Aim The aim of this study was to evaluate the novice performance of advanced bimanual laparoscopic skills using the articulating FlexDex™ laparoscopic needle holder in two-dimensional (2D) and three-dimensional (3D) visual systems. Method In this prospective randomised trial, novices (n=40) without laparoscopic experience were recruited from a university cohort and randomised into two groups, which used the FlexDex™ and 2D or the FlexDex™ and 3D. Both groups performed 10 repetitions of a validated assessment task. Times taken and error rates were measured, and assessments were made based on completion times, error rates and learning curves. Results The intervention group that used FlexDex™ and 3D visual output completed 10 attempts of the standardised laparoscopic task quicker than the control group that used FlexDex™ with standard 2D visual output (268 seconds vs 415 seconds taken for the first three attempts and 176 seconds vs 283 seconds taken for the last three attempts, respectively). Moreover, each attempt was completed faster by the intervention group compared to the control group. The difference in average time for the first three and last three attempts reached statistical significance (P < 0.001). Conclusion Combination of 3D visual systems and the FlexDex™ laparoscopic needle holder resulted in superior task performance speed, leading to shorter completion times and quicker learning effect. Although the 3D group demonstrated lower mean error rates, it did not reach statistical significance.
IntroductionIn the United Kingdom (UK), complications that arise following the administration of Botulinum Toxin are reported to the Medicines and Health Regulatory Agency (MHRA) via the Yellow Card Reporting Scheme. Over the past decade, there has been a significant increase in the number of non‐surgical aesthetic procedures. Concerns have been raised that the MHRA is not fully capturing complications in terms of volume and impact on patients.AimThis novel study explores the lived experiences of individuals who have experienced an adverse event following administration of Botulinum Toxin for aesthetic purposes. Using a combination of qualitative and quantitative methodologies, this analysis evaluates data relating to long‐lasting physical, psychological, emotional, and financial sequelae of complications arising from cosmetic Botulinum Toxin injections in the UK.MethodsA mixed method, qualitative and quantitative approach was adopted to gain comprehensive insights into patients' experiences. A focus group which comprised patient representatives, psychologists, and researchers reached a consensus on a 17‐question survey which was disseminated via social media channels. Deductive thematic analysis was used to analyse coded themes. Furthermore, for secondary analysis, sentiment analysis was used computationally as an innovative approach to identify and categorise free text responses associated with sentiments using natural language processing (NLP).ResultsIn the study, 655 responses were received, with 287 (44%) of respondents completing all questions. The mean age of respondents was 42.6 years old. 94.1% of respondents identified as female. In the sample, 79% of respondents reported an adverse event following their procedure, with the most common event being reported as ‘anxiety’. Findings revealed that 69% of respondents reported long‐lasting adverse effects. From the responses, 68.4% reported not having recovered physically, 63.5% of respondents stated that they had not recovered emotionally from complications, and 61.7% said that they have not recovered psychologically. In addition, 84% of respondents stated that they do not know who regulates the aesthetics industry. Furthermore, 92% of participants reported that their clinic or practitioner did not inform them about the Yellow Card Reporting Scheme. The sentiment analysis using the AFINN Lexicon yielded adjusted scores ranging from −3 to +2, with a mean value of −1.58.ConclusionThis is the largest survey in the UK completed by patients who experienced an adverse outcome following the aesthetic administration of Botulinum Toxin. Our study highlights the extent of the challenges faced by patients who experience an adverse event from physical, emotional, psychological, and financial perspectives. The lack of awareness of MHRA reporting structures and the lack of regulation within the UK's cosmetic injectables sector represent a significant public health challenge.
Study question Does fertility treatment (FT) increase the risk of recurrence of Borderline Ovarian Tumours (BOTs)? Summary answer There is a significant association between recurrence of BOTs and exposure to FT (p = 0.025). What is known already The association between pregnancy or controlled ovarian stimulation (COS) and risk of recurrence of BOTs is a controversial topic of interest amongst clinicians and women undergoing treatment. Some studies report a risk of non- invasive relapse following ovarian stimulation between 19.4-23%, whereas earlier case-control studies have shown no significant association.It is important to consider that most studies are limited by their retrospective analysis, with an emphasis on the incidence of primary BOTs following exposure to FT. Whereby, data regarding the risk of disease recurrence following spontaneous pregnancy (SP) or COS specifically, remains sparse. Study design, size, duration A retrospective cohort of women who underwent fertility sparing surgery (FSS) for the management of BOTs between the 1st January 2004 and 31st December 2020 at Imperial College Healthcare NHS Trust, with prospective follow up of reproductive outcomes and recurrence of disease following surgery. Participants/materials, setting, methods Subgroup analysis included a control group of all women not exposed to FT or SP and a non-control group of those who achieved either SP or underwent FT following FSS for the management of BOTs. The recurrence rate of BOTs was determined within each subgroup. Main results and the role of chance 90 women underwent FSS for BOTs. Subgroup analysis confirmed 38.9% (35/90) were in the control group, 50% (45/90) in the non-control and 11.1% (10/90) lost to follow up. In the non-control group, 35.6% (16/45) achieved SP only and 64.4% (29/45) underwent FT. FT included COS for oocyte cryopreservation only (24.4%; 11/45), intracytoplasmic sperm insemination (ICSI) ± fresh or frozen embryo transfer (24.4%; 11/45) and those who underwent COS but also achieved SP without returning to their cryopreserved gametes (15.5%; 7/45). Within the non-control group, 75.6% (34/45) of women conceived, with a livebirth rate per pregnancy of 58.7% (27/46). The recurrence rate in the control and non-control groups were 20% (7/35) and 22.2% (10/45) respectively (p = 0.025) and 24.1% (7/29) following FT. Recurrence rates were 18.8% (3/16) after SP only, 0% (0/11) following oocyte cryopreservation only, 18.2% (2/11) ICSI ± embryo transfer and 71.4% (5/7) in those who underwent COS and achieved a SP. All recurrence of disease presented as serous BOTs. Within the FT group, logistic regression analysis demonstrated no significant predictors of disease recurrence. A combination of SP and FT is significantly associated with recurrence when compared to the following groups: control (p = 0.000), SP only (p = 0.001) and COS only (p = 0.015). Limitations, reasons for caution Due to the partial retrospective nature of the study, certain clinical information was not adequately documented and the subgroups compared were of unequal sample size, whilst overall sample size is also considered low. There was also a lack of control for confounders which may affect disease recurrence. Wider implications of the findings Despite the risk of recurrence of BOTs associated with FT, cases are often non invasive and successfully managed with further FSS with excellent prognosis. This evidence should be used to counsel women of reproductive age to ensure they can fulfil their reproductive aspirations, despite a diagnosis of BOT. Trial registration number NA
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