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: Staple line bleeding can be a major intraoperative complication during laparoscopic sleeve gastrectomy, requiring reinforcing interventions that may diminish the integrity of the staple line and put patients at risk for postoperative hemorrhage or leak. To improve outcomes associated with surgery, surgeons may benefit from an alternative stapler that produces a drier staple line and requires less staple line manipulation.Methods: Sixty consecutive laparoscopic sleeve gastrectomy procedures were performed by three surgeons; 30 sleeves using the AEON TM Endostapler on THICK MODE and 30 using the Echelon Flex TM Powered Stapler with pulse technique. Stapler performance was measured by incidence and degree of staple line bleeding. Images of the first firing and fundus were taken with the laparoscope 10 seconds after the final firing. Images were evaluated by a third-party blinded evaluator and given a "bleeding score," a qualitative measure of intra-operative staple-line bleeding (1 = no bleeding to 5 = profuse bleeding). Results:The AEON TM Endostapler demonstrated a lower mean (6 standard error) "bleeding score" versus the Echelon Flex TM (2.1 6 0.1 vs. 2.6 6 0.1; p = 0.01). The AEON TM Endostapler had 15 cases (50%) with no bleeding at the fundus; the Echelon Flex TM had 7 cases (23%) with no bleeding at the fundus. The AEON TM Endostapler had 0 cases (0%) with profuse bleeding; the Echelon Flex TM had 2 cases (7%) with profuse bleeding. Conclusion:The AEON TM Endostapler is a significantly drier alternative to the Echelon Flex TM Powered Stapler, producing a much drier staple line and decreasing the need for other bleeding control methods.
Purpose: This study aimed to understand patients' experiences undergoing cancer surgery during the COVID-19 pandemic. In response to COVID-19, many elective cancer surgeries were delayed creating a massive backlog of cases. Patients' experiences with surgical delays may inform healthcare systems' responses to the backlog of cases and guide preparations for future healthcare emergencies.Methods: This was a qualitative description study. Patients undergoing general surgery for cancer at two university-a liated hospitals between March 2020 and January 2021 were invited to one-to-one interviews. Patients were purposefully selected using quota sampling until interviews produced no new information (i.e., thematic saturation). Interviews were conducted using a semi-structured guide and analyzed according to inductive thematic analysis.Results: Twenty patients were included [mean age 64±12.9; male (n=10); surgical delay (n=14); cancer sites: breast (n=8), skin (n=4), hepato-pancreato-biliary (n=4), colorectal (n=2), and gastro-esophageal (n=2)]. When determining their willingness to undergo surgery, patients weighed the risk of COVID-19 infection against the urgency of their disease. Changes to the hospital environment (e.g., COVID-19 preventative measures) and deviations from expected treatment (e.g., alternative treatments, remote consultations, rescheduled care) caused diverse psychological responses, ranging from increased satisfaction to severe distress. Patients employed several coping strategies to mitigate distress, including eliciting reassurance from care providers, seeking information from unconventional sources, and reframing care interruptions.Conclusions: Changes in care during the pandemic elicited diverse psychological responses from patients undergoing cancer surgery. Coping was facilitated by consistent communication with providers, emphasizing the importance of patient-centered expectation setting as we prepare for the future within and beyond the pandemic.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.