Evidence map›Paper›PMID 35365509›Full record

Trial reportBMJ open2022

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

Ruben P J Meijer, Robin A Faber, Okker D Bijlstra, Jeffrey P B M Braak, Elma Meershoek-Klein Kranenbarg, Hein Putter, J Sven D Mieog, Koos Burggraaf, Alexander L Vahrmeijer, Denise E Hilling and 1 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04712032 (A PHASE III, RANDOMISED CONTROLLED TRIAL ASSESSING THE VALUE OF INDOCYANINE GREEN IN THE LEAKAGE RATE OF COLORECTAL ANASTOMOSES), which is not on this map. Cited by 19 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 4 pooled it
3.2field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04712032 phase3unknown statusnot on this map

A phase iii, randomised controlled trial assessing the value of indocyanine green in the leakage rate of colorectal anastomoses

TypeinterventionalSponsorLeiden University Medical CenterRan2020 to 2022Enrolled978ConditionsColo-rectal Cancer, Crohn Disease, Resectable Colorectal CarcinomaArmsICG-guided bowel perfusion assessment
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 34 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Ruben P J MeijerDepartment of Surgery, Leiden University Medical Center, Leiden, Netherlands.ORCID 0000-0002-6705-0745
Robin A FaberDepartment of Surgery, Leiden University Medical Center, Leiden, Netherlands.
Okker D BijlstraDepartment of Surgery, Leiden University Medical Center, Leiden, Netherlands.
Jeffrey P B M BraakDepartment of Surgery, Leiden University Medical Center, Leiden, Netherlands.ORCID 0000-0002-0214-3078
Elma Meershoek-Klein KranenbargDepartment of Surgery, Leiden University Medical Center, Leiden, Netherlands.
Hein PutterDepartment of Surgery, Leiden University Medical Center, Leiden, Netherlands.
J Sven D MieogSurgery, Leiden University Medical Center, Leiden, Zuid-Holland, Netherlands.
Koos BurggraafCentre for Human Drug Research, Leiden, South Holland, Netherlands.
Alexander L VahrmeijerSurgery, Leids Universitair Medisch Centrum, Leiden, Zuid-Holland, Netherlands.
Denise E HillingDepartment of Surgery, Leiden University Medical Center, Leiden, Netherlands d.hilling@erasmusmc.nl.
AVOID study group
Leiden University Medical Center · NLCentre for Human Drug Research · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionAnastomotic leakage (AL) is one of the major complications after colorectal surgery. Compromised tissue perfusion at the anastomosis site increases the risk of AL. Several cohort studies have shown that indocyanine green (ICG) combined with fluorescent near-infrared imaging is a feasible and reproducible technique for real-time intraoperative imaging of tissue perfusion, leading to reduced leakage rates after colorectal resection. Unfortunately, these studies were not randomised. Therefore, we propose a randomised controlled trial to assess the value of ICG-guided surgery in reducing AL after colorectal surgery. METHODS AND ANALYSIS: A multicentre, randomised controlled clinical trial will be conducted to assess the benefit of ICG-guided surgery in preventing AL. A total of 978 patients scheduled for colorectal surgery will be included. Patients will be randomised between the Fluorescence Guided Bowel Anastomosis group and the Conventional Bowel Anastomosis group. The primary endpoint is clinically relevant AL (defined as requiring active therapeutic intervention or reoperation) within 90 days after surgery. Among the secondary endpoints are 30-day clinically relevant AL, all-cause postoperative complications, all-cause and AL-related mortality, surgical and non-surgical reinterventions, total surgical time, length of hospital stay and all-cause and AL-related readmittance. ETHICS AND DISSEMINATION: This protocol has been approved by the Medical Ethical Committee Leiden-Den Haag-Delft (METC-LDD) and is registered at ClinicalTrials.gov and trialregister.nl. The results of this study will be reported through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NCT04712032; NL7502.

Indexed as

Colorectal SurgeryDigestive System Surgical ProceduresAnastomosis, SurgicalAnastomotic LeakHumansIndocyanine GreenIndocyanine GreenGastrointestinal imagingGastrointestinal tumoursInflammatory bowel diseaseSURGERY

Identifiers

PMID35365509
PMCPMC8977759
OpenAlexW4221033479

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.