ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31104 results sorted by trial registration date.
  • The hospital costs associated with postoperative complications following small bowel resection surgery

    The purpose of this study is to determine the costs associated with post-operative complications of those undergoing a small bowel resection. Accurately defining the costs of complications allows institutions to make more informed decisions as to what areas comprise a significant cost percentage, and then implement strategies to mitigate this. This study is conducted using a review of medical records, and no patient contact is required. Who is it for? This is a retrospective study evaluating the costs of complications of adult patients who underwent a small bowel resection at the Austin Hospital between January 2013 and June 2018. Study details The aim of this study is to outline the health costs of postoperative complications in patients who undergo small bowel resection surgery. We consider the incidence, type and severity of these complications and expand on the surgical method used in relation to small bowel resection. Further, we highlight the importance of evaluating the components of healthcare cost profiles relevant to patients undergoing small bowel resection. We hypothesise that patients who suffer complications would incur greater costs as compared to patients who did not have a complication. We also hypothesised that as the complication severity increased, there would also be an increase in costs. It is hoped that this study will outline the costs of postoperative complications in patients who undergo small bowel resection surgery, and highlight the importance of evaluating the components of healthcare cost profiles relevant to patients undergoing small bowel resection.

  • Do bisphosphonate tablets improve bone health in patients on dialysis

    We hypothesise that in patients on dialysis, with normal or elevated bone turnover, the use of bisphosphonates will improve some or all of BMD, the trabecular bone score (indicating changes to bone microarchitectural parameters), cortical parameters and the buckling ratio assessed by hip structural analysis, and 3D-Shaper hip parameters that independently assess cancellous and cortical compartments from DXA images. If improvements in these parameters are seen with bisphosphonates, a larger study with fracture outcomes is proposed

  • Nasal solgel therapy performance in post operative sinus surgery patients

    Chronic rhinosinusitis (CRS) is a heterogeneous, multifactorial disease defined by sinonasal inflammation persisting more than 12 weeks. According to the Australian National Health Survey, in 2007-2008, 9.2% of the Australian population suffer from CRS. Along with sinonasal symptoms, patients frequently suffer with low mood, poor sleep and fatigue leading to significant direct and indirect costs to the health system. Despite the prevalence of the condition in the community and the burden both physically and financially, there is an ongoing search for an efficient and practical method to deliver ongoing treatment. The recent International Consensus Statement on the treatment of CRS include nasal saline irrigation and intranasal corticosteroid sprays/drops with the addition of a short course of oral corticosteroids for the CRS with nasal polyps (CRSwNP) subgroup. Topical therapy offers the benefits of high local concentrations without the systemic side effects, however in unoperated sinuses, delivery to the sinus mucosa is limited and less than 2% of the irrigated volume reaches the sinuses. Endoscopic sinus surgery (ESS) is essential to allow topical treatment to effectively reach the sinus cavities and is the treatment of choice in patients who fail to respond to appropriate medical therapy (AMT). The intention of ESS is to restore natural sinus ventilation and drainage pathways, relieve nasal obstruction with the preservation of mucosa, and ultimately allow CRS treatment to be de-escalated from systemic to topical treatments for long-term management. Topical steroids are an integral component of postoperative care in ESS. There is high-level evidence supporting their use, which has been shown to significantly improve patient’s self-reported symptoms and endoscopic scores at 6 & 12 months. In the clinical setting, steroids are mixed into high volume washes for delivery. Unfortunately, these devices have short mucosal contact time and require daily use. Ideal drug preparation should be delivered in a manner to optimise mucosal contact time with steady absorption & minimal wastage. Mucoadhesive, thermoresponsive in situ gelling systems (solgels) pose a potential vector for drug delivery. These polymer-based gels can be formulated to rapidly transform in situ from a liquid to gel once at sinonasal temperature and slowly release a drug to the target tissue. Recently, these soluble gels have been analysed ex-vivo in human nasal tissue and demonstrated prolonged mucosal contact time and sustained release of dexamethasone. Establishing the viability of these gels in-vivo opens an innovative method for drug delivery to the sinonasal mucosa with potential to treat a broad range of sinus conditions. This aim of this trial is to assess the use of solgels as a vector to deliver steroid to surgically opened sinus cavities. Assessment of delivery to sinuses, residence time & local side effects will be the primary areas of interest.

