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BACKGROUND: Acute cholecystitis is one of the most common diagnoses presenting to emergency general surgery and is managed either operatively or conservatively. However, operative rates vary widely across the world. This real-world population analysis aimed to describe the current clinical management and outcomes of patients with acute cholecystitis across Scotland, UK. METHODS: This was a national cohort study using data obtained from Information Services Division, Scotland. All adult patients with the admission diagnostic code for acute cholecystitis were included. Data were used to identify all patients admitted to Scottish hospitals between 1997 and 2019 and outcomes tracked for inpatients or after discharge through the unique patient identifier. This was linked to death data, including date of death. RESULTS: A total of 47 558 patients were diagnosed with 58 824 episodes of acute cholecystitis (with 27.2 per cent of patients experiencing more than one episode) in 46 Scottish hospitals. Median age was 58 years (interquartile range (i.q.r.) 43-71), 64.4 per cent were female, and most (76.1 per cent) had no comorbidities. A total of 28 741 (60.4 per cent) patients had an operative intervention during the index admission. Patients who had an operation during their index admission had a lower risk of 90-day mortality compared with non-operative management (OR 0.62, 95% c.i. 0.55-0.70). CONCLUSION: In this study, 60 per cent of patients had an index cholecystectomy. Patients who underwent surgery had a better survival rate compared with those managed conservatively, further advocating for an operative approach in this cohort.
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Colecistitis Aguda , Manejo de la Enfermedad , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Colecistectomía/normas , Colecistectomía/estadística & datos numéricos , Colecistitis Aguda/diagnóstico , Colecistitis Aguda/mortalidad , Colecistitis Aguda/cirugía , Colecistitis Aguda/terapia , Estudios de Cohortes , Hospitalización/estadística & datos numéricos , Escocia , Anciano , Tasa de SupervivenciaRESUMEN
AIM: The aim of this study was to translate the Dutch patient-reported outcome measure-haemorrhoidal impact and satisfaction score (PROM-HISS) to English and perform a cross-cultural validation. METHOD: The ISPOR good practice guidelines for the cross-cultural validation of PROMs were followed and included two steps: (1) Two forward and two backward translations. The forward translation concerned the translation from the source language (Dutch) to the target language (English), performed by two independent English speakers, one medical doctor and one nonmedical. Subsequently, a discussion about discrepancies in the reconciled version was performed by a stakeholder group. (2) Cognitive interviews were held with patients with haemorrhoidal disease (HD), probing the comprehensibility and comprehensiveness of the PROM-HISS. RESULTS: Discrepancies in the reconciled forward translation concerned the terminology of HD symptoms. Furthermore, special attention was paid to the response options, ranging from "not at all", indicating minor symptoms, to "a lot", implying many symptoms. Consensus among the stakeholder group about the final version of the translated PROM-HISS was reached. Interviews were conducted with 10 native English-speaking HD patients (30% female), with a mean age of 44 years (24-83) and primarily diagnosed with grade II HD (80%). The mean time to complete the PROM-HISS was 1 min 43 s. Patients showed a good understanding of the questions and response options, found all items relevant and did not miss important symptoms or topics. CONCLUSION: The translated English language PROM-HISS is a valid tool to assess symptoms of HD, its impact on daily activities and patient satisfaction with HD treatment.
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Comparación Transcultural , Satisfacción del Paciente , Humanos , Femenino , Adulto , Masculino , Reproducibilidad de los Resultados , Lenguaje , Traducciones , Medición de Resultados Informados por el Paciente , Satisfacción Personal , Encuestas y CuestionariosRESUMEN
Wireless Capsule Endoscopy is a medical procedure that uses a small, wireless camera to capture images of the inside of the digestive tract. The identification of the entrance and exit of the small bowel and of the large intestine is one of the first tasks that need to be accomplished to read a video. This paper addresses the design of a clinical decision support tool to detect these anatomical landmarks. We have developed a system based on deep learning that combines images, timestamps, and motion data to achieve state-of-the-art results. Our method does not only classify the images as being inside or outside the studied organs, but it is also able to identify the entrance and exit frames. The experiments performed with three different datasets (one public and two private) show that our system is able to approximate the landmarks while achieving high accuracy on the classification problem (inside/outside of the organ). When comparing the entrance and exit of the studied organs, the distance between predicted and real landmarks is reduced from 1.5 to 10 times with respect to previous state-of-the-art methods.
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Endoscopía Capsular , Endoscopía Capsular/métodos , Tracto Gastrointestinal , Movimiento (Física)RESUMEN
Artificial intelligence (AI) applications have become widely popular across the healthcare ecosystem. Colon capsule endoscopy (CCE) was adopted in the NHS England pilot project following the recent COVID pandemic's impact. It demonstrated its capability to relieve the national backlog in endoscopy. As a result, AI-assisted colon capsule video analysis has become gastroenterology's most active research area. However, with rapid AI advances, mastering these complex machine learning concepts remains challenging for healthcare professionals. This forms a barrier for clinicians to take on this new technology and embrace the new era of big data. This paper aims to bridge the knowledge gap between the current CCE system and the future, fully integrated AI system. The primary focus is on simplifying the technical terms and concepts in machine learning. This will hopefully address the general "fear of the unknown in AI" by helping healthcare professionals understand the basic principle of machine learning in capsule endoscopy and apply this knowledge in their future interactions and adaptation to AI technology. It also summarises the evidence of AI in CCE and its impact on diagnostic pathways. Finally, it discusses the unintended consequences of using AI, ethical challenges, potential flaws, and bias within clinical settings.
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AIM: The faecal immunochemical test (FIT) for faecal haemoglobin (f-Hb) helps determine the risk of colorectal cancer (CRC) and has been integrated into symptomatic referral pathways. 'Safety netting' advice includes considering referral for persistent symptoms, but no published data exists on repeated FITs. We aimed to examine the prevalence of serial FITs in primary care and CRC risk in these patients. METHOD: A multicentre, retrospective, observational study was conducted of patients with two or more consecutive f-Hb results within a year from three Scottish Health Boards which utilize FIT in primary care. Cancer registry data ensured identification of CRC cases. RESULTS: Overall, 135 396 FIT results were reviewed, of which 12 359 were serial results reported within 12 months (9.1%), derived from 5761 patients. Of these, 42 (0.7%) were diagnosed with CRC. A total of 3487 (60.5%) patients had two f-Hb < 10 µg/g, 944 (16.4%) had f-Hb ≥ 10 µg/g followed by <10 µg/g, 704 (12.2%) f-Hb < 10 µg/g followed by ≥10 µg/g and 626 (10.9%) had two f-Hb ≥ 10 µg/g. The CRC rate in each group was 0.1%, 0.4%, 1.4% and 4.0%, respectively. Seven hundred and thirty four patients submitted more than two FITs within a year. The likelihood of one or more f-Hb ≥ 10 µg/g rose from 40.4% with two samples to 100% with six, while the CRC rate fell from 0.8% to 0%. CONCLUSION: Serial FITs within a year account for 9.1% of all results in our Boards. CRC prevalence amongst symptomatic patients with serial FIT is lower than in single-FIT cohorts. Performing two FITs within a year for patients with persistent symptoms effectively acts as a safety net, while performing more than two within this timeframe is unlikely to be beneficial.
