Evidence map›Paper›PMID 26370286›Full record

Trial reportTrials2015

A comparison of Percutaneous femoral access in Endovascular Repair versus Open femoral access (PiERO): study protocol for a randomized controlled trial.

Bastiaan P Vierhout, Ben R Saleem, Alewijn Ott, Jan Maarten van Dijl, Ties D van Andringa de Kempenaer, Maurice E N Pierie, Jan T Bottema, Clark J Zeebregts

Open access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
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. Cited by 5 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 4 pooled it
1.2field-weighted citation impact, top 20% 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.

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

5 citing papers in PubMed, 4 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Transverse versus vertical groin incision for femoral artery approach.The Cochrane database of systematic reviews · 2020
    Pooled it
  4. Pooled it
  5. Article
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 at 5 institutions in 1 country.

Bastiaan P VierhoutDepartment of Surgery, Wilhelmina Ziekenhuis Assen, Europaweg-Zuid 1, 9401 RK, Assen, The Netherlands. bas.vierhout@wza.nl.
Ben R SaleemDepartment of Surgery (Division of Vascular Surgery), University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. r.b.saleem@gmail.com.
Alewijn OttDepartment of Microbiology, CERTE, Groningen, The Netherlands. a.ott@certe.nl.
Jan Maarten van DijlDepartment of Medical Microbiology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. j.m.van.dijl@med.umcg.nl.
Ties D van Andringa de KempenaerDepartment of Surgery, Medical Center Leeuwarden, Leeuwarden, The Netherlands. t.van.andringa.de.kempenaer@znb.nl.
Maurice E N PierieDepartment of Vascular Surgery, Isala Hospital, Zwolle, The Netherlands. m.pierie@isala.nl.
Jan T BottemaDepartment of Surgery, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. j.t.bottema@umcg.nl.
Clark J ZeebregtsDepartment of Surgery (Division of Vascular Surgery), University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. c.j.a.m.zeebregts@umcg.nl.
University Medical Center Groningen · NLCanisius-Wilhelmina Ziekenhuis · NLCerte · NLIsala · NLMedisch Centrum Leeuwarden · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAccess for endovascular repair of abdominal aortic aneurysms (EVAR) is obtained through surgical cutdown or percutaneously. The only devices suitable for percutaneous closure of the 20 French arteriotomies of the common femoral artery (CFA) are the Prostar(™) and Proglide(™) devices (Abbott Vascular). Positive effects of these devices seem to consist of a lower infection rate, and shorter operation time and hospital stay. This conclusion was published in previous reports comparing techniques in patients in two different groups (cohort or randomized). Access techniques were never compared in one and the same patient; this research simplifies comparison because patient characteristics will be similar in both groups. METHODS/

designPercutaneous access of the CFA is compared to surgical cutdown in a single patient; in EVAR surgery, access is necessary in both groins in each patient. Randomization is performed on the introduction site of the larger main device of the endoprosthesis. The contralateral device of the endoprosthesis is smaller. When we use this type of randomization, both groups will contain a similar number of main and contralateral devices. Preoperative nose cultures and perineal cultures are obtained, to compare colonization with postoperative wound cultures (in case of a surgical site infection). Furthermore, patient comfort will be considered, using VAS-scores (Visual analog scale). Punch biopsies of the groin will be harvested to retrospectively compare skin of patients who suffered a surgical site infection (SSI) to patients who did not have an SSI. DISCUSSION: The PiERO trial is a multicenter randomized controlled clinical trial designed to show the consequences of using percutaneous access in EVAR surgery and focuses on the occurrence of surgical site infections.

trial registrationNTR4257 10 November 2013, NL44578.042.13.

Indexed as

Aortic Aneurysm, AbdominalBlood Vessel Prosthesis ImplantationCatheterization, PeripheralClinical ProtocolsEndovascular ProceduresFemoral ArteryHumansNetherlandsResearch DesignRisk FactorsSurgical Wound InfectionTime FactorsTreatment OutcomeWound Healing

Identifiers

PMID26370286
PMCPMC4570236
OpenAlexW1893271372

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.