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

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31615 results sorted by trial registration date.
  • An expressive writing randomised controlled trial with colorectal cancer patients: A test of the underlying mechanism

    This study will test an expressive writing intervention with bowel cancer patients to determine whether participation in the intervention leads to improved physical functioning, lessened psychological distress and increased personal growth, compared to those who do not participate in the intervention. Expressive writing is the writing of deep thoughts and feelings connected to a person's cancer diagnosis and treatment experiences. Participants in the intervention group will write in a journal for 30 minutes, 4 times, over 3 weeks. Participants will fill out questionnaires before and after the intervention as well as 2 months later, to determine whether they experience positive change, and changes over time.

  • Long-term health effects of high and low carbohydrate diets in obese subjects with the metabolic syndrome

    Obesity is a major health problem, which contributes to significant morbidity and mortality in Australia. Energy restriction and exercise are commonly advocated as lifestyle approaches for the modification of cardiovascular disease risk factors such as obesity, hyperlipidemia, impaired glucose tolerance, and insulin resistance. In response to the increasing concerns about the rising level of obesity, there has been a multitude of “fad” diets developed outside the medical and nutritional recommendations for healthy eating and with this an increased popularity of diets very low in carbohydrates. However, due to the scant scientific evidence available for the long-term efficacy and safety of these diets, and their impact on risk factors for cardiovascular disease, cancer, renal function, bone health, psychosocial function and the capacity to undertake concurrent physical activity, there is a lack of evidenced-based public health recommendations and policy regarding these dietary patterns. This study will provide scientific evidence to validate optimum dietary recommendations for weight loss that can be used by health professionals who have a strong need for a rational basis for their advice to counsel obese patients.

  • The effect of rate of administration of tramadol on incidence of post operative nausea and vomiting after any surgical operation for which significant postoperative pain is expected

