No registrations found.
ID
Source
Brief title
Health condition
Laparoscopic colorectal surgery, ureter.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
Fluorescence of the ureter on different time points after injection.
Background summary
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.
Study objective
Improved and earlier delineation of the course of the ureter by intraoperative fluorescence imaging.
Study design
Primary and secondary outcomes will be assessed during (and after) surgery.
Intervention
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.
Inclusion criteria
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.
Exclusion criteria
1. Known methylene blue hypersensitivity;
2. Pregnant, breast-feeding women;
3. Medication use: SSRI’s;
4. Aged < 18 years.
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 | NL3454 |
| NTR-old | NTR3605 |
| Other | METC / CCMO : 12-2-041 / NL40950.068.12; |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |