Evidence map›Paper›PMID 26123286›Full record

Trial reportBMC surgery2015

Multicentre randomized controlled trial comparing ferric(III)carboxymaltose infusion with oral iron supplementation in the treatment of preoperative anaemia in colorectal cancer patients.

W A A Borstlap, C J Buskens, K M A J Tytgat, J B Tuynman, E C J Consten, R C Tolboom, G Heuff, N van Geloven, B A van Wagensveld, C A C A Wientjes and 12 more

Erratum issued Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC surgery, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02243735 (Multicenter Randomized Controlled Trial Comparing Ferric), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
3.4field-weighted citation impact, top 8% 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.

NCT02243735 phase4unknown statusnot on this map

Multicenter Randomized Controlled Trial Comparing Ferric(III)Carboxymaltose Infusion With Oral Iron Suppletion in the Treatment of Preoperative Anaemia in Colorectal Cancer Patients

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2014 to 2019Enrolled198ConditionsAnemia, Colorectal Carcinoma, SurgeryArmsFerrous fumarate, ferric(III)carboxymaltose
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Article
  6. Iron metabolism in colorectal cancer.Frontiers in oncology · 2023
    Review
  7. Article
  8. Article
  9. Review
  10. Intravenous Irons: From Basic Science to Clinical Practice.Pharmaceuticals (Basel, Switzerland) · 2018
    Review
  11. Article
  12. Review
  13. Review
  14. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 11 institutions in 2 countries.

W A A BorstlapDepartment of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. w.a.borstlap@amc.uva.nl.
C J BuskensDepartment of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
K M A J TytgatDepartment of Gastroenterology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
J B TuynmanDepartment of Surgery, VU University Medical Centre, Amsterdam, The Netherlands.
E C J ConstenDepartment of Surgery, Meander Medical Centre, Amersfoort, The Netherlands.
R C TolboomDepartment of Surgery, Meander Medical Centre, Amersfoort, The Netherlands.
G HeuffDepartment of Surgery, Spaarne Hospital, Hoofddorp, The Netherlands.
N van GelovenDepartment of Surgery, Tergooi Hospital, Hilversum, The Netherlands.
B A van WagensveldDepartment of Surgery, Sint Lucas Andreas Hospital, Amsterdam, The Netherlands.
C A C A WientjesDepartment of Gastroenterology, Sint Lucas Andreas Hospital, Amsterdam, The Netherlands.
M F GerhardsDepartment of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
S M M de CastroDepartment of Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
J JansenDepartment of Gastroenterology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands.
A W H van der VenDepartment of Surgery, Flevo Hospital, Almere, The Netherlands.
E van der ZaagDepartment of Surgery, Gelre Hospital, Apeldoorn, The Netherlands.
J M OmlooDepartment of Surgery, Gelre Hospital, Apeldoorn, The Netherlands.
H L van WestreenenDepartment of Surgery, Isala Hospital, Zwolle, The Netherlands.
D C WinterDepartment of Surgery, St. Vincent's Hospital, Dublin, Ireland.
R P KennellyDepartment of Surgery, St. Vincent's Hospital, Dublin, Ireland.
M G W DijkgraafClinical Research Unit, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
P J TanisDepartment of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
W A BemelmanDepartment of Surgery, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
University of Amsterdam · NLOLVG · NLGelre Hospitals · NLMeander Medisch Centrum · NLSint Lucas Andreas Hospital · NLSt. Vincent's University Hospital · IEAmsterdam UMC Location VUmc · NLDe Kinderkliniek · NLIsala · NLSpaarne Ziekenhuis · NLTergooi · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAt least a third of patients with a colorectal carcinoma who are candidate for surgery, are anaemic preoperatively. Preoperative anaemia is associated with increased morbidity and mortality. In general practice, little attention is paid to these anaemic patients. Some will have oral iron prescribed others not. The waiting period prior to elective colorectal surgery could be used to optimize a patients' physiological status. The aim of this study is to determine the efficacy of preoperative intravenous iron supplementation in comparison with the standard preoperative oral supplementation in anaemic patients with colorectal cancer. METHODS/

designIn this multicentre randomized controlled trial, patients with an M0-staged colorectal carcinoma who are scheduled for curative resection and with a proven iron deficiency anaemia are eligible for inclusion. Main exclusion criteria are palliative surgery, metastatic disease, neoadjuvant chemoradiotherapy (5 × 5 Gy = no exclusion) and the use of Recombinant Human Erythropoietin within three months before inclusion or a blood transfusion within a month before inclusion. Primary endpoint is the percentage of patients that achieve normalisation of the haemoglobin level between the start of the treatment and the day of admission for surgery. This study is a superiority trial, hypothesizing a greater proportion of patients achieving the primary endpoint in favour of iron infusion compared to oral supplementation. A total of 198 patients will be randomized to either ferric(III)carboxymaltose infusion in the intervention arm or ferrofumarate in the control arm. This study will be performed in ten centres nationwide and one centre in Ireland. DISCUSSION: This is the first randomized controlled trial to determine the efficacy of preoperative iron supplementation in exclusively anaemic patients with a colorectal carcinoma. Our trial hypotheses a more profound haemoglobin increase with intravenous iron which may contribute to a superior optimisation of the patient's condition and possibly a decrease in postoperative morbidity.

trial registrationClincalTrials.gov: NCT02243735 .

Indexed as

Administration, OralAdolescentAdultAgedAged, 80 and overAnemia, Iron-DeficiencyClinical ProtocolsColorectal NeoplasmsDietary SupplementsFemaleFerric CompoundsFerrous CompoundsFumaratesHematinicsHumansInfusions, Intravenousferric carboxymaltoseFerric CompoundsFerrous CompoundsFumaratesHematinicsMaltose

Identifiers

PMID26123286
PMCPMC4485873
OpenAlexW1821722194

What OpenQuestion holds

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LicenceCC BY
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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.