IMPORTANCEThe overprescription of opioids to surgical patients is recognized as an important factor contributing to the opioid crisis. However, the value of prescribing opioid analgesia (OA) vs opioid-free analgesia (OFA) after postoperative discharge remains uncertain. OBJECTIVE To investigate the feasibility of conducting a full-scale randomized clinical trial (RCT) to assess the comparative effectiveness of OA vs OFA after outpatient general surgery. DESIGN, SETTING, AND PARTICIPANTSThis parallel, 2-group, assessor-blind, pragmatic pilot RCT was conducted from January 29 to September 3, 2020 (last follow-up on October 2, 2020). at 2 university-affiliated hospitals in Montreal, Quebec, Canada. Participants were adult patients (aged Ն18 years) undergoing outpatient abdominal (ie, cholecystectomy, appendectomy, or hernia repair) or breast (ie, partial or total mastectomy) general surgical procedures. Exclusion criteria were contraindications to drugs used in the trial, preoperative opioid use, conditions that could affect assessment of outcomes, and intraoperative or early complications requiring hospitalization. INTERVENTIONSPatients were randomized 1:1 to receive OA (around-the-clock nonopioids and opioids for breakthrough pain) or OFA (around-the-clock nonopioids with increasing doses and/or addition of nonopioid medications for breakthrough pain) after postoperative discharge. MAIN OUTCOMES AND MEASURESMain outcomes were a priori RCT feasibility criteria (ie, rates of surgeon agreement, patient eligibility, patient consent, treatment adherence, loss to follow-up, and missing follow-up data). Secondary outcomes included pain intensity and interference, analgesic intake, 30-day unplanned health care use, and adverse events. Between-group comparison of outcomes followed the intention-to-treat principle.RESULTS A total of 15 surgeons were approached; all (100%; 95% CI, 78%-100%) agreed to have patients recruited and adhered to the study procedures. Rates of patient eligibility and consent were 73% (95% CI, 66%-78%) and 57% (95% CI, 49%-65%), respectively. Seventy-six patients were randomized (39 [51%] to OA and 37 [49%] to OFA) and included in the intention-to-treat analysis (mean [SD] age, 55.5 [14.5] years; 50 [66%] female); 40 (53%) underwent abdominal surgery, and 36 (47%) underwent breast surgery. Seventy-five patients (99%; 95% CI, 93%-100%) adhered to the allocated treatment; 1 patient randomly assigned to OFA received an opioid prescription.Seventeen patients (44%) randomly assigned to OA consumed opioids after discharge. Seventythree patients (96%; 95% CI, 89%-99%) completed the 30-day follow-up. The rate of missing questionnaires was 37 of 3724 (1%; 95% CI, 0.7%-1.4%). All the a priori RCT feasibility criteria were fulfilled. (continued) Key Points Question Is it feasible to conduct a randomized clinical trial (RCT) comparing opioid analgesia with opioidfree analgesia after outpatient general surgery? Findings In this pilot RCT, 76 patients were randomized 1:1 to receive opioid or opioid-free analgesia ...
Background Recent literature reports a decrease in healthcare-seeking behaviours by adults during the Covid-19 pandemic. Given that emergency general surgery (GS) conditions are often associated with high morbidity and mortality if left untreated, the objective of this study was to describe and quantify the impact of the Covid-19 pandemic on rates of emergency department (ED) utilization and hospital admission due to GS conditions. Methods This cohort study involved the analysis of an institutional database and retrospective chart review. We identified adult patients presenting to the ED in a network of three teaching hospitals in Montreal, Canada during the first wave of the Covid-19 pandemic (March13–May13, 2020) and a control pre-pandemic period (March13–May13, 2019). Patients with GS conditions were included in the analysis. ED utilization rates, admission rates and 30-day outcomes were compared between the two periods using multivariate regression analysis. Results During the pandemic period, 258 patients presented to ED with a GS diagnosis compared to 351 patients pre-pandemically (adjusted rate ratio (aRR) 0.75; p < 0.001). Rate of hospital admission during the pandemic was also significantly lower (aRR = 0.77, p < 0.001). Patients had a significantly shorter ED stay during the pandemic (adjusted mean difference 5.0 h; p < 0.001). Rates of operative management during the pandemic were preserved compared to the pre-pandemic period. There were no differences in 30-day complications (adjusted odds ratio (aOR) 1.46; p = 0.07), ED revisits (aOR 1.10; p = 0.66) and (re)admissions (aOR 1.42; p = 0.22) between the two periods. Conclusion There was a decrease in rates of ED utilization and hospital admissions due to GS conditions during the first wave of the Covid -19 pandemic; however, rates of operative management, complications and healthcare reutilization were unchanged. Although our findings are not generalizable to patients who did not seek healthcare, it was possible to successfully uphold institutional standards of care once patients presented to the ED. Supplementary Information The online version contains supplementary material available at 10.1007/s00464-021-08956-3.
Introduction: This study aims to determine the accuracy of radiological imaging compared with surgical pathology in patients with periurethral (PU) and anterior vaginal wall (AVW) lesions.Methods: This study is a retrospective analysis of 126 women who underwent surgical treatment for PU and AVW masses between 2011 and 2020. Clinicopathological data were extracted along with radiological findings from medical records. The primary outcome was the diagnostic accuracy of preoperative imaging compared to the gold standard, pathological diagnosis. The secondary outcome was the rate of imaging correcting the clinical diagnosis.Results: A total of 126 women with a median age of 42 underwent surgical treatment for PU and AVW masses. The most diagnoses were periurethral cysts (PUC) (52%) and urethral diverticulum (UD) (39%). Clinical diagnosis was accurate in 102 cases (81%) for the group of pathological diagnoses.Magnetic resonance imaging (MRI) and transvaginal ultrasound (TV US) were performed in 82 (65%) and 22 (17%) cases. The accuracy of MRI and TV US for the diagnosis of PU and AVW lesions was 76% and 82%, respectively. MRI and TV US corrected the clinical diagnosis in five (6%) and two (9%) cases, respectively. Voiding cystourethrography (VCUG) and double balloon urethrography (DBU), each performed in six (5%) cases, were accurate in four (67%) and three (50%) cases. No statistical difference was found for any imaging modality compared to clinical diagnosis. Conclusion:Clinical diagnosis based on pelvic and cystoscopy examinations was sufficient for diagnosing PU and AVW masses and was not significantly different from imaging diagnosis. Imaging may be helpful with preoperative surgical planning in selected cases.
Background: Controversy exists regarding the risk of cardiovascular disease (CVD) associated with androgen deprivation therapy (ADT) in patients with prostate cancer. We sought to evaluate the association between gonadotropin-releasing hormone (GnRH) agonists versus GnRH antagonist and the risk of CVD in patients with prostate cancer with or without prior CVD. Patients and Methods: Using administrative databases from Quebec, Canada, we identified first-time GnRH agonists and antagonist (degarelix) users between January 2012 and June 2016. Follow-up ended at the earliest of the following: first CVD event (myocardial infarction [MI], stroke, ischemic heart disease [IHD], arrhythmia, and heart failure [HF]); switch of GnRH group; death; or December 31, 2016. Inverse probability of treatment weighting (IPTW) based on the propensity score was used to control for potential confounding. IPTW-Cox proportional hazards model accounting for competing risks was used to evaluate the association of interest. Results: Among 10,785 patients identified, 10,201 and 584 were on GnRH agonists and antagonist, respectively. Median age was 75 years (interquartile range, 69–81 years) for both groups. A total of 4,152 (40.7%) men in the GnRH agonists group and 281 (48.1%) men in the GnRH antagonist group had CVD in the 3-year period prior to ADT initiation. Risk of HF was decreased in the antagonist group compared with the GnRH agonist group among patients with prior CVD (hazard ratio [HR], 0.46; 95% CI, 0.26–0.79). Risk of IHD was decreased in the antagonist group in patients without prior CVD (HR, 0.26; 95% CI, 0.11–0.65). Use of antagonist was associated with an increased risk of arrhythmia among patients with no prior CVD (HR, 2.34; 95% CI, 1.63–3.36). Conclusions: Compared with GnRH agonists, the GnRH antagonist was found to be associated with a decreased risk of HF, specifically among patients with prior CVD. Among those with no prior CVD, the GnRH antagonist was associated with a decreased risk of IHD but an increased risk of arrhythmia.
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