Evidence map›Paper›PMID 26314740›Full record

Trial reportTrials2015

The PRECious trial PREdiction of Complications, a step-up approach, CRP first followed by CT-scan imaging to ensure quality control after major abdominal surgery: study protocol for a stepped-wedge trial.

Jennifer Straatman, Miguel A Cuesta, W H Hermien Schreurs, Boudewijn J Dwars, Huib A Cense, Herman Rijna, D J A Eric Sonneveld, Frank C den Boer, Elly S M de Lange-de Klerk, Donald L van der Peet

Registry-linked trialOpen access · goldAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02102217 (PREdiction of Complications), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 15% 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.

NCT02102217 nacompletednot on this map

PREdiction of Complications: A Step-up Approach, CRP First Followed by CT-scan Imaging to Ensure Quality Control After Major Abdominal Surgery

TypeinterventionalSponsorAmsterdam UMC, location VUmcRan2015 to 2020Enrolled525ConditionsPostoperative ComplicationsArmsPRECious
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 18 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Long-Term Survival After Complications Following Major Abdominal Surgery.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2016
    Observational
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

10 authors at 7 institutions in 1 country.

Jennifer StraatmanDepartment of Gastrointestinal Surgery, VU Medical Center, De Boelelaan 1117, 1081, , HV, Amsterdam, The Netherlands. je.straatman@vumc.nl.
Miguel A CuestaDepartment of Gastrointestinal Surgery, VU Medical Center, De Boelelaan 1117, 1081, , HV, Amsterdam, The Netherlands. ma.cuesta@vumc.nl.
W H Hermien SchreursDepartment of Surgery, Medisch Centrum Alkmaar, Wilhelminalaan 12, 1815, , JD, Alkmaar, The Netherlands. w.h.schreurs@mca.nl.
Boudewijn J DwarsDepartment of Surgery, Slotervaart Ziekenhuis, Louseweg 6, 1066, , EC, Amsterdam, The Netherlands. chbdw@slz.nl.
Huib A CenseDepartment of Surgery, Rode Kruis Ziekenhuis, Vondellaan 13, 1942, , LE, Beverwijk, The Netherlands. hcense@rkz.nl.
Herman RijnaDepartment of Surgery, Spaarne Gasthuis, Vondelweg 999, 2026, , BW, Haarlem, The Netherlands. rijna@kg.nl.
D J A Eric SonneveldDepartment of Surgery, Westfries Gasthuis, Maelsonstraat 3, 1624, , NP, Hoorn, The Netherlands. dja.sonneveld@westfriesgasthuis.nl.
Frank C den BoerDepartment of Surgery, Zaans Medisch Centrum, Koningin Julianaplein 58, 1502, , DV, Zaandam, The Netherlands. boer.f@zaansmc.nl.
Elly S M de Lange-de KlerkDepartment of Epidemiology and Biostatistics, VU Medical Center, De Boelelaan 1117, 1081, , HV, Amsterdam, The Netherlands. esm.delange@vumc.nl.
Donald L van der PeetDepartment of Gastrointestinal Surgery, VU Medical Center, De Boelelaan 1117, 1081, , HV, Amsterdam, The Netherlands. d.vdpeet@vumc.nl.
Amsterdam UMC Location VUmc · NLMedisch Centrum Alkmaar · NLRode Kruis Ziekenhuis · NLSlotervaartziekenhuis · NLSpaarne Gasthuis · NLWestfriesgasthuis · NLZaans Medisch Centrum · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAfter major abdominal surgery (MAS), 20% of patients endure major complications, which require invasive treatment and are associated with increased morbidity and mortality. A quality control algorithm after major abdominal surgery aimed at early identification of patients at risk of developing major complications can decrease associated morbidity and mortality. Literature studies show promising results for C-reactive protein (CRP) as an early marker for postoperative complications, however clinical significance has yet to be determined.

methodsA multicenter, stepped wedge, prospective clinical trial including all adult patients planned to undergo elective MAS. The first period consists of standard postoperative monitoring, which entails on demand additional examinations. This is followed by a period with implementation of postoperative control according to the PRECious protocol, which implicates standardized measurement of CRP levels. If CRP levels exceed 140 mg/L on postoperative day 3,4 or 5, an enhanced CT-scan is performed. Primary outcome in this study is a combined primary outcome, entailing all morbidity and mortality due to postoperative complications. Complications are graded according to the Clavien-Dindo classification. Secondary outcomes are hospital length of stay, patients reported outcome measures (PROMs) and cost-effectiveness. Data will be collected during admission, three months and one year postoperatively. Approval by the medical ethics committee of the VU University Medical Center was obtained (ID 2015.114). DISCUSSION: the PRECious trial is a stepped-wedge, multicenter, open label, prospective clinical trial to determine the effect of a standardized postoperative quality control algorithm on postoperative morbidity and mortality, and cost-effectiveness.

trial registrationwww.ClinicalTrials.gov, NCT02102217. Registered 5 February 2015.

Indexed as

Tomography, X-Ray ComputedAbdomenAlgorithmsBiomarkersClinical ProtocolsC-Reactive ProteinDigestive System Surgical ProceduresEarly DiagnosisElective Surgical ProceduresHumansNetherlandsPostoperative ComplicationsPredictive Value of TestsProspective StudiesQuality ControlQuality Indicators, Health CareBiomarkersC-Reactive Protein

Identifiers

PMID26314740
PMCPMC4552415
OpenAlexW2108352471

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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.