ResearchPad - 1737 https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease: the PREDIC-DIV study protocol of a prospective multicentric transnational observational study]]> https://www.researchpad.co/article/elastic_article_9139 Diverticulitis is among the most common abdominal disorders. The best treatment strategy for this complicated disease as well as for recurrent stages is still under debate. Moreover, little knowledge exists regarding the effect of different therapeutic strategies on the health-related quality of life (HrQoL). Therefore, the PREDIC-DIV (PREDICtors for health-related quality of life after elective sigmoidectomy for DIVerticular disease) study aims to assess predictors of a change in HrQoL in patients after elective sigmoidectomy for diverticular disease.Methods and analysisA prospective multicentre transnational observational study was started in November 2017. Patients undergoing elective sigmoid resection for diverticular disease were included. Primary outcome includes HrQoL 6 months postoperatively, staged by the Gastrointestinal Quality of Life Index (GIQLI). Secondary outcomes include HrQoL 6 months after sigmoidectomy, assessed using the Short Form 36 Questionnaire and a custom-made Visual Analogue Scale-based inventory; HrQoL after 12 and 24 months; postoperative morbidity; mortality; influence of surgical technique (conventional laparoscopic multiport operation vs robotic approach); histological grading of inflammation and morphological characteristics of the bowel wall in the resected specimen; postoperative functional changes (faecal incontinence, faecal urge, completeness of emptying, urinary incontinence, sexual function); disease-specific healthcare costs; and changes in economic productivity, measured by the iMTA Productivity Cost Questionnaire. The total follow-up will be 2 years.Ethics and disseminationThe protocol was approved by the medical ethical committee of the Bavarian Medical Council (report identification number: 2017-177). The study was conducted in accordance with the Declaration of Helsinki. The findings of this study will be submitted to a peer-reviewed journal (BMJ Open, Annals of Surgery, British Journal of Surgery, Diseases of the Colon and the Rectum). Abstracts will be submitted to relevant national and international conferences.Trial registration numberThe study is registered with the ClinicalTrials.gov register as NCT03527706; Pre-results. ]]> <![CDATA[Strategies aimed at preventing chronic opioid use in trauma and acute care surgery: a scoping review protocol]]> https://www.researchpad.co/article/N23c4601b-2a4d-4310-b62d-3b85aee8f88d Globally every year, millions of patients sustain traumatic injuries and require acute care surgeries. A high incidence of chronic opioid use (up to 58%) has been documented in these populations with significant negative individual and societal impacts. Despite the importance of this public health issue, optimal strategies to limit the chronic use of opioids after trauma and acute care surgery are not clear. We aim to identify existing strategies to prevent chronic opioid use in these populations.Methods and analysisWe will perform a scoping review of peer-reviewed and non-peer-reviewed literature to identify studies, reviews, recommendations and guidelines on strategies aimed at preventing chronic opioid use in patients after trauma and acute care surgery. We will search MEDLINE, EMBASE, PsycINFO, CINHAL, Cochrane Central Register of Controlled Trials, Web of Science, ProQuest and websites of trauma and acute care surgery, pain, government and professional organisations. Databases will be searched for papers published from 1 January 2005 to a maximum of 6 months before submission of the final manuscript. Two reviewers will independently evaluate studies for eligibility and extract data from included studies using a standardised data abstraction form. Preventive strategies will be classified according to their types and targeted trauma populations and acute care surgery procedures.Ethics and disseminationResearch ethics approval is not required as this study is based on the secondary use of published data. This work will inform research and clinical stakeholders on the required next steps towards the uptake of effective strategies aimed at preventing chronic opioid use in trauma and acute care surgery patients. ]]> <![CDATA[Rates of knee arthroplasty in patients with a history of arthroscopic chondroplasty: results from a retrospective cohort study utilising the National Hospital Episode Statistics for England]]> https://www.researchpad.co/article/N2ae36f7b-5a38-4283-b258-d63006aa36eb The purpose of this study was to analyse the rate of knee arthroplasty in the population of patients with a history of arthroscopic chondroplasty of the knee, in England, over 10 years, with comparison to general population data for patients without a history of chondroplasty.DesignRetrospective cohort study.SettingEnglish Hospital Episode Statistics (HES) data.Participants and interventionsPatients undergoing arthroscopic chondroplasty in England between 2007/2008 and 2016/2017 were identified. Patients undergoing previous arthroscopic knee surgery or simultaneous cruciate ligament reconstruction or microfracture in the same knee were excluded.OutcomesPatients subsequently undergoing a knee arthroplasty in the same knee were identified and mortality-adjusted survival analysis was performed (survival without undergoing knee arthroplasty). A Cox proportional hazards model was used to identify factors associated with knee arthroplasty. Relative risk of knee arthroplasty (total or partial) in comparison to the general population was determined.ResultsThrough 2007 to 2017, 157 730 eligible chondroplasty patients were identified. Within 1 year, 5.91% (7984/135 197; 95% CI 5.78 to 6.03) underwent knee arthroplasty and 14.22% (8145/57 267; 95% CI 13.94 to 14.51) within 5 years. Patients aged over 30 years with a history of chondroplasty were 17.32 times (risk ratio; 95% CI 16.81 to 17.84) more likely to undergo arthroplasty than the general population without a history of chondroplasty.ConclusionsPatients with cartilage lesions of the knee, treated with arthroscopic chondroplasty, are at greater risk of subsequent knee arthroplasty than the general population and for a proportion of patients, there is insufficient benefit to prevent the need for knee arthroplasty within 1 to 5 years. These important new data will inform patients of the anticipated outcomes following this procedure. The risk in comparison to non-operative treatment remains unknown and there is an urgent need for a randomised clinical trial in this population. ]]> <![CDATA[Long-term patient satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort: study protocol for a retrospective cohort study with development of a novel scoring system for patient selection]]> https://www.researchpad.co/article/Nd2c568e1-df5a-4300-8266-47e66a1453aa