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Neoplasias Colorrectales , Humanos , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/epidemiología , Sensibilidad y Especificidad , Prevalencia , Estudios Retrospectivos , Hemoglobinas/análisis , Heces/química , Sangre Oculta , Detección Precoz del Cáncer/métodos , Atención Primaria de Salud , ColonoscopíaRESUMEN
BACKGROUND: There is debate about whether the distance from hospital, or rurality, impacts outcomes in patients admitted under emergency general surgery (EGS). The aim of this study was to determine whether distance from hospital, or rurality, affects the mortality of emergency surgical patients admitted in Scotland. METHODS: This was a retrospective population-level cohort study, including all EGS patients in Scotland aged 16 years or older admitted between 1998 and 2018. A multiple logistic regression model was created with inpatient mortality as the dependent variable, and distance from hospital (in quartiles) as the independent variable of interest, adjusting for age, sex, co-morbidity, deprivation, admission origin, diagnosis category, operative category, and year of admission. A second multiple logistic regression model was created with a six-fold Scottish Urban Rural Classification (SURC) as the independent variable of interest. Subgroup analyses evaluated patients who required operations, emergency laparotomy, and inter-hospital transfer. RESULTS: Data included 1 572 196 EGS admissions. Those living in the farthest distance quartile from hospital had lower odds of mortality than those in the closest quartile (OR 0.829, 95 per cent c.i. 0.798 to 0.861). Patients from the most rural areas (SURC 6) had higher odds of survival than those from the most urban (SURC 1) areas (OR 0.800, 95 per cent c.i. 0.755 to 0.848). Subgroup analysis showed that these effects were not observed for patients who required emergency laparotomy or transfer. CONCLUSION: EGS patients who live some distance from a hospital, or in rural areas, have lower odds of mortality, after adjusting for multiple covariates. Rural and distant patients undergoing emergency laparotomy have no survival advantage, and transferred patients have higher mortality.
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Hospitalización , Hospitales , Estudios de Cohortes , Mortalidad Hospitalaria , Humanos , Estudios RetrospectivosRESUMEN
AIM: The aim of this work was to evaluate the performance of colon capsule endoscopy (CCE) in a lower gastrointestinal diagnostic care pathway. METHOD: This large multicentre prospective clinical evaluation recruited symptomatic patients (patients requiring investigation of symptoms suggestive of colorectal pathology) and surveillance patients (patients due to undergo surveillance colonoscopy). Patients aged 18 years or over were invited to participate and undergo CCE by a secondary-care clinician if they met the referral criteria for a colonoscopy. The primary outcome was the test completion rate (visualization of the whole colon and rectum). We also measured the need for further tests after CCE. RESULTS: A total of 733 patients were invited to take part in this evaluation, with 509 patients undergoing CCE. Of these, 316 were symptomatic patients and 193 were surveillance patients. Two hundred and twenty-eight of the 316 symptomatic patients (72%) and 137 of the 193 surveillance patients (71%) had a complete test. It was found that 118/316 (37%) of symptomatic patients required no further test following CCE, while 103/316 (33%) and 81/316 (26%) required a colonoscopy and flexible sigmoidoscopy, respectively. Fifty-three of the 193 surveillance patients (28%) required no further test following CCE, while 104/193 (54%) and 30/193 (16%) required a colonoscopy and flexible sigmoidoscopy, respectively. No patient in this evaluation was diagnosed with colorectal cancer. Two patients experienced serious adverse events - one capsule retention with obstruction and one hospital admission with dehydration due to the bowel preparation. CONCLUSION: CCE is a safe, well-tolerated diagnostic test which can reduce the proportion of patients requiring colonoscopy, but the test completion rate needs to be improved to match that of lower gastrointestinal endoscopy.
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Endoscopía Capsular , Neoplasias Colorrectales , Estudios de Cohortes , Colonoscopía , Neoplasias Colorrectales/diagnóstico , Neoplasias Colorrectales/patología , Humanos , Estudios ProspectivosRESUMEN
BACKGROUND: Emergency general surgery (EGS) is a high-volume and high-risk surgical service. Interhospital variation in EGS outcomes exists, but there is disagreement in the literature as to whether hospital admission volume affects in-hospital mortality. Scotland collects high-quality data on all admitted patients, whether managed operatively or nonoperatively. Our aim was to determine the relationship between hospital admission volume and in-hospital mortality of EGS patients in Scotland. Second, to investigate whether surgeon admission volume affects mortality. METHODS: This national population-level cohort study included EGS patients aged 16 years and older, who were admitted to a Scottish hospital between 2014 and 2018 (inclusive). A logistic regression model was created, with in-hospital mortality as the dependent variable, and admission volume of hospital per year as a continuous covariate of interest, adjusted for age, sex, comorbidity, deprivation, surgeon admission volume, surgeon operative rate, transfer status, diagnosis, and operation category. RESULTS: There were 376,076 admissions to 25 hospitals, which met our inclusion criteria. The EGS hospital admission rate per year had no effect on in-hospital mortality (odds ratio [OR], 1.000; 95% confidence interval [CI], 1.000-1.000). Higher average surgeon monthly admission volume increased the odds of in-hospital mortality (>35 admissions: OR, 1.139; 95% CI, 1.038-1.250; 25-35 admissions: OR, 1.091; 95% CI, 1.004-1.185; <25 admissions was the referent). CONCLUSION: In Scotland, in contrast to other settings, EGS hospital admission volume did not influence in-hospital mortality. The finding of an association between individual surgeons' case volume and in-hospital mortality warrants further investigation. LEVEL OF EVIDENCE: Care management, Level IV.
