Surgery (Austin & Northern Health) - Research Publications

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    Validation of a Novel Patient Specific CT-Morphometric Technique for Quantifying Bone Graft Resorption Following the Latarjet Procedure.
    Francis-Pester, FW ; Waltenspül, M ; Wieser, K ; Hoy, G ; Ek, ET ; Ackland, DC ; Ernstbrunner, L (MDPI AG, 2022-09-20)
    Bone graft resorption following the Latarjet procedure has received considerable concern. Current methods quantifying bone graft resorption rely on two-dimensional (2D) CT-scans or three-dimensional (3D) techniques, which do not represent the whole graft volume/resorption (i.e., 2D assessment) or expose patients to additional radiation (i.e., 3D assessment) as this technique relies on early postoperative CT-scans. The aim of the present study was to develop and validate a patient-specific, CT-morphometric technique combining image registration with 3D CT-reconstruction to quantify bone graft resorption following the Latarjet procedure for recurrent anterior shoulder instability. Pre-operative and final follow-up CT-scans were segmented to digitally reconstruct 3D scapula geometries. A virtual Latarjet procedure was then conducted to model the timepoint-0 graft volume, which was compared with the final follow-up graft volume. Graft resorption at final follow-up was highly correlated to the 2D gold standard-technique by Zhu (Kendall tau coefficient = 0.73; p < 0.001). The new technique was also found to have excellent inter- and intra-rater reliability (ICC values, 0.931 and 0.991; both p < 0.001). The main finding of this study is that the technique presented is a valid and reliable method that provides the advantage of 3D-assessment of graft resorption at long-term follow-up without the need of an early postoperative CT-scan.
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    Case Report: Midshaft clavicle fracture with concomitant high grade (Type V) acromioclavicular joint dislocation.
    Cosic, F ; Ernstbrunner, L ; Hoy, GA ; Ooi, KS ; Ek, ET (Frontiers Media SA, 2022)
    INTRODUCTION: Concomitant acromioclavicular joint dislocation and midshaft clavicle fracture are rare injuries, generally resulting from high energy trauma, with limited previous experience in management. CASE: A 30 year old male presented following a pushbike accident. He had suffered a head on collision with another cyclist. Radiographic examination demonstrated a displaced midshaft clavicle fracture with a Rockwood Type V acromioclavicular joint dislocation. Operative management was undertaken using a dual plating technique. At six month follow up the patient demonstrated full range of motion and had no pain. CONCLUSION: Appropriate radiographic evaluation and careful intraoperative assessment are required using the principles of management for acromioclavicular joint injuries, along with stabilization of the mid-clavicular fracture to reduce the risk of non-union.
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    Role of PSMA PET-guided metastases-directed therapy in oligometastatic recurrent prostate cancer
    Alberto, M ; Yim, A ; Papa, N ; Siva, S ; Ischia, J ; Touijer, K ; Eastham, JA ; Bolton, D ; Perera, M (FRONTIERS MEDIA SA, 2022-08-18)
    Oligometastatic prostate cancer (OMPC) has been proposed as an intermediary state between localised disease and widespread metastases, with varying definitions including 1, 3, or ≤5 visceral or bone metastasis. Traditional definitions of OMPC are based on staging with conventional imaging, such as computerised tomography (CT) and whole-body bone scan (WBBS). Novel imaging modalities such as prostate-specific membrane antigen positron emission tomography (PSMA PET) have improved diagnostic utility in detecting early metastatic prostate cancer (PC) metastases compared with conventional imaging. Specifically, meta-analytical data suggest that PSMA PET is sensitive in detecting oligometastatic disease in patients with biochemical recurrence (BCR) post-radical treatment of PC. Recent trials have evaluated PSMA PET-guided metastases-directed therapy (MDT) in oligometastatic recurrent disease, typically with salvage surgery or radiotherapy (RT). To date, these preliminary studies demonstrate promising results, potentially delaying the need for systemic therapy. We aim to report a comprehensive, multidisciplinary review of PSMA-guided MDT in OMPC. In this review, we highlight the utility of PMSA PET in biochemically recurrent disease and impact of PSMA PET on the definition of oligometastatic disease and outline data pertaining to PSMA-guided MDT.
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    Randomized, double-blind, placebo-controlled phase 3 study of paclitaxel {plus minus} napabucasin in pretreated advanced gastric or gastroesophageal junction adenocarcinoma.
    Shah, MA ; Shitara, K ; Lordick, F ; Bang, Y-J ; Tebbutt, NC ; Metges, J-P ; Muro, K ; Lee, K-W ; Shen, L ; Tjulandin, S ; Hays, JL ; Starling, N ; Xu, R-H ; Sturtz, K ; Fontaine, M ; Oh, C ; Brooks, E ; Xu, B ; Li, W ; Li, CJ ; Borodyansky, L ; Van Cutsem, E (American Association for Cancer Research (AACR), 2022-05-26)
    PURPOSE: To compare napabucasin (generator of reactive oxygen species) plus paclitaxel with paclitaxel only in patients with second-line advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. EXPERIMENTAL DESIGN: In the double-blind, phase III BRIGHTER study (NCT02178956), patients were randomized (1:1) to napabucasin (480 mg orally twice daily) plus paclitaxel (80 mg/m2 intravenously weekly for 3 of 4 weeks) or placebo plus paclitaxel. The primary endpoint was overall survival (OS). Secondary endpoints included progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and safety. RESULTS: Overall, 714 patients were randomized (napabucasin plus paclitaxel, n = 357; placebo plus paclitaxel, n = 357). 72.1% were male, 74.6% had gastric adenocarcinoma, and 46.2% had peritoneal metastases. The study was unblinded following an interim analysis at 380 deaths. The final efficacy analysis was performed on 565 deaths (median follow-up, 6.8 months). No significant differences were observed between napabucasin plus paclitaxel and placebo plus paclitaxel for OS (6.93 vs. 7.36 months), PFS (3.55 vs. 3.68 months), ORR (16% vs. 18%), or DCR (55% vs. 58%). Grade {greater than or equal to}3 adverse events occurred in 69.5% and 59.7% of patients administered napabucasin plus paclitaxel and placebo plus paclitaxel, respectively, with grade {greater than or equal to}3 diarrhea reported in 16.2% and 1.4%, respectively. CONCLUSION: Adding napabucasin to paclitaxel did not improve survival in patients with pretreated advanced gastric or GEJ adenocarcinoma. Consistent with previous reports, the safety profile of napabucasin was driven by manageable gastrointestinal events; grade {greater than or equal to}3 diarrhea occurred at a higher frequency with napabucasin plus paclitaxel versus placebo plus paclitaxel.
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    Early Versus Postoperative Chemical Thromboprophylaxis Is Associated with Increased Bleeding Risk Following Abdominal Visceral Resections: a Multicenter Cohort Study
    Liu, DS ; Newbold, R ; Stevens, S ; Wong, E ; Fong, J ; Mori, K ; Wong, DJ ; Gill, AS ; Lee, S ; Jamel, W ; Crowe, A ; Howard, T ; Jain, A ; Beh, PS ; Slevin, M ; Fleming, N ; Bennet, S ; Chung, C (SPRINGER, 2022-03-22)
    BACKGROUND: Abdominal visceral resections incur relatively higher rates of postoperative bleeding and venous thromboembolism (VTE). While guidelines recommend the use of perioperative chemical thromboprophylaxis, the most appropriate time for its initiation is unknown. Here, we investigated whether early (before skin closure) versus postoperative commencement of chemoprophylaxis affected VTE and bleeding rates following abdominal visceral resection. METHODS: Retrospective review of all elective abdominal visceral resections undertaken between January 1, 2018, and June 30, 2019, across four tertiary-referral hospitals. Major bleeding was defined as the need for blood transfusion, reintervention, or > 20 g/L fall in hemoglobin from baseline. Clinical VTE was defined as imaging-proven symptomatic disease < 30 days post-surgery. RESULTS: A total of 945 cases were analyzed. Chemoprophylaxis was given early in 265 (28.0%) patients and postoperatively in 680 (72.0%) patients. Mean chemoprophylaxis exposure doses were similar between the two groups. Clinical VTE developed in 14 (1.5%) patients and was unrelated to chemoprophylaxis timing. Postoperative bleeding occurred in 71 (7.5%) patients, with 57 (80.3%) major bleeds, requiring blood transfusion in 48 (67.6%) cases and reintervention in 31 (43.7%) cases. Bleeding extended length-of-stay (median (IQR), 12 (7-27) versus 7 (5-11) days, p < 0.001). Importantly, compared to postoperative chemoprophylaxis, early administration significantly increased the risk of bleeding (10.6% versus 6.3%, RR 1.45, 95% CI 1.05-1.93, p = 0.038) and independently predicted its occurrence. CONCLUSIONS: The risk of bleeding following elective abdominal visceral resections is substantial and is higher than the risk of clinical VTE. Compared with early chemoprophylaxis, postoperative initiation reduces bleeding risk without an increased risk of clinical VTE.
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    PEDAL protocol: a prospective single-arm paired comparison of multiparametric MRI and 18F-DCPFyl PSMA PET/CT to diagnose prostate cancer
    Tran, V ; Hong, A ; Sutherland, T ; Taubman, K ; Lee, S-F ; Lenaghan, D ; Sethi, K ; Corcoran, NM ; Lawrentschuk, N ; Woo, H ; Tarlinton, L ; Bolton, D ; Spelman, T ; Thomas, L ; Booth, R ; Hegarty, J ; Perry, E ; Wong, L-M (BMJ PUBLISHING GROUP, 2022-09-01)
    INTRODUCTION: Prostate-specific membrane antigen positron emission tomography (PSMA-PET) has emerged as valuable imaging to assessing metastatic disease in prostate malignancy. However, there has been limited studies exploring the utility PSMA-PET as primary imaging assessing for index lesions prior to biopsy. The primary objective of this study is to compare the diagnostic accuracy of 18-fluorine PSMA (18F DCFPyL PSMA) PET scans to multiparametric MRI (mpMRI) to detect primary prostate cancer at prostate biopsy. METHODS AND ANALYSIS: The PEDAL trial is a multicentre, prospective, single-arm, paired comparison, non-randomised phase III trial in subjects considered for diagnostic prostate biopsy. Subjects who are eligible for a diagnostic mpMRI prostate will undergo additional same-day 18 F DCFPyl PSMA PET/CT of the chest, abdomen and pelvis. Software coregistration of the mpMRI and PSMA-PET/CT images will be performed. The reporting of the mpMRI prostate, PSMA-PET/CT and PSMA PET/MRI coregistration will be performed blinded. The diagnostic accuracy of PSMA PET/CT alone, and in combination with mpMRI, to detect prostate cancer will be assessed. Histopathology at prostate biopsy will be used as the reference standard. Sample size calculations estimate that 240 subjects will need to be recruited to demonstrate 20% superiority of PSMA-PET/CT. The sensitivity, specificity, positive predictive value and negative predictive value of the combination of mpMRI prostate and PSMA PET/CT compared with targeted and systematic prostate biopsy will be evaluated. It is hypothesised that PSMA PET/CT combined with mpMRI prostate will have improved diagnostic accuracy compared with mpMRI prostate alone for detection of prostate cancer in biopsy-naïve men, resulting in a significant impact on patient management. ETHICS AND DISSEMINATION: This study was approved by the independent Human Research Ethics Committee. Results will be published in peer-reviewed medical journals with eligible investigators will significantly contribute. TRIAL REGISTRATION NUMBER: ACTRN12620000261910.
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    Protocol describing a systematic review and mixed methods consensus process to define the deteriorated ward patient.
