Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates
AVOID
A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES
1 other identifier
interventional
978
1 country
1
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) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 colorectal-cancer
Started Jul 2020
Shorter than P25 for phase_3 colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2020
CompletedFirst Submitted
Initial submission to the registry
January 14, 2021
CompletedFirst Posted
Study publicly available on registry
January 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedJanuary 15, 2021
January 1, 2021
2 years
January 14, 2021
January 14, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
90-days Anastomotic Leakage (AL) rate
Anastomotic leakage rate
90 days
Secondary Outcomes (4)
30-days Anastomotic Leakage ( AL) rate
30 days
complication rate
90 days
mortality
90 days
days in hospital stay
90 days
Study Arms (2)
Image Guided Bowel Anastomosis group
EXPERIMENTALICG-guided perfusion assessment
Conventional Bowel Anastomosis group
NO INTERVENTIONconventional perfusion assessment
Interventions
ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Leiden University Medical Centerlead
- Medical Center Haaglandencollaborator
- Catharina Ziekenhuis Eindhovencollaborator
- Haga Hospitalcollaborator
- Jeroen Bosch Ziekenhuiscollaborator
- Amphia Hospitalcollaborator
- Alrijne Hospitalcollaborator
- IJssellandcollaborator
Study Sites (1)
Leiden University Medical Center
Leiden, South Holland, 2333 ZA, Netherlands
Related Publications (2)
Faber RA, Meijer RPJ, Droogh DHM, Jongbloed JJ, Bijlstra OD, Boersma F, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Holman FA, Mieog JSD, Neijenhuis PA, van Staveren E, Bloemen JG, Burger JWA, Aukema TS, Brouwers MAM, Marinelli AWKS, Westerterp M, Doornebosch PG, van der Weijde A, Bosscha K, Handgraaf HJM, Consten ECJ, Sikkenk DJ, Burggraaf J, Keereweer S, van der Vorst JR, Hutteman M, Peeters KCMJ, Vahrmeijer AL, Hilling DE. Indocyanine green near-infrared fluorescence bowel perfusion assessment to prevent anastomotic leakage in minimally invasive colorectal surgery (AVOID): a multicentre, randomised, controlled, phase 3 trial. Lancet Gastroenterol Hepatol. 2024 Oct;9(10):924-934. doi: 10.1016/S2468-1253(24)00198-5. Epub 2024 Aug 13.
PMID: 39151436DERIVEDMeijer RPJ, Faber RA, Bijlstra OD, Braak JPBM, Meershoek-Klein Kranenbarg E, Putter H, Mieog JSD, Burggraaf K, Vahrmeijer AL, Hilling DE; AVOID study group. AVOID; a phase III, randomised controlled trial using indocyanine green for the prevention of anastomotic leakage in colorectal surgery. BMJ Open. 2022 Apr 1;12(4):e051144. doi: 10.1136/bmjopen-2021-051144.
PMID: 35365509DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Vahrmeijer, MD, PhD
LUMC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Intraoperative imaging is unable to blind the surgeon. Patient is only blinded preoperatively.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
January 14, 2021
First Posted
January 15, 2021
Study Start
July 1, 2020
Primary Completion
July 1, 2022
Study Completion
October 1, 2022
Last Updated
January 15, 2021
Record last verified: 2021-01
Data Sharing
- IPD Sharing
- Will not share