Medicine
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This repository contains the published and unpublished research of the Faculty of Medicine by the staff members of the faculty
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Item Hydroxychloroquine for post-exposure prophylaxis of COVID-19 among naval personnel in Sri Lanka: study protocol for a randomized, controlled trial(BioMed Central, 2020) Niriella, M.A.; Ediriweera, D.S.; de Silva, A.P.; Premaratna, R.; Balasooriya, P.; Duminda, K.D.; Malavige, N.G.; Wanigasuriya, K.; Lekamwasam, S.; Kularathne, S.A.; Siribaddana, S.; de Silva, H.J.; Jayasinghe, S.BACKGROUND: The first case of a coronavirus 2019 (COVID-19) infection in a Sri Lankan was reported on March 11, 2020. The situation in Sri Lanka changed with the rapid increase of personnel contracting COVID-19 in a naval base camp that housed more than 4000 people. This provided a unique opportunity to study the effectiveness of hydroxychloroquine (HCQ) for post-exposure prophylaxis (PEP), while taking stringent, non-pharmacologic, public health measures to prevent spread. Our aim is to study the effectiveness and safety of HCQ for PEP among naval personnel with exposure to COVID-19-positive patients. METHODS/DESIGN: This is a placebo-controlled, randomized, clinical trial carried out in the naval base camp and quarantine centers of the Sri Lanka Navy, Ministry of Defense, Sri Lanka. Navy personnel who are exposed to a patient with confirmed COVID-19 infection but test negative for the virus on reverse real-time polymerase chain reaction (rRT-PCR) at recruitment will be randomized, 200 to each arm, to receive HCQ or placebo and monitored for the development of symptoms or rRT-PCR positivity for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus for 14 days. DISCUSSION: This trial will provide high-quality evidence of the effectiveness and safety of HCQ as PEP for COVID-19. The study design is unique due to the circumstances of the outbreak in a confined area among otherwise healthy adults, at a relatively early stage of its spread. TRIAL REGISTRATION: Sri Lanka Clinical Trials Registry (SLCTR) SLCTR/2020/011. Registered on 04 May 2020. KEYWORDS: COVID-19; HCQ; Hydroxychloroquine; Post-exposure; Prophylaxis; Randomized controlled trial; SARS-CoV-2; Sri Lanka.Item Cost evaluation, quality of life and pelvic organ function of three approaches to hysterectomy for benign uterine conditions: study protocol for a randomized controlled trial(BioMed Central, 2017) Ekanayake, C.; Pathmeswaran, A.; Kularatna, S.; Herath, R.; Wijesinghe, P.BACKGROUND: Hysterectomy is the commonest major gynaecological surgery. Although there are many approaches to hysterectomy, which depend on clinical criteria, certain patients may be eligible to be operated in any of the several available approaches. However, most comparative studies on hysterectomy are between two approaches. There is also a relative absence of data on long-term outcomes on quality of life and pelvic organ function. There is no single study which has considered quality of life, pelvic organ function and cost-effectiveness for the three main types of hysterectomy. Therefore, the objective of this study is to provide evidence on the optimal route of hysterectomy in terms of cost-effectiveness by way of a three-armed randomized control study between non-descent vaginal hysterectomy, total laparoscopic hysterectomy and total abdominal hysterectomy. METHODS: A multicentre three-armed randomized control trial is being conducted at the professorial gynaecology unit of the North Colombo Teaching Hospital, Ragama, Sri Lanka and gynaecology unit of the District General Hospital, Mannar, Sri Lanka. The study population is women needing hysterectomy for non-malignant uterine causes. Patients with a uterus > 14 weeks, previous pelvic surgery, those requiring incontinence surgery or pelvic floor surgery, any medical illness which caution/contraindicate laparoscopic surgery and who cannot read and write will be excluded. The main exposure variable is non-descent vaginal hysterectomy and total laparoscopic hysterectomy. The control group will be patients undergoing total abdominal hysterectomy. The primary outcome is time to recover following surgery, which is the earliest time to resume all of the usual activities done prior to surgery. In total, 147 patients (49 per arm) are needed to have 80% power at α-0.01 considering a loss to follow-up of 20% to detect a 7-day difference between the three routes; TLH versus TAH versus NDVH. The economic evaluation will take a societal perspective and will include direct costs in relation to allocation of healthcare resources and indirect costs which are borne by the patient. A micro-costing approach will be adopted to calculate direct costs from the time of presentation to the gynaecology clinic up to 6 months after surgery. Incremental cost-effectiveness ratios (ICER) will be obtained by calculating the incremental costs divided by the incremental effects (time to recover and QALYs gained) for the intervention groups (NDVH and TLH) over the standard care (TAH) group. DISCUSSION: The cost of the procedure, quality of life and pelvic organ function following the three main routes of hysterectomy are important to clinicians and healthcare providers, both in developed and developing countries.Item Hypothermia for encephalopathy in low and middle-income countries (HELIX): study protocol for a randomised controlled trial(BioMed Central, 2017) Thayyil, S.; Oliveira, V.; Lally, P.J.; Swamy, R.; Bassett, P.; Chandrasekaran, M.; Mondkar, J.; Mangalabharathi, S.; Benkappa, N.; Seeralar, A.; Shahidullah, M.; Montaldo, P.; Herberg, J.; Manerkar, S.; Kumaraswami, K.; Kamalaratnam, C.; Prakash, V.; Chandramohan, R.; Bandya, P.; Mannan, M.A.; Rodrigo, R.; Nair, M.; Ramji, S.; Shankaran, S.; HELIX Trial groupBACKGROUND: Therapeutic hypothermia reduces death and disability after moderate or severe neonatal encephalopathy in high-income countries and is used as standard therapy in these settings. However, the safety and efficacy of cooling therapy in low- and middle-incomecountries (LMICs), where 99% of the disease burden occurs, remains unclear. We will examine whether whole body cooling reduces death or neurodisability at 18-22 months after neonatal encephalopathy, in LMICs. METHODS: We will randomly allocate 408 term or near-term babies (aged ≤ 6 h) with moderate or severe neonatal encephalopathy admitted to public sector neonatal units in LMIC countries (India, Bangladesh or Sri Lanka), to either usual care alone or whole-body cooling with usual care. Babies allocated to the cooling arm will have core body temperature maintained at 33.5 °C using a servo-controlled cooling device for 72 h, followed by re-warming at 0.5 °C per hour. All babies will have detailed infection screening at the time of recruitment and 3 Telsa cerebral magnetic resonance imaging and spectroscopy at 1-2 weeks after birth. Our primary endpoint is death or moderate or severe disability at the age of 18 months. DISCUSSION: Upon completion, HELIX will be the largest cooling trial in neonatal encephalopathy and will provide a definitive answer regarding the safety and efficacy of cooling therapy for neonatal encephalopathy in LMICs. The trial will also provide important data about the influence of co-existent perinatal infection on the efficacy of hypothermic neuroprotection.Item Topiramate's effectiveness on weight reduction in overweight/obese persons with schizophrenia: study protocol for a randomized controlled trial(BioMed Central, 2017) Chandradasa, M.; Champika, L.; de Silva, S.; Kuruppuarachchi, K.A.L.A.BACKGROUND: Schizophrenia is a psychiatric disorder with a higher mortality than that of the general population. Most of the deaths are due to cardiovascular causes and are related to metabolic risks. This risk is due not only to antipsychotics but also to inherent factors of the disorder. Studies in the West have shown topiramate to be effective in schizophrenia to reduce weight gain and for symptomatic control. Whether this is effective for South Asians is not known. It is important because South Asians have a higher risk of metabolic syndrome. We aim to conduct a double-blind, randomized controlled trial comparing topiramate add-on therapy with treatment as usual with antipsychotics in patients with schizophrenia in an outpatient setting in Sri Lanka. METHODS/DESIGN: Ninety patients with schizophrenia presenting to the Colombo North Teaching