ANZCTR search results

Families of children with type 1 diabetes (T1D) have reported high fat and high protein (HF/HP) meals as ‘difficult’ foods, causing prolonged hyperglycaemia after eating. A newly developed Hybrid Closed Loop (HCL) system with an Auto-Mode function uses real-time glucose levels to deliver basal insulin in micro amounts. Yet, there is little evidence on whether Auto-Mode is more effective than standard insulin pump therapy (Manual Mode) at reducing glucose excursions caused by HF/HP foods. This pilot study examines the impact of Auto-Mode on glucose excursions following HF/HP meals compared to Manual Mode. Participants are asked to consume standardised frozen beef lasagne and margherita pizza two nights a week for four weeks, under controlled conditions (4 meals in Manual Mode, 4 meals in Auto-Mode). It is hypothesised that the use of the Auto Mode will reduce glucose excursions after eating HF/HP foods when compared to the participant’s preferred insulin bolus pattern delivery in Manual Mode.

The objective of this study is to compare clinical and radiological outcomes in robotic-arm assisted TKA using mechanical alignment (MA TKA) versus robotic-arm assisted TKA with functional alignment (FA TKA). Both FA TKA and MA TKA are performed through similar skin incisions, robotic-guidance, and use identical implants. In MA TKA, bone is prepared and implants positioned to ensure that that the overall alignment of the leg is in neutral. In FA TKA, the bone is prepared and implants positioned to restore the natural alignment of the patient’s leg. Both of these surgical techniques provide excellent outcomes in TKA but it is not known which of the two techniques is better for patient recovery. Mako robotic-assisted TKA is an established treatment for arthritis of the knee joint. The positions of the implants and overall alignment of the leg are important as they influence how quickly the implants wear out and need replacing. The aim of this study is to determine if patient recovery is better with functionally aligned Mako robotic-assisted total knee arthroplasty (FA TKA) or mechanically aligned Mako robotic-assisted total knee arthroplasty (MA TKA)

Physical frailty (functional decline including muscle weakness) is one of the significant public health problems in elderly and is strongly correlated with poor health outcomes including cardiovascular diseases, but we do not know why this occurs. Frailty is associated with the initial stages of vascular dysfunction, inflammation and vitamin D deficiency. Low vitamin D levels are common among old people due to low dietary intake, less sun exposure and low level of production in the body. Previous research show that vitamin D supplements can improve both vascular function and physical frailty (including muscle function). Therefore, this project will determine if the reduction of inflammation using vitamin D supplementation can prevent people becoming frail.

The WSLHD HREC has approved project, certifying that the study proposal meets the requirements of the National Statement. The ethical approval for this research project is granted to be conducted at Blacktown Mount Druitt Hospital. The WSLHD HREC has been accredited by the NSW Department of Health as a lead HREC to provide the single ethical and scientific review of proposals to conduct research within the NSW public health system. This lead HREC is constituted and operates in accordance with the National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research and the CPMP/ICH Note for Guidance on Good Clinical Practice. The request to undertake the above protocol was reviewed by a subcommittee of members of the Scientific Advisory Committee (SAC) and the Human Research Ethics Committee (HREC) (Western Sydney Local Health District).

Anastomotic leakage (AL) is a serious complication of intestinal surgery, resulting in increased morbidity and mortality. This study aims to explore the simple and non-invasive approach of measuring the enzymes amylase and lipase in the drain fluid following a low extra-peritoneal anastomosis to detect AL at an early stage in the post-operative recovery. The hypothesis is based on the premise that luminal content of the colon is high in amylase and lipase and that drain fluid levels will rise above the normal serum reference range when an AL occurs. Who is it for? You may be eligible for this study if you are aged 18 or older, you have undergone a low or ultra low colorectal operation without a diverting loop ileostomy, and have had placement of a rectal tube and a pelvic drain at surgery. Patients undergoing the above surgical operations for any indication will be eligible for this study. Study details All participants enrolled in this study will have a sample of drain fluid collected daily from their surgical drain whilst the pelvic drain is in place. Insertion of pelvic drains is an element of the standard of care following colorectal surgery. It is hoped this research will determine whether enzymes such as amylase and lipase in fluids drained from an intestinal surgical site can indicate whether a patient has experienced an AL from their intestinal join following surgery, at an earlier time point than when diagnosed based on clinical signs.

Prostate cancer is the most common cancer in men, accounting for 25% of all cancer, with approximately 75% of those cancers arise posteriorly in the peripheral zone of the gland just adjacent to the rectum. Dose escalation in prostate cancer radiotherapy leads to improved tumor control rates however a dilemma arises in the balance between radiation dose and unacceptable rectal adverse effects (including diarrhoea and bleeding) which can complicate therapy in up to 20% of patients (due to the proximity of the prostate and the rectum). In some cases symptoms may evolve into a chronic course, negatively impacting on patients long term quality of life. Researchers have tried various technologies to protect rectal tissue when radiation is being delivered to the prostate. One such paradigm is the use of an inert protective synthetic hydrogel (made up of 90% water) called SpaceOAR, that is currently the only commercially available product for prostate-rectum separation. SpaceOAR is a transperineal inserted spacer (TIS) that is injected as a liquid into the anterior perirectal fat. When it solidifies, it forms a small protective barrier and space between the rectum and the prostate for the duration of radiotherapy treatment. Over a few months SpaceOAR dissolves and is absorbed by the body. A reasonable body of accumulated published literature has reported on the clinical utility of rectal spacers in phase II cohorts involving men undergoing external beam and brachytherapy to standard doses, with significant decrease in rectal toxicity. These results are echoed by the experience of Epworth Radiation Oncology, using conventional doses. The current trial is a prospective, non-randomized, single arm open-label study aimed at assessing the safety and efficacy of treating men with clinically localized prostate cancer to 82Gy using Intensity modulated Radiotherapy following the insertion of rectal SpaceOAR® hydrogel. The primary aims of this trial are to assess the inicidence of clinically notifiable toxicity and impact of health-related quality of life up to 36 months following radiotherapy.

