Comparing cefazolin/ metronidazole, piperacillin-tazobactam, or c efoxitin as surgical antibiotic prophylaxis in patients undergoing pancreaticoduodenectomy: A retrospective cohort study.

BACKGROUND: Preoperative antibiotic options for pancreaticoduodenectomy (PD) include cefoxitin (CX), piperacillin-tazobactam (PT), or combined cefazolin and metronidazole (CM). Recent studies suggest the superiority of PT over CX, but evidence for CM is unclear. OBJECTIVE: To explore the impact of preoperative antibiotic selection (CM vs. PT and CX vs. PT) on the development of surgical site infections (SSI). METHODS: Consecutive adult patients at one institution who underwent PD from November 2017 to December 2021 and received either CM, PT, or CX preoperatively, were included. The primary outcome was SSI. Secondary outcomes included postoperative infections and clinically significant postoperative pancreatic fistula (POPF). Logistic regression models were used. RESULTS: Among 127 patients included in the study, PT, CM, and CX were administered in 46 (36.2%), 44 (34.6%), and 37 (29.4%) patients, respectively. There were 32 (27.1%) SSI, 20 (36.1%) infections, and 21 (22.9%) POPF events. PT use was associated with reduced risk of SSI compared to CX (OR: 0.32, 95% CI: 0.11-0.89, p = 0.03), but there was no difference as compared to CM (OR: 0.75, 95% CI: 0.27-2.13, p = 0.59). There were no differences in secondary outcomes. CONCLUSION: PT reduced SSI rates compared to CX but was no different to CM among patients undergoing PD at our center.

REporting quality of PilOt randomised controlled trials in surgery (REPORTS): a methodological survey protocol.

INTRODUCTION: The aim of this methodological review is to evaluate the completeness of reporting of surgical pilot and feasibility randomised trials as per the Consolidated Standards of Reporting Trials (CONSORT) extension to randomised pilot and feasibility trials. Moreover, we aim to assess for the presence of spin reporting and inconsistency between abstract and main text reporting in surgical pilot and feasibility randomised trials. METHODS AND ANALYSIS: A comprehensive, electronic search strategy will be used to identify studies indexed in Medline, Embase and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Studies will be included if they are pilot or feasibility randomised trials of surgical interventions. The primary outcome will be overall CONSORT statement extension to randomised pilot and feasibility trials checklist completeness. This will be defined as trials reporting each of the 40 items in the CONSORT statement extension to randomised pilot and feasibility trials checklist. Secondary outcomes will include the reporting of individual studies as per the CONSORT extension to randomised pilot and feasibility trials, the use of spin reporting strategies, trial factors associated with reporting quality and spin strategy use, and consistency between abstract and main text reporting. Poisson and logistic regressions will be performed to explore the association between trial factors and completeness of reporting as measured by the number of reported CONSORT items. ETHICS AND DISSEMINATION: This is a methodological survey that has been registered a priori on the International Prospective Register for Systematic Reviews (PROSPERO) (CRD42023475512). Local ethics approval is not required. We plan to disseminate study results through peer-reviewed publication and conference presentations.

Pilot and feasibility trials in surgery are incompletely reported according to the CONSORT checklist: a meta-research study.

OBJECTIVES: Given the key role that pilot and feasibility (PAF) trials play in addressing the challenges of surgical trials, adequate reporting completeness is essential. Our aim was to assess completeness of reporting and evaluate if the items of the Consolidated Standards of Reporting Trials (CONSORT) extension for PAF trials have been reported in surgical PAF trials. STUDY DESIGN: This is a metaresearch study reported according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Studies were included if they were pilot or feasibility randomized trials evaluating a surgical intervention. The primary outcome was overall adherence to the CONSORT statement extension to randomized PAF trials checklist. A Poisson regression was performed to explore the association between research factors and reporting completeness. SETTING: MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched from January 1-December 31, 2011 and 2021. RESULTS: After screening 1991 citations, 38 studies from 2011 to 34 studies from 2021 were included. The mean CONSORT reporting score across all included studies was 21.5 (standard deviation 6.3). After excluding items that were not applicable to all studies, a mean of 20.1 (standard deviation 6.1) of 34 items (0.59) were reported. Studies published in 2021 (vs 2011) did not have a greater number of CONSORT items reported (incidence rate ratio [IRR] 1.01, 95% confidence interval [CI] 0.89-1.15). Studies registered in a clinical trial registry (IRR 1.29, 95% CI 1.12-1.48) and randomizing more than 50 patients (IRR 1.16, 95% CI 1.04-1.30) were associated with more CONSORT items reported. CONCLUSION: The reporting completeness of surgical PAF trials is poor and has not improved after the publication of the CONSORT extension.

Modified frailty index predicts postoperative morbidity in adhesive small bowel obstruction: analyzing the National Inpatient Sample 2015-2019.

BACKGROUND: There are limited data identifying predictors of postoperative outcomes in adhesive small bowel obstruction (ASBO). This study used the National Inpatient Sample (NIS) to assess the efficacy of the modified frailty index (mFI) to predict postoperative morbidity among patients undergoing an operation for ASBO. METHODS: A retrospective analysis of the NIS between September 1, 2015, and December 31, 2019, was performed to identify adult patients who underwent nonelective operative intervention for ASBO. The mFI was used to stratify patients as either frail (mFI value ≥ 0.27) or robust (mFI value < 0.27). The primary outcomes were overall in-hospital postoperative morbidity and mortality. The secondary outcomes were system-specific morbidity, length of stay (LOS), total in-hospital healthcare cost, and discharge disposition. Univariable and multivariable regressions were used. RESULTS: Overall, 23251 robust patients and 6122 frail patients were included. Adjusted analyses demonstrated that frail patients had increased in-hospital mortality (adjusted odds ratio [aOR], 2.16; 95% CI, 1.80-2.60), postoperative morbidity (aOR, 1.63; 95% CI, 1.52-1.74), postoperative LOS (adjusted mean difference [aMD], 0.97 days; 95% CI, 0.73-1.21), and total in-hospital healthcare costs (aMD, $18,921; 95% CI, $14,608-$23,235) and were less likely to be discharged home (aOR, 0.59; 95% CI, 0.55-0.63). The findings were unchanged on subgroup analysis of patients undergoing open operation and those older than 65 years of age. CONCLUSION: The mFI may predict postoperative outcomes for ASBO. Stratifying patients based on frailty may assist clinicians and patients in making informed decisions, setting realistic expectations, and proactively planning postoperative disposition.

Concurrent Use of Statins in Patients Undergoing Curative Intent Treatment for Triple Negative Breast Cancer: A Systematic Review and Meta-Analysis.

Pre-clinical studies in triple negative breast cancer (TNBC) suggest that statins may inhibit cell proliferation, promote cell-cycle arrest, induce apoptosis, change the tumor microenvironment, and improve effectiveness of other therapies. Observational studies have demonstrated variable effects from statin therapy on oncologic outcomes in these patients. As such, we aimed to pool previous data via a systematic review and meta-analysis to elucidate the impact of concurrent statin use on oncologic outcomes for patients with TNBC. Medline, EMBASE, CENTRAL, and PubMed were systematically searched from inception through to June 2022. Studies were included if they compared patients with TNBC receiving and not receiving statin therapy concurrently with oncologic treatment for curative intent in terms of recurrence and survival in a non-metastatic setting. The primary outcomes were 5-year disease-free survival (DFS) and 5-year overall survival (OS). A pairwise meta-analyses was performed using inverse variance random effects. Risk of bias was assessed with the ROBINS-I and the GRADE approach was conducted to assess quality of evidence. From 4014 citations, 5 studies with 625 patients on statin therapy and 2707 patients not on statin therapy were included. There was a significant increase in 5-year DFS for patients on statin therapy compared to patients not on statin therapy (OR 1.44, 95% CI 1.04-1.98, P = .03). No significant difference was noted in 5-year OS between the 2 groups (OR 1.12, 95% CI 0.86-1.47, P = .40). Included studies were at moderate-to-high risk of bias. The GRADE quality of evidence was very low. This review presents very low-quality evidence that concurrent use of statins with oncologic treatment may potentially improve long-term DFS for patients with TNBC undergoing curative intent therapy. Future research by way of large, prospective study is required to further clarify the clinical utility of statins on patients undergoing treatment for TNBC.

Financial toxicity risk among patients with gastric banding complications in the United States: analysis of the National Inpatient Sample.

BACKGROUND: Laparoscopic adjustable gastric banding (AGB) was historically among the most performed bariatric procedures but has fallen out of favor in recent years due to poor long-term weight loss and high revisional surgery rates. Significant financial hardship of medical care, known as "financial toxicity," can occur from experiencing unexpected complications of AGB. OBJECTIVE: To investigate the risk of financial toxicity among patients being admitted for AGB complications. SETTING: United States. METHODS: All uninsured and privately-insured patients who were admitted for AGB complications were identified from the National Inpatient Sample 2015-2019. Publicly available government data (U.S. Census Bureau, Bureau of Labor, The Centers for Medicare and Medicaid Services) were utilized to estimate patient income, food expenditures, and average maximum out-of-pocket expenditures. Financial toxicity was defined as total admission cost from AGB complications ≥40% of postsubsistence income. RESULTS: Among 28,005 patients, 66% patients had private insurance and 44% patients were uninsured. Median total admission cost was $12,443 (interquartile range $7959-$19,859) and $15,182 for those who received revisional bariatric surgery. Approximately 55% of the uninsured patients and 1% of insured patients were at risk of financial toxicity after admission for banding-related complications. Patients who had an emergency admission, revisional surgery, or postoperative intensive care unit admission were more likely to experience financial catastrophe following admission (P < .01). CONCLUSIONS: About 1 in 2 uninsured patients admitted for AGB-related complications were at risk of financial toxicity. In addition to surgical risks, providers should consider the potential financial consequences of AGB when counselling patients on their choice of surgery.