Dataset Information

Prevention of severe infectious complications after colorectal surgery using oral non-absorbable antimicrobial prophylaxis: results of a multicenter randomized placebo-controlled clinical trial.

ABSTRACT:

Background

Surgical 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.

Methods

The 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.

Results

The 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).

Conclusions

Observational 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 registration

The PreCaution trial is registered in the Netherlands Trial Register under NL5932 (previously: NTR6113) as well as in the EudraCT register under 2015-005736-17.

SUBMITTER: Mulder T

PROVIDER: S-EPMC7294517 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description: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.

Project description:The use of titanium during maxillofacial fixation is limited due to its palpability, mutagenic effects and interference with imaging, which lead to the requirement for subsequent removal. The use of a biologically absorbable fixation material will potentially eliminate these limitations. In this meta-analysis, we analyzed the complications of absorbable fixation in maxillofacial surgery.We performed a systematic search of PubMed, Embase, Cochrane Central Register of Systematic Reviews and Cochrane Central Register of Controlled Trials for trials published through December 2012. Data extracted from literature were analyzed with Review manager 5.0.24.Relevant data was extracted from 20 studies (1673 participants) and revealed that patients in the absorbable group had significantly more complications than those in the titanium group (RR = 1.20; 95% CI: 1.02-1.42; P = 0.03) in all enrolled maxillofacial surgeries. For bimaxillary operation subgroup, the absorbable fixation group did not have a significant increase in complications when compared with the titanium group (RR = 1.89; 95% CI: 0.85-4.22; P = 0.12). There was no significant difference observed between the absorbable and titanium groups receiving a bilateral sagittal split ramus osteotomy (BSSRO) (RR = 1.45; 95% CI: 0.84-2.48; P = 0.18) and Le Fort I osteotomy (RR = 0.65; 95% CI: 0.34-1.23; P = 0.18). The combined results of the five trials revealed that the absorbable group had a significantly lower rate of complications compared to the titanium group (RR = 0.71; 95% CI: 0.52-0.97; P = 0.03) in fracture fixation.This meta-analysis shows that absorbable fixation systems used for fixation in maxillofacial surgery do not have adequate safety profiles. Subgroup indicated the safety of absorbable fixation systems was superior during fracture fixation. The absorbable fixation systems tend to have a similar favorable safety profile as titanium fixation during Le Fort I, bimaxillary operation and BSSRO.

Project description:BACKGROUND:Postoperative pulmonary complications (PPCs) are common and significant problems for oral and maxillofacial surgery patients. Dexmedetomidine (DEX), an ?2-adrenoreceptor agonist, has been proven having lung protection effects. However, since now, there has not been final conclusion about whether DEX can reduce the incidence of PPCs. We hypothesize that, in oral and maxillofacial surgery with fibular free flap reconstruction patients, DEX may decrease the incidence of PPCs. METHODS:This was a prospective, double-blind, randomized, placebo-controlled, single-centered trial with two parallel arms. A total of 160 patients at intermediate-to-high risk of PPCs undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy were enrolled and randomized to receive continuous infusion of either DEX or placebo (normal saline). 0.4 ?g/kg of DEX was given over 10mins as an initial dose followed by a maintaining dose of 0.4 ?g/kg/h till the second day morning after surgery. At the same time, the normal saline was administered a similar quantity. The primary outcome was the incidence of PPCs according to Clavien-Dindo score within 7?days after surgery. RESULTS:The two groups had similar characteristics at baseline. 18(22.5%) of 80 patients administered DEX, and 32(40.0%) of 80 patient administered placebo experienced PPCs within the first 7?days after surgery (relative risk [RR] 0.563,95% confidence interval [CI] 0.346-0.916; P?=?0.017). In the first 7?days after surgery, the DEX group had a lower incidence of PPCs and a better postoperative survival probability (Log-rank test, P?=?0.019), and was less prone to occur PPCs (Cox regression, P?=?0.025, HR?=?0.516). When the total dose of DEX was more than 328??g, the patients were unlikely to have PPCs (ROC curve, AUC?=?0.614, P?=?0.009). CONCLUSIONS:For patients undergoing oral and maxillofacial surgery with fibular free flap reconstruction and tracheotomy who were at intermediate or high risk of developing PPCs, continuous infusion of DEX could decrease the occurrence of PPCs during the first 7?days after surgery and shorten the length of hospital stay after surgery, but did not increase the prevalence of bradycardia or hypotension. TRIAL REGISTRATION:Chinese Clinical Trial Registry, www.chictr.org.cn, number: ChiCTR1800016153; Registered on May 15, 2018.