ANZCTR search results

Sucralfate has some weak evidence of being effective in the management of posttonsillectomy pain in paediatric populations. However, the current literature is limited. For this trial, 170 children will be recruited preoperatively and randomised to either receive sucralfate or placebo solution. This will be in addition to the standard Monash Health posttonsillectomy analgaesia protocol. The children will gargle and swallow 5 mLs of the study mixture four times a day. Parents will be provided with a set of questionnaires to complete for each postoperative day, consisting of the parents’ postoperative pain measure, the functional limitation scale and the FACES pain scale – revised. They will also be asked about their child’s quality of sleep, how much analgaesia the child has received, any contact with medical practitioners required, whether their child tolerates the study mixture and any side effects they notice.

Debilitating fatigue; unrefreshing sleep and poor daytime functioning are core features of many neuropsychiatric conditions including chronic fatigue syndrome (CFS) and major depression. Understanding of the aetiologies of these conditions is still incomplete and symptom management strategies have only limited efficacy. Accumulating evidence suggests that abnormalities in the function of the autonomic nervous system play a role in the sleep disturbance and chronic fatigue in these conditions. In particular, autonomic activity is characterized by neural hyper-vigilance and a marked loss of parasympathetic, vagus nerve activity that persist even during sleep. Measures of beat-to-beat heart rate variability (HRV) provide well-established, reliable indices of autonomic functioning, which consistently correlate with the severity and outcome of a spectrum of fatiguing disorders, including autoimmune and cardiovascular disease, chronic pain, depression, and CFS . For example, low HRV was repeatedly found to be a strong correlate of unrefreshing sleep, daytime fatigue and cognitive impairment in CFS. Mindfulness-based stress reduction and relaxation methods are increasingly utilised with the aim to restore autonomic balance. It is believed that the beneficial effects of these approaches are mediated via their impact on neural circuits involved in self-regulation, and on key stress-response pathways. However, individuals can have very different responses to different relaxations methods; and recent analyses revealed that some patients do not respond optimally to some. The main of the current study is to conduct a randomized control trial (RCT) to determine the efficacy and specific benefits of a 4 week personalised relaxation intervention, pre-tested to optimise the individuals' own HRV. Subjective health outcomes and parasympathetic autonomic activity (indexed by HRV) in patients with CFS and depression will be compared to a ‘monitoring only’ control condition. We anticipate that daily practice of a personalised relaxation method before sleep will be substantively more effective in improving sleep quality, daytime fatigue and functioning in both patient groups compared to treatment as usual with symptom monitoring. We further anticipate that restoration of HRV will contribute to positive health outcomes. The findings from this research will facilitate a better understanding of the pathophysiological mechanisms operating in chronic fatigue conditions.

The conservative fluid feasibility study is a phase II, prospective parallel-group (1:1) randomised controlled study (N=100). The aim is to determine if a conservative fluid management strategy, compared to usual care, can achieve a clinically significant reduction in intravenous fluid intake in critically ill adults admitted to ICU for more than 48 hours. Most general adult intensive care unit (ICU) patients who are expected to remain in ICU for more than 2 days will be eligible. Patients in the intervention (conservative) group will receive intravenous fluid therapy according to a succinct fluid practice guideline comprising bolus fluid, maintenance fluid, replacement of lost fluid, and fluid administered with drugs or other infusions. Patients in the control group will receive fluid in a usual way using a basic guideline. The primary outcome is mean hourly fluid intake from the time of randomisation until the morning of day 2 after randomisation. Secondary outcomes include adherence to the fluid guidelines and fluid balance

The primary purpose of this trial is to evaluate the efficacy of a community-based exercise program, The Life Now Exercise Program, for improving physical and psychosocial wellbeing in cancer patients and survivors. The exercise program is hypothesized to improve wellbeing in people with cancer. Who is it for? You may be eligible to enroll in this trial if you are aged 18 or over and are currently receiving cancer treatment or completed cancer treatment within the previous two years. Study details All participants enrolled in this trial will complete the Life Now Exercise Program. This involves twice weekly supervised group exercise sessions for three months. Sessions will last approximately one hour and comprise of a combination of aerobic, strength and flexibility training. Participants will also be asked to complete home exercise of their choosing to a total of at least 150 minutes of exercise per week, including the supervised sessions. It is hoped that this trial will provide information on whether an exercise program can mitigate and rehabilitate the adverse effects of cancer and its treatment and improve physical and psychosocial wellbeing amongst current cancer patients and recent cancer survivors.

The human gut secretes a number of hormones to regulate food intake and blood sugar. Ghrelin is a hormone secreted from the stomach before meals, which promotes food intake. Glucagon-like peptide-1 (GLP-1) is secreted from the small and large intestines after meals, and is known to suppress food intake and improve blood sugar control. In this trial, we want to investigate whether saline solutions administered into the small intestine will affect the secretion of ghrelin and GLP-1, and the sensation of hunger and satiety.

The primary purpose of this study is to identify supportive and palliative care needs from the perspective of bereaved family carers of deceased advanced melanoma patients from diagnosis of advanced disease to death. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, are English-speaking and were the main carer of a person who died 2 to 18 months previously as a result of melanoma. Study details All participants in this study will complete a single 30-90 minute interview about supportive care needs from diagnosis to death of a family member with advanced melanoma. It is hoped that from these interviews, researchers will identify the supportive care needs of these individuals.

There are increasing concerns regarding the treatment efficacy of azithromycin 1g single dose for the treatment of rectal chlamydia infections with treatment failure rates up to 21% being reported. There is no pharmacokinetic data available to determine if low rectal tissue concentrations contribute to treatment failure. The purpose of this study is to provide the world first evidence of the pharmacokinetics of azithromycin 1g in rectal tissue

The primary purpose of this trial is to assess the impact of the Navigate online decision aid (DA) on the uptake of active surveillance as a management option for low risk prostate cancer patients. This can be achieved by assessing the impact of the online DA on decision making, confusion and distress, and decisional regret and by increasing the understanding of treatment options and side-effects for patients recently diagnosed with low risk prostate cancer (LRPC). Who is it for? You may be eligible to enrol in this trial if you are aged 18 years or over, and have been diagnosed with low risk prostate cancer within the last three months. Participants can be recruited Australia wide through an online self-referral or clinician-referral process (refer to website below). Study details All participants enrolled in this trial will be randomly allocated (by chance) to receive access to the Navigate DA, or to receive links to the Prostate Cancer Foundation of Australia (PCFA) website, an existing information website for men with prostate cancer. Participants' partners will also have access to the allocated information resource. Participants and their partners will then be followed up at 1, 3 and 6 months to assess updake of active surveillance as the first line management option, preparedness for decision making, decisional conflict, regret, satisfaction, relationship outcomes and quality of life using questionnaires. It is hoped that this trial will provide information on the impact of the Navigate DA on the uptake of active surveillance, reducing confusion and distress associated with decision making regarding LRPC diagnosis.

Patients on dialysis lack the ability to excrete water adequately and accumulate water in-between dialysis sessions. This excess fluid accumulated needs removal on dialysis. Traditionally the amount of excess fluid accumulated by the patient is estimated by clinical examination. Whilst large fluid excess (volume overload) is relatively easy to detect on clinical examination, it is unreliable for detecting subtle fluid excess. Underestimation of the amount of fluid to be removed on dialysis leads to long term volume overload that results in a number of detrimental effects such as high blood pressure, heart failure and other disorders of the heart and blood vessels that eventually lead to increased mortality. Overestimation of the amount of fluid that needs to be removed on dialysis, results in volume deficit causing post-dialysis fatigue, low blood pressure, dizziness, cramps, seizure and dialysis interruptions that can result in under dialysis. The use of objective measures to supplement the clinical assessment of volume status in dialysis patients is gaining attention. Some of the techniques used have focused on measuring inferior vena cava diameter, bioimpedance and circulating blood volume. These techniques do not convey information on heart function that is critical to patients’ tolerance and response to fluid removal on dialysis. The measure of lung water, the accumulation of which reflects both heart function and the circulating blood volume appear to be much better at identifying patients at risk of adverse volume dependent clinical outcomes and to monitor effects of fluid removal aimed at preventing these adverse outcomes. Recently a quick, simple and easy to learn measure of lung water using ultrasonography has been validated in dialysis patients. The current study aims to assess the feasibility of introducing routine assessment, by the renal unit staff, of volume status in our dialysis patients by measuring their lung water using bedside ultrasonography. We will evaluate the acceptability of the procedure to the operators and patients along with the inter-observer variability. The sensitivity of the ultrasound changes to changes in body weight following dialysis, and the proportion of patients with lung water post-haemodialysis will also be assessed.

In patients with symptomatic medial compartment (inner side), knee osteoarthritis (OA) and associated genu varum (bowing of the lower limb) performing a high tibial osteotomy (HTO) can provide pain relief by changing the shape of the limb. The shape changes the point at which compressive load crosses the knee. This unloads the painful arthritic side of the knee and transfer load to the undamaged lateral compartment (outside)of the knee. There are two widely used HTO techniques. These are the medial opening wedge (MO) and the lateral closing wedge (LC) HTO. Intraoperative computer navigation can increase the accuracy and precision of the intended correction but has not been used for the LC technique. It is unclear in the literature, which approach yields the highest patient satisfaction as very few studies have been done that compare the two techniques. Additionally, there are even fewer studies that have examined the changes to gait mechanics that take effect as a result of the described procedures. To detect a difference between the two procedures, patients will undergo preoperative and postoperative radiographic (x-ray) and functional joint assessments. In addition, investigators will assess changes to the patients' gait by performing analysis at a Gait Laboratory. Aims and Hypothesis: 1) That the same correction achieved intraoperatively using two different osteotomy techniques will produce the same correction to standing limb shape and gait mechanics 2) Computer navigated LC wedge is as accurate as computer navigated MO wedge HTO. Research Design: The design of this project is a single centre, multi-surgeon, prospective, randomised controlled trial. (Evidence Level II) Materials and Methods: Patients planned to undergo a HTO procedure at the investigators' clinic who fit study inclusion criteria, may be approached to voluntarily participate in the study. Patients will be randomised to the MO wedge HTO group or LC wedge HTO group at time of consent. Alignment corrections associated with the procedure will be standardised to 3.5 degrees of valgus. Patients will undergo assessments preoperatively, and postoperatively for followup in clinic at six weeks, six months and yearly.