ANZCTR search results

Dysplasia is an important precursor to bowel cancer in IBD, which can be very challenging to detect. Previous studies suggest that dysplasia is detected in approximately 9% of colonoscopies performed for IBD surveillance. Dye-based chromoendoscopy (DBC) which involves spraying the entire colon with contrast materia such as indigo carmine or methylene blue is thought of as the current gold standard for dysplasia detection. However, dye-based chromoendoscopy is expensive, time consuming and difficult to perform, which limits its use as a surveillance test. A routine survey of Australian Gastroenetrologists suggests that more than half did not use the dye-spray technique. Virtual chromoendoscopy with Pentax i-scan Optical Enhancement(OE) uses in-built technology in the endoscope processor with the same principles as dye-based chromoendoscopy to enhance colonic mucosal pit and vessel pattern. We therefore hypothesise that virtual chromoendoscopy is non-inferior to dye spray chromoendoscopy in detecting dysplasia. It will also consume less resources and time. The aim of our study is to compare virtual and dye-based chromoendoscopy in a prospective tandem colonoscopy study. Research design & methods: We plan to conduct a prospective study, enrolling patients with known IBD who are due to have their standard surveillance colonoscopy to look for dysplasia. A tandem colonoscopy model will be used. Enrolled participants will have a colonoscopy using virtual chromoendoscopy with i-scan OE first during insertion and withdrawal. All lesions detected will be removed or biopsied, as appropriate. On completion of withdrawal, a second look will be performed with dye-spraying as is the current clinical practice. This will allow any additional pathology detected to be treated.

Two hundred primary hip replacements with Delta-Motion heads and cups were performed between December 2008 and December 2009 and were followed-up for a minimum of five years. The two hundred patients have been reviewed at regular intervals, and data has been obtained from the patients pre-operatively, and post-operatively at 6 weeks, 6 months or 1 year, and at a minimum of 5 years. Patient outcome were assessed using The Harris Hip Score and X-rays were taken for radiographic evaluation. The aim of the study is to measure clinical and radiographic outcomes such as ceramic breakage and squeaking to verify the clinical effectiveness of the product that is new to the market. The primary objective of the study is to investigate the clinical outcome of the Delta-Motion hip system and to demonstrate improved range of motion, head engagement and stability of the replaced hip. The null hypothesis is that the large diameter ceramic on ceramic bearing will not improve patient outcomes compared with published data. Complications will also be assessed and x-rays will be used to validate component positioning and quality of bone in-growth.

The 123-Magic parenting program provides strategies for parents with children aged 2-12 to reduce children's undesirable behaviours, such as temper tantrums. The program is taught to parents by a number of social services and practitioners but has not yet been formally evaluated in Australia for use with children diagnosed with ADHD. Aim: Evaluation of the original 1-2-3 Magic DVD-based program for use with children diagnosed with ADHD, in comparison to a control group. Significance: The 1-2-3 Magic program has been taught to parents throughout Australia; however, the effectiveness of the program for use with children diagnosed with ADHD has not been evlauated in Australia. Expected reaserch outcome: It is expected that the techniques shown in the 1-2-3 Magic DVD will be of benefit to parents in reducing children's undesirable behaviours (i.e., children diagnosed with ADHD).

The study will compare the intervention of driving instructor lessons with the use of a driving simulator to undertake driving tasks in order to identify the most effective rehabilitation approach for returning to driving post stroke or traumatic brain injury. This study will identify the most effective rehabilitation approach for returning to driving in order to inform clinical practice.

Patellofemoral osteoarthritis (PF OA) is a leading cause of pain, disability and health expenditure in Australia, has no cure, and there is little evidence for effective treatments. Pilot data shows that simple contoured shoe inserts (foot orthoses) worn in everyday footwear can reduce pain in older adults with PF OA immediately and after 2 months of wear. This clinical trial will investigate whether contoured shoe inserts are an efficacious longer-term intervention for PF OA. The primary aim is to compare the 3-month efficacy of prefabricated, contoured shoe inserts to flat shoe inserts for reducing the severity of knee pain in people with PF OA. The FOOTPATH trial is a multicentre, randomised, controlled, assessor-blinded superiority trial with two parallel groups and 12-month follow-up. 160 participants aged 50 years and older will be randomly allocated to receive either contoured shoe inserts or flat shoe inserts. Outcomes will be evaluated at 3 and 12 months. Secondary aims will compare the 3- and 12-month effects of contoured inserts and flat inserts on pain, global improvement, function, quality of life, self-efficacy, kinesiophobia, adverse events and use of co-interventions, while cost-effectiveness will be evaluated at 12 months.

