Anastomotic leakage (AL) is one of the major complications after gastrointestinal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Indocyanine green (ICG) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. Unfortunately, these studies were not randomized. Therefore, we propose a nationwide randomized controlled trial to identify the value of ICG for AL in colorectal anastomosis.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
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. |
Interventional |
Eligible Ages | 18 Years and Over |
Gender | All |
Trial ID:
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. |
NCT04712032 |
Phase
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. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Leiden University Medical Center |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Alexander Vahrmeijer, MD, PhD |
Principal Investigator Affiliation | LUMC |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Recruiting |
Countries | Netherlands |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Colo-rectal Cancer, Crohn Disease, Resectable Colorectal Carcinoma |
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