We will evaluate the effects of a 10-week obesity prevention intervention Healthy Conversations @ Playgroup, to promote healthy lifestyle behaviours (dietary intake, physical activity, screen time and sleep) and support autonomy supportive parenting practices related to the four obesity risk behaviours in young children attending community playgroups. It is expected that children randomized to the Healthy Conversations intervention playgroups will show significantly better diet quality, physical activity, screen time, and sleep behaviours immediately after the intervention at 10 weeks and at 6-months follow-up, and significantly lower BMI z-scores at 6-months follow-up, than children randomized to the wait-listed control playgroups. Additionally, it is expected that parents of children randomized to the intervention playgroups will show significantly better parenting practices related to child obesity risk behaviours immediately after the intervention at 10 weeks and at 6-months follow-up, than children randomized to the wait-listed control playgroups .

This study aims to determine the effectiveness of a practice change intervention in increasing the provision of recommended gestational weight gain care by antenatal services. Relative to usual antenatal appointments, it is hypothesised that the intervention will achieve increases in the proportion of post intervention appointments in which gestational weight gain care is consistent with guideline recommendations: assessment (predicted 15% increase); brief advice (predicted 14% increase); referral (predicted 9% increase). The study will be conducted as a stepped-wedge controlled trial, with staggered implementation of the intervention across maternity services in three health sectors within Hunter New England Local Health District, New South Wales, Australia. The intervention will consist of evidence-based, locally tailored practice change strategies including guidelines and procedures, system prompts, leadership support, training, and audit and feedback. The prevalence of woman-reported assessment, advice and referral for gestational weight gain will be the primary outcomes of interest. Cross-sectional measurement of outcomes will occur via telephone interviews with a random sample of women who attend the services each week. An intervention effect will be determined by an increase in recommended care delivery across the sites. Economic analyses will be undertaken to assess the cost, cost effectiveness and budget impact of the practice change intervention. Women’s weight gain during pregnancy, diet, physical activity and intervention acceptability will also be measured.

Testing the clinical performance of hs-cTn assays from different manufacturers in the assessment of acute myocardial infarction is crucial. The Siemen’s Atellica hs-cTn assay has previously been evaluated using only two patient cohorts, one in Scotland and one in the United States. Each of these evaluations tested a different strategy for ruling in and ruling out heart attack. As such, there is limited data available around how well this assay will be perform for a Queensland population of patients with suspected acute coronary syndrome. We propose an observational study to evaluate the performance of the Siemen's Atellica hs-cTn assay. To complete this research, two sources of data will be used. First, we will prospectively collect data from five Queensland Health sites. The data collected will include clinical data and a small amount of additional blood taken during the routine blood test. Second, we will use existing blood samples stored as part of a previous research project. The combined data will be used to identify the diagnostic accuracy of the Siemen's Atellica hs-cTnI assay for 30-day cardiac outcomes of AMI and cardiac death in patients presenting to emergency departments.. We hypothesise that this study will identify an appropriate low level cut-off value for safe rule out of AMI on index presentation specific for this assay.

Patients near the end of life may suffer from an array of distressing symptoms, including pain, nausea, agitation, confusion and distress. Many patients will be delirious, with up to 88% of palliative care inpatients suffering a terminal delirium. When patients are distressed at the end of life, and other targeted symptomatic management has been unsuccessful, or when patients are struggling with confusion or distress, the treatment offered may be sedation, in order to relieve symptoms of anxiety, restlessness, emotional anguish and distress. Patients who require sedation at the end of life often appear comfortable to treating clinicians, but the loss of biographical life and interaction is often difficult and distressing to family and loved ones, and to patients themselves. Whilst comfort does appear to be maintained, the use of alternative sedation to allow meaningful biographical interaction with a patients loved ones could be considered desirable, especially if comfort could be preserved. Dexmedetomidine is an imidazole alpha-2 receptor agonist utilised commonly in the intensive care and anaesthetic environments. Dexmedetomidine was investigated in a clinical trial setting at the Port Kembla Palliative Care Unit (Joint University of Wollongong and Illawarra Shoalhaven Local Health District Human Research Ethics Committee (2018/247) as a potential therapeutic option for terminal delirium and rousable sedation, with results showing a trend to interactive sedation and decreased delirium. Standard care for distress at the end of life has typically involved benzodiazepine infusions, in Australia the most commonly utilised is midazolam. Despite this, the evidence base for benzodiazepine infusions at the end of life is not robust, with usage predominantly predicated on professional consensus and guidelines. Small-scale observational studies and retrospective analysis have been performed, but there is minimal evidence in the literature for actual efficacy trials, especially in patients treated with midazolam in the terminal phase of life. Given the gap in knowledge, the investigators propose a randomised controlled trial into the use of dexmedetomidine versus midazolam via continuous subcutaneous infusion (CSCI) in patients for sedation at the end of life. The subcutaneous (SC) route is chosen for this study as the preferred route of delivery as this conforms to the current standard of care for medication infusions given within the ISLHD for palliative care patients, and in NSW.