ANZCTR search results

The aim of this pilot study is to assess the feasibility of sentinel lymph node detection in patients with apparent early stage endometrial carcinoma in the Australia setting. The hypothesis is that carrying out SLN detection in women with presumed early stage endometrial cancer, would prevent the morbidity associated with a formal pelvic lymph node dissection while attempting to identify the cohort that will be upstaged on final pathology. This will help to identify the women who could potentially benefit from adjuvant radiotherapy in preventing a loco-regional recurrence following the management of endometrial cancer. This feasibility study will help us determine if SLN detection is feasible in women with low risk endometrial cancer.

There are a number of complications that women who are obese during pregnancy may develop and can impact on their health an don the health of their baby. There are also longer term risk for infants born including being overweight or obese in childhood and an increased risk of diabetes and heart disease in later life. Metformin lowers blood glucose by improving insulin sensitivity and is commonly used to treat diabetes and gestational diabetes. Women who are obese are more likely to be insulin resistant and in pregnancy this increases the risk of developing gestational diabetes. Insulin resistance raises blood glucose levels and provides excess nutrients to the baby increasing the chance that they will be born large for gestational age. Metformin may modify this risk. This study is a double blind placebo controlled trial; women will be randomly allocated to receive metformin or an identical placebo. All women in the study will receive dietary and exercise advice from a qualified dietitian throughout their pregnancy to help them adopt a healthy diet and lifestyle. Information about the woman’s pregnancy, birth and postnatal admission and the baby’s postnatal hospital stay will be obtained from case notes.

To assess whether providing General Practitioners with reminders about their patients’ HbA1c results from a Chronic Disease Management Register leads to better diabetes control. This will be determined via GP Practice Visits and HbA1c levels.

Post operative wound healing plays a significant role in an individuals health and wellbeing following surgery. Current research has idenitifed that post surgical wound healing delays leads to increases in morbidity and mortality and increases the economic burden to wider healthcare system. The research will engage surgeons and clinicians in an interventional clinical trial of a negative pressure device, applied post-operatively to assist in the prevention of wound dehiscence and infection. The potential outcome of this trial will have a major impact in relation to post-surgical patient wound care and the potential to reduce the economic burden of post surgical wound dehiscence

The purpose of this study is to determine the optimum blood glucose target for critically ill patients with high blood glucose levels. This will be done by changing the insulin protocol in ICU for a period of 6 months to compare to the current standard protocol.

To analyse the outcomes of surgery to correct apical vaginal prolapse using the Capio Suturing Device.

Poor oral health during pregnancy can affect the well being of the mother and baby. Poor maternal oral health increases the chance of infants developing early dental decay and is strongly associated with adverse pregnancy outcomes such as preterm and low birth weight babies. Unfortunately, many expectant mothers are unaware of the implications of poor oral health. Further, due to various reasons, many women do not seek dental care during pregnancy. According to new Perinatal Oral Health guidelines, dental treatment is safe during pregnancy and this is the period when mothers need to be screened for oral risks, counseled on oral hygiene and receive necessary dental treatment. To achieve this, prenatal care providers need to play an important role. At present there is a lack of emphasis being placed on perinatal oral health by prenatal care providers in Australia. Pregnant women, have no system in place that can offer them regular oral assessment during pregnancy and prompt dental treatment at minimal or no cost as experienced in other countries. To address the oral health needs of pregnant women, the study investigators have developed a unique midwifery initiated oral health dental service (MIOH-DS) model to promote and maintain maternal oral health. This service incorporates oral health guidelines into normal midwifery practice and provides appropriate care pathways where pregnant women can be referred for prompt dental treatment. Extensive pilot work has been conducted by the study investigators to develop the MIOH-DS. We now propose to test the MIOH-DS more extensively through a mulitcentre randomised trial across three large hospitals in Western Sydney The aim of this study is to determine the effectiveness of a Midwife Initiated Oral Health-Dental Service (MIOH-DS). The MIOH-DS will provide pregnant women with oral assessments and dental referrals by midwives, and provide dental services which we expect will improve women’s oral health status, uptake of dental services, oral health knowledge, quality of oral health, and potentially influence the incidence of low birth weight and preterm births. We anticpate that pregnant woman receiving the MIOH-DS will have, a 20% increase in the access/uptake of dental services; a 30% improvement in women’s oral health and a 30% increase in their knowledge about maternal oral health.

