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Constipation and faecal incontinence (FI) are major health problems associated with significant personal and economic burden. First line treatment for these disorders is conservative and includes dietary modification and medication. If these fail, current guidelines recommend assessing physiological abnormalities by anorectal manometry (ARM) and balloon expulsion testing (BET). The results of these are then used to guide further management of the patients, including biofeedback therapy, neuromodulation and surgical interventions. Given the central role of ARM, a relative surprisingly lack of standardization is apparent in the literature. Factors such as catheter type, study protocol and analysis of results vary widely. With regards to FI, a wide range of values is reported as ‘normal’ for anal sphincter function, and experts recommend that each unit have their own range of values for defining abnormalities. For patients with constipation, ARM and BET are required for diagnosing dyssenrgic defecation, which has been shown to be a strong predictor of biofeedback success. Nevertheless, making this diagnosis, which includes evidence of an uncoordinated defection manoeuvre, is controversial at best, with conflicting data on the specifics of the procedure and diagnosis. The sensory component of the defecation process is also slowly being elucidated. Whereas patients with constipation may display rectal hyposensitivity, patients with FI may display either hypo or hyper sensitivity. This may have implications for the treatment of these disorders, as anorectal biofeedback can be used to teach patients how to modulate their sensory thresholds, leading to improved outcomes. Notwithstanding, how best to assess for these rectal sensory abnormalities, and what are the normal cut-offs that should be used, is still unclear. We thus aim to describe the normal sensorimotor physiology as assessed by ARM in healthy volunteers. Specifically, we aim to (1) establish normal range of values for our specific equipment and protocol and (2) evaluate comparative methods for assessing sensorimotor function. These results will be used to enhance our ability to define normal and abnormal defecatory physiology and help treat future patients with these distressing chronic conditions.

The research project aims to better understand how pressure injuries occur and to explore blood flow in seriously ill patients in two lying positions used in the intensive care unit (ICU): on the back and on the side, at 2.5-hour and 4-hour time intervals. The body’s ability to carry oxygenated blood to the tissue is tested using non-invasive, pain-free Doppler technology which measures the time taken for the blood flow to return to the small blood vessels in the tissue, near the surface of the skin. The research project will look into the effect patient body mass index (BMI), level of sickness, patient lying position and the effect that length of time in one lying position has on blood flow to the skin for the ICU patients. The patients will be assessed in the first 72-hours of admission, when they are the most ill and skin checks for pressure injuries will be completed 3-4 times per week until the patients leave hospital.

Ketogenesis is the process by which ketone bodies, during times of starvation, are produced via fatty acid metabolism. Although much feared by physicians, mild ketosis can have therapeutic potential in a variety of disparate disease states. The principle ketones include acetoacetate (AcAc), Beta-hydroxybutyrate (BHB) and acetone. In times of starvation and low insulin levels, ketones supply up to 50% of basal energy requirements for most tissues, and up to 70% for the brain. Other than glucose, ketones are the only substances capable of fulfilling the energy requirements of the brain. We have previously demonstrated that the ketone levels in adults with acute brain injury (ABI) are low. The aim of this study is to provide a feeding regimen that has the potential to increase ketone levels in patients with ABI. 20 patients with ABI admitted to Princess Alexandra Hospital Intensive Care Unit will be included. Each patient will be fed with an enteral formulation consisting of ketocal and protifar (produced by Nutricia Australia), which will provide the necessary energy and protein requirements. Both feeds are commercially available in Australia and used extensively in the paediatric population. The major difference between this feed and standard feed is the lack of carbohydrates to stimulate ketogenesis. The feeds will be continued for 7 days or until the patient is extubated or discharged from ICU. We will be measuring ketone levels and a number of other metabolites on a daily basis. Our goal is to demonstrate that this feeding regimen is capable of inducing ketosis in adults.