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Servicio de Urgencia en Hospital/estadística & datos numéricos , Tratamiento de Urgencia/mortalidad , Complicaciones Posoperatorias/mortalidad , Procedimientos Quirúrgicos Operativos/mortalidad , Carga de Trabajo/estadística & datos numéricos , Adolescente , Adulto , Anciano , Estudios de Cohortes , Tratamiento de Urgencia/efectos adversos , Tratamiento de Urgencia/estadística & datos numéricos , Femenino , Mortalidad Hospitalaria , Hospitales de Alto Volumen/estadística & datos numéricos , Hospitales de Bajo Volumen/estadística & datos numéricos , Humanos , Masculino , Persona de Mediana Edad , Admisión del Paciente/estadística & datos numéricos , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos , Escocia/epidemiología , Cirujanos/estadística & datos numéricos , Procedimientos Quirúrgicos Operativos/efectos adversos , Procedimientos Quirúrgicos Operativos/estadística & datos numéricos , Adulto JovenRESUMEN
AIM: Biological treatment is effective in maintaining remission in ulcerative colitis (UC), although the effect on colectomy rates remains unclear. In the UK the use of antitumour necrosis factor and anti-α4ß7 treatments for maintenance therapy in UC was restricted until 2015. The aim of this study was to describe the impact that this change in the prescribing of biologicals had on colectomy rates for UC. METHOD: All patients (adult and paediatric) with a diagnosis of UC who received maintenance biological treatment and/or underwent a colectomy in Lothian, Scotland between 2005 and 2018 were identified. Linear and segmental regression analyses were used to identify the annual percentage change (APC) and temporal trends (statistical joinpoints) in biological prescription and colectomy rates. RESULTS: Rates of initiation of maintenance biological therapy increased from 0.05 per 100 UC patients in 2005 to 1.26 in 2018 (p < 0.001). Colectomy rates per 100 UC patients fell from 1.47 colectomies in 2005 to 0.44 in 2018 (p < 0.001). The APC for colectomy decreased by 4.1% per year between 2005 and 2014 and by 18.9% between 2014 and 2018. Temporal trend analysis (2005-2018) identified a significant joinpoint in colectomy rates in 2014 (p = 0.019). CONCLUSION: The use of maintenance biological therapy increased sharply following the change in guidance. This has been paralleled by a significant reduction in the rates of colectomy over the same time period.
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Colitis Ulcerosa , Adalimumab , Adulto , Niño , Colectomía , Colitis Ulcerosa/tratamiento farmacológico , Colitis Ulcerosa/cirugía , Humanos , Infliximab , Estudios Retrospectivos , Factor de Necrosis Tumoral alfaRESUMEN
BACKGROUND: Simulation has an increasingly prominent role in modern vascular surgery training. However, it is important to understand how simulation is most effectively delivered to best use the time and resources available. The aim of this narrative review is therefore to critically appraise open technical skill acquisition in the operating room environment and provide recommendations for the future development of evidence-based simulation for open vascular surgery. METHODS: A systematic search strategy was used to retrieve relevant studies from PubMed, Medline, Web of Science, EMBASE, and the Cochrane databases in July 2019. Included papers were independently screened by two reviewers. Data were subsequently extracted using a standardized proforma and thematically analyzed. RESULTS: Thirteen studies were included. All demonstrated that simulation is effective in improving confidence and/or competence in performing open technical skills when assessed by previously validated metrics. However, not all participants or course schedules achieved equal benefit, with distributed practice for junior trainees over several weeks achieving a greater improvement in technical skill compared with senior trainees or longer course schedules for some tasks. CONCLUSIONS: Simulation can be an effective adjunct to traditional operative experience for technical skill acquisition in open vascular surgery. Future work should focus on developing models to address a wider range of training needs, as well as further defining the optimum schedule for the style, content, and timing of simulation for specific learner groups.