    Malycha, J ; Andersen, C ; Redfern, OC ; Peake, S ; Subbe, C ; Dykes, L ; Phillips, A ; Ludbrook, G ; Young, D ; Watkinson, PJ ; Flabouris, A ; Jones, D (BMJ, 2022-09-19)
    INTRODUCTION: Most patients admitted to hospital recover with treatments that can be administered on the general ward. A small but important group deteriorate however and require augmented organ support in areas with increased nursing to patient ratios. In observational studies evaluating this cohort, proxy outcomes such as unplanned intensive care unit admission, cardiac arrest and death are used. These outcome measures introduce subjectivity and variability, which in turn hinders the development and accuracy of the increasing numbers of electronic medical record (EMR) linked digital tools designed to predict clinical deterioration. Here, we describe a protocol for developing a new outcome measure using mixed methods to address these limitations. METHODS AND ANALYSIS: We will undertake firstly, a systematic literature review to identify existing generic, syndrome-specific and organ-specific definitions for clinically deteriorated, hospitalised adult patients. Secondly, an international modified Delphi study to generate a short list of candidate definitions. Thirdly, a nominal group technique (NGT) (using a trained facilitator) will take a diverse group of stakeholders through a structured process to generate a consensus definition. The NGT process will be informed by the data generated from the first two stages. The definition(s) for the deteriorated ward patient will be readily extractable from the EMR. ETHICS AND DISSEMINATION: This study has ethics approval (reference 16399) from the Central Adelaide Local Health Network Human Research Ethics Committee. Results generated from this study will be disseminated through publication and presentation at national and international scientific meetings.
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    Patient safety in community-based mental healthcare: A systematic scoping review
    Averill, P ; Vincent, C ; Reen, G ; Sevdalis, N ; Henderson, C (Royal College of Psychiatrists, 2022-06)
    Introduction There is limited existing research about patient safety issues in mental healthcare. A lack of evidence is particularly pronounced in relation to safety in community-based mental health services, where the majority of care is provided. To date, reviews of mental health patient safety literature have focused primarily on inpatient care settings. Objectives This systematic scoping review will aim to identify and synthesise literature about the types of patient safety problems in adult community-based mental health settings, the causes of these problems, and evaluated safety interventions in this care context. Methods A systematic search was conducted on 19th June 2020 and refreshed on 23rd October 2021, across five databases: Medline, Embase, PsycINFO, Health Management Information Consortium, and Cumulative Index to Nursing and Allied Health Literature. The search strategy focused on three key elements: ‘mental health’, ‘patient safety’ and ‘community-based mental health services’. Retrieved articles were screened at title, abstract and subject heading level, followed by full-text screen of longlisted articles. Results In this presentation, the findings of this systematic scoping review will be described, based on synthesised literature about safety incidents, broader care delivery problems, their causes, and evaluated patient safety interventions to address these issues. Conclusions This study will offer learning opportunities about the safety problems, contributory factors, and safety interventions in adult community-based mental health services, as described in the evidence base. Review findings will also help to ascertain gaps in existing research, which should be addressed in future studies. Disclosure NS is the director of London Safety and Training Solutions Ltd, which offers training in patient safety, implementation solutions and human factors to healthcare organisations and the pharmaceutical industry. The other authors have no competing interests.
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    Removing unwanted variation from large-scale RNA sequencing data with PRPS
    Molania, R ; Foroutan, M ; Gagnon-Bartsch, JA ; Gandolfo, LC ; Jain, A ; Sinha, A ; Olshansky, G ; Dobrovic, A ; Papenfuss, AT ; Speed, TP (NATURE PORTFOLIO, 2022-09-15)
    Accurate identification and effective removal of unwanted variation is essential to derive meaningful biological results from RNA sequencing (RNA-seq) data, especially when the data come from large and complex studies. Using RNA-seq data from The Cancer Genome Atlas (TCGA), we examined several sources of unwanted variation and demonstrate here how these can significantly compromise various downstream analyses, including cancer subtype identification, association between gene expression and survival outcomes and gene co-expression analysis. We propose a strategy, called pseudo-replicates of pseudo-samples (PRPS), for deploying our recently developed normalization method, called removing unwanted variation III (RUV-III), to remove the variation caused by library size, tumor purity and batch effects in TCGA RNA-seq data. We illustrate the value of our approach by comparing it to the standard TCGA normalizations on several TCGA RNA-seq datasets. RUV-III with PRPS can be used to integrate and normalize other large transcriptomic datasets coming from multiple laboratories or platforms.