No registrations found.
ID
Source
Brief title
Health condition
ureteral damage, Near infrared fluorescence imaging, Methylene blue
Sponsors and support
Intervention
Outcome measures
Primary outcome
Intra-operative identification rate, defined as the number of ureters that were identified with the fluorescent signal of methylene blue during operation.
Secondary outcome
1. Signal-to-background signal of the identified ureters;
2. Difference between dose groups.
Background summary
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.
Study objective
Fluorescent near-infrared imaging can be used to identify the ureters using a low dose methylene blue.
Study design
The primary and secondary outcomes will be assessed during surgery.
Intervention
Patients will receive standard of care. During surgery, methylene blue will be injected intravenously to identify the ureters using NIR fluorenscence.
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
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
Inclusion criteria
1. Patients planned to undergo surgery in the lower abdomen;
2. Minimum age of 18.
Exclusion criteria
1. Allergy for Methylene blue;
2. Patients using SSRIs, SNRIs of TCAs;
3. Pregnancy;
4. Severe renal impairment;
5. Patients with a G6PD deficiency.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3349 |
| NTR-old | NTR3481 |
| Other | METC LUMC : P10.001 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |