- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04712032
Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates (AVOID)
January 14, 2021 updated by: Alexander Vahrmeijer, Leiden University Medical Center
A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES
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.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
978
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Alexander Vahrmeijer, MD, PhD
- Phone Number: 071 526 9111
- Email: a.l.vahrmeijer@lumc.nl
Study Contact Backup
- Name: Ruben Meijer, MD
- Phone Number: 071 526 9111
- Email: r.p.j.meijer@lumc.nl
Study Locations
-
-
Zuid-Holland
-
Leiden, Zuid-Holland, Netherlands, 2333 ZA
- Recruiting
- Leiden University Medical Center
-
Contact:
- Ruben Meijer, MD
- Phone Number: +31 71 526 9111
- Email: r.p.j.meijer@lumc.nl
-
Contact:
- Robin Faber
- Email: r.a.faber@lumc.nl
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Image Guided Bowel Anastomosis group
ICG-guided perfusion assessment
|
ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.
|
No Intervention: Conventional Bowel Anastomosis group
conventional perfusion assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
90-days Anastomotic Leakage (AL) rate
Time Frame: 90 days
|
Anastomotic leakage rate
|
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality
Time Frame: 90 days
|
90 days
|
|
30-days Anastomotic Leakage ( AL) rate
Time Frame: 30 days
|
Anastomotic leakage rate
|
30 days
|
complication rate
Time Frame: 90 days
|
90 days
|
|
days in hospital stay
Time Frame: 90 days
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexander Vahrmeijer, MD, PhD, LUMC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2020
Primary Completion (Anticipated)
July 1, 2022
Study Completion (Anticipated)
October 1, 2022
Study Registration Dates
First Submitted
January 14, 2021
First Submitted That Met QC Criteria
January 14, 2021
First Posted (Actual)
January 15, 2021
Study Record Updates
Last Update Posted (Actual)
January 15, 2021
Last Update Submitted That Met QC Criteria
January 14, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P19.079
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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