1. Prevention of severe infectious complications after colorectal surgery using preoperative orally administered antibiotic prophylaxis (PreCaution)
- Author
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Mulder, Tessa, Kluytmans-van den Bergh, Marjolein F Q, De Smet, Anne Marie G A, van 't Veer, Nils E, Roos, Daphne, Nikolakopoulos, Stavros, Bonten, Marc J M, Kluytmans, Jan A J W, PreCaution Study Group, Surgery, Medical Microbiology & Infectious Diseases, Microbes in Health and Disease (MHD), and Critical care, Anesthesiology, Peri-operative and Emergency medicine (CAPE)
- Subjects
Male ,Time Factors ,DIGESTIVE-TRACT ,Administration, Oral ,Medicine (miscellaneous) ,Infection control ,law.invention ,Study Protocol ,0302 clinical medicine ,Randomized controlled trial ,Risk Factors ,Colon surgery ,law ,Clinical endpoint ,Pharmacology (medical) ,Cumulative incidence ,030212 general & internal medicine ,Antibiotic prophylaxis ,Colectomy ,Digestive System Surgical Procedures ,Netherlands ,Randomized Controlled Trials as Topic ,lcsh:R5-920 ,SELECTIVE DECONTAMINATION ,Preoperative oral antibiotic prophylaxis ,Incidence ,INTENSIVE-CARE UNITS ,Colorectal surgery ,Anti-Bacterial Agents ,Drug Combinations ,Treatment Outcome ,030220 oncology & carcinogenesis ,SURGICAL SITE INFECTIONS ,Tobramycin ,Female ,lcsh:Medicine (General) ,Surgical site infection ,OROPHARYNX ,medicine.medical_specialty ,Colon ,Drug intervention trial ,Drug Administration Schedule ,CLINICAL-TRIAL ,03 medical and health sciences ,Double-Blind Method ,Internal medicine ,medicine ,Humans ,Surgical Wound Infection ,Mortality ,Placebo ,METAANALYSIS ,MECHANICAL BOWEL PREPARATION ,Colistin ,business.industry ,Rectum ,Perioperative ,Antibiotic Prophylaxis ,Clinical trial ,COLON SURGERY ,business ,RESISTANCE - 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. Electronic supplementary material The online version of this article (doi:10.1186/s13063-018-2439-4) contains supplementary material, which is available to authorized users.
- Published
- 2018