Status:
UNKNOWN
Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Medical Center Haaglanden
Catharina Ziekenhuis Eindhoven
Conditions:
Colo-rectal Cancer
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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) combin...
Eligibility Criteria
Inclusion
- Scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis;
- Patients aged over 18 years old;
- Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions;
- Signed informed consent prior to any study-mandated procedure;
Exclusion
- Known allergy or history of adverse reaction to ICG, iodine or iodine dyes;
- Severe liver or kidney insufficiency;
- Hyperthyroidism or a benign thyroid tumour;
- Pregnant or breastfeeding women;
- Scheduled for palliative surgery or terminal ill
- Scheduled for a diverting stoma
- 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;
- Subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid;
- Emergency surgery
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2022
Estimated Enrollment :
978 Patients enrolled
Trial Details
Trial ID
NCT04712032
Start Date
July 1 2020
End Date
October 1 2022
Last Update
January 15 2021
Active Locations (1)
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1
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333 ZA