This prospective, population based longitudinal study of children, with cerebral palsy, aged 18 months to 5 years will track early motor development and will utilise magnetic resonance imaging to determine the anatomical pattern and likely aetiology and timing of the brain lesion. This will help predict the likely need for, type and timing of interventions(spasticity management, rehabilitation, orthopaedic surgery) and their associated costs, this study will enable more informed resource planning for cerebral palsy in young children for the future.

This project compared arteriovenous agreement between pH and pCO2 for patients undergoing non-invasive ventilation in ED

T2DM is the fastest growing chronic illness in Australia, with over 3.2 million people estimated to have diabetes and pre-diabetes, and a further 275 individuals being diagnosed with diabetes every day. As diabetes is the 6th leading cause of death in Australia, interventions to manage this condition and its complications should be a priority for Australian society. Despite many theoretical advantages of eggs in T2DM, there is a general paucity of good quality prospective data on the effects of high egg consumption in this group. There has only been one short duration clinical investigation in people with T2DM (Pearce KL, Clifton PM, Noakes M. Egg consumption as part of an energy-restricted high –protein diet improves blood lipid and blood glucose profiles in individuals with type 2 diabetes. Br J Nutr, 2011, 105: 584-592). After 12 weeks, participants with T2DM on a high cholesterol, reduced energy diet (2 eggs/day) lost the same amount of weight and had similar improvements in lipids, blood pressure and glycaemic control as those on an isoenergetic low cholesterol diet. The major limitations of this study were its short duration (12 weeks), the null finding in the primary outcome for which the study was powered (10% difference in the change in LDL-C between groups), and participants being prescribed a reduced energy diet which could be a confounding factor. Eggs contain a number of important nutrients that may reduce the risk of cardiovascular disease including folate, long chain omega 3 fatty acids, and arginine (a precursor for nitric oxide). They have also been shown to improve HDL-C (Pearce KL, Clifton PM, Noakes M. Egg consumption as part of an energy-restricted high–protein diet improves blood lipid and blood glucose profiles in individuals with type 2 diabetes. Br J Nutr, 2011, 105: 584-592; Mutungi G, Ratliff, J, Puglisi, M et al. Dietary cholesterol from eggs increases plasma HDL cholesterol in overweight men consuming a carbohydrate-restricted diet. J Nutr 2008; 138: 272-276). Improvements in HDL-C are known to reduce cardiovascular risk (Barter P, Gotto AM, LaRosa JC et al. HDL cholesterol, very low levels of LDL cholesterol, and cardiovascular events, N Engl J Med 2007; 357: 1301-1310). Eggs are a nutrient-dense food, yet are not high in energy. Despite being rich in cholesterol, the amount of total fat and saturated fat in eggs is not high and the fat in eggs is predominantly unsaturated (44% monounsaturated; 11% polyunsaturated). In addition to potential beneficial effects of eggs on circulating lipid levels, higher protein eating patterns may have benefits for weight loss by inducing increased satiety and enhancing metabolic rate and lipid metabolism. Thus eggs are unlikely to be detrimental to people with T2DM and may be beneficial. Despite this, there is a negative perception toward egg consumption in people with diabetes. This notion largely results from world-wide press releases that have followed the publication of a number of epidemiological studies indicating that a high egg consumption, though not associated with adverse cardiovascular outcomes in the general population, may be associated with worse outcomes in people with T2DM (Hu FB, Stampfer MJ, Rimm EB et al. A prospective study of egg consumption and risk of cardiovascular disease in men and women, JAMA 1999; 281: 1387-94; Djousse L & Gaziano JM. Egg consumption in relation to cardiovascular disease and mortality: the Physicians’ Health Study. Am J Clin Nutr 2008; 87: 964-9). While epidemiological studies may provide insight into possible associations, they do not show causal relationships and findings are often affected by many confounding, and often hidden, factors. For example, at the time that these studies were being conducted, a public health campaign was advising people to limit their cholesterol intake, including their consumption of eggs. Therefore, individuals that were consuming > 7 eggs per week at this time may have been less likely to follow healthy dietary and lifestyle advice in general. It would be impossible to control for these factors from the available data. Furthermore the theoretical increase in cardiac risk from the cholesterol contained in eggs is likely to be minimal when compared to other cardiovascular risk factors including saturated fat intake, lack of physical activity, smoking, hypertension and obesity. To address the limitations of previously conducted research, this prospective, randomised controlled study will include both an active intervention (initial 3 month weight maintenance period followed by a 3 month weight loss period) and follow-up period (6 months) to determine the potential health benefits of a high egg diet in pre-diabetes and those with T2DM. Both groups will be stratified during the randomisation process according to medication usage. The palatability and acceptability of both the diets will be examined throughout the 12 month study.