The primary purpose of this study is to evaluate the usefulness of the FoundationOne(Registered Trademark) genetic profiling test for patients diagnosed with cancer of unknown primary, a cancer where the location of the cancer cannot yet be found. Who is it for? Patients may be eligible to participate in this study if they are aged 18 years or over and have been diagnosed with metastatic or advanced unresectable cancer of unknown primary. In order to complete the FoundationOne (Registered Trademark) testing, study participants must have adequate tissue available from a tumour biopsy. Study details All participants in this study will receive the FoundationOne(Registered Trademark) test. This test involves testing cancer cells from a sample of tumour tissue obtained during a biopsy. The results of the test will be discussed between each study participant and his/her treating physician, along with results from any other diagnostic tests performed, and a treatment plan will be agreed upon. The results of the FoundationOne(Registered Trademark) test may provide information that could help physicians decide which treatment could be the most beneficial in treating cancer of unknown primary. Physicians will follow study participants approximately every 3 months and provide information about study participants’ status and treatment. The purpose of collecting the Information from the FoundationOne(Registered Trademark) test and the results of the patients’ treatment(s) is to learn about the usefulness of the FoundationOne(Registered Trademark) test results for decision-making by treating physicians.

This study is an open-label, non-randomized, dose-defining study of daily deferasirox in overweight or obese patients with type 2 diabetes (T2D). This study is designed to assess the feasibility (safety and tolerability) of deferasirox administered daily, based on the rate of Dose Limiting Toxicities (DLTs), i.e. pre-defined adverse events. A DLT is defined as an adverse event or abnormal laboratory value occurring at any time which is assessed as clinically relevant which is considered to be related to the study treatment, unrelated to disease, disease progression, inter-current illness, or concomitant medications, and warrants stopping or reducing the medication. Toxicities will be assessed using the NCI CTCAE, version 3.0.

This research is aimed at improving outcomes for patients with chronic rhinosinusitis, particularly the cohort of patients who experience persistent CRS symptoms despite optimum medical and surgical therapy, termed as recalcitrant CRS (rCRS). We hope that we are able to developed an agent that could help manage persistent infections in patients with chronic rhinosinusitis even after they have had surgery and potentially improve patient's symptoms and reduce the need for revision surgery. The primary end point of this study is to: 1. To assess the efficacy of Chitodex-Budesonide-Mupirocin gel in treating patients with recalcitrant chronic rhinosinusitits Measured by: 1) Eradication of bacteria confirmed with microbiological swab 2) Independently scored video endoscopic examination of sinuses pre and post treatment 3) Patient's symptoms score pre and post treatment The secondary end point of this study is to: 1. Assess the tolerability of the treatment gel vs oral antibiotics

Stress incontinence (SUI) is defined as urinary leakage with activities that increase intra-abdominal pressure (e.g. cough, sneeze, laugh and exercise). SUI is a prevalent condition with high burden of suffering. Midurethral slings (MUS) have become the operation of choice for treatment of female stress urinary incontinence. MUS are synthetic tapes that are implanted transvaginally to support the urethra. The urethra is a tube that connects the bladder to the outside of the body and removes urine from the body. Midurethral slings can be deployed in a retropubic or transobturator fashion. A retropubic approach involves tunneling the sling from the suburethral region, in close contact to the bladder in the retropubic space (behind the pubic bone), to the lower abdominal wall. In contrast, the transobturator approach involves the passage of a sling through the obturator membrane which is further away from the bladder. This approach has been shown to have a reduced rate of intra-operative bladder perforation. Recent systematic reviews of retropubic or transobturator midurethral tapes suggest equivalent efficacy, at least in the medium term. Both midurethral systems continue to have clinically significant complications such as bladder injuries, vagina mesh exposures, voiding difficulty, denovo (new onset) urgency and groin/thigh pain reported. Retropubic slings have more hematoma, bladder perforations, whereas transobturator slings have less over active bladder symptoms and less voiding difficulties. The minisling is a single incision sling system with small integrated self-fixating tips that anchor into the obturator internus muscle. This potentially avoids complications associated with trocar passage through retropubic or transobturator route. Comparative trials of retropubic against transobturator slings have shown retropubic slings to be superior in the cure rates of women with intrinsic sphincter deficiency (a severe form of stress urinary incontinence – ISD) . Randomised trials of minislings against transobturator slings have shown similar results, with the added advantage of less overactive bladder symptoms and voiding difficulties. The self-fixating tips of the minislings allow them to be placed under more tension, whilst retaining the advantages of the transobturator sling. The retropubic sling comes with superior efficacy, but has higher risks of pelvic hematoma, bladder perforations, denovo urgency and voiding dysfunction. Minislings, placed under more tension, may provide equivalent or better results than retropubic slings in patients with ISD, whilst retaining the advantages of transobturator slings. We seek to examine if the minisling is as efficacious as the retropubic sling for women with urodynamic stress incontinence (USI) and intrinsic sphincter deficiency (ISD) and compare their clinical outcomes.

