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Chest infections can occur in as many as 1 out of every 2 patients after they have had major bowel, stomach, liver or kidney surgery. This is serious and costly. Chest infections dramatically increase the risk of death following surgery, and the average length of time spent in hospital is doubled. Studies have shown that getting up, and out of bed, and walking as early as possible after surgery with a Physiotherapist reduces this chance of getting a chest infection down to as low as 1 in 20. Unfortunately, these studies have also included time spent with a Physiotherapist before the operation on learning how to do breathing exercises and how to get going again soon after the operation. So, it is really hard to say for certain if this significant reduction in chest infections is down, not just to the amount of walking a patient does after the operation, but also to the level of education they received before the operation. No clinical trial to this point has specifically looked at how effective this type of pre-operative education is, in its own right, in reducing the risk of a chest infection after an operation. The LIPPSMAck POP trial will provide education and training from a Physiotherapist to half of the patients about to undergo major abdominal surgery. The other half will get a pamphlet covering the same sort of information. All patients will get a follow up session with a physiotherapist on the first day after their surgery. The trial will compare these two groups and see if there is any difference in rates of chest infections and how long they stay in hospital. The result of this trial will assist in determining the wisest and most cost effective way to allocate Physiotherapy services to people having a major abdominal operation and assist them in recovering from their operation as quickly as possible.

Background, aims & objectives: In some pregnancies, the blood types of mother and baby are not the same – this may cause problems for the baby. The mother’s immune system may ‘see’ the baby’s blood type as a threat, a process called sensitisation. This is called Rhesus disease and can cause anaemia, jaundice, and possibly serious consequences. Ways of preventing Rhesus disease are both safe and well-established, and used as part of regular antenatal care at KEMH. This involves an injection of anti-D antibody to maintain a protective level of this antibody in the blood. This dampens the body’s immune response to the baby’s blood, and greatly reduces the risk of Rhesus disease. With current prevention methods, the risk of Rhesus disease is less than 1%. There are two main approved dosing regimes, 1) the single-dose regime and 2) the double-dose regime. Both have advantages and disadvantages. Currently, Australia uses a double-dose regime, but is considering moving to a single-dose regime. Although widely used in the UK, Europe and USA, the single dose has not been studied locally in Australia. At present, women at KEMH receive two doses of anti-D during their pregnancy. This study will investigate both regimes to identify any difference in protection that lasts up to the time of delivery. A smaller study will review all women with evidence of sensitisation in the last 3 years to identify the possible causes. The results of the studies will help doctors optimise the preventive treatment, and help reduce the impact of Rhesus disease. Study population: Anti-D Dosage Study: We will recruit 300 Rhesus-negative pregnant women who have a negative antibody screen, and have no history of adverse reactions to anti-D injections. Anti-D Sensitization Review: We will recruit women with evidence of sensitisation to the Rhesus-D antigen in the last 3 years. Based on population estimates, there will be up to 30 eligible women for this study in WA. Study design & methods: Anti-D Dosage Study: Three hundred women will be recruited from antenatal clinics in KEMH at <28 weeks of pregnancy. Women will be allocated to one of two groups. The control group will receive standard antenatal care, which includes two injections of anti-D antibody, six weeks apart (at 28 and 34 weeks of gestation). The single-dose group will receive one, larger dose injection of anti-D at 28 weeks. At delivery, all participants will have a blood test which checks for anti-D antibody. All participants will otherwise receive standard care for the prevention of sensitisation, including a) receiving additional anti-D injections after any potential sensitizing events during pregnancy and b) receiving an injection of anti-D antibody after delivery if their baby is Rhesus-positive. Relevant medical information will be extracted from medical records. Anti-D Sensitization Review: All women with evidence of sensitisation to the Rhesus-D antigen in the last 3 years will be interviewed and their medical records reviewed to identify, if possible, the timing and potential contributing factors for sensitisation. Outcomes: This study will provide unique data for the National Blood Authority and Australian clinicians. It will provide information about the proportion of women that still have circulating anti-D at the time of delivery using the Australian two-dose (625IU) regime. This will enable a direct comparison to that achieved by the one-dose (1500IU) regime that is currently being proposed for Australian pregnant women. The sensitization review will also provide information to further advance Rhesus disease prevention in Australia by identifying potential targets for education campaigns. Potential ethical issues: There is minimal risk to participants as the intervention (a single dose of anti-D antibody) is an approved regime used in routine clinical practice in Europe and the USA.

The aim of this research project is to evaluate the effectiveness of the resource, “Rheumatoid Arthritis for Physiotherapists – eLearning” (RAP-eL), in improving confidence and knowledge of best-practice physiotherapy management of rheumatoid arthritis. The evaluation of the RAP-eL resource aims to answer two research questions: 1. Is the RAP-eL resource effective in improving physiotherapists’ confidence and knowledge in the management of rheumatoid arthritis? 2. Are changes in confidence and knowledge retained over time?

The study aims to identify relevant issues and information needs of women who have considered or have had neoadjuvant chemotherapy treatment within the last five years for initially operable cancer, and incorporate them into a prospective questionnaire and decision aid for women diagnosed with operable breast cancer considering neoadjuvant chemotherapy. Who is it for? You may be eligible to join this study if you are aged over 18 years, have had a diagnosis of invasive breast cancer in the last 5 years, have been offered or have discussed neoadjuvant chemotherapy as a treatment option and have completed a surgical intervention for breast cancer. Trial details Participants in this study will be interviewed once over the phone to identify the issues faced and their prevalence and impact on decision making, and the level of distress associated with treatment for women who have considered or have had neoadjuvant chemotherapy treatment within the last five years for initially operable breast cancer. The findings will be incorporated into a prospective questionnaire and subsequent decision aid for women considering neoadjuvant chemotherapy for operable breast cancer.

Over the last several years, our research team has been systematically developing an internet-based CBT program for the treatment of childhood anxiety disorders. The program has demonstrated effectiveness when offered with minimal therapist assistance. The current study examines the efficacy of this program when offered in a self-help only mode.

This study is comparing the use of low dose radioactive seeds to standard treatment for surgical removal guidance in breast cancer patients. Who is it for? You may be eligible to join this study, if you are a female aged 18 years or above and have been diagnosed with breast cancer that is non-palpable (i.e. the surgeon cannot feel it), and thus require a procedure known as localisation. Trial details: When an abnormal area in the breast needs to be removed after a needle biopsy (and the surgeon cannot feel it), the abnormal area is localised. We are comparing two different localisation techniques in this study. Participants will be randomly (by chance) assigned to one of two techniques. Participants in one group will undergo a procedure known as ROLLILS (radioguided occult lesion localisation and removal of impalpable breast cancers). This involves inserting a low-dose sterilised radioactive iodine seed into the patient's cancer under local anaesthesia with imaging guiding. The patient will then undergo breast conserving surgery within 4 days, during which the surgeon uses the seed to guide removal of the impalpable cancer. Participants in the other group will undergo the standard treatment, known as hook-wire guided localisation (HWL). This is when a hook-wire is placed in the breast on the day of breast conserving surgery by a radiologist. Participants are followed for up to 5 years post-surgery in order to evaluate clinical and cosmetic outcomes, disease recurrence and patient satisfaction. A cost benefit analysis will also be undertaken.

The purpose of the study is to determine the efficacy and safety of a Marinova seaweed supplement in improving symptoms in participants with diagnosed osteoarthritis of the knee. The primary hypothesis is that the oral administration of the study medication over 12 weeks will result in a statistically significant decrease in osteoarthritis symptoms in comparison with a placebo.

The primary focus of this study is dizziness in the community dwelling elderly. Neck pain and dysfunction can cause dizziness and may be an important under-investigated risk factor for falls in the elderly. Neck manipulation is known to be effective for neck pain. There is also preliminary evidence that physical treatments administered to the neck (including manipulation) may improve dizziness. This study will use clinical rigorous research methods to determine whether chiropractic manipulation can be used to successfully treat dizziness, thereby lowering the likelihood of falls in the elderly. Falls in the elderly are a significant public health problem in need of new and innovative management strategies.

Pain is a common presenting symptom in the emergency department patient population with opioids being the cornerstone of treatment for moderate to severe pain. Fentanyl is a safe and effective opioid drug which is commonly used in adults and children for this indication. Rapid analgesia is usually effected in emergency patients by administering an opioid via the intravenous route but this can be associated with pain, inconvenience and delay as it requires the insertion of an intravenous cannula. The intranasal route of administration of opioids offers an attractive alternative as it is non invasive and does not require intravenous access. It also provides an alternative where intravenous access is difficult or not required and where nausea and vomiting prevent oral drug administration. In a number of patients intravenous access may then be completely avoided. The intranasal (IN) route has increasingly been viewed as an alternative route for drug administration. It is commonly used in the paediatric population where more invasive methods of drug delivery (intravenous or intramuscular) may result in significant discomfort, anxiety and increased stress during a hospital visit. The effective treatment of acute pain in children with intranasal opioids such as fentanyl is well documented. There is also evidence in adult acute and chronic pain settings that fentanyl in analgesic doses by the intranasal route provides effective analgesia. A significant limitation of using IN fentanyl in the adult population in the hospital setting is the inability to access the concentrated formulation (300mcg/ml). This preparation is more expensive than the widely available standard formulation (50mcg/ml) fentanyl and so is not widely accessible for use. Effective IN analgesia in adults requires the more concentrated formulation of fentanyl due nasal absorption considerations. This is a non-randomised single group study of IN fentanyl in 150 adult patients with moderate to severe pain from all causes. Patients presenting with pain greater or equal to 6 out of 10 will be given a dose of concentrated (300mcg/ml) IN fentanyl. Pain scores will be taken at regular intervals over 60 minutes. If there is no response by 15 minutes a second dose of fentanyl will be given. If no appreciable pain relief occurs by 30 minutes, standard IV opioid analgesia will be given. The results of this study will provide information on the effectiveness of fentanyl in the treatment of moderate to severe pain in adult ED patients and will allow us to determine future sample sizes for prospective comparative studies of fentanyl to other pain relievers used in the ED.

This study is evaluating the safety, tolerability and pharmacokinetics of RPH-203 following a single dose in health male volunteers as a potential treatment for secondary cancer of the bone. Who is it for? You may be eligible to join this study if you are aged between 18 and 45 years old, have a body mass index between 19kg/m2 and 30kg/m2, have a negative Quantiferon (Registered Trademark) test, male and healthy. Trial details Participants in this study will be randomly (by chance) divided into 6 sequential dose cohorts to receive 10.0mg, 30.0mg, 60.0mg, 120.0mg, 180.0mg of RPH-203 or matching placebo. Cohorts will receive a single dose of 10.0mg, 30.0mg or 60.0mg of RPH-203 subcutaneously, or a single dose of 60.0mg, 120.0mg or 180.0mg intravenously. As this is a dose escalation study, the first group will receive the lowest dose and when it is determined safe, the second group will receive a higher dose. Participants will be told which group they will take part in and what the dose level will be. As this is the first time this drug is being given in humans, 2 participants from the first dosing group will be given the drug first. 1 will be receiving the active drug and the other will receive the placebo. The assignment will be done at random. The remaining 6 participants will be given the drug at least 48 hours later when the drug is deemed safe. Participants will be advised if they are intended to be the first 2 participants before they come to the unit for dosing. All 8 participants will be dosed together for all other dosing groups. Participants will be admitted and be required to stay in the study unit for 3 days and be required to attend outpatient visits on 5 occasions for monitoring and assessment. This study is being conducted at the Centre for Clinical Studies.