Evidence map›Paper›PMID 41998794›Full record

ArticleTrials2026

Statistical analysis plan for Fluid Optimisation in Emergency Laparotomy (FLO-ELA) Trial; a multi-centre randomised trial of cardiac output-guided fluid therapy compared to usual care in patients undergoing major emergency gastrointestinal surgery.

Neil J Walker, Gordon Forbes, Brennan C Kahan, Melanie Smuk, Rachel Phillips, Olivier Quintin, Kim May Lee, Mark R Edwards

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

8 authors.

Neil J WalkerPragmatic Clinical Trials Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, Queen, UK. neil.walker@qmul.ac.uk.ORCID http://orcid.org/0000-0001-8265-518X
Gordon ForbesDepartment of Biostatistics & Health Informatics, Institute of Psychiatry, King's College London, Psychology & Neuroscience, London, UK.
Brennan C KahanMRC Clinical Trials Unit at UCL, University College London, London, UK.
Melanie SmukCentre for Genomics & Child Health, Blizard Institute, Queen Mary University of London, London, UK.
Rachel PhillipsImperial Clinical Trials Unit, School of Public Health, Imperial College London, London, UK.
Olivier QuintinPragmatic Clinical Trials Unit, Wolfson Institute of Population Health, Queen Mary University of London, London, Queen, UK.
Kim May LeeDepartment of Biostatistics & Health Informatics, Institute of Psychiatry, King's College London, Psychology & Neuroscience, London, UK.
Mark R EdwardsDepartment of Anaesthesia, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust, Tremona Road, Southampton, SO16 6YD, UK.

Funding

Health Technology Assessment Programme 15/80/54
6 · The paper itself

Abstract

backgroundFLO-ELA is a multi-centre, parallel-group, open-label, randomised controlled trial (RCT) looking at the effect of minimally invasive cardiac output monitoring in the management of patients aged 50 years and above undergoing emergency gastrointestinal surgery. The primary outcome is days alive and out of hospital within 90 days of randomisation (DAOH-90). This article describes the statistical analysis plan (SAP) for this trial. The estimand and analytical approach presented here may be appropriate for clinical trials in a similar setting (critical care surgery). METHODS AND

designFLO-ELA is a superiority trial, incorporating an early-stage pilot phase, conducted at 63 UK hospitals. Participants are randomised on a 1:1 basis to the intervention or control group using a minimisation algorithm which balances on the following two factors (i) age, split into 3 groups, and (ii) American Society of Anesthesiologists (ASA) category, 5 categories on an ordinal scale reflecting participants' baseline co-morbidities. In this SAP, we define the estimands and strategies for handling intercurrent events for each study outcome, then give a detailed description of planned analyses including general analytical principles, analytical framework for primary, secondary and process measure outcomes, approach to missing data and supplementary analyses looking at heterogeneity in treatment effect between key subgroups and potential differences in outcomes pre and post onset of Covid pandemic in the UK.

trial registrationISRCTN 14729158. Registered on 02 May 2017.

Indexed as

Cardiac OutputDigestive System Surgical ProceduresFluid TherapyLaparotomyData Interpretation, StatisticalEquivalence Trials as TopicHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeUnited KingdomDays alive and out of hospitalEmergency laparotomyEstimandLength of stayMortalityPerioperative careStatistical analysis plan

Identifiers

PMID41998794
PMCPMC13217997

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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.