Trial reportAntimicrobial resistance and infection control2020
Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial.
Trial report in Antimicrobial resistance and infection control, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 14 citations in OpenAlex.
- EAES, SAGES, and ESCP rapid guideline: bowel preparation for minimally invasive colorectal resection.Surgical endoscopy · 2023Guideline
- Mechanical bowel preparation and antibiotics in elective colorectal surgery: network meta-analysis.BJS open · 2023Pooled it
- Preoperative combined mechanical and oral antibiotic bowel preparation for preventing complications in elective colorectal surgery.The Cochrane database of systematic reviews · 2023Pooled it
- Impact of oral antibiotic prophylaxis on surgical site infection after rectal surgery: results of randomized trial.International journal of colorectal disease · 2021Trial
- Mismatch of populations between randomised controlled trials of perioperative interventions in major abdominal surgery and current clinical practice.Perioperative medicine (London, England) · 2023Review
- The Role of Antibiotic Prophylaxis in Anastomotic Leak Prevention during Elective Colorectal Surgery: Systematic Review and Meta-Analysis of Randomized Controlled Trials.Antibiotics (Basel, Switzerland) · 2023Review
- A Network Meta-Analysis and GRADE Assessment of the Effect of Preoperative Oral Antibiotics with and Without Mechanical Bowel Preparation on Surgical Site Infection Rate in Colorectal Surgery.Annals of surgery open : perspectives of surgical history, education, and clinical approaches · 2022Article
- Mechanical plus oral bowel preparation with paromomycin and metronidazole reduces infectious complications in elective colorectal surgery: a matched case-control study.International journal of colorectal disease · 2021Observational
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
19 authors at 8 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSurgical site infections (SSIs) are common complications after colorectal surgery. Oral non-absorbable antibiotic prophylaxis (OAP) can be administered preoperatively to reduce the risk of SSIs. Its efficacy without simultaneous mechanical cleaning is unknown.
methodsThe Precaution trial was a double-blind, placebo-controlled randomized clinical trial conducted in six Dutch hospitals. Adult patients who underwent elective colorectal surgery were randomized to receive either a three-day course of preoperative OAP with tobramycin and colistin or placebo. The primary composite endpoint was the incidence of deep SSI or mortality within 30 days after surgery. Secondary endpoints included both infectious and non-infectious complications at 30 days and six months after surgery.
resultsThe study was prematurely ended due to the loss of clinical equipoise. At that time, 39 patients had been randomized to active OAP and 39 to placebo, which reflected 8.1% of the initially pursued sample size. Nine (11.5%) patients developed the primary outcome, of whom four had been randomized to OAP (4/39; 10.3%) and five to placebo (5/39; 12.8%). This corresponds to a risk ratio in the intention-to-treat analysis of 0.80 (95% confidence interval (CI) 0.23-2.78). In the per-protocol analysis, the relative risk was 0.64 (95% CI 0.12-3.46).
conclusionsObservational data emerging during the study provided new evidence for the effectiveness of OAP that changed both the clinical and medical ethical landscape for infection prevention in colorectal surgery. We therefore consider it unethical to continue randomizing patients to placebo. We recommend the implementation of OAP in clinical practice and continuing monitoring of infection rates and antibiotic susceptibilities.
trial registrationThe PreCaution trial is registered in the Netherlands Trial Register under NL5932 (previously: NTR6113) as well as in the EudraCT register under 2015-005736-17.
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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.