Improved and earlier delineation of the course of the ureter by intraoperative fluorescence imaging.
ID
Bron
Verkorte titel
Aandoening
Laparoscopic colorectal surgery, ureter.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Assess 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.
Achtergrond van het onderzoek
Colorectal 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.
Doel van het onderzoek
Improved and earlier delineation of the course of the ureter by intraoperative fluorescence imaging.
Onderzoeksopzet
Primary and secondary outcomes will be assessed during (and after) surgery.
Onderzoeksproduct en/of interventie
Standard 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.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Known methylene blue hypersensitivity;
2. Pregnant, breast-feeding women;
3. Medication use: SSRI’s;
4. Aged < 18 years.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3454 |
| NTR-old | NTR3605 |
| Ander register | METC / CCMO : 12-2-041 / NL40950.068.12; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |