Real-time intraoperatieve detectie van ureters.

Intraoperative Near-Infrared Fluorescence Imaging of ureters using Low-Dose Methylene Blue.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20719

Enrollment

Registered

2012-06-13

Start date

2012-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ureteral damage, Near infrared fluorescence imaging, Methylene blue

Interventions

Patients will receive standard of care. During surgery, methylene blue will be injected intravenously to identify the ureters using NIR fluorenscence.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients planned to undergo surgery in the lower abdomen; 2. Minimum age of 18.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
Intra-operative identification rate, defined as the number of ureters that were identified with the fluorescent signal of methylene blue during operation.	—

Secondary

Measure	Time frame
1. Signal-to-background signal of the identified ureters; 2. Difference between dose groups.	—

Contacts

Public ContactC.J.H. Velde, van de

Leiden University Medical Center (LUMC), Department of Surgical Oncology, P.O. Box 9600

c.j.h.van_de_velde@lumc.nl+31 (0)71 5262309

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)