Anastomotic Leakage and Value Of Indocyanine Green in Decreasing Leakage Rates

Conditions

Colo-rectal Cancer, Crohn Disease, Resectable Colorectal Carcinoma

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.

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.

2024-08-1344 citations

10.1016/s2468-1253(24)00198-5

AVOID; a phase III, randomised controlled trial using indocyanine green for the prevention of anastomotic leakage in colorectal surgery

R.P. Meijer, Robin A. Faber, Okker D. Bijlstra, Jeffrey P. B. M. Braak, Elma Meershoek‐Klein Kranenbarg et al. (10 authors)

BMJ Open2022-04-0132 citations

10.1136/bmjopen-2021-051144

Interventions

DRUGICG-guided bowel perfusion assessment

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Masking description

Intraoperative imaging is unable to blind the surgeon. Patient is only blinded preoperatively.

Intervention model description

National randomized controlled trial.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

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

Design outcomes

Primary

Measure	Time frame	Description
90-days Anastomotic Leakage (AL) rate	90 days	Anastomotic leakage rate

Secondary

Measure	Time frame	Description
30-days Anastomotic Leakage ( AL) rate	30 days	Anastomotic leakage rate
complication rate	90 days	—
mortality	90 days	—
days in hospital stay	90 days	—

Countries

Netherlands

Contacts

Primary ContactAlexander Vahrmeijer, MD, PhD

a.l.vahrmeijer@lumc.nl071 526 9111

Backup ContactRuben Meijer, MD

r.p.j.meijer@lumc.nl071 526 9111

Outcome results

None listed