Retrospective multi-center study of robotic-assisted cholecystectomy: after-hours surgery and business-hours surgery outcomes.

The effect of robotic-assisted cholecystectomy (RAC), when performed after hours, on perioperative outcomes has not been evaluated against outcomes achieved during normal business hours. Subjects 18-80 years old who underwent da Vinci robotic-assisted cholecystectomy from August 2018 to February 2021 were included. Baseline and 30-day perioperative outcomes were retrospectively and consecutively collected and analyzed. Inverse probability treatment weighting (IPTW) was performed to balance patient characteristics between groups. A weighted comparative analysis was followed. Outcomes from 505 patients (after hours, n = 169; business hours, n = 336) undergoing RAC across 5 U.S. medical institutions were analyzed. The higher rates of acute cholecystitis and gallbladder inflammation, gangrene, and intraoperative abnormalities in the after-hours group were associated with higher rates of urgent cases and longer operative times-but not increased complication rates-compared to the business-hours group. There were no significant differences in rates of intraoperative or postoperative complications, readmissions, or reoperations. Integrated da Vinci Firefly fluorescence imaging system was used extensively, and the critical view of safety was achieved in > 96% of cases in both groups. No conversions occurred in the after-hours group compared to four conversions in the business-hours group (p = 0.0266). After-hours patients had shorter outpatient lengths of stay. No mortalities were reported for either group (p = 0.0139). After-hours RAC with integrated da Vinci Firefly imaging performed by surgeons experienced in RAC is associated with similar or improved outcomes than the same procedures during business hours in terms of complications, conversions, readmissions, reoperations, and length of stay. ClinicalTrials.gov identifier: NCT04551820; August 5, 2020.

Genetic causes of fractures and subdural hematomas: fact versus fiction.

Genetic disorders are in the differential diagnosis when young children present with unexplained fractures or intracranial hemorrhage. For medical and legal reasons, it is imperative to make the correct diagnosis and provide clear, evidence-based explanations of how alternative diagnoses were ruled out. A genetics consultation in cases of suspected child physical abuse should synthesize the history of present illness, medical history, family history, physical examination, and radiologic and laboratory findings in consultation with other specialists. The medical geneticist highlights how these disorders truly present. When the natural history of a genetic disorder is understood, it becomes clear that genetic disorders are not mysterious or difficult to diagnose. As highlighted in this case-based review, mainstream medical practice allows for differentiation among the intracranial and skeletal manifestations of osteogenesis imperfecta, Menkes disease, glutaric acidemia type 1 and child physical abuse. This review also highlights how a genetic disorder, Ehlers-Danlos syndrome, can be misused in a courtroom. Finally, this review summarizes when genetic testing is appropriate in cases of suspected child physical abuse.

Assessment of unintended volume loss of six closed system transfer devices.

INTRODUCTION: Closed system transfer devices (CSTDs) are used to prepare and administer hazardous drugs. Previous studies have explored the vapor and fluid containment performance of CSTDs. A less obvious consideration is the effect of CSTD use on the intended dose for small volume administrations. We assessed six CSTDs to determine if they contribute to volume loss and delivery of less than the intended dose during simulated drug administration. METHODS: Using an analytical balance, we obtained the mass of each CSTD at four points during simulated drug preparation and subcutaneous administration using sterile water. We used the masses to determine the average volume loss (VL) for each CSTD. RESULTS: Using ANOVA, we identified significant differences in volume loss (VL) among the mean VL (F(6,59) = 18.45, p = 6.19 × 10-12) for the six CSTDs and control (no CSTD). Four CSTDs had a VL that was statistically different than the control (p < 0.05); the VL for two CSTDs was not statistically different than the control (p > 0.05). Volume loss did not depend on administration volume. CONCLUSION: Volume loss performance varied among CSTDs. Volume loss may be clinically significant for small volumes but is not likely clinically significant for larger volumes. It is the authors' opinion that 3 mL represents a reasonable administration threshold below which volume loss should be considered clinically significant. Users should consider volume loss in context of the tasks, drugs, users, and environments where CSTDs will be used. The United States Pharmacopeia (USP) General Chapter <800>: Hazardous Drugs-Handling in Healthcare Settings recognizes the lack of CSTD performance standards. USP <800> recommends independent performance evaluation of CSTDs based on peer-reviewed studies. Our study adds to the comparative performance evaluations of CSTDs available on the market at the time of this review.