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Educación de Postgrado en Medicina , Entrenamiento Simulado , Cirujanos/educación , Procedimientos Quirúrgicos Vasculares/educación , Competencia Clínica , Humanos , Internado y Residencia , Curva de AprendizajeRESUMEN
BACKGROUND: Currently, there is no consensus regarding the best treatment option in recurrent haemorrhoidal disease (HD), due to a lack of solid evidence. The Napoleon trial aims to provide high-level evidence on the comparative effectiveness and cost-effectiveness of repeat rubber band ligation (RBL) versus sutured mucopexy versus haemorrhoidectomy in patients with recurrent HD. METHODS: This is a multicentre randomized controlled trial. Patients with recurrent HD grade II and III, ≥18 years of age and who had at least two RBL treatments in the last three years are eligible for inclusion. Exclusion criteria include previous rectal or anal surgery, rectal radiation, pre-existing sphincter injury or otherwise pathologies of the colon and rectum, pregnancy, presence of hypercoagulability disorders, and medically unfit for surgery (ASA > III). Between June 2020 and May 2022, 558 patients will be randomized to receive either: (1) RBL, (2) sutured mucopexy, or (3) haemorrhoidectomy. The primary outcomes are recurrence after 52 weeks and patient-reported symptoms measured by the PROM-HISS. Secondary outcomes are impact on daily life, treatment satisfaction, early and late complication rates, health-related quality of life, costs and cost-effectiveness, and budget impact. Cost-effectiveness will be expressed in societal costs per Quality Adjusted Life Year (QALY) (based on EQ-5D-5L), and healthcare costs per recurrence avoided. DISCUSSION: The best treatment option for recurrent HD remains unknown. The comparison of three generally accepted treatment strategies in a randomized controlled trial will provide high-level evidence on the most (cost-) effective treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT04101773.
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Hemorreoidectomía , Hemorroides , Análisis Costo-Beneficio , Hemorroides/cirugía , Humanos , Estudios Multicéntricos como Asunto , Recurrencia Local de Neoplasia , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Recto/cirugía , Resultado del TratamientoRESUMEN
BACKGROUND: Parastomal hernia (PSH) can be repaired surgically, but results to date have been disappointing, with reported recurrence rates of 30 to 76%. Other types of intervention are therefore needed to improve the quality of life of people with PSH. One potential intervention is physical activity. We hypothesise that the intervention will increase core activation and control across the abdominal wall at a site of potential weakness and thus reduce the risk of PSH progression. Increases in physical activity will improve body image and quality of life (QoL). METHODS: Subjects and sampleThere were approximately 20 adults with a bowel stoma and PSH. People with previous PSH repair will be excluded as well as people who already do core training.Study designThis is a feasibility study of a randomised controlled trial with 2 months follow-up, in 2 sites using mixed methods. Stage 1 involves intervention development and in stage 2, intervention and trial parameters will be assessed.InterventionA theoretically informed physical activity intervention was done, targeting people with PSH.Main outcome of feasibility studyThe main outcome is the decision by an independent Study Steering Committee whether to proceed to a full randomised controlled trial of the intervention.Other outcomesWe will evaluate 4 intervention parameters-fidelity, adherence, acceptability and safety and 3 trial parameters (eligible patients' consent rate, acceptability of study design and data availability rates for following endpoints): I.Diagnosis and classification of PSHII.Muscle activationIII.Body composition (BMI, waist circumference)IV.Patient reported outcomes: QoL, body image and physical functioningV.Physical activity;VI.Psychological determinants of physical activityOther dataIncluded are other data such as interviews with all participants about the intervention and trial procedures.Data analysis and statistical powerAs this is a feasibility study, the quantitative data will be analysed using descriptive statistics. Audio-recorded qualitative data from interviews will be transcribed verbatim and analysed thematically. DISCUSSION: The feasibility and acceptability of key intervention and trial parameters will be used to decide whether to proceed to a full trial of the intervention, which aims to improve body image, quality of life and PSH progression. TRIAL REGISTRATION: ISRCTN15207595.