Hospital will be randomized to intervention and control groups equally using permuted block randomization. Patients with comorbid metabolic disorders and taking prescribed weight-controlling medications will be excluded. The intervention group will be prescribed topiramate in addition to their antipsychotics in a predefined dosing regimen targeting a dose of 100 mg per day. The control subjects are to receive a placebo. As the primary outcome, anthropometric measurements including weight, waist circumference, skinfold thickness, and body mass index will be recorded at baseline and monthly during the study period of 3 months. The secondary outcome is the change in symptoms according to the clinician-administered Brief Psychiatric Rating Scale. Assessment of capacity will be performed and informed consent obtained from all subjects. Ethics approval has been obtained from the ethical review committee of the Faculty of Medicine, University of Kelaniya, and the trial has been registered in the Sri Lanka Clinical Trials Registry. DISCUSSION: In this double-blind, randomized controlled trial, we will attempt to assess the effectiveness of topiramate as an add-on therapy compared with treatment as usual for weight control in patients with schizophrenia. To our knowledge, this is the first such study in South Asia, where metabolic risks are found to be higher than in the West and could have unique ethnic factors related to weight gain in schizophrenia.Item Multicomponent intervention versus usual care for management of hypertension in rural Bangladesh, Pakistan and Sri Lanka: study protocol for a cluster randomized controlled trial(BioMed Central, 2017) Jafar, T.H.; Jehan, I.; de Silva, H.A.; Naheed, A.; Gandhi, M.; Assam, P.; Finkelstein, E.A.; Quigley, H.L.; Bilger, M.; Khan, A.H.; Clemens, J.D.; Ebrahim, S.; Turner, E.L.; Kasturiratne, A.; for COBRA-BPS Study GroupBACKGROUND: High blood pressure (BP) is the leading attributable risk for cardiovascular disease (CVD). In rural South Asia, hypertension continues to be a significant public health issue with sub-optimal BP control rates. The goal of the trial is to compare a multicomponent intervention (MCI) to usual care to evaluate the effectiveness and cost-effectiveness of the MCI for lowering BP among adults with hypertension in rural communities in Bangladesh, Pakistan and Sri Lanka. METHODS/DESIGN: This study is a stratified, cluster randomized controlled trial with a qualitative component for evaluation of processes and stakeholder feedback. The MCI has five components: (1) home health education by government community health workers (CHWs), (2) BP monitoring and stepped-up referral to a trained general practitioner using a checklist, (3) training public and private providers in management of hypertension and using a checklist, (4) designating hypertension triage counter and hypertension care coordinators in government clinics and (5) a financing model to compensate for additional health services and provide subsidies to low income individuals with poorly controlled hypertension. Usual care will comprise existing services in the community without any additional training. The trial will be conducted on 2550 individuals aged ≥40 years with hypertension (with systolic BP ≥140 mm Hg or diastolic BP ≥90 mm Hg, based on the mean of the last two of three measurements from two separate days, or on antihypertensive therapy) in 30 rural communities in Bangladesh, Pakistan and Sri Lanka. The primary outcome is change in systolic BP from baseline to follow-up at 24 months post-randomization. The incremental cost of MCI per CVD disability-adjusted life years averted will be computed. Stakeholders including policy makers, provincial- and district-level coordinators of relevant programmes, physicians, CHWs, key community leaders, hypertensive individuals and family members in the identified clusters will be interviewed. DISCUSSION: The study will provide evidence of the effectiveness and cost-effectiveness of MCI strategies for BP control compared to usual care in the rural public health infrastructure in South Asian countries. If shown to be successful, MCI may be a long-term sustainable strategy for tackling the rising rates of CVD in low resourced countries.