A multicenter study of initial experience with single-incision robotic cholecystectomies (SIRC) demonstrating a high success rate in 465 cases.

BACKGROUND: Recently, the robotic single-site platform has been used to ameliorate the difficulties seen in single-incision laparoscopic surgery (SILC) while preserving the benefits of standard laparoscopic cholecystectomy. The purpose of this study is to describe the clinical outcomes of a large series of single-incision robotic cholecystectomy (SIRC). METHODS: Medical records of consecutive patients who underwent SIRC were retrospectively reviewed. All procedures were performed by six surgeons at five different North American centers involved in the study. All patients included in the study underwent a cholecystectomy attempted through single site at the umbilicus, using the da Vinci(®) Surgical System (Intuitive Surgical Inc. Sunnyvale, CA). RESULTS: A total of 465 patients met study criteria. Median age was 48 years (range 18-89); 351 (75.5 %) were female and 304 (66.4 %) were overweight or obese. Except for gender, case characteristics differed significantly by surgeon/site. Previous abdominal surgery was reported for 226 (48.6 %) cases. SIRC was successfully completed in 455 (97.8 %) cases, and there were no conversions to open surgery. Median surgical time was 52 min with a decreasing trend after 55-85 cases. Male gender, obesity and diagnoses other than biliary dyskinesia were independent predictors of longer surgical times. The complication rate was 2.6 %. CONCLUSIONS: Our large, multicenter study demonstrates that robotic single-site cholecystectomy is safe and feasible in a wide range of patients.

Learning curve and early clinical outcomes for a robotic surgery novice performing robotic single site cholecystectomy.

BACKGROUND: A rapid training protocol has been developed for robotic surgery novices to learn robotic single-incision techniques. This study assesses the learning curve and early clinical results for a robotic surgery novice starting single-site cholecystectomy. METHODS: A chart review was performed on the surgeon's first 55 patients to undergo this procedure. RESULTS: Average patient age was 46.01 ± 4.25 (range 21-86) years and BMI was 26.57 ± 4.25 (range 19.4-36.6) kg/m(2) . The mean port placement with docking time was 11.34 ± 3.74 (range 7-23) min. Mean console time was 28.74 ± 11.04 (range 15-66) min. Average total OR time was 61.84 ± 14.66 (range 40-105) min. All procedures were successfully completed without conversion or added ports. Complications included several minor procedural gall bladder perforations and miscellaneous postoperative symptomatic complaints. CONCLUSION: Robotic single site cholecystectomy can be safely performed by a robotic novice within a minimal learning curve and have early clinical results that are comparable to the published data of robotic experts.

Long-term results of full-dose gemcitabine with radiation therapy compared to 5-fluorouracil with radiation therapy for locally advanced pancreas cancer.

PURPOSE: To retrospectively compare the efficacy and toxicity of full-dose gemcitabine based chemoradiotherapy (GemRT) versus 5-fluorouracil (5-FU) based chemoradiotherapy (5FURT) for locally advanced pancreas cancer (LAPC). METHODS: From January 1998 to December 2008, 93 patients with LAPC were treated either with 5FURT (n=38) or GemRT (n=55). 5FURT consisted of standard-field radiotherapy given concurrently with infusional 5-FU or capecitabine. GemRT consisted of involved-field radiotherapy given concurrently with full-dose gemcitabine (1000mg/m(2) weekly) with or without erlotinib. The follow-up time was calculated from the time of diagnosis to the date of death or last contact. RESULTS: Patient characteristics were not significantly different between treatment groups. The overall survival (OS) was significantly better for GemRT compared to 5FURT (median 12.5months versus 10.2months; 51% versus 34% at 1year; 12% versus 0% at 3years; 7% versus 0% at 5years, respectively; all P=0.04). The OS benefit of GemRT was maintained on subset analysis without concurrent erlotinib or with sequential gemcitabine (all P<0.05). The rates of distant metastasis, subsequent hospitalization, acute and late grade 3-5 gastrointestinal toxicities were not significantly different between the GemRT and 5FURT groups. CONCLUSIONS: GemRT was associated with an improved OS compared to standard 5FURT. This approach yielded long-term survivors and was not associated with increased hospitalization or severe gastrointestinal toxicity.

