ANZCTR search results

Sudden cardiac death (SCD) due to recurrent ventricular tachycardia (VT) is an important clinical sequela in patients with structural heart disease. VT generally occurs as a result of electrical re-entry in the presence of arrhythmogenic substrate (scar). Scar tissue forms due to an ischemic cardiomyopathy (ICM) from prior coronary obstructive disease or a non-ischemic cardiomyopathy (NICM) from an inflammatory or genetic disease. AADs can reduce VT recurrence, but have significant limitations in treatment of VT. For example, amiodarone has high rates of side effects/toxicities and a finite effective usage before recurrence. ICDs prevent cardiac arrest and sudden death from VT, but do not stop VT occurring. Recurrent VT and ICD therapies decrease QOL, increase hospital visits, mortality, morbidity and risk of death. Improvement in techniques for mapping and ablation of VT have made CA an alternative. Currently, there is limited evidence to guide clinicians either toward AAD therapy or CA in patients with NICM. This data shows significant benefit of CA over medical therapy in terms of VT free survival, survival free of VT storm and VT burden. Observational studies suggest that CA is effective in eliminating VT in NICM patients who have failed AADs, resulting in reduction of VT burden and AAD use over long term follow up. Furthermore, there is limited data on the efficacy of CA in early ICM with VT, or advanced ICM with VT. RCT data is almost exclusively on patients with modest ICM with VT, and this is not representative of the real-world scenario of patients with structural heart disease presenting with VT. Therefore the primary objective is to determine in all patients with structural heart disease and spontaneous or inducible VT, if catheter ablation compared to standard medical therapy with anti-arrhythmic drugs results in a reduction of a composite endpoint of recurrent VT, VT storm and death at a median follow up of 18 months.

Haemorrhoidal symptoms are among the commonest complaints of mankind, it can occur in up to 80% of the population, involving any age and affecting both males and females equally. Surgical haemorrhoidectomy is most commonly used for 3rd or 4th degree haemorrhoids. However, surgery is associated with severe postoperative pain that is a source of such anxiety that some patients decide not to undergo the operation. Due to this, another non-surgical method can be used such as rubber band ligation, however this still requires pain relief. Research has suggested that current forms of pain relief are short term, caused more pain. Therefore, topical local anaesthetic agents are the next appealing option although have not been as successful as anticipated. Lignocaine in combination with Diltiazem are options that have not been used in this area and could potentially be more effective in relieving pain. This trial will examine the role of diltiazem and lignocaine in reducing post-procedure pain.

Brief description of the study purpose The study aims to Investigate the psychosocial and behavioural impact of genetic testing for familial melanoma. It also evaluates a training program for clinicians to provide genetic testing for familial melanoma, based on participant satisfaction. Who is it for? You may be eligible for this study if you are 18 years or older, with 3 primary melanomas and/or a family member with 1 or more invasive melanomas and 2 or more other invasive melanomas and/or pancreatic cancer among first-degree or second-degree relatives on the same side of the family. Study details Participation in the study will involve a pre-testing genetic counselling and education visit. You will be seen by either a genetic counsellor (standard practice of care), or by a clinician who has received training to provide genetic testing (the 'intervention group'). Participants will then have their saliva collected for genetic testing, and will attend a second visit to receive their test results. At both visits, participants will be asked to complete questionnaires (approx 30 mins). One month after receiving their genetic test results, participants will asked to complete a phone interview where questions about their experience in the study will be discussed. Participants will also be required to answer questionnaires about the psychological impact of genetic testing and regarding their sun protective behaviour after results have been received. A link to the questionnaires will be emailed to participants at 1 week, 3 months and 12 months after receiving their results, and can be completed online. It is hoped this study will provide greater insight into the role of genetic testing and the impact on mental health, and sun protective behaviour.

The Alfred Hospital is an adult major trauma centre, and receives in excess of 65,000 patient presentations per year. This study is an open-label randomised controlled trial of one dose of Methoxyflurane (3mL) administered after streaming to eligible patients compared to standard care. The primary outcome will be defined as the proportion of participants achieving significant pain reduction. We consider significant pain reduction as at least a 50% drop in the initial pain score at 30 min from presentation to the ED. Secondary outcomes will be the mean pain score at 30 min, the proportion of participants achieving a drop in pain scores of at least 3 standard points on the numerical 11-point pain scale, and the use of any opioid analgesia. Participants will be asked to indicate the intensity of pain at 30, 60, and 90 min after administration of analgesia, with a printed numeric rating scale of 0 (no pain) to 10 (worst pain imaginable), with all integers between 0 and 10, inclusive, available. Participants’ reported pain scores will be recorded contemporaneously and the participants will not be reminded of the previous score.

