ANZCTR search results

Objective: To compare reduction of pain following laparoscopy after ablation or excision of endometriosis. Design: A prospective, randomized, double-blind study. Setting: Endometriosis and pelvic pain clinic at a university teaching hospital. Patients: Women of reproductive age presenting with pelvic pain and visually proven endometriosis. Interventions: Subjects completed a questionnaire rating their various pains using visual analogue scales (VAS). Following visual identification subjects were randomised to treatment with ablation or excision by supervised training gynecologists as primary surgeon. Follow-up questionnaires documented pain levels every 3 months for 1 year then 6 monthly until 5 years. Main Outcome Measure: Change in pain VAS scores during 5 years post-operation and rates of pregnancy, repeat surgery and use of hormonal medication Results: There was a reduction in all pain scores over the five year follow up in both treatment groups. A significantly greater reduction in sex pain VAS scores was seen in the excision group at 3 years 6 months (p=0.015); 4 years 6 months (p=0.047) and at 5 years (p=0.031). More women went on to use medical treatments for endometriosis amongst the ablation group (p=0.004) by 5 years. Conclusions: Surgical treatment of endometriosis provides symptom reduction for up to 5 years. There are some limited areas, such as deep dyspareunia, where excision is more effective than ablation.

The objective of this study is to determine wether local endometrium trauma (LET), applied once during the mid-luteal phase of the cycle preceding in vitro fertilization (IVF) treatment, can improve the chance of pregnancy for women with recurrent implantation failure. The primary aim of this study will be the prescence of fetal heart activity seen on transvaginal ultrasound approximately four weeks after embryo trasnfer. The secondary outcome will be the effect of the LET procedure on positive pregnancy test two weeks after embryo transfer, ongoing pregnancy, pregnancy outcome and complications up to delivery. Endometrail tissue collected during the LET will be analysed for putative markers of successful implantation.

Our primary objective is to determine the effect of 5 days of dietary energy restriction (i.e. ~30 vs. the normal energy balance of ~45kcal/kg FFM/day) on muscle myofibrillar fractional synthetic rate (FSR; directly measured muscle protein synthesis) at rest as measured by primed constant infusion of ring-[13C6]phenylalanine. Our secondary objectives involve examining whether the anabolic stimulus of protein ingestion and resistance exercise will significantly increase FSR (post-exercise FSR). If an exercise plus nutrition intervention rescues the deleterious effect of a hypocaloric diet on muscle FSR this will provide novel and practical information for effective weight management in which fat mass can be reduced without loss of muscle mass.

Major joint surgery is associated with significant blood loss which often requires transfusion. Tranexamic acid is a recommended medication to assist with limiting blood loss. It acts by preventing the breakdown of blood clot. The usual dosage is multiple intravenous injections. The optimal dose is unknown. This study will examine the effects of direct injection of tranexamic acid into the site of surgery and compare this to the intravenous route. The hypothesis is that this will be as effective if not more effective than intravenous use and is easier to administer.

The administration of intravenous crystalloid fluid (also known as fluid therapy) is a ubiquitous intervention in patients undergoing surgery. Worldwide, the most commonly used crystalloid fluids available for patients undergoing major surgery include Saline (0.9%) or the balanced fluid solutions - Hartmann’s and Plasmalyte. Choice of fluid therapy is based frequently dependent on geography, and choice of fluid amongst anaesthetists at Austin Hospital is similar to worldwide practices. Saline has been used in clinical practice for fluid therapy since the late 1800s. While it is the most commonly used IV fluid in the world recent data raise the possibility that it might increase the risk of developing kidney damage in acutely unwell patients compared to fluids with lower concentrations of chloride such as Plasmalyte. While this increased risk of kidney damage with the use of saline is plausible, current data are insufficient to recommend clinical practice change and data from an interventional trial are urgently needed. However, the design of such a Trial requires sufficient pilot data to establish feasibility, safety power calculations and define an optimal study protocol. This study aims are to provide high quality pilot data in a rapid time frame to address this important question and to help decide whether a pivotal randomized controlled trial is justified. Thus, all patients undergoing surgery at Austin Hospital will be assigned to receive either Saline (0.9%) or the balanced crystalloid solution Plasmalyte as the primary crystalloid fluid in a blinded fashion during two study periods. The study will be conducted over a 4-month period allowing including two periods of 6 weeks each where all patients will receive the intervention, with a three week wash-in and a three week wash-out period for each group. Blinded study fluid will be used for all crystalloid therapy in all participants. Austin Hospital staff specialists in anaesthesia agree that on the basis of current evidence, Saline (0.9%) and Plasmalyte are equally acceptable for crystalloid fluid therapy in every situation requiring major surgery with the exclusion of surgery for liver transplantation, renal transplantation and patients with raised intracranial pressure, where specific hospital perioperative fluid protocols are used in these settings. Both Saline (0.9%) and Plasmalyte will be available for open-label administration in the rare situations, where, in the opinion of the treating anaesthetist or clinician, there is a clinical indication for one fluid or the other. This may occur, for example, in the setting of severe acidosis where the higher chloride content of saline may make this fluid problematic because it may increase the severity of such acidosis. All adult patients who receive blinded or open-label fluid during one of the two-month study blocks will be analysed. The primary outcome will be the proportion of patients with kidney injury or failure based on established criteria. Secondary outcomes will include delta creatinine (the difference between baseline and peak creatinine), serum electrolyte levels, bicarbonate level, requirement for renal replacement therapy, complications and in-hospital mortality. All of the data required for this study are collected routinely as part of standard clinical care and/or quality assurance activities. The study will establish the pilot feasibility, safety and preliminary efficacy evidence base for the design of a large interventional trial to inform clinicians looking after major surgery patients as to whether Saline (0.9%) or Plasmalyte or solution is the preferred crystalloid fluid in this setting. Hospitals involved: Austin Hospital Number of participants: Given the current theatre workload at Austin Hospital, approximately 1000 participants will be recruited in each group. A total of 2000 participants are expected.

The study aims to investigate the effects of short term supplementation with either palm-tocotrienol or palm-carotene on blood vessel function and cardiovascular disease risk in participants at risk of impaired vascular function. We hypothesise that supplementation with both palm-tocotrienol and palm-carotene will improve blood vessel function and cardiovascular disease risk factors compared to a control supplement.

This is a single-centre, controlled, study using induced blood stage malaria (IBSM) infection to characterize the effectiveness of ferroquine as a potential treatment of early Plasmodium falciparum blood stage infection in healthy volunteers. The study will be conducted in 2 cohorts (n= 8 in each) using different oral doses of ferroquine.

FAME2 is a multi-centre, randomised, double-blind, placebo-controlled clinical trial. Participants will be randomised to receive fenofibrate (145mg daily for 24 weeks) or placebo (145mg daily for 24 weeks) in a parallel group, double blind design. Randomisation lists will be generated by a statistician and provided to the study centres ensuring both investigators and participants are blinded to drug assignment. Screening and randomization will occur at Visit 1 and 2. Participants will receive a phone call at three weeks in addition with a blood test, drug safety check and recording of any adverse events. Another phone call will occur at three months. Here again participants drug safety and compliance will be checked along with any adverse events. The final visit will occur at the end of six months.

When dental x-rays are performed, there are many structures visible on the x-ray besides the teeth and jaws. One important structure that is sometimes seen is the carotid artery, which supplies blood to the brain. If this artery becomes calcified or “hardened”, it can been seen on a dental orthopantomogram (OPG). Hardening of the arteries can eventually cause these arteries to become blocked, which can lead to a stroke. Some people will have warning signs before having a stroke, but many patients are unaware that they were at risk. We are interested to see if the finding of calcified arteries on routine dental x-rays is related to narrowing of these vessels that could potentially lead to stroke. We will select patients attending for x-rays who are aged 18 years and over. Half of the participants will have calcified carotid arteries on their OPG, and half will not have visible carotid artery calcification, to provide a comparison group. We will ask study participants to attend The Queen Elizabeth Hospital on a single occasion to undergo a carotid artery ultrasound study. The data will then be analysed to ascertain whether carotid artery calcification can predict arterial narrowing, which can help predict stroke risk.

Childhood obesity is associated with reduced levels of fitness, damage to blood vessels, impaired hormone regulation and decreased heart function. These can lead to poor quality of life, increased risk of heart disease as an adult and premature death. Exercise is beneficial for obese individuals, however the most effective exercise prescription for obese children and adolescents is not yet known. In many adult populations, high intensity interval training has been shown to be superior to traditional continuous moderate-intensity exercise modes. The objective of the study is to investigate the effects of high intensity exercise intensity on myocardial and arterial function, intra-abdominal fat and cardiovascular disease risk factors in obese children and adolescents over one year. The hypothesis is that high intensity aerobic interval training will be significantly better at improving myocardial and vascular function and decreasing intra-abdominal fat compared to moderate intensity exercise and diet intervention only (control) in children and adolescents.