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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:BackgroundThe use of intravenous antibiotics at anaesthetic induction in colorectal surgery is the standard of care. However, the role of mechanical bowel preparation, enemas, and oral antibiotics in surgical site infection, anastomotic leak, and other perioperative outcomes remains controversial. The aim of this study was to determine the optimal preoperative bowel preparation strategy in elective colorectal surgery.MethodsA systematic review and network meta-analysis of RCTs was performed with searches from PubMed/MEDLINE, Scopus, Embase, and the Cochrane Central Register of Controlled Trials from inception to December 2022. Primary outcomes included surgical site infection and anastomotic leak. Secondary outcomes included 30-day mortality rate, ileus, length of stay, return to theatre, other infections, and side effects of antibiotic therapy or bowel preparation.ResultsSixty RCTs involving 16 314 patients were included in the final analysis: 3465 (21.2 per cent) had intravenous antibiotics alone, 5268 (32.3 per cent) had intravenous antibiotics + mechanical bowel preparation, 1710 (10.5 per cent) had intravenous antibiotics + oral antibiotics, 4183 (25.6 per cent) had intravenous antibiotics + oral antibiotics + mechanical bowel preparation, 262 (1.6 per cent) had intravenous antibiotics + enemas, and 1426 (8.7 per cent) had oral antibiotics + mechanical bowel preparation. With intravenous antibiotics as a baseline comparator, network meta-analysis demonstrated a significant reduction in total surgical site infection risk with intravenous antibiotics + oral antibiotics (OR 0.47 (95 per cent c.i. 0.32 to 0.68)) and intravenous antibiotics + oral antibiotics + mechanical bowel preparation (OR 0.55 (95 per cent c.i. 0.40 to 0.76)), whereas oral antibiotics + mechanical bowel preparation resulted in a higher surgical site infection rate compared with intravenous antibiotics alone (OR 1.84 (95 per cent c.i. 1.20 to 2.81)). Anastomotic leak rates were lower with intravenous antibiotics + oral antibiotics (OR 0.63 (95 per cent c.i. 0.44 to 0.90)) and intravenous antibiotics + oral antibiotics + mechanical bowel preparation (OR 0.62 (95 per cent c.i. 0.41 to 0.94)) compared with intravenous antibiotics alone. There was no significant difference in outcomes with mechanical bowel preparation in the absence of intravenous antibiotics and oral antibiotics in the main analysis.ConclusionA bowel preparation strategy with intravenous antibiotics + oral antibiotics, with or without mechanical bowel preparation, should represent the standard of care for patients undergoing elective colorectal surgery.

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.

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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