Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:1. Scheduled for laparoscopic or robotic-assisted 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;
Exclusion Criteria:1. Known allergy or history of adverse reaction to ICG, iodine or iodine dyes; 2. Severe liver or kidney insufficiency; 3. Hyperthyroidism or a benign thyroid tumour; 4. Pregnant or breastfeeding women; 5. Scheduled for palliative surgery or terminal ill. 6. Scheduled for a diverting stoma. 7. 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; 8. Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid; 9. Emergency surgery
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Leiden University Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Alexander Vahrmeijer, MD, PhD|
|Principal Investigator Affiliation||LUMC|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Colo-rectal Cancer, Crohn Disease, Resectable Colorectal Carcinoma|
Experimental: Image Guided Bowel Anastomosis group
ICG-guided perfusion assessment
No Intervention: Conventional Bowel Anastomosis group
conventional perfusion assessment
Drug: - ICG-guided bowel perfusion assessment
ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.