    Research Aim The manufacturer’s current recommendation for the rate of administration of tramadol is over 2-3 minutes. In spite of this, many clinicians administer tramadol as a slow infusion as they believe that this reduces the incidence of some side effects including nausea and vomiting. The aim of this research is to determine whether there is a different incidence of nausea and vomiting when tramadol is administered slowly or rapidly. Study Outline Patients greater than or equal to 18 years of age presenting for significant non-abdominal surgery at the Royal Melbourne Hospital will be studied. These patients are at significant risk of post-operative pain and often require continuing post-operative analgesia. After informed consent, patients will undergo their respective surgical operations under a standardised general anaesthetic. All patients will receive intravenous morphine for intra-operative analgesia and morphine patient-controlled analgesia (PCA) for post-operative analgesia. Patients will be randomised to receive tramadol or placebo, immediately postoperatively, in the post-anaesthetic care unit (PACU) in one of the following ways: 1)Intravenous tramadol (2.5 mg/kg) fast (conventional therapy over 120 seconds as per manufacturer’s product information) 2)Intravenous tramadol (2.5 mg/kg) slowly (over 30 minutes) 3)Placebo (no tramadol) Postoperatively, when the patient is fully awake and able to speak, they will be asked to rate their pain on a 100mm visual analogue scale (0 = No pain to 100mm = Worst imaginable pain). Patients will only receive tramadol or placebo in one of the above ways if they rate their pain as greater than 30mm on a 100mm visual analogue scale. Otherwise they will be excluded from the trial. At this point in the PACU, they will receive their trial drug (tramadol or placebo) as planned. Patients will be reviewed at 0 (before administration of tramadol/ placebo), 0.25, 0.5, 1, 2 and 3 hours after the administration of tramadol or placebo is commenced. Recordings for nausea, using a visual analogue scale (0 = No nausea to 100mm = Worst imaginable nausea), and episodes of vomiting will be the main clinical outcomes measured. Additionally, PCA usage, pain scores and patient satisfaction will be recorded. 4. Study Endpoints Primary End Point: Comparative peak change from baseline in nausea visual analogue score (VAS) scores between fast, slow and placebo tramadol administration groups. Secondary End Points: Comparative vomiting frequencies, morphine PCA usage, pain scores, duration spent in PACU and patient satisfaction scores between fast, slow and placebo tramadol administration groups. Research Plan This trial will be conducted in the operating theatres and surgical wards of the Royal Melbourne Hospital. Ethics committee approval will be obtained prior to the commencement of the trial. Patients presenting for the trial who meet the eligibility criteria will be approached and written informed consent will be obtained. This will occur in the pre-admission clinic or day of surgery admission area of the Royal Melbourne Hospital. Eligibility Inclusion Criteria • Males and females aged 18-50 years • English spoken as first language, or fluent as a second language • Scheduled to have elective non-abdominal surgery under general anaesthesia (including general, orthopaedic, plastic, ENT, urologic, dental or vascular surgery) • Requiring general anaesthesia • Significant post-operative pain requiring opioid therapy expected Exclusion Criteria • Inadequate English comprehension • History of allergy or sensitivity to tramadol or morphine • History of previous episode of significant post operative nausea and vomiting • History of significant motion sickness • Epilepsy • Administration of tramadol within previous 36 hours • American Society of Anaesthesiologists’ (ASA) physical status IV or V, reflecting serious cardiorespiratory co-morbidity. • Currently taking selective serotonin receptor inhibitor, tricyclic antidepressant or monoamine oxidase inhibitor drugs • Currently taking prophylactic antiemetics • Pregnancy Randomisation and Blinding A three-arm prospective randomised double-blind controlled trial will be undertaken. All eligible patients will be randomised preoperatively to one of three groups by using sealed opaque envelopes containing the information regarding whether the patient is to receive tramadol ‘fast’ or ‘slow’ or receive placebo. Envelopes will not be opened until after consent is obtained. Randomisation will be performed using a computer-generated list. All patients will be blinded to which group they are in and all will receive a loading dose of 2.5 mg/kg of tramadol (or placebo) intravenously as this has been shown to be the optimum amount required for maximal efficacy with minimal side effects. The study drugs will be prepared by a research nurse/ pain nurse and labelled ‘Fast’ or ‘Slow’. One or both of theses study drugs will be placebo but the identity will be unknown to the patient, PACU nurse looking after that patient and investigator (Dr Sud Agarwal, Dr Malcolm Hogg or AMS Medical Student) who will be collecting data from that patient. The PACU nurse will administer the drugs blind to the identity of the drugs. The identity of the ‘Fast’ and ‘Slow’ study drugs will be