Background: Loss of smell or olfactory dysfunction (OD)s a common yet under- addressed problem with an estimated 5% of the general population having no functioning sense of smell. OD secondary to viral infections (eg: Covid-19) is one of the leading causes. Isolation, depression, anxiety, risk of danger from hazards such as toxic gas and spoiled food, weight loss/ gain secondary to loss of appetite are all prevalent negative impacts associated with OD. Various treatment options have been tried to treat smell loss after viral infection. Smell training has been tried with good results in the immediate post-viral phase. Evidence behind treatment with steroids has not shown to have proven effectiveness. With this, a key problem for patients and their clinicians is the lack of proven an effective therapeutic treatment option. Based on previous studies, there is some evidence supporting the regenerative potential of retinoic acid, the metabolically active form of Vitamin A in regeneration of olfactory receptor neurons. It is based on this concept that we have chosen Vitamin A as our study comparator in this two-arm randomised trial to determine proof of conceptMethods/Design: The study will compare 10,000 IU once daily Vitamin A self-administered intranasal drops versus peanut oil drops (placebo) delivered over 12 weeks in patients with post viral olfactory loss. Eligible patients will be recruited from the Smell & Taste Clinic and randomised to receive vitamin A drops or placebo in a 2:1 ratio. They will then be invited to attend the Brain Imaging Centre at the University of East Anglia on two occasions, 3 months apart, Serial MRI scanning will enable volumetric measurement of the OB and ROS; fMRI will then be conducted using an olfactometer to deliver pulsed odours – phenethylalcohol (rose-like) and hydrogen sulphide (rotten eggs). Participants will also undergo a standard smell test at both visits as well as complete a quality-of-life questionnaire. Change in OB volume on MRI will be the primary outcome measure.Discussion: We expect the outputs of this study to enable a subsequent randomised controlled trial of Vitamin A versus placebo. With PPI input we will make the outputs publicly available using journals, conferences and social media via Fifth Sense. We have already prepared a draft RCT proposal in partnership with the Norwich Clinical Trials Unit and would plan to develop this further considering the findings.Trial registration: ISRCTN registry 39523. Date of registration in primary registry: 23rd February 2021
Background Nasal bone fractures are treated by manipulation under general or local anaesthesia procedures. Data on long-term benefits of manipulation under local anaesthesia are limited. This study aimed to quantify the proportion of patients requiring septoplasty or septorhinoplasty after manipulation under general and local anaesthesia procedures. Methods Anonymised data were collected from electronic records of all patients who underwent manipulation under anaesthesia at our centre over a 10-year period, including demographics, manipulation under anaesthesia timing and further surgery requirements. Results The study identified 625 manipulation under general anaesthesia and 52 manipulation under local anaesthesia procedures. Manipulation under local anaesthesia procedures were performed earlier (local anaesthesia = 9 days, general anaesthesia = 15 days; p < 0.05) and were more likely to achieve manipulation (local anaesthesia = 83 per cent, general anaesthesia = 76 per cent; p < 0.05). There was no difference between techniques in the percentage of patients requiring further surgery. Conclusion This paper describes a large cohort of patients who underwent manipulation under anaesthesia over a 10-year period. Manipulation under local anaesthesia procedures have increased since the coronavirus disease 2019 pandemic, and the results are comparable to manipulation under general anaesthesia, with reduced delays between injury and manipulation.
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