Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

Study Purpose

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.

Recruitment Criteria

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

More Inclusion & Exclusion Criteria

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

Trial Details

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

Arms & Interventions

Arms

Experimental: Image Guided Bowel Anastomosis group

ICG-guided perfusion assessment

No Intervention: Conventional Bowel Anastomosis group

conventional perfusion assessment

Interventions

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

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International Sites

Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands

Status

Recruiting

Address

Leiden University Medical Center

Leiden, Zuid-Holland, 2333 ZA

Site Contact

Ruben Meijer, MD

r.p.j.meijer@lumc.nl

+31 71 526 9111

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