recorded by the research nurse/ pain nurse and will not be made available to the investigators. ‘Fast’ group – will receive 2.5 mg/kg tramadol (made to 10 ml with addition of saline) intravenously over 2 minutes and 10 ml saline via a syringe driver over 30 minutes. ‘Slow’ group – will receive 10 ml saline over 2 minutes and 2.5 mg/kg tramadol (made to 10 ml with addition of saline) intravenously via a syringe driver over 30 minutes. ‘Placebo’ group – will receive 10 ml saline over 2 minutes and 10 ml saline via syringe driver over 30 minutes. Postoperative assessment regarding nausea, pain, vomiting frequency, patient satisfaction and morphine PCA usage will be performed by a second blinded second investigator. Sample Size Calculation The sample size of 150 patients is calculated based on reported peak nausea visual analogue scores in response to 2.5 mg/kg of intravenous tramadol: ? = 0.05 ? = 0.2 ? = 0.3 (a 3 out of 10 difference on a ten point Visual Analogue Score) ? = 0.5 (Standard Deviation)15 Calculates sample size required in each group as 44 for p<0.05. Sample sizes of 50 for each group have been chosen to allow for patients dropping out or being excluded after recruitment. This sample size was calculated using the UCLA statistical sample size calculator. Nausea Score Estimation Nausea after the administration of tramadol will be obtained at described time intervals (t = 0, 0.25, 0.5, 1, 2 and 3 hours) using a 100-mm visual analogue scale. All participants will be asked to make a mark on a continuous scale to indicate the level of nausea experienced. Procedure Operative Period All patients will be given a standardised general anaesthetic for their surgical procedure with patient and equipment monitoring implemented as per the Australian and New Zealand College of Anaesthetists’ guidelines. A standard and widely practiced anaesthetic technique will be utilised. This will include midazolam, fentanyl, propofol (and atracurium for relaxant general anaesthesia) for induction followed by maintenance with sevoflurane in 50% oxygen in nitrogen. All patients who had relaxant general anaesthesia will receive neostigmine and glycopyrrolate reversal. Inhaled anaesthetic concentration will be at the discretion of the attending anaesthetist. Morphine, paracetamol or NSAIDs may be utilised for intraoperative analgesia. Wound infiltration with local anaesthetics by surgeons at any time of the procedure is permissible, but the use of tramadol or any antiemetics are not permitted intraoperatively or postoperatively unless it is being administered as part of this trial or as rescue anti-emesis. Post-operative Period In the PACU immediately following the end of their operation, all patients will receive tramadol or placebo as per the directions for the group they have been randomised to (see above under Randomisation and Blinding). Patients in all groups will be asked to describe their nausea, pain, dizziness and patient satisfaction score on four separate 100-mm visual analogue scales (VAS) at 0, 0.25, 0.5, 1, 2 and 3 hours after commencement of administration of tramadol. In addition, PCA usage and any episodes of vomiting will be recorded for all patients within the three hour period. ‘Rescue Analgesia’ Any patient who continues to have inadequate analgesia even after receiving paracetamol, NSAIDs and morphine via PCA will be reviewed by the pain registrar on call at that time and will be given morphine intravenous boluses until their pain is relieved. ‘Rescue Anti-emesis' Any patient who continues to experience significant nausea (greater than 70 mm on VAS) or who vomits will be reviewed by the pain registrar on call at that time and will be offered antiemetics: 10-20 mg metoclopramide and/ or 0.02 mg/kg droperidol and/ or 4-8 mg dexamethasone and/or ondansetron 4-8 mg until their nausea/ vomiting is relieved. Data Collection Pre-operative: age, sex, height, weight, ASA physical status, operation, smoking status, menstrual status (if applicable), history of motion sickness, history of PONV. These (along with duration of anaesthesia) include all the factors cited by Apfel as prospective predictors which allow PONV risk scoring16. Intra-operative: IV morphine total dose, fentanyl/ paracetamol/ NSAID/ alpha-2 agonist usage, estimated average sevoflurane expired end-tidal concentration, estimated average inspired oxygen concentration, use of local anaesthetic wound infiltration, any surgical complications, total surgical time, duration of anaesthesia. Post-operatively: (in theatre PACU and hospital wards): analgesic requirements (IV and oral opioids, paracetamol, NSAIDS), pain scores, requirement for any ‘rescue analgesia’, nausea VAS, pain VAS, dizziness VAS, patient satisfaction VAS, total morphine PCA usage, requirement for any ‘rescue anti-emesis’, number of episodes (if any) of vomiting and duration of stay in PACU. Nausea, pain, dizziness and satisfaction data will be collected by a second blinded investigator who will ask all patients to mark a standard 100 mm VAS. Any clinically significant event during the course of the study period (3 h) (such as seizures, rash etc) will be recorded. A Log will be kept including the number of eligible patients, refusals, recruited and randomised patients, dropouts and completed participants.

