Real-time intraoperative near-infrared fluorescence ureteral guidance in laparoscopic colorectal surgery: a feasibility study

Recruiting

Conditions: colorectal cancer
crohn's disease
inflammatory bowel disease
10017943
10017998

Registration Number: NL-OMON41258

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 10

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

Not able to give written informed consent
Known methylene blue hypersensitivity
Pregnant, breast-feeding women
Aged < 18 years
Use of medication: SSRIs
Not willing to participate

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Intraoperative earlier and clearer identification of ureter<br /><br><br /><br>Assessment of NIRF technique, by:<br /><br>- Video analysis<br /><br>- Intraoperative registration form:<br /><br>--> Recognition of the ureter: identification of the ureter at set time<br /><br>points: at least every 2 minutes during the phase of identifying the course of<br /><br>the ureter.<br /><br>--> Speed and efficiency of the procedure<br /><br>--> Safety of the procedure<br /><br><br /><br>Time measurement:<br /><br>- time until ureteral identification is obtained<br /><br>- total operating time<br /><br><br /><br>Later on, this can be compared to conventional laparoscopic colorectal<br /><br>procedures.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>We will register complications caused during the procedure:<br /><br>- Ureteral injury<br /><br><br /><br>We will register unsuspected adverse effects of the administered fluorescent<br /><br>dye.</p><br>