Anastomotic leakage and Value Of Indocyanin green in Decreasing leakage rates

A Phase III, Randomised Controlled Trial Assessing the Value of Indocyanine Green in the Leakage Rate of Colorectal Anastomoses.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28098

Enrollment

978

Registered

2019-01-30

Start date

2020-03-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal resections

Interventions

ICG during bowell perfusion assessment

Eligibility

Inclusion criteria

Inclusion criteria: 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;

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
90 day leakage rate	—

Secondary

Measure	Time frame
30 day leakage rate Alteration of surgery 30 and 90 day mortality	—

Contacts

Public ContactRuben Meijer

LUMC

r.p.j.meijer@lumc.nl0628431784

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)