.001 METC LUMC
- Public TitleReal-time intraoperatieve detectie van ureters.
- Scientific TitleIntraoperative Near-Infrared Fluorescence Imaging of ureters using Low-Dose Methylene Blue.
- ACRONYMGREEN LIGHT
- hypothesisFluorescent near-infrared imaging can be used to identify the ureters using a low dose methylene blue.
- Healt Condition(s) or Problem(s) studiedNear-infrared fluorescence imaging, Ureteral damage, Methylene blue
- Inclusion criteria1. Patients planned to undergo surgery in the lower abdomen;
2. Minimum age of 18.
- Exclusion criteria1. Allergy for Methylene blue;
2. Patients using SSRIs, SNRIs of TCAs;
3. Pregnancy;
4. Severe renal impairment;
5. Patients with a G6PD deficiency.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate1-sep-2012
- Target number of participants15
- InterventionsPatients will receive standard of care. During surgery, methylene blue will be injected intravenously to identify the ureters using NIR fluorenscence.
- Primary outcomeIntra-operative identification rate, defined as the number of ureters that were identified with the fluorescent signal of methylene blue during operation.
- Secondary outcome1. Signal-to-background signal of the identified ureters;
2. Difference between dose groups.
- TimepointsThe primary and secondary outcomes will be assessed during surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. C.J.H. Velde, van de
- CONTACT for SCIENTIFIC QUERIESMD, PhD A.L. Vahrmeijer
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryIatrogenous ureteral injury is a rare, but serious complication of lower abdominal surgery. Ureteral damage is often missed and it can lead to severe morbidity such as genitourinary fistula formation or major renal complications. Near-infrared (NIR) fluorescence imaging is a promising technique that offers intraoperative, real-time, visual information during surgery. Methylene blue (MB) becomes a moderate-strength fluorophore emitting at 700 nm when diluted to levels that are almost undetectable to the human eye. Since MB is cleared renally, we hypothesized that low-dose MB can be used as a NIR fluorescent tracer for intraoperative identification of the ureters.
- Main changes (audit trail)
- RECORD13-jun-2012 - 30-jun-2012


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