ANZCTR search results

There is convincing evidence that OAB reduces iSSI in elective colorectal surgery. However, although there is a trend in AL many of these papers have mixed results. A recent network meta-analysis Woodfield et al had elaborated the need for future high-powered studies for assessing AL in elective colorectal surgery. Currently, there are no local studies looking into the effect of pre-operative oral antibiotics as part of mechanical bowel preparation in the Australian and New Zealand context. We aim to conduct a multi-centred randomised controlled trial on the efficacy of OAB in elective colorectal resection with anastomosis and the risk of post-operative AL and iSSI. Our hypothesis is that the addition of oral antibiotics to standard care for patients undergoing elective colorectal resection will reduce anastomotic leak and incisional surgical site infections.

This is a phase 1 study of the pharmacokinetics and safety of three doses of Virofonol (polyphenol rich sugar cane extract) in healthy volunteers.

Chronic disease, such as lipoedema, has a negative impact on mental health and is associated with increased psychological distress, depression and anxiety. This project uses a randomised-controlled design (with an active intervention and waitlist control condition) to investigate the impact of an online, group based psychological intervention using compassion focused therapy (CFT) to improve the mental well­being of women with Lipoedema. Using a 10-week intervention design and follow-up at 8-weeks and 24-weeks post intervention completion, participants will engage in an online delivered group intervention, Participants will complete measures at baseline, post intervention and follow-­up. In addition, a subset of participants will contribute to an understanding of the biological mechanisms underpinning psychological change through gut-­brain related changes in microbiome. This project aims to improve the mental health of participants and provide critical, integrated bio­psychological and therapeutic focused research to promote well­being in lipoedema.

People who complete mindfulness programs tend to report improvements in mental health such as a reduction in psychological stress and an increase in wellbeing. The aim of this research project is to evaluate a popular four-week online mindfulness program and its effects on mental health (and on factors related to mental health) when compared to doing nothing at all. While this program has been rated very positively by individuals who have completed it in the past, further research is required to evaluate its effectiveness.

The advent of technology that can enable immersive and engaging, high-dose practice, has led to new opportunities for restoring function in neurological patients. ECU’s Neurorehabilitation and Robotics (Edwards) Lab has acquired the Mindpod motion capture and gaming system, that enables fun exploration and practice using whole arm-hand in large movements to guide a dolphin to swim in a gaming environment. We test if this immersive digital gaming system in patients with MS, can safely and feasibly be conducted and can have positive effects on cognition, motor function, fatigue and quality of life.

The Nutromics Sensor Device is a wearable device that is minimally invasive and can be placed on the skin peripherally or centrally. The device will provide vancomycin measurements once cleared and in clinical setting to be used in the diagnosis and treatment of vancomycin overdose and in monitoring of levels of vancomycin in order to help ensure appropriate therapy.

The ENIGMA (Evaluation of Nitrous oxide In the Gas Mixture in Anaesthesia) Trial was a large (n = 2,050) pragmatic multicentre randomised trial in patients undergoing major surgery. The incidence of clinically significant postoperative pulmonary complications (PPCs) measured by routine chest radiography and postoperative full blood and microbiology testing, as well a septic complications, were found to be increased with N2O. The larger ENIGMA 2 Trial (n = 7,000) did not confirm the findings of ENIGMA that N2O increased rates of wound infection or sepsis. Unfortunately, ENIGMA 2 did not prospectively collect data on pulmonary complications. Given the pragmatic nature of the protocol for measurement of PPC incidence used in ENIGMA, it was seen as feasible to replicate it post hoc in the ENIGMA 2 trial sample, using data collected as part of routine postoperative clinical management in these patients. This was done in the cohort of patients recruited to the ENIGMA 2 Trial within Australia, which consisted of over 2,500 patients or approximately 35% of total trial recruitment.

Evidence suggests that making healthier food choices is beneficial for people with multiple sclerosis (MS), and making dietary changes can give people with MS a sense of control over their disease. People with MS often turn to the internet for information about diet, and are faced with conflicting information from the “special diets” promoted for MS. People with MS want clear information on what dietary changes to make, and how to make healthy food choices. To meet this need, we will develop and run an online nutrition education program for people with MS, using a variety of ways to present the information. The free six-week program will be co-designed with people with MS and MS health professionals, and will provide information on diet and MS, including: how diet might affect MS symptoms; gut health; foods to eat and avoid; meal-planning; dietary supplements; understanding scientific research; current and emerging research in diet and MS; and “special diets” promoted or sold for MS. We expect that completing the program will help people with MS make healthier food choices and improve their nutrition knowledge and skills. We will assess the suitability of the content, format, and duration of the program.

PET biomarkers (i.e. Aß and tau) are currently used to identify and characterise individuals with pre-clinical and clinical dementia, particularly Alzheimer's disease (AD), for research purposes. Therefore, to get a better understanding of dementia, it is desirable to evaluate separately both the brain distribution of Aß and tau accumulation. The primary aim of this phase II trial is to quantify global and regional Amyloid (Aß) and tau in older adults at various stages of dementia risk. Further, we aim to analyse how PET markers change over time. This will allow for comprehensive clinical characterisation of a sample of older adults at-risk for developing dementia. This 5-year study will recruit a subsample of participants involved in an ongoing long-term observational study being conducted through the Healthy Brain Ageing clinic, Sydney, Australia. Participants will be enrolled into the study after the informed consent process has been completed and met all inclusion criteria and none of the exclusion criteria. PET scans will be acquired at the imaging facility according to sites where PET tracers will be available (i.e. Macquarie University, Liverpool Hospital, Royal North Shore Hospital and North Shore Private Hospital). Depending on funding, tracer availability, and participant willingness, they may be offered follow-up scans every two years for the duration of the study, leading to a maximum of three scanning sessions over five years (Year 1, Year 3, Year 5).

Migraine symptoms overlap with those of ocular surface disease. We hypothesise that by treating dry eye disease, and hence reducing neuroinflammation, and the stress stimulus to corneal nerves, that we can reduce the severity and frequency of migraines in migraine sufferers. Treatment for dry eye disease with topical lubricant eye drops is likely to be preferable to existing therapies for migraine as the side effect profile is minimal. This study will randomly allocate people with migraines to either Systane Hydration eye drops (test) or saline eye drops (control), each to be used as one eye drop to each eye, four times a day for four weeks. At four weeks, participants will be evaluated for their migraine severity and frequency and swapped over to the alternate eye drop for a further four weeks, followed by a final visit.