Anastomotic leakage and Value Of Indocyanin green in Decreasing leakage rates
- Conditions
- Colorectal resections
- Registration Number
- NL-OMON28098
- Lead Sponsor
- Olympus Nederland BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 978
1.Scheduled for laparoscopic colorectal resection with primary anastomosis;
2.Patients aged over 18 years old;
3.Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
4.Signed informed consent prior to any study-mandated procedure;
1.Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
2.Severe liver insufficiency;
3.Hyperthyroidism or a benign thyroid tumour;
4.Pregnant or breastfeeding women;
5.Scheduled for palliative surgery or terminal ill
6.Any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives (following a detailed medical history and physical examination;
7.Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
8.Emergency surgery
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 90 day leakage rate
- Secondary Outcome Measures
Name Time Method 30 day leakage rate<br>Alteration of surgery <br>30 and 90 day mortality