search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Fluorescentiebeeldvorming van de ureter tijdens kijkoperaties van de dikkedarm.


- candidate number13304
- NTR NumberNTR3605
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-sep-2012
- Secondary IDs12-2-041 / NL40950.068.12; METC / CCMO
- Public TitleFluorescentiebeeldvorming van de ureter tijdens kijkoperaties van de dikkedarm.
- Scientific TitleReal-time intraoperative near-infrared fluorescence ureteral guidance in laparoscopic colorectal surgery: A feasibility study.
- ACRONYMNIRF-Ureter
- hypothesisImproved and earlier delineation of the course of the ureter by intraoperative fluorescence imaging.
- Healt Condition(s) or Problem(s) studiedLaparoscopic colorectal surgery, Ureter
- Inclusion criteria1. Patients scheduled for laparoscopic colorectal surgery (i.e. rectal surgery, sigmoid resection, right hemicolectomy or ileocecal resection);
2. Males and females (not pregnant);
3. Age >18 years;
4. No hypersensitivity for methylene blue.
- Exclusion criteria1. Known methylene blue hypersensitivity;
2. Pregnant, breast-feeding women;
3. Medication use: SSRIís;
4. Aged < 18 years.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-sep-2012
- planned closingdate1-feb-2013
- Target number of participants10
- InterventionsStandard laparoscopic colorectal surgery will be performed after preoperative intravenous administration of optical dye methylene blue. Using a dedicated laparoscopic device (for both white light and fluorescence imaging) the ureter will be visualized non-invasively during surgery.
- Primary outcomeAssess the feasibility of earlier and more clear identification of the course of the ureter by fluorescence imaging: comparing the conventional white light image to the fluorescence image.
- Secondary outcomeFluorescence of the ureter on different time points after injection.
- TimepointsPrimary and secondary outcomes will be assessed during (and after) surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. R.M. Schols
- CONTACT for SCIENTIFIC QUERIESMD. PhD. L.P.S. Stassen
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Maastricht University Medical Center (MUMC+)
- PublicationsN/A
- Brief summaryColorectal surgery is the latest form of high-volume-surgery for which laparoscopic techniques have now widely been introduced. Ureteral injury during this surgery is rare but, when it occurs, it can be a serious problem. The early detection and prevention of ureteral injury are important. Fluorescence ureteral identification with preoperative methylene blue administration is a promising new technique for easier and earlier intraoperative visualization of the ureter. Aim of this prospective observational study is to assess the feasibility and image quality of fluorescence imaging of the ureter during laparoscopic colorectal surgery, using a newly developed laparoscopic fluorescence system.
- Main changes (audit trail)
- RECORD11-sep-2012 - 26-sep-2012


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl