ANZCTR search results

Endometriosis is a chronic gynaecological disease affecting 11.4% of women by age 40-44. Endometriosis occurs when endometrial-like tissue, similar to the tissue lining the womb, starts to grow in other parts of the body outside of the womb. The most troublesome symptom associated with endometriosis is pelvic pain (period pain, persistent pelvic pain [PPP], pain during or after sexual intercourse, or pain associated with going to the toilet). This can have significant effects on normal day-to-day activities and overall quality of life. Following surgery to diagnose and treat endometriosis, patients have a 6-67% chance of requiring re-operation for recurrence. The aim of the work described in this application is: To establish a clinical prediction model for recurrent disease. Hypothesis - We can predict risk of endometriosis recurrence using readily available clinical variables.

Primary sclerosing cholangitis (PSC) is a progressive, chronic liver disease leading to end stage liver-failure with limited treatment options. Case series and a recent systematic review and meta-analysis found that antibiotic therapy and in particular treatment with the non-absorbable antibiotic vancomycin was associated with substantial clinical improvement or even remission of PSC and the concomitant inflammation of the bowel. Against this background we aim in a placebo-controlled trial in PSC patients with and without  concomitant IBD to define the effects of antibiotic therapy on disease activity. It is hypothesised that targeted modulation of the microbiota with vancomycin will improve clinical outcomes for these patients.

VA-ECMO is a life-saving therapy in patients with cardiovascular or respiratory failure. The use of VA-ECMO is increasing and has doubled globally in the last 5 years. Percutaneous cannulation can be achieved using ultrasound guidance, even in unfavourable clinical and/or environmental conditions. If the patient recovers and can be weaned from VA-ECMO, or if ongoing VA-ECMO support is futile and no longer meets its intended goals, withdrawal of the VA-ECMO is required. Removal of the large (15-21F) femoral arterial cannulas is typically performed in an open surgical procedure. However, surgical decannulation is associated with several complications such as bleeding, delayed wound healing and infections. In addition, there is an increased strain on healthcare resources: patients need a vascular or cardiac surgeon, general anaesthesia, theatre time with support of a perfusionist, and transport to and from the theatre. To circumvent this, manual compression and suture-based vascular closure devices have been used in VA-ECMO decannulation, but both were associated with an increased risk of bleeding (5-10%) or requiring additional steps during initial VA-ECMO cannulation. The MANTA vascular closure device is a collagen plug based device, that is increasingly used in large bore interventional therapies such as transcatheter aortic valve implantation, endovascular aneurysm repair or periprocedural of left ventricular assist devices. This is a non-randomised open-label feasibility study. We aim to include 20 patients on VA-ECMO in which decannulation of ECMO support is pursued by the treating team, to investigate the safety and feasibility of percutaneous decannulation of femoral VA-ECMO using the MANTA VCD.

The goal of this innovation is to reduce in hospital trip hazards, improve nursing staff utilisation on the wards, increase mobility aid adherence, increase adherence to post-operative orthopaedic precautions. With the bottom-line to reduce the number of risk factors that lead to in hospital falls. To test the effectiveness of this innovation I would like to propose a pilot study with hospital-based intervention research design. With a follow-up questionnaire to allow for comparisons to be made between the intervention and the control group.

Hip fractures are a common occurrence in the community and cause severe acute pain. Traditional methods of analgesia rely heavily on systemic opioid administration, which has several predictable and undesirable side-effects. Consequently, there has been a recent emphasis on peripheral nerve blockade as an opioid sparing analgesic in patients with hip fractures. The blockade is usually performed with long-acting local anaesthetics and works by decreasing pain transmission from the site of injury to the central nervous system. There has been recent research into the role of adjuvants, such as dexamethasone, added to the nerve blockade injectate. These adjuvants are purported to improve duration of analgesia, but these findings have not yet been replicated in emergency department patients with hip fractures. This study aims to assess the duration of analgesia gained from plain ropivacaine ultrasound guided fascia iliaca compartment block (USG-FICB) as compared to ropivacaine USG-FICB augmented by intracompartmental dexamethasone. This is a single-centre, prospective, double blinded randomised control study design which aims to assess the duration of analgesia gained from plain ropivacaine USG-FICB as compared to ropivacaine USG-FICB augmented by intracompartmental dexamethasone. Enrolled patients will be randomised to receive an USG-FICB with either ropivacaine + dexamethasone OR ropivacaine + placebo (i.e. ropivacaine alone). Duration of analgesia will be assessed based on timing of breakthrough opioid following the USG-FICB.

Overview: Raynaud's Phenomenon is characterised by spasms of blood vessels in the peripheries and in both hands and feet it can lead to pain, ulceration, and amputation of fingers and toes. It is a common feature of the autoimmune disease, Systemic Sclerosis. The pain and difficulty in using the fingers creates substantial limitations on everyday activities with subsequent decrease in the quality of daily living. A patient of one of the investigators had the initiative to try electrically heated gloves and found them "life changing". This project is a pragmatic clinical trial to examine the usefulness of heated gloves for these patients. Participants will have Raynaud's Phenomenon secondary to Systemic Sclerosis. A cross-over randomised controlled trial design will be used with the interventions being: (a) use of electrically heated gloves, or (b) routine practice. The trial will take place during the Adelaide winter months of July to Sept. The objective of the trial is to determine whether use of electrically heated gloves improves quality of life for patients with Raynaud's Phenomenon compared to their usual practice.

The primary aim of this study is to examine to acceptability and efficacy of an internet delivered VCBT for GAD. A secondary aim is to examine the acceptability and efficacy of a brief VCBT treatment for GAD. The aim of this study is to recruit and treat participants with generalized anxiety disorder using a cognitive behavioural treatment program administered remotely via internet videoconferencing. Participants in the treatment group will begin the program immediately, and their results will be compared with a waitlist control condition. Participants in Group 2 will receive access to a brief version of the program when Group 1 completes treatment (Week 10). Outcome measures will be administered at baseline, mid treatment, post treatment and 3 month follow-up. Based on the limited existing literature it is hypothesized that high intensity VCBT will 1) be acceptable to individuals with GAD; 2) result in significant reductions in symptoms, resulting in large within-group and between-group effect sizes at post-treatment and three-month follow up; and 3) brief VCBT will result in outcomes similar to those seen in standard face-to-face treatment.

The primary objective of this study is to evaluate the effect of CYP3A/P-gp inhibition on the pharmacokinetics of GS-5718 and the effect of GS-5718 on the pharmacokinetics of OATP/BCRP substrates.

The purpose of this study is determine whether it is possible to use a drug called prazosin when men are undergoing radiotherapy for the treatment of prostate cancer. Who is it for? You may be eligible for this study if you are an adult man who has been diagnosed with non-metastatic prostate cancer. Study details All participants in this study will be asked to take prazosin two times day starting the week before and until the completion of their radiotherapy treatment for prostate cancer. There will be 6 dose levels that participants could be assigned to depending at what stage they enroll; the doses range between 0.5mg twice daily and 5mg twice daily. The dose will start at 0.5mg twice daily one week before radiotherapy starts and, if necessary, increase each week until the target dose is reached. Participants will be monitored throughout the treatment period to determine if they are willing to take the medication alongside their radiation, and followed for 9 months for any side effects. Participants will also be asked to provide blood samples at 3, 6 and 9 months after commencing the study, however these are part of standard follow-up tests after radiotherapy for prostate cancer. It is hoped that this study will help determine if it is possible to use prazosin while participants are completing radiotherapy, and help guide the development of a large scale clinical trial which will be used to investigate the efficacy of prazosin combined with radiotherapy

Augmentation of anterior cruciate ligament reconstruction using autologous hamstring graft, with a modified iliotibial band tenodesis or lateral extracapsular tenodesis, for patients with a residual pivot shift: A 2 year prospective randomised controlled trial comparing recurrence rate and clinical outcome. Background: Approximately 10% of ACLs injuries are associated with damage to the anterolateral complex (ALC) of the knee, manifest as greater anterolateral rotatory instability (ALRI). The pivot shift test is the best available clinical test for ALRI. Addition of an ALC reconstructive procedure can improve stability of the knee and clinical outcome in these patients following ACL reconstruction. There is little data comparing the efficacy of the various ALC procedures. Hypothesis: We hypothesized that the clinical outcome would be similar when either a modified ilio-tibial band tenodesis (MITBT) or lateral extracapsular tenodesis (LET) was added to ACL reconstruction. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: The inclusion criteria were a residual pivot shift following ACL reconstruction, in a skeletally mature patient, pre-injury Tegner Activity Score of at least 7, desirous to return to a similar level of activity, an intact contra-lateral ACL ligament and consenting to be randomly allocated to either treatment group. Patients in group A underwent MITBT, those in group B, LET, in addition to their ACL reconstruction. The primary outcome was recurrent ACL rupture and / or meniscal tears. Secondary outcomes were the Knee injury Osteoarthritis and Outcome Score (KOOS), International Knee Documentation Committee (IKDC) score, ACL Quality of Life Questionnaire (QOL) and Tegner activity scores (TAS). Patients were reviewed at 12, and 24 months postoperatively. Statistical comparison of the groups was performed, P<0.05 denoting significance. A power analysis determined that 140 patients were required to achieve a power of 80% and 5% risk of a type 1 error.