Acute intracerebral haemorrhage (ICH) is the most serious and least treatable form of stroke, accounting for at least 10% of the 20 million new strokes (including 50,000+ Australians) that occur in the world each year. Survivors of ICH are at high risk of recurrent ICH and other serious cardiovascular events. While there is strong evidence that this risk can be reduced by lowering the BP of patients after ICH, such as from the PROGRESS trial undertaken by several of the applicants, many patients with ICH do not receive blood pressure lowering and if they do, receive treatment so that their BP is inadequately controlled. The aim of this study is to demonstrate the superiority of a combination of fixed low-dose generic BP lowering agents as a “Triple Pill” strategy on top of standard of care for the prevention of recurrent stroke in patients with a history of ICH and high normal or low grade hypertension in a large-scale, international, double-blind, placebo-controlled, randomised controlled trial.

It is known that moderate-intensity physical activity enhances health, fitness and functioning in people with cerebral palsy (CP). Anecdotal evidence indicates high training loads designed to develop Paralympic swimmers may elicit excellent clinical outcomes. The primary aim of the program of research will be to evaluate the therapeutic benefit of a performance-focused swimming intervention for people with cerebral palsy who have high support needs. We hypothesise that outcomes of the study will substantiate the anecdotal evidence. Specifically, that high training loads will improve health, fitness and functioning in people with cerebral palsy who have high support needs. 3 young people with moderate to severe cerebral palsy who are insufficiently active for health, but are interested in participating in competitive sport, will be recruited. The study will adopt a concurrent multiple baseline design with 5 phases: A1-B1-A2-B2-A3. The first phase is a baseline testing phase (A1) for participants 1, 2 and 3 lasting 10 weeks, 16 weeks and 22 weeks respectively. There will be 5, 8 and 11 baseline data points for participants 1, 2 and 3 respectively. The intervention will then be introduced to participants in a staggered sequence. The first part of the intervention is a 16 week performance-focused swimming training phase (B1) during which there will be 8 data collection points. The training program will comprise of moderate to high intensity swimming, aerobic, strength, neuromotor and flexibility training which is individually tailored to optimise swimming performance. The intensity and duration of training sessions will vary but will be steadily increased throughout the phase. This phase will be followed by a 5-week maintenance phase (A2), in which there will be no training. There will be 5 data collection points in this phase. Participants will then undergo the second part of the intervention - a further 16 week training phase (B2), which will mirror phase B1. There will be 8 data collection points in this phase. Finally, participants will undergo a further 5 week maintenance phase in which there will be no training. There will be 5 data collection points in this phase, which will mirror phase A2. Outcomes will relate to health, fitness and functioning, and findings are expected to provide an indication of the therapeutic value of sports participation for the population of interest. The study is expected to have implications for neurological rehabilitation.

This study aims to determine whether self-management, and self-management support from a physiotherapist, can assist people after mild stroke to increase physical activity levels. Self-management, in this case, is when patients make the decisions about their own health and physical activity, with the assistance and support of a physiotherapist. Physical activity is important after stroke because it reduces the risks associated with recurrent stroke, such as high blood pressure, high cholesterol and high blood sugars. Research has also shown a direct link between increased physical activity and decreased risk of stroke. Many people after mild stroke do not participate in a healthy amount of physical activity, even though they are physically capable of doing so. A physiotherapist will provide 5 sessions of support to people after mild stroke over a 3 month period, which will include education, generation of goals, barriers and solutions for being physically active, development of a weekly physical activity schedule, selection of strategies to monitor physical activity, feedback, encouragement and praise. It is expected that this will result in stroke survivors completing a healthy amount of physical activity each week, as well as improving their confidence in their ability to be physically active, and improving their health status, such as blood pressure, cholesterol, and blood sugars. This group will be compared with a control group, who receive an information booklet only.