Evidence map›Paper›PMID 29351789›Full record

ArticleTrials2018

Prevention of severe infectious complications after colorectal surgery using preoperative orally administered antibiotic prophylaxis (PreCaution): study protocol for a randomized controlled trial.

Tessa Mulder, Marjolein F Q Kluytmans-van den Bergh, Anne Marie G A de Smet, Nils E van 't Veer, Daphne Roos, Stavros Nikolakopoulos, Marc J M Bonten, Jan A J W Kluytmans, PreCaution Study Group

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 3 pooled it
2.1field-weighted citation impact, top 14% 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

7 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Observational
  6. Article
  7. The use of oral antibiotics and mechanical bowel preparation in elective colorectal resection for the reduction of surgical site infection.Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland · 2020
    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

9 authors at 3 institutions in 1 country.

Tessa MulderDivision Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. t.mulder-2@umcutrecht.nl.ORCID http://orcid.org/0000-0003-4556-0338
Marjolein F Q Kluytmans-van den BerghDivision Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Anne Marie G A de SmetDepartment of Critical Care, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Nils E van 't VeerDepartment of Clinical Pharmacy, Amphia Hospital, Breda, The Netherlands.
Daphne RoosDepartment of Surgery, Reinier de Graaf Gasthuis, Delft, The Netherlands.
Stavros NikolakopoulosDivision Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Marc J M BontenDivision Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Jan A J W KluytmansDivision Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
PreCaution Study Group
Utrecht University · NLUniversity Medical Center Groningen · NLReinier de Graaf Hospital · NL

Funding

ZonMw 522002011
6 · The paper itself

Abstract

backgroundColorectal surgery is frequently complicated by surgical site infections (SSIs). The most important consequences of SSIs are prolonged hospitalization, an increased risk of surgical reintervention and an increase in mortality. Perioperative intravenously administered antibiotic prophylaxis is the standard of care to reduce the risk of SSIs. In the last few decades, preoperative orally administered antibiotics have been suggested as additional prophylaxis to further reduce the risk of infection, but are currently not part of routine practice in most hospitals. The objective of this study is to evaluate the efficacy of a preoperative orally administered antibiotic prophylaxis (Pre-OP) in addition to intravenously administered perioperative antibiotic prophylaxis to reduce the incidence of deep SSIs and/or mortality after elective colorectal surgery. METHODS/

designThe PreCaution trial is designed as a multicenter, double-blind, randomized, placebo-controlled clinical trial that will be carried out in The Netherlands. Adult patients who are scheduled for elective colorectal surgery are eligible to participate. In total, 966 patients will be randomized to receive the study medication. This will either be Pre-OP, a solution that consists of tobramycin and colistin sulphate, or a placebo solution. The study medication will be administered four times daily during the 3 days prior to surgery. Perioperative intravenously administered antibiotic prophylaxis will be administered to all patients in accordance with national infection control guidelines. The primary endpoint of the study is the cumulative incidence of deep SSIs and/or mortality within 30 days after surgery. Secondary endpoints include both infectious and non-infectious complications of colorectal surgery, and will be evaluated 30 days and/or 6 months after surgery. DISCUSSION: To date, conclusive evidence on the added value of preoperative orally administered antibiotic prophylaxis in colorectal surgery is lacking. The PreCaution trial should determine the effects of orally administered antibiotics in preventing infectious complications in elective colorectal surgery.

trial registrationNetherlands Trial Register, ID: NTR6113 . Registered on 11 October 2016; EudraCT 2015-005736-17.

Indexed as

Antibiotic ProphylaxisAdministration, OralAnti-Bacterial AgentsColectomyColistinColonDigestive System Surgical ProceduresDouble-Blind MethodDrug Administration ScheduleDrug CombinationsFemaleHumansIncidenceMaleNetherlandsRandomized Controlled Trials as TopicAnti-Bacterial AgentsColistinDrug CombinationsTobramycinColorectal surgeryDrug intervention trialInfection controlMortalityPlaceboPreoperative oral antibiotic prophylaxisRandomized controlled trialSurgical site infection

Identifiers

PMID29351789
PMCPMC5775605
OpenAlexW2784798834

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.