  • Nasal solgel therapy performance in healthy volunteers

    Chronic rhinosinusitis (CRS) is a common condition in which the cavities around nasal passages (sinuses) become inflamed and swollen for at least 12 weeks, despite treatment attempts. This then causes mucous build up. According to the Australian National Health Survey, in 2007-2008, 9.2% of the Australian population reported to suffer from this condition. Symptoms include difficulty breathing through the nose, the area around the eyes and face may feel swollen and the patient may have facial pain or tenderness. Patients also frequently suffer from depression, poor sleep and fatigue leading to significant direct and indirect costs to the health system. Even though this condition is common in the community, there is an ongoing search for an efficient and practical method to deliver ongoing treatment that decreases the financial and physical burdens of CRS. The most recent accepted standard treatment of CRS include nasal saline irrigation (washing the nasal passages with a mild salt water solution) and intranasal corticosteroid sprays/drops (applying medicine directly into the nose through drops or spray). Corticosteroids are medicines that assist in treating inflammation in the body. Current practice of adding a corticosteroid to the saline wash solution means the medication does not stay in the nose for very long and this then requires daily treatment. Applying the corticosteroid directly to the inside of the nose (nasal mucosa) offers the benefits of treating CRS directly with high local concentrations without the systemic (whole body) side effects. There has been recent interest in the use of soluble gels, that gradually dissolve, which are applied directly to the inside of the nose to deliver these medicines. These soluble gels slowly release the medication into the surrounding tissue. These gels have the potential to change the way medications are delivered to the nasal mucosa and thus the treatment of CRS. The aims of this trial is to ascertain: 1. how long the soluble gel takes to dissolve once applied to the nasal mucosa 2. if the addition of a corticosteroid medication to the soluble gel affects the time it takes to dissolve.

  • Early detection of extravasation injuries in children with critical illness

    Peripheral intravenous catheters (PIVCs) are small hollow tubes inserted into veins for medical therapy in most children admitted to a Paediatric Intensive Care Unit (PICU). However, extravasation or ‘leaking’ of fluid into surrounding tissues remains a harmful complication. Nursing surveillance and assessment of PIVCs assists in detection of extravasation. However, demanding clinician workloads and the inability of some patients to communicate symptoms during critical illness has proved early detection challenging. In order to improve early detection of extravasation injuries, ivWatch® was developed as continuous and non-invasive monitor of PIVCs. It consists of a patient monitor, an optical sensor cable, and a sterile, disposable receptacle for attaching the sensor to the patient’s skin, near the PIVC site. Using infrared light, ivWatch® manufacturers claim the device can detect early signs of extravasation. However, there are few clinical data regarding the effectiveness, acceptability and value of ivWatch®. We are undertaking an efficacy trial to test the feasibility of a larger trial to evaluate the effectiveness of ivWatch®, versus surveillance by clinicians, to identify extravasations within the PICU. We believe this technology has the potential to significantly improve treatment provision and increase patient safety within all critical care settings.

  • Post-operative high intensity interval training in patients undergoing major foregut cancer surgery: A randomised controlled trial

    The purpose of this study is to assess the effect of early intervention exercise after surgery on mood and post-operative outcomes. Who is it for? You may be eligible for this study if you are aged 18 or over, and undergoing major foregut cancer surgery. Study details Participants in this study will be randomised by blocking, into two groups. Participants in one group will receive standard care which includes, enhanced recovery after surgery protocol. The other group will start exercise from the first post-operative day until discharge from hospital. The exercises will involve two sessions daily, one resistance training and one cardio training. The resistance training will involve chest press, knee extension, bicep curl, shoulder press, lateral raise, calf raises and sit to stand. The cardio training will involve walking, arm cycling, leg cycling, and step ups. The sessions will last approximately 10-45 minutes. As a part of this study, all participants will answer questionnaires and undergo simple fitness tests prior to surgery, when leaving the hospital, and at 1 month and 3 months after discharge from hospital. It is hoped this research will demonstrate starting exercise sooner will results in improved mood and physical outcomes.

  • Intravenous iron for treatment of Sub-optimal iron stores in Non-Anaemic Patients presenting for major Surgery

    Iron infusions are a commonly used therapy to correct iron deficiency anaemia (low blood haemoglobin). They are used with increasing frequency in surgical patients with the aim being to optimise a patient’s own blood stores prior to surgery and improve post-surgical outcomes. International guidelines recommend the pre-operative administration of iron to surgical patients who are not anaemic, but have iron stores considered sub-optimal, when substantial blood loss that would result in depletion postoperatively is anticipated. However, this is based on limited evidence, and with uncertain outcomes. This pilot study will examine the feasibility and tolerability of a research protocol to compare outcomes (including recovery of iron stores, exposure to blood transfusion and quality of recovery after surgery) in a group of hospital patients having major surgery. Non-anaemic patients with suboptimal iron will either receive an iron infusion pre-operatively or placebo. Patients will be examined by questionnaire, physiological testing and blood tests post-operatively and at one month after their operation to quantify and qualify outcomes for comparison between these groups.

  • Food from Home Study: Dietary acculturation and heart disease risk factors among Chinese Immigrants in Australia

    Chinese immigrants are at increased risk for obesity and non-communicable disease (e.g diabetes, cardiovascular disease) after migration due to an interacting set of factors, including dietary change, cultural barriers, and genetic predisposition. To better understand the increased risk among immigrants, it is important to consider the dietary shift that occurs when Chinese immigrants move to Australia. The goal of our research study is to understand how and why Chinese immigrants change their dietary habits after migration and what impact these dietary changes have on risk factors for diabetes and cardiovascular disease. We hypothesise that over the two-year observation period there will be 1) evidence of dietary acculturation in Chinese immigrants to Australia; and 2) changes in risk factors for cardiovascular disease and diabetes.

  • Treating depressed Australian workers using an app-based intervention: A randomised controlled trial (Anchored)

    This application is for the purpose of conducting a randomised controlled trial (RCT) of a smartphone-based intervention (Anchored) aimed at reducing depression and promoting mental health and wellbeing within Australian workers. The app has previously undergone pilot testing for feasibility, usability and acceptability. Participants will be randomised to one of two conditions: (1) the Anchored app (a CBT, mindfulness, and behavioral activation-based smartphone app) and (2) a psycho-educational online resource. Post-intervention assessment will occur 30 days after baseline, and follow-up assessment will occur 3 and 6 months after baseline. All assessment will be completed online. Key outcomes include: depression symptoms, anxiety symptoms, stress, wellbeing, resilience, function, burnout, work productivity, and lifestyle elements.

  • Replacement of hospital clinic appointments with telehealth appointments delivered directly to the home for people with cystic fibrosis (CF)

    This project aims evaluate a way of delivering care that allows people with cystic fibrosis to receive approximately half of their outpatient care in their own home. The study will use telehealth, a system where the hospital staff and the patient each log into a video call and all questions and assessments are performed online. By using telehealth, patients will not need to travel, which may lead to increased satisfaction as well as cost savings for individuals and the healthcare system. The study aims to measure how satisfied patients are with receiving care in their own home. The study will also determine the costs to the patient and how much of a burden it is on patients to have their appointments at home compared to travelling to the hospital. This is an important study because, as technology improves and the healthcare system has the ability to provide more care without seeing patients in person, there is a responsibility to carefully study if using technology is beneficial to the patient or if this may be detrimental to the patient. Patients that choose to be part of the study will be randomly divided into two groups. One group, named the ‘usual care group’ will continue to attend the hospital for all of their appointments, this represents no change to their usual care. The second group, named the ‘telehealth group), will attend the hospital for approximately half of their appointments only and will remain home for approximately half of their appointments with the hospital staff conducting the appointment via telehealth.

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