Feasibility of Prospectively Comparing Opioid Analgesia With Opioid-Free Analgesia After Outpatient General Surgery: A Pilot Randomized Clinical Trial.

Importance: The 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 Participants: This 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 ≥18 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. Interventions: Patients 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 Measures: Main 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. Seventy-three 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. Conclusions and Relevance: The findings of this pilot RCT support the feasibility of conducting a robust, full-scale RCT to inform evidence-based prescribing of analgesia after outpatient general surgery. Trial Registration: ClinicalTrials.gov Identifier: NCT04254679.

Serotonergic antidepressants and increased bleeding risk in patients undergoing breast biopsy.

OBJECTIVES: Recent investigations have shown that serotonergic antidepressant (SAd) use may increase the risk of peri-operative bleeding events. Our objective was to evaluate the possibility of a similar association in patients undergoing radiologic breast biopsies. METHODS: We used data from 3890 patients undergoing 6300 biopsy procedures between January 2011 and October 2014 in the Breast Clinic of McGill University Health Centre, Montreal, Canada. In this case-control study, cases were patients reported to have abnormal bleeding during their biopsy by board-certified radiologists. A control group of nonbleeders was selected using matching according to age and type of biopsy. The correlation between abnormal bleeding and SAd use was assessed using bivariate and multivariate statistical analyses. RESULTS: There were 97 patients with abnormal bleeding and 137 matched controls; 10 bleeders (cases) were on SAds (7 citalopram, 3 paroxetine) while only 1 nonbleeder (control group) was on a SAd (low-dose sertraline, 25 mg/day). SAds were significantly associated with increased bleeding risk (10.3% versus 0.7%, Fisher's Exact p = 0.001). Moreover, after adjusting for confounding factors (age, type of biopsy, size of biopsy, needle caliber, pathology result and nonsteroidal anti-inflammatory drug use, multivariate logistic regression confirmed that SAds were associated with elevated bleeding risk (16.2, 95% confidence interval 1.87-140.1, p = 0.01). CONCLUSIONS: This is the first study demonstrating increased bleeding events in breast biopsy patients using SAds. Clinicians should be aware that SAds may be associated with peri-operative bleeding risk, even in relatively minor procedures such as breast biopsies.

Assessing clinical judgment using the Script Concordance test: the importance of using specialty-specific experts to develop the scoring key.

BACKGROUND: The Script Concordance test (SCT) assesses clinical judgment. The purpose of this study was to determine whether a specialty-specific scoring key improves the validity of the SCT. METHODS: Thirty experts from 6 general surgery disciplines answered questions pertaining to their area of expertise. We created a scoring key of 5 amalgamated expert panel members. The answers of 227 general surgery residents were analyzed. RESULTS: The optimized test had a reliability level (Cronbach α) of .81. Scores increased progressively throughout all levels of training, with R5s scoring higher than R4s (R1, 42.7 ± 7.1; R2, 47.6 ± 7.5; R3, 48.7 ± 6.7; R4, 49.8 ± 7.7; R5, 52.9 ± 9.3). The average score of juniors (R1s + R2s, 45.1 ± 7.6) was significantly lower (P < .001) than seniors (R3s + R4s + R5s, 50.4 ± 8.0). CONCLUSIONS: We showed that specialty-specific experts must be used to develop the scoring key. This has important implications in the application of the SCT on a wider level.

The script concordance test as a measure of clinical reasoning: a national validation study.

INTRODUCTION: The script concordance test (SCT) is an innovative tool for clinical reasoning assessment. It has previously been shown to be a reliable and valid measure of clinical reasoning among general surgical residents. PURPOSE: To determine if the SCT maintained its validity and reliability when administered on a national level. METHODS: The test was administered to 202 residents (51 R1, 45 R2, 45 R3, 28 R4, and 33 R5) in 9 general surgery programs across Canada. RESULTS: The optimized version of the test had a reliability (Cronbach alpha) of .85. Scores increased progressively from R1 (64.5 ± 7.6) to R2 (69.5 ± 5.8) to R3 (69.9 ± 6.7) to R4 (72.0 ± 6.2) with a dip in the R5s (68.3 ± 8.6). The test was able to differentiate junior (R1+ R2 = 66.8 ± 7.2) from senior residents (R3 + R4 + R5 = 70.0 ± 7.3, P = .001) across all the programs. CONCLUSIONS: The SCT maintained its reliability and validity as a measure of intraoperative clinical reasoning among general surgical residents when administered across multiple centers. We believe that the SCT can be developed to measure clinical reasoning in high-stakes national examinations.

A case of unresectable rectal necrosis.

Introduction. Necrosis of the rectum is an uncommon finding due to abundant collateral vasculature. Its management remains challenging, without clear consensus in the literature. Case Report. We describe a case of a 53-year-old woman with multiple medical comorbidities that presented in septic shock and hematochezia. Colonoscopy revealed ischemic colitis. Conservative management was instituted. At two weeks, she presented evidence of peritonitis. Exploratory laparotomy revealed extensive necrosis of the left colon and rectum. Due to dense inflammation, resection was deemed unsafe. Therefore, a transverse ostomy with mucosal fistula was preformed. Multiple drains were left in place. The patient healed uneventfully. Conclusion. This case illustrates that, if extensive dissection of the distal colon and rectum is unsafe due to the patient's critical condition or technical feasibility, then a diverting ostomy of the proximal viable bowel along with a mucus fistula and good drainage of the abdomen represents an acceptable alternative.

