colorectal cancer crohn's disease inflammatory bowel disease
Conditions
Interventions
Study subjects receive 1 intravenous injection of methylene blue (dose:
0.5mg/kg bodyweight
= 10mg/ml methylene blue).
Methylene blue will be administered directly after induction of anesthesia, to
obtain intraoperative fluorescence imaging of the ureter using the Karl Storz
laparoscopic
Sponsors
Medisch Universitair Ziekenhuis Maastricht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients scheduled for laparoscopic colorectal surgery (i.e. rectal surgery, sigmoid resection, right hemicolectomy or ileocecal resection) Able to understand the nature of the study and what will be required of them Males and females (not pregnant) Age >18 years No hypersensitivity for methylene blue Willing to participate
Exclusion criteria
Exclusion criteria: Not able to give written informed consent Known methylene blue hypersensitivity Pregnant, breast-feeding women Aged
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative earlier and clearer identification of ureter Assessment of NIRF technique, by: - Video analysis - Intraoperative registration form: --> Recognition of the ureter: identification of the ureter at set time points: at least every 2 minutes during the phase of identifying the course of the ureter. --> Speed and efficiency of the procedure --> Safety of the procedure Time measurement: - time until ureteral identification is obtained - total operating time Later on, this can be compared to conventional laparoscopic colorectal procedures. | — |
Secondary
| Measure | Time frame |
|---|---|
| We will register complications caused during the procedure: - Ureteral injury We will register unsuspected adverse effects of the administered fluorescent dye. | — |
Countries
Netherlands
Outcome results
None listed