CClinicalTrials.gg
Sign In
Status unknownNCT04712032AVOIDUpdated Jan 15, 2021

Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

A Phase 3 interventional study of ICG-guided bowel perfusion assessment in Colo-rectal Cancer, Crohn Disease and Resectable Colorectal Carcinoma, sponsored by Leiden University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-15.

Sponsored by Leiden University Medical Center · Phase 3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 6 months after the study started (first participant enrolled Jul 2020, registered Jan 2021).
Phase
Phase 3
Study type
Interventional
Enrollment
978
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colo-rectal Cancer
  • Crohn Disease
  • Resectable Colorectal Carcinoma
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.

This study's planned enrollment of 978 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Leiden University Medical Center is the lead sponsor of 326 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
978 participants (estimated)

Study arms

  • Experimental
    Image Guided Bowel Anastomosis group

    ICG-guided perfusion assessment

    Drug: ICG-guided bowel perfusion assessment

  • No intervention
    Conventional Bowel Anastomosis group

    conventional perfusion assessment

Interventions

  • DrugICG-guided bowel perfusion assessment

    ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.

06

What researchers measure

Primary outcomes

  1. 90-days Anastomotic Leakage (AL) rate

    Anastomotic leakage rate

    Time frame: 90 days

Secondary outcomes

  1. 30-days Anastomotic Leakage ( AL) rate

    Anastomotic leakage rate

    Time frame: 30 days

  2. complication rate

    Time frame: 90 days

  3. mortality

    Time frame: 90 days

  4. days in hospital stay

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • Leiden University Medical Center
    Leiden, Zuid-Holland 2333 ZA, Netherlands
    Recruiting
08

References and documents

Publications

  • Meijer 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. PubMed 35365509 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04712032
Lead sponsor
Leiden University Medical Center
Collaborators
Medical Center Haaglanden, Catharina Ziekenhuis Eindhoven, Haga Hospital, Jeroen Bosch Ziekenhuis, Amphia Hospital, Alrijne Hospital, IJsselland
Responsible party
Alexander Vahrmeijer (Principal Investigator, Leiden University Medical Center) — Principal investigator
First posted
Jan 15, 2021
Start date
Jul 1, 2020
Primary completion
Jul 1, 2022 (estimated)
Completion
Oct 1, 2022 (estimated)
Last update
Jan 15, 2021

Study contacts

Alexander Vahrmeijer, MD, PhD
Contact
a.l.vahrmeijer@lumc.nl
071 526 9111
Ruben Meijer, MD
Contact
r.p.j.meijer@lumc.nl
071 526 9111
Alexander Vahrmeijer, MD, PhD
principal investigator · LUMC

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colorectal Neoplasms→

Other studies from this sponsor

Leiden University Medical Center

Start the discussion