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Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol.

ABSTRACT: INTRODUCTION:Despite 40 randomised controlled trials (RCTs) investigating preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP) to reduce surgical site infection (SSI) rate following colon surgery, there has never been an RCT published comparing OA alone versus no preparation. Of the four possible regimens (OA alone, MBP alone, OA plus MBP and no preparation), randomised evidence is conflicting for studied groups. Furthermore, guidelines vary, with recommendations for OA alone, OA plus MBP or no preparation. The National Surgical Quality Improvement Program (NSQIP) has automated data collection for surgical patients. Similarly, the 'REthinking Clinical Trials' (REaCT) platform increases RCT enrolment by simplifying pragmatic trial design. In this novel RCT protocol, we combine REaCT and NSQIP to compare OA alone versus no preparation for SSI rate reduction in elective colon surgery. To our knowledge, this is the first published RCT protocol that leverages NSQIP for data collection. In our feasibility study, 67 of 74 eligible patients (90%) were enrolled and 63 of 67 (94%) were adherent to protocol. The 'REaCT-NSQIP' trial design has great potential to efficiently generate level I evidence for other perioperative interventions. METHODS AND ANALYSIS:SSI rates following elective colorectal surgery after preoperative OA or no preparation will be compared. We predict 45% relative rate reduction of SSI, improvement in length of stay, reduced costs and increased quality of life, with similar antibiotic-related complications. Consent, using the 'integrated consent model', and randomisation on a mobile device are completed by the surgeon in a single clinical encounter. Data collection for the primary end point is automatic through NSQIP. Analysis of cost per weighted case, cost utility and quality-adjusted life years will be done. ETHICS AND DISSEMINATION:This study is approved by The Ontario Cancer Research Ethics Board. Results will be disseminated in surgical conferences and peer-reviewed journals. TRIAL REGISTRATION NUMBER:NCT03663504; Pre-results, recruitment phase.

SUBMITTER: Apte SS

PROVIDER: S-EPMC7351286 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol.

Apte Sameer S SS Moloo Husein H Jeong Ahwon A Liu Michelle M Vandemeer Lisa L Suh Kathryn K Thavorn Kednapa K Fergusson Dean A DA Clemons Mark M Auer Rebecca C RC

BMJ open 20200709 7

<h4>Introduction</h4>Despite 40 randomised controlled trials (RCTs) investigating preoperative oral antibiotics (OA) and mechanical bowel preparation (MBP) to reduce surgical site infection (SSI) rate following colon surgery, there has <i>never</i> been an RCT published comparing OA alone versus no preparation. Of the four possible regimens (OA alone, MBP alone, OA plus MBP and no preparation), randomised evidence is conflicting for studied groups. Furthermore, guidelines vary, with recommendati ...[more]

PMID: 32647023

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Project description:ImportanceThere has been a resurgence of interest in the use of mechanical bowel preparation (MBP) and oral antibiotics (OAB) before elective colorectal surgery. Until now, clinical trials and meta-analyses have not compared all 4 approaches (MBP with OAB, OAB only, MBP only, or no preparation) simultaneously.ObjectiveTo perform a network meta-analysis to clarify which approach in colorectal surgery is associated with the lowest rate of surgical site infection (SSI).Data sourcesFive electronic databases were searched, including PubMed, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, ACP Journal Club. and Database of Abstracts of Review of Effectiveness from database inception to November 27, 2017.Study selectionOnly data from randomized clinical trials were included. Inclusion criteria were RCTs that reported on SSI rates or other complications based on MBP or OAB status. Quality of studies was appraised by the Cochrane Collaboration risk of bias tool.Data extraction and synthesisThe study was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.Main outcomes and measuresTotal, incisional, and organ/space SSI rates. Secondary outcomes included rates of anastomotic leak, mortality, readmissions/reoperations, urinary tract infection, and pulmonary complications.ResultsThirty-eight randomized clinical trials among 8458 patients (52.1% male) were included, providing 4 direct comparisons and 2 indirect comparisons for 8 outcome measures. On Bayesian analysis, MBP with OAB vs MBP only was associated with reduced SSI (odds ratio [OR], 0.71; 95% equal-tail credible interval [CrI], 0.57-0.88). There was no significant difference between MBP with OAB vs OAB only (OR, 0.95; 95% CrI, 0.56-1.62). Oral antibiotics without MBP was not associated with a statistically significant reduction in SSI compared with any other group (except for a risk reduction in organ/space SSI when indirectly compared with no preparation) (OR, 0.13; 95% CrI, 0.02-0.55). There was no difference in SSI between MBP only vs no preparation (OR, 0.84; 95% CrI, 0.69-1.02).Conclusions and relevanceIn this network meta-analysis of randomized clinical trials, MBP with OAB was associated with the lowest risk of SSI. Oral antibiotics only was ranked as second best, but the data available on this approach were limited. There was no difference between MBP only vs no preparation. In addition, there was no difference in rates of anastomotic leak, readmissions, or reoperations between any groups.