Vitamin K deficiency mimicking child abuse.

Supplemental vitamin K is required for normal hemostasis in infancy. Infants born outside the hospital may not receive prophylactic vitamin K. They may suffer from bleeding into various tissues and are likely to present to the emergency department. This report describes an infant born at home who presented with intracranial bleeding and signs and symptoms consistent with child abuse. Further investigations confirmed the diagnosis of Vitamin K deficiency. Although it is important to consider child abuse when the history and examination are consistent with the diagnosis, it is equally important to consider other potential diagnoses including Vitamin K deficiency.

Ximelagatran: an oral direct thrombin inhibitor.

OBJECTIVE: To present the chemistry, pharmacology, and pharmacokinetics of ximelagatran, an oral direct thrombin inhibitor (DTI), and to review available comparative clinical trial data evaluating its efficacy and safety relative to other antithrombotic agents in the prevention and treatment of thromboembolism. DATA SOURCES: A search of the PubMed and Cochrane databases (1995-August 2004), supplemented by a manual search of article bibliographies, conference abstracts, and data on file from the manufacturer, was conducted. Key search terms were ximelagatran, melagatran, H376/95, and direct thrombin inhibitors. STUDY SELECTION AND DATA EXTRACTION: Pertinent information from available clinical trials, including study design, patient demographics, dosing regimens, anticoagulant comparators, methods for evaluating effectiveness, treatment outcomes, adverse events, and pharmacokinetic and pharmacodynamic evaluations, was extracted. DATA SYNTHESIS: Ximelagatran is an orally administered DTI under development for use in the treatment of venous thromboembolism (VTE), long-term prevention of a second VTE event, stroke secondary to atrial fibrillation, prevention of VTE after orthopedic procedures, and recurrent ischemic events after acute myocardial infarction. CONCLUSIONS: Ximelagatran, in twice-daily doses of 24 or 36 mg, is an alternative to low-molecular-weight heparins or warfarin in thromboprophylaxis following orthopedic knee replacement, atrial fibrillation, or initial treatment of VTE. Improved outcomes versus placebo were seen in the long-term prevention of VTE in patients who completed an initial 6 months of treatment. Liver-related effects need further clarification.

Developing an algorithm for treating heparin-induced thrombocytopenia.

Heparin-induced thrombocytopenia (HIT) is a serious and common complication of heparin therapy that can lead to significant losses of life and limb. It is often under-recognized and, therefore, goes untreated until thrombosis develops. This article is meant to provide specific recommendations for treating patients with immune-mediated HIT, whether or not it is associated with thrombosis. These recommendations are based on our clinical experience treating patients with HIT and our evaluation of the published data on the efficacy and safety of lepirudin and argatroban, the 2 drugs approved by the Food and Drug Administration for treating HIT. Based on these criteria, we consider lepirudin the treatment of choice in all patients with HIT except those with severe or deteriorating renal function.

Antithrombotic agents: implications in dentistry.

Thrombosis and the complicating emboli that can result are important causes of illness and death. Thrombosis is of greater overall clinical importance in terms of morbidity and mortality than all of the hemorrhagic disorders combined. Agents such as heparin, low-molecular weight heparin, warfarin, aspirin, ticlopidine, clopidogrel, and tirofiban are used to prevent venous or arterial thrombosis. Patients taking these antithrombotic agents may be at risk for excessive bleeding after invasive dental procedures. The current antithrombotic agents used in medicine are reviewed, and the dental management of patients taking these agents is discussed.