Enteral feeding is standard of care in critically ill patients, however delivery is often inadequate with observational studies reporting patients only receive 60% of estimated energy needs. A primary reason for inadequate nutrient delivery is delayed gastric emptying, which occurs in up to 50% of mechanically ventilated critically ill patients. While standard enteral formulas contain 1 kcal/ml, it is common practice for an energy-dense formula (2kcal/ml) to be prescribed by clinicians to enable higher caloric delivery in a smaller volume, as a way of circumventing the effects of delayed gastric emptying. However, at present there is no evidence to support the concept that use of an energy-dense formula will enable greater calorie delivery and nutrient absorption. It has been demonstrated, in health, that gastric emptying occurs at a constant rate based on caloric delivery approximating 1-4 kcal/min and rather than volume dependent. Therefore, the aim of this study is to evaluate the effect of calorie concentration on the rate of gastric emptying in critically ill patients.

This research project will investigate the effect of a dairy-derived nutritional supplement on physical health, mobility and well-being when combined with a physical activity program in 45-65 year-old women identified as habitually sedentary. The project has been designed to determine whether supplementation augments the positive response to a healthy lifestyle that includes moderate-level physical activity, and therefore whether supplementation is a beneficial addition to a healthy, active lifestyle. This is a 4-month randomised controlled trial in which 240 healthy, sedentary women will be randomised to receive: 1) a Fortified Milk Product (FMP) containing addition protein, vitamin D and calcium or a Non-Fortified drink (NFD). All women will also be asked to undertake a supervised gym-based exercise program twice a week under the supervision of accredited exercise trainers and one home-based training session. The multimodal exercise program will consist of strength, mobility and balance/functional training. Participants will undergo testing at baseline and after completion of the intervention (week 16) in the clinical lab at Deakin University. The main outcome for the study is functional muscle power, Secondary outcomes include: muscle strength, function, mobility and balance, body composition, cardiovascular health (blood pressure), circulating bone, cartilage, inflammatory and hormonal markers and perceptions of health, Dietary and physical activity habits will also be assessed. This study is important as the findings will underpin more precise exercise and nutrition guidelines for the prevention (and management) of age-related loss in muscle health and function in sedentary middle-aged adults, along with the ongoing refinement of community-based initiatives for the management of these age-related changes.

Head injury is common, affecting Australians at a rate of 107 per 100,000 people. Its outcome varies from complete recovery to disability. Two recognised tools predict these outcomes, based on presentation: CRASH (Corticosteroid Randomisation after Significant Head injury) and IMPACT (International Mission for Prognosis and analysis of Clinical Trials in TBI (Traumatic Brain Injury)). Clinical studies independently validated them. One reported study compared them within a non-Australian community. Study Aim: To compare CRASH’s efficacy against IMPACT in predicting severe head injury outcomes. Research design: -Recruiting severe head injury patients admitted to Princess Alexandra Hospital as participants. -Collect symptom details from first admission and after six months. -Calculate participants’ CRASH and IMPACT scores and compare with actual outcomes. Reviewing participants after six months provides information relating initial presentation to recovery. The results would identify whether CRASH or IMPACT better predicts outcomes. This knowledge may influence future patient care and research.

Prevalence of obesity is increasing. Contrary to popular belief, literature has shown that overweight and mildly obese have infact been shown to have increased survival benefit compared to normal weight in non-cardiac and cardiac conditions. All the studies that have reported this paradoxical relationship were based on BMI; BMI is not a measure of body fat. This study is to investigate the association between obesity and postoperative in-hospital adverse outcomes following elective cardiac surgery. Several measures of obesity will be compared including BMI, WC, HC, NC and WHR . We will also be measuring body frailty and its association with adverse outcomes. The patients will be followed up until 2 years through phone contact and registries.

The treatment and pathophysiology of tremor in Multiple Sclerosis (MS) remains a significant challenge and unmet need, requiring further clinical research. We recently performed a phase II, randomized, controlled, crossover study demonstrating the efficacy of Botulinum toxin type A (BoNT-A) for treatment of MS tremor. This peer-reviewed NHMRC funded project proposes a detailed study of phenomenological, electrophysiological characteristics of MS tremor patients before and after BoNT-A or placebo treatment. The results of this study will help generate class I evidence that is required to translate treatment of MS tremor with BoNT-A into clinical practice. We aim to define predictors of the response to treatment and to better understand the underlying pathophysiology of MS tremor.