Decrease in leakage rate for the ICG group
Bron
Verkorte titel
Aandoening
Colorectal resections
Ondersteuning
Olympus Nederland BV
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
90 day leakage rate
Achtergrond van het onderzoek
Rationale: 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.
Objective: The primary objective is to compare the difference in clinically relevant AL rate between perfusion assessment with ICG and standard surgery in colorectal anastomoses.
Study design: National randomized controlled trial. Total of 978 patients in two evenly distributed groups.
Study population: Patients aged over 18 years old scheduled for laparoscopic colorectal resection with primary anastomosis.
Intervention: Patients will be allocated to two groups; Image Guided Bowel Anastomosis group (IGBA) or the Conventional Bowel Anastomosis group (CBA). Patients in the IGBA group will receive a repeated dose of 5 milligram ICG, with a maximum of 10 milligram per patient. Imaging of the anastomosis will take place right after bowel resection and after finalization of the anastomosis. Based on the surgeon’s evaluation he or she may change the level of the anastomosis.
The CBA group will receive no study related intervention. The decision of the level of anastomosis in this group is made according to the current standard of care.
In both groups the anastomosis is created by the surgeon’s preference.
Main study parameters/endpoints: The main endpoint is the clinically relevant anastomosis leakage rate at 90 days.
Doel van het onderzoek
Decrease in leakage rate for the ICG group
Onderzoeksopzet
Interim analysis after 50% of patients completed the 90 days
Onderzoeksproduct en/of interventie
ICG during bowell perfusion assessment
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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;
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7502 |
CCMO | NL68858.058.19. |