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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04712032
Other study ID # P19.079
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date July 1, 2020
Est. completion date October 1, 2022

Study information

Verified date January 2021
Source Leiden University Medical Center
Contact Alexander Vahrmeijer, MD, PhD
Phone 071 526 9111
Email a.l.vahrmeijer@lumc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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) 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 information / eligibility

Status Recruiting
Enrollment 978
Est. completion date October 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
ICG-guided bowel perfusion assessment
ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.

Locations

Country Name City State
Netherlands Leiden University Medical Center Leiden Zuid-Holland

Sponsors (8)

Lead Sponsor Collaborator
Leiden University Medical Center Alrijne Hospital, Amphia Hospital, Catharina Ziekenhuis Eindhoven, Haga Hospital, IJsselland, Jeroen Bosch Ziekenhuis, Medical Center Haaglanden

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary 90-days Anastomotic Leakage (AL) rate Anastomotic leakage rate 90 days
Secondary 30-days Anastomotic Leakage ( AL) rate Anastomotic leakage rate 30 days
Secondary complication rate 90 days
Secondary mortality 90 days
Secondary days in hospital stay 90 days
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