Workplace injuries have a major impact upon workers, employers and society in general. While most work-related injuries heal within a few weeks, a considerable proportion of workers have ongoing pain and disability for months and years following the injury (e.g., Henschke et al., 2007, Social Research Centre, 2018). A common corollary following a workplace injury is chronic pain. In 2007 the estimated total cost of chronic pain in Australia due to absenteeism and lost productivity while at work was $11.7 billion (Access Economics Report, 2007, and their latest report, 2019, indicates these figures have multiplied in the intervening period). Chronic pain is often associated with markedly reduced quality of life, high levels of distress and often co-occurs with mental disorders, such as depression and anxiety (e.g., Arnow et al., 2006). Furthermore, there is only a brief window of opportunity to prevent these sorts of outcomes for injured workers. The longer injured workers are away from work, the greater their risk of never returning (e.g., Landstad et al., 2009). In Australia chronic back pain has been identified as one of the major reasons middle-aged workers drop out of the workforce (Schofield et al., 2011).

This is a feasibility study of normothermic machine perfusion technology in human DCD kidneys deemed suitable for transplantation. If preliminary results are encouraging a larger prospective RCT will be required to confirm whether this technology improves Kidney transplant outcomes in the clinical setting. Experimental data and early non randomised clinical studies from Europe appear to show a significant benefit, by reducing the need for post transplant dialysis.

Achilles tendinopathy is a common, painful and disabling musculoskeletal condition. There is a treatment called radial shockwave therapy (rSWT) that produces a pressure wave that enters the Achilles tendon. Some studies report positive findings for this treatment in insertional Achilles tendinopathy but it is not certain whether rSWT is better than placebo. The proposed study is a two-arm, parallel group, double-blind randomised prospective trial. Participants will be block-randomised into sham rSWT or rSWT groups with a 1:1 ratio. All participants will receive weekly rSWT (sham rSWT or rSWT) once per week over a three-week period, and will also receive an identical evidence-based exercise intervention to be completed for the duration of the trial, which removes ethical concerns of withholding treatment. Participants and outcome assessors will be blinded to treatment allocation.

Falls are a debilitating and common problem in Australian hospitals and it is estimated that between 310 falls occur per 1,000 bed days in Australian hospitals. Even though they are associated with increased length of stay and injuries, falls mitigation strategies have not had a great deal of success to date in hospital environments. Previous attempts to prevent falls have focused on clinician education and environmental modifications. The current project will use qualitative methods for a series of interviews with patients and clinicians to understand their views and knowledge on falls prevention educational interventions.

This study will examine the effect of Fibre-fix (dietary fibre supplement) on the human gut microbiome and faecal metabolites of people with Irritable Bowel Syndrome (IBS) who consume a diet low in fermentable oligosaccharide, disaccharides, monosaccharides and polyols (FODMAP). A low FODMAP diet reduces the intake of fermentable fibres, leading to insufficient fermentation by the gut microbiota. This can thereby reduce the production of short chain fatty acids (SCFA, e.g. butyrate) in the large intestine and influence on modulation of sleep and mental health. A randomized double-blind placebo controlled study design is proposed to examine whether Fibre-fix supplement, added to an existing low FODMAP diet may help modulate gastrointestinal function, improve markers of sleep and mental health and promote increased quality of life in IBS patients. Participants will provide stool samples, and complete questionnaires about sleep and mental health before and after the 3-week intervention. Gut health biomarkers: faecal microbiome composition, faecal pH and butyrate levels, and alteration of sleep and mental conditions will be examined. A repeated measures ANOVA using the Statistical Package for the Social Sciences (SPSS) version 25.0 will be used to assess the differences between groups after adjustment for confounding variables. We expect a shift in the diversity of the microbiota and associated increase in the butyrate levels and improvement in general mental health and sleep in those who receive Fibre -fix compared to those who receive control. In addition, the benefits of RS are likely to reduce IBS symptoms and improve gut health whilst on a low FODMAP diet, proposing a long-term dietary solution for those with IBS. The proposed mental health and sleep benefits may have a flow-on effect in terms of lowering the occurrence of other comorbidities, such as depression and work absenteeism which have economic costs, thereby lowering the burden on the healthcare system and reducing healthcare costs for those with IBS.

The primary purpose of this project is to determine whether the use of melatonin improves the quality of sleep in patients undergoing major abdominal surgery. Melatonin is a natural hormone secreted by the pineal gland. Melatonin when given at night works to promote sleep by helping to regulate the body's bio clock and sleep-wake cycles. It is well known that sleep quality in hospital is poor and can cause insufficient sleep which reduces natural immune function. Major abdominal surgery leads to the release of both pro-inflammatory and anti-inflammatory chemical in the blood.. Melatonin could be an effective adjunct medication not only to assist in improving sleep but to dampen the inflammatory response after surgery.