Introduction

Laparoscopic anti-reflux surgery is standard of care in surgical treatment of gastro-oesophageal reflux disease and is not without risks of adverse effects, including disruption of the fundoplication and postfundoplication dysphagia, in some cases leading to reoperation. Non-surgical factors such as pre-existing anxiety or depression influence postoperative satisfaction and symptom relief. Previous studies have focused on a short-term follow-up or only certain aspects of disease, such as reoperation or postoperative quality of life. The aim of this study is to evaluate long-term patient-satisfaction and durability of laparoscopic anti-reflux surgery in a large Danish cohort using a comprehensive multimodal follow-up, and to develop a clinically applicable scoring system usable in selecting patients for anti-reflux surgery.

Methods and analysis

The study is a retrospective cohort study utilising data from patient records and follow-up with patient-reported quality of life as well as registry-based data. The study population consists of all adult patients having undergone laparoscopic anti-reflux surgery at The Department of Surgery, Kolding Hospital, a part of Lillebaelt Hospital Denmark in an 11-year period. From electronic records; patient characteristics, preoperative endoscopic findings, reflux disease characteristics and details on type of surgery, will be identified. Disease-specific quality of life and dysphagia will be collected from a patient-reported follow-up. From Danish national registries, data on comorbidity, reoperative surgery, use of pharmacological anti-reflux treatment, mortality and socioeconomic factors will be included. Primary outcome of this study is treatment success at follow-up.

Ethics and dissemination

Study approval has been obtained from The Danish Patient Safety Agency, The Danish Health Data Authority and Statistics Denmark, complying to Danish and EU legislation. Inclusion in the study will require informed consent from participating subjects. The results of the study will be published in peer-reviewed medical journals regardless of whether these are positive, negative or inconclusive.

Trial registration number

Clinicaltrials.gov (NCT03959020).

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<![CDATA[Arthroscopic meniscectomy versus non-surgical or sham treatment in patients with MRI confirmed degenerative meniscus lesions: a protocol for an individual participant data meta-analysis]]> https://www.researchpad.co/article/N0d779ff8-c1e0-4dcf-b4bc-cf85dceb5de0

Introduction

Arthroscopic partial meniscectomy (APM) after degenerative meniscus tears is one of the most frequently performed surgeries in orthopaedics. Although several randomised controlled trials (RCTs) have been published that showed no clear benefit compared with sham treatment or non-surgical treatment, the incidence of APM remains high. The common perception by most orthopaedic surgeons is that there are subgroups of patients that do need APM to improve, and they argue that each study sample of the existing trials is not representative for the day-to-day patients in the clinic. Therefore, the objective of this individual participant data meta-analysis (IPDMA) is to assess whether there are subgroups of patients with degenerative meniscus lesions who benefit from APM in comparison with non-surgical or sham treatment.

Methods and analysis

An existing systematic review will be updated to identify all RCTs worldwide that evaluated APM compared with sham treatment or non-surgical treatment in patients with knee symptoms and degenerative meniscus tears. Time and effort will be spent in contacting principal investigators of the original trials and encourage them to collaborate in this project by sharing their trial data. All individual participant data will be validated for missing data, internal data consistency, randomisation integrity and censoring patterns. After validation, all datasets will be combined and analysed using a one-staged and two-staged approach. The RCTs’ characteristics will be used for the assessment of clinical homogeneity and generalisability of the findings. The most important outcome will be the difference between APM and control groups in knee pain, function and quality of life 2 years after the intervention. Other outcomes of interest will include the difference in adverse events and mental health.

Ethics and dissemination

All trial data will be anonymised before it is shared with the authors. The data will be encrypted and stored on a secure server located in the Netherlands. No major ethical concerns remain. This IPDMA will provide the evidence base to update and tailor diagnostic and treatment protocols as well as (international) guidelines for patients for whom orthopaedic surgeons consider APM. The results will be submitted for publication in a peer-reviewed journal.

PROSPERO registration number

CRD42017067240.

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<![CDATA[‘French LARS score’: validation of the French version of the low anterior resection syndrome (LARS) score for measuring bowel dysfunction after sphincter-preserving surgery among rectal cancer patients: a study protocol]]> https://www.researchpad.co/article/N9af731a3-e6f3-41a1-97ac-2c49c83f110f

Introduction

Many bowel problems following low anterior resection (LAR) for rectal cancer considerably impair the quality of life (QoL) of patients. The LAR syndrome (LARS) scale is a self-report questionnaire to identify and assess bowel dysfunction after rectal cancer surgery. It has been translated and validated in several languages but not in French (metropolitan French). The primary objective is to adapt the LARS scale to the French language (called French-LARS score) and to assess its psychometric properties. Secondary objectives are to assess both the prevalence and severity of LARS and to measure their impact on QoL.

Methods and analysis

A French multicentre observational cohort study has been designed. The validation study will include translation of the LARS scale following the current international recommendations, assessment of its reliability, convergent and discriminant validities, sensitivