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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
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
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:https://​doi.​org/​10.​1186/​s13063-018-2439-4) contains supplementary material, which is available to authorized users.

Abstract

Background

Colorectal 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/design

The 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 registration

Netherlands Trial Register, ID: NTR6113. Registered on 11 October 2016; EudraCT 2015-005736-17.
Zusatzmaterial
Additional file 1: Case Report Form. (DOCX 42 kb)
13063_2018_2439_MOESM1_ESM.docx
Additional file 2: SPIRIT 2013 Checklist used as a guideance for the development of the PreCaution study protocol. (DOC 120 kb)
13063_2018_2439_MOESM2_ESM.doc
Literatur
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