Fluorescent near-infrared imaging can be used to identify the ureters using a low dose methylene blue.
ID
Bron
Verkorte titel
Aandoening
ureteral damage, Near infrared fluorescence imaging, Methylene blue
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Intra-operative identification rate, defined as the number of ureters that were identified with the fluorescent signal of methylene blue during operation.
Achtergrond van het onderzoek
Iatrogenous 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 ¡Ö 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.
Doel van het onderzoek
Fluorescent near-infrared imaging can be used to identify the ureters using a low dose methylene blue.
Onderzoeksopzet
The primary and secondary outcomes will be assessed during surgery.
Onderzoeksproduct en/of interventie
Patients will receive standard of care. During surgery, methylene blue will be injected intravenously to identify the ureters using NIR fluorenscence.
Publiek
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Wetenschappelijk
Department of Surgical Oncology,
P.O. Box 9600
C.J.H. Velde, van de
Leiden 2300 RC
The Netherlands
+31 (0)71 5262309
c.j.h.van_de_velde@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Patients planned to undergo surgery in the lower abdomen;
2. Minimum age of 18.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Allergy for Methylene blue;
2. Patients using SSRIs, SNRIs of TCAs;
3. Pregnancy;
4. Severe renal impairment;
5. Patients with a G6PD deficiency.
Opzet
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| Register | ID |
|---|---|
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