Project description:BACKGROUND:In October 2012, The Centers for Medicare and Medicaid Services (CMS) began publicly reporting American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) surgical outcomes on its public reporting website, Hospital Compare. Participation in this CMS-NSQIP initiative is voluntary. Our objective was to compare CMS-NSQIP participating hospitals with ACS NSQIP hospitals that elected not to participate. STUDY DESIGN:Hospital Compare and American Hospital Association Annual Survey data were merged to compare CMS-NSQIP participants with nonparticipants. Regression models were developed to assess predictors of participation and to assess if hospitals differed on 32 process, 10 patient experience (Hospital Consumer Assessment of HealthCare Providers and Systems [HCAHPS]), and 16 outcomes (Hospital Compare and Agency for Healthcare Research Quality) measures. Additionally, performance on 2 waves of publicly reported ACS NSQIP surgical outcomes measures was compared. RESULTS:Of the 452 ACS NSQIP hospitals, 80 (18%) participated in CMS-NSQIP public reporting. Participating hospitals had more beds, admissions, operations, and were more often accredited (Commission on Cancer and the Council of Teaching Hospitals [COTH] [p < 0.05]). Only COTH membership remained significant in adjusted analyses (odds ratio 2.45, 95% CI 1.12 to 5.35). Hospital performance on process, HCAHPS, and outcomes measures were not associated with CMS-NSQIP participation for 54 of 58 measures examined. Hospitals with "better-than-average" performance were more likely to publicly report the Elderly Surgery measure (p < 0.05). In wave 2, an increased proportion of new participants reported "worse-than-average" outcomes. CONCLUSIONS:There were few measurable differences between CMS-NSQIP participating and nonparticipating hospitals. The decision to voluntarily publicly report may be related to the hospital's culture of quality improvement and transparency.

Project description:Of background dataThere is growing interest in identifying nutritional biomarkers associated with poor outcomes of elective spine surgery. Prealbumin and transferrin are both biomarkers of nutritional status that can be obtained from clinical laboratories. However, associations of preoperative measures of these nutritional biomarkers across their range with risk of complications from spine surgery have not been fully investigated.ObjectiveDetermine associations of preoperative prealbumin and transferrin levels with 30-day risk of complication among elective spine surgery patients.Study designCohort study with preoperative prealbumin and transferrin collected as standard of care.Outcome measures30-day risk of medical complication.MethodsData were obtained from medical records of 274 consecutive adult patients ages ?50 years who underwent elective spine surgery from June 2013 to June 2014. Prealbumin (mg/dL), serum transferrin (mg/dL), and preoperative factors were abstracted from medical records. Prealbumin and transferrin levels were categorized into quartiles and as below versus median or higher. The primary outcome measure was 30-day risk of medical complication, such as renal failure or infections. Associations of the biomarkers with outcome risk were assessed with chi-square tests and with risk ratios (RR) and 95% confidence intervals (CI) estimated with multivariable log-binomial regression.ResultsThe 274 adults studied had a median prealbumin level of 27.4?mg/dL and a median transferrin level of 265.0?mg/dL. The 30-day risk of complication was 12.8% (95% CI: 8.8%-16.7%). Risk of complication did not vary by quartile for either prealbumin (P?=?.26) or transferrin (P?=?.49) and was not associated either with prealbumin (below median, RR?=?1.1, 95% CI: 0.8, 1.5) or transferrin (below median, RR?=?1.1, 95% CI: 0.8, 1.6).ConclusionsAmong adults undergoing elective spine surgery, the 30-day risk of complication was not associated with prealbumin or transferrin. Nutrition status, as measured by prealbumin and transferrin, does not appear to be associated with complication risk.Level of evidenceLevel III.

Dataset Information

Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol.

Publications

Prospective randomised controlled trial using the REthinking Clinical Trials (REaCT) platform and National Surgical Quality Improvement Program (NSQIP) to compare no preparation versus preoperative oral antibiotics alone for surgical site infection rates in elective colon surgery: a protocol.

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