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BACKGROUND: We hypothesise that a physical activity (PA) intervention will improve the quality of life (QoL) of people with a stoma. A feasibility study of the intervention and trial parameters is necessary to inform a future main trial. METHODS: Participants received a weekly PA consultation by telephone, video conferencing, or face-to-face for 12 weeks with a PA instructor who prescribed physical activities and supported participants by addressing stoma-related concerns and using behaviour change techniques. A feasibility study of the intervention and trial parameters was conducted in three UK sites using mixed methods. RESULTS: The number of eligible patients consenting to the study was 30 out of 174 (17%). Most participants were female (73%); 73% had an ileostomy and 27% a colostomy; mean time since diagnosis was 6 months. A total of 18 (64%) participants completed pre- (baseline) and post-intervention (follow-up) measures. Results show an improvement on all scales measuring QoL and disease-specific fatigue. The median PA consultation rate per participant was eight sessions. Participants reported completing 75% or more of the prescribed PA each week. Eight stoma-related themes were identified from qualitative interviews: fear of hernia, bending down, fatigue, pain, prolapse, surgical wounds, stoma appliance, and stigma. The intervention appeared to address these issues. CONCLUSION: This feasibility study demonstrated that a novel manualised PA intervention for people with a stoma is safe, feasible, and acceptable, and shows promise for improving outcomes. However, difficulties with recruitment will need to be carefully considered to ensure the success of future studies in this area. TRIAL REGISTRATION: ISCTN, ISRCTN58613962; Registered 14/9/2017.
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BACKGROUND: Scottish Surgical Boot Camps are the induction course for new start Core Surgical Trainees (Residents) in Scotland. The aim is to capitalise on trainees' receptiveness at a time of transition, and to give them a safe and "flying start." At their inception, these were the first such courses in the UK to integrate technical and non-technical skills training. As well as knowledge and skills, trainees have learned norms and expectations of a community of professional practice. METHODS: Over 9 consecutive years of delivery and quality improvement, faculty have learned much about the safe use of simulation, as an adjuvant training modality for a range of competences required in the operating room, the clinic/office, the wards and other clinical domains. CONCLUSION: In this paper we describe the development and content of the course, discuss the importance of the whole "activity system," and present some evaluation data. We give tips for success, such as using simulations of escalating complexity, and the power of seemingly incidental Learning Outcomes.
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Internado y Residencia , Competencia Clínica , Simulación por Computador , Educación de Postgrado en Medicina , Quirófanos , EscociaRESUMEN
BACKGROUND: Physical activity (PA) is positively associated with quality of life. People with a stoma are less likely to engage in PA than those without a stoma. METHODS: In this feasibility intervention study, we will perform the following: (1) Develop a PA intervention for people with a stoma. An Expert Working Group of behavioural scientists, exercise scientists, clinicians and a Patient Advisory Group of people with a bowel stoma will meet with the research team to inform the development of a PA intervention for people with a stoma. A manual of the intervention will be the main output. (2) Explore PA instructors' experiences of delivering the PA intervention. PA instructors will record on paper the number of PA consultations with each patient and a researcher will interview the PA instructors about their experiences of delivering the intervention. (3) Assess the level of patient (bowel cancer or inflammatory bowel disease (IBD) patients with a stoma between 6 weeks and 24 months post-surgery) engagement with the PA intervention and their views on intervention acceptability and usefulness. Patients will keep a PA diary to record daily pedometer recorded step count and type and duration of activities. A researcher will interview patients about their experiences of the PA intervention. (4) Assess screening, eligibility, consent, data completion, loss to follow up, and missing data rates, representativeness of participants and potential treatment effects. A researcher will record on paper all study procedure parameters. Quality of life (stoma-quality of life; Functional Assessment of Cancer Therapy, Short IBD questionnaire), fatigue (FACIT fatigue scale) and PA (accelerometer) will be measured pre- and post-intervention in patients. For IBD patients only, blood will be taken to measure systemic inflammation. DISCUSSION: We hypothesise that a PA intervention will be an effective means of improving the quality of life of people with a stoma. Before embarking on a full randomised controlled trial to test this hypothesis, a PA intervention needs to be developed and a feasibility study of the proposed PA intervention conducted. TRIAL REGISTRATION: ISRCTN58613962, Protocol version: 0.1. 14 September 2017.
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OBJECTIVE: Our objective was to compare the cost effectiveness of stapled haemorrhoidopexy (SH) and traditional haemorrhoidectomy (TH) in the treatment of grade II-IV haemorrhoidal disease from the perspective of the UK national health service. METHODS: An economic evaluation was conducted alongside an open, two-arm, parallel-group, pragmatic, multicentre, randomised controlled trial conducted in several hospitals in the UK. Patients were randomised into either SH or TH surgery between January 2011 and August 2014 and were followed up for 24 months. Intervention and subsequent resource use data were collected using case review forms and questionnaires. Benefits were collected using the EQ-5D-3L (EuroQoL-five dimensions-three levels) instrument. The primary economic outcome was incremental cost measured in pounds (£), year 2016 values, relative to the incremental benefit, which was estimated using quality-adjusted life-years (QALYs). Cost and benefits accrued in the second year were discounted at 3.5%. The base-case analysis was based on imputed data. Uncertainty was explored using univariate sensitivity analyses. RESULTS: Participants (n = 777) were randomised to SH (n = 389) or TH (n = 388). The mean cost of SH was £337 (95% confidence interval [CI] 251-423) higher than that of TH and the mean QALYs were -0.070 (95% CI -0.127 to -0.011) lower than for TH. The base-case cost-utility analysis indicated that SH has zero probability of being cost effective at both the £20,000 and the £30,000 threshold. Results from the sensitivity analyses were similar to those from the base-case analysis. CONCLUSIONS: The evidence suggests that, on average, the total mean costs over the 24-month follow-up period were significantly higher for the SH arm than for the TH arm. The QALYs were also, on average, significantly lower for the SH arm. These results were supported by the sensitivity analyses. Therefore, in terms of cost effectiveness, TH is a superior surgical treatment for the management of grade II-IV haemorrhoids when compared with SH.
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INTRODUCTION: Liver surgery is widely used as a treatment modality for various liver pathologies. Despite significant improvement in clinical care, operative strategies, and technology over the past few decades, liver surgery is still risky, and optimal preoperative planning and anatomical assessment are necessary to minimize risks of serious complications. 3D printing technology is rapidly expanding, and whilst appliactions in medicine are growing, but its applications in liver surgery are still limited. This article describes the development of models of hepatic structures specific to a patient diagnosed with an operable hepatic malignancy. METHODS: Anatomy data were segmented and extracted from computed tomography and magnetic resonance imaging of the liver of a single patient with a resectable liver tumor. The digital data of the extracted anatomical surfaces was then edited and smoothed, resulting in a set of digital 3D models of the hepatic vein, portal vein with tumor, biliary tree with gallbladder, and hepatic artery. These were then 3D printed. RESULTS: The final models of the liver structures and tumor provided good anatomical detail and representation of the spatial relationships between the liver tumor and adjacent hepatic structures and could be easily manipulated and explored from different angles. CONCLUSIONS: A graspable, patient-specific, 3D printed model of liver structures could provide an improved understanding of the complex liver anatomy and better navigation in difficult areas and allow surgeons to anticipate anatomical issues that might arise during the operation. Further research into adequate imaging, liver-specific volumetric software, and segmentation algorithms are worth considering to optimize this application.