Anorectal melanoma: diagnosis and treatment.

An increase in the incidence of anorectal melanoma has recently been noted in the United States. Anorectal melanoma is an uncommon and lethal condition, with a median survival of <20 months. Unfortunately, nonspecific symptoms also attributable to common and benign conditions (eg, hemorrhoids) cause significant delay in its diagnosis. Although it has not been validated by clinical trials, abdominoperineal resection has historically been the treatment of choice for this disease. However, for the past 2 decades, a lack of clear survival benefit has led to a shift toward less-mutilating wide local excisions. Controversy still exists regarding the benefit of radiation therapy and chemotherapy. Furthermore, the value of nodal surgery in anorectal melanoma is unclear. In this article, we review the history and current status of management of anorectal melanoma, with a particular focus on surgical controversies and challenges in optimizing survival.

Analysis of clinical applicability of the breast cancer nomogram for positive sentinel lymph node: the canadian experience.

BACKGROUND: A Breast Cancer Nomogram (BCN) for predicting nonsentinel lymph node (NSLN) involvement has been developed and prospectively tested in several series. However, its clinical applicability has never been tested among surgeons. METHODS: The BCN was applied to 209 SLN-positive patients. Its performance was assessed by the area under the receiver-operating characteristic (ROC) curve. Surgeons in Quebec were surveyed to determine the predicted NSLN positivity below which they would not dissect the axilla. The accuracy of the BCN was determined in this clinically relevant range. RESULTS: The predictive accuracy of the BCN had an area under the ROC curve of 0.687. Almost half of interviewed surgeons treat over 20 breast cancer per year. Fourteen out of 82 surgeons questioned would never leave the patient without a completion axillary dissection after a positive SLN, regardless of the BCN result. Seventy one percent of them would not complete axillary dissection if the prediction of a positive NSLN was

Nail-Patella syndrome: a case report and anesthetic implications.

PURPOSE: To report a case of asystole during combined epidural and general anesthesia occurring in a patient with Nail-Patella syndrome (NPS), and to review the management and anesthetic implications of this rare genetic syndrome. CLINICAL FEATURES: A 64-yr-old male with NPS, renal impairment and coronary artery disease presented for right hemicolectomy for colon cancer. Following initiation of surgery and during insertion of a nasogastric tube there was sudden loss of the patient's pulse oxymetry, and arterial pressure waveforms with an asystolic electrocardiogram signal. Atropine 0.6 mg i.v. was administered and after an asystolic period of 20-30 sec, myocardial activity commenced at 110 beatsxmin(-1) with return of normal vital signs and no further sequelae. CONCLUSIONS: Nail-Patella syndrome can present with an array of anomalies that may be associated with perioperative complications. Glaucoma, nephropathy, vasomotor dysfunction, fragile teeth, abnormal muscle, skeletal and nerve anatomy as well as involvement of the central and/or peripheral nervous systems are common findings. In this setting it is postulated that a vasovagal reflex from esophageal stimulation by nasogastric tube placement may have caused the asystolic event. This response could have been exaggerated by the sympatholytic combination of neuraxial block, preoperative beta-blockade, and potential autonomic dysfunction secondary to NPS. Awareness of this uncommon disease and its presentation may serve to caution the anesthesiologist regarding the perioperative implications of patients with this syndrome.

A novel method of assessing clinical reasoning in surgical residents.

At present, surgical educators can readily assess knowledge with multiple-choice examinations, and inanimate models can be used to assess technical skills. Clinical judgment and reasoning are indispensable skills used by expert surgeons to solve ill-defined problems encountered in the emergency department, clinic, and operating room. The Script Concordance Test, a new tool of clinical reasoning assessment, can test the elaborated networks of knowledge that experienced surgeons develop over the years. It allows for multiple different approaches to the same problem and could be developed as both a formative and summative assessment tool in general surgery residency programs. This article explores the theoretical and practical aspects of the Script Concordance Test.

Successful use of letrozole in male breast cancer: a case report and review of hormonal therapy for male breast cancer.

Male breast cancer is an uncommon occurrence. Treatment of male breast cancer is typically extrapolated from data on the treatment of female breast cancer. Recently, aromatase inhibition has been proven as an effective therapy for female breast cancer, particularly in the setting of advanced cancers. The efficacy of aromatase inhibitors in males, however, has not been established. We report the successful treatment of a male with locally advanced breast cancer using the aromatase inhibitor letrozole.

A case of penile melanoma illustrating the low sensitivity of frozen sections in the assessment of sentinel lymph nodes.

A 75 year-old uncircumcised man presented with a 1.1mm thick malignant melanoma on the ventral aspect of the glans penis. He underwent isosulfan blue and technetium 99m guided sentinel lymph node (SLN) biopsy and distal penectomy with 2 cm margins. This is the third reported case of penile melanoma using both markers for SLN mapping. While frozen sections and H& E stains were negative, S-100 and HMB-45 immunohistochemistry revealed micrometastasis in one of the sentinel nodes. This case illustrates that any discussion with the patient about management and prognosis should await immunohistochemistry results.