  • Effect of Rosiglitazone on Glucocorticoid-stimulated 11betaHSD-1 Activity in Skeletal Muscle

    The study will investigate whether pretreatment with the drug Rosiglitazone attenuates the increase in activity of muscle 11betaHSD-1 following treatment with the potent steroid dexamethasone. Dexamethasone is well known to cause an increase in blood glucose levels in people with type 2 diabetes and we are investigating a possible mechanism for this.

  • Trial of colonic stenting for large bowel obstruction

    For patients with malignant bowel obstruction that cannot be cured, palliative surgery is often required to relieve the obstruction. This usually requires the formation of a stoma or opening where the bowel is brought to the suface of the skin. An alternative to surgery is the placement of a metal tube or stent through the obstruction to allow the passage of stool. As these surgical interventions are palliative the most important outcomes are those relating to the patients quality of life. This study will determine whether patients' quality of life is greater following stent insertion than surgery to relieve bowel obstruction. It will also compare complication rates and resource utilisation for each intervention. An economic evaluation will determine the relative cost-effectiveness of the 2 procedures.

  • Weight loss and exercise in PCOS Study 2006

    Australia and other Western communities face an “epidemic of obesity” among its people, particularly in the young. The health problems of obesity include diabetes mellitus, hyperlipidemia, micro- and macrovascular disease, disability and early death. Major public health interventions are required in Australia to reverse this serious and expensive trend. This is particularly true in young overweight women with polycystic ovary syndrome (PCOS) who have significant psychological, reproductive and metabolic consequences during the first five decades of life. Although research indicates that weight loss via dietary restriction can restore health and reverse the reproductive and metabolic consequences of PCOS, there is a lack of scientific understanding of the combined role of physical exercise in managing this condition. Furthermore, there remains no attempt to define the optimal mode of exercise to achieve long-term reproductive fitness and metabolic health and consequently a lack of exercise recommendations for this population exists. The overall significance of this research proposal is to provide scientific evidence for the effects of physical exercise combined with dietary weight loss to improve ovulatory rates and reproductive health in overweight women with PCOS. This study will also provide information on what, if any, is the most efficacious form of exercise for improving reproductive function in this patient group. This information will assist in the development and refinement of guidelines for managing PCOS through lifestyle behavioural change. Precise guidelines would be of great use for firstly improving conception rates through improvements in the metabolic state and secondly through minimising longer term diabetic and cardiovascular mortality and morbidity. Systematic study of the effects of exercise and variants of its modalities in combination with dietary change is imperative in order to make appropriate public health recommendation and to counsel individual patients.

  • The efficacy of two alternative suture anchors, Panalok and bioraptor 2.3 for primary stabilisation of the shoulder for instability and identification of risk factors for recurrence of the shoulder instability post operation

    During stabilisation of the shoulder which has been unstable (dislocated) the surgeon attaches back the damaged ligament to the bone with a 'Panalok" suture anchor. This is tied into place with a separate suture made of either panacryl which dissolves or ethibond which does not. The hypothesis is that there is no differenvce between the sutures but the bioabsorbable (dissolving) suture theoretically should be preferred because is disolves away completed and reduces the risk of foreign body reactions. The sutures are dyed the same colour so the surgeon, the patient , the ward staff and outcome assessors are blinded

  • A study of the efficacy of the addition of a ropivacaine infusion to the analgesia provided by pre-emptive ropivacaine and intra-operative parecoxib for peri-operative pain management in adults undergoing elective arthroscopic rotator cuff surgery: a randomised double blind placebo controlled trial.

    The study was to assess the efficacy in reducing pain of the addition of a slow soaker infusion of Ropivacaine (a local anaesthetic) compared with a placebo of normal saline via fine catheter placed inside the sholder joint at the end of the operation. The amount of additional narcotic agents and oral analgesics required by the patients was measured between the active and placebo groups. The hypothesis was that the local analgesic did not give better pain relief or reduce the amount of extra analgesics required. In this randomised placebo controlled trial the surgeon, the patient, the ward nurses , physiotherapists and outcome assessor were all blinded to the treatment allocation.

  • The validity and reliability of the University of California,Los Angeles (UCLA) shoulder score for use as a self assessment postal questionnaire in patients following rotator cuff surgery to assess outcome

    The UCLA shoulder score is used to asess the outcome of rotator cuff surgery in the shoulder. Currently this score is assessed clinically- requiring patients to attend for a doctor's appointment. The hypothesis is that with adequate instruction the patient could complete this form at home and this would increase participation in studies which may follow up patients 10 years later. These patients would not have to travel long distances for a clinical assessment for research purposes only. Patients, assessors 1 & 2 are blinded.

  • Heart Transplant Myocardial Fibrosis Study

    Primary purpose of the trial is to assess the effect of spironolactone on improving heart function, and its ability to reduce the amount of fibrosis (scar tissue) in the transplant heart of patients who have evidence of stiff hearts and therefore likely have increased scar tissue in the hearts. The investigators including cardiologists seeing the participants in the outpatient clinic and performing the cardiac biopsies and coronary sinus blood sampling, nursing staff involved in the heart transplant outpatient clinic, the cardiologists reporting on the Echocardiograms and Cardiac MRI; and the pathologists reporting on the blood investigations will be blinded to the treatment arm that the patient has been randomized into. The research study pharmacist will be performing the randomization from the Pharmacy department at The Alfred Hospital, and records of patient randomization will be stored in a sealed envelope for the duration of the patient's involvement in the trial, but accessible in case it becomes medically necessary (eg for adverse effects) to withdraw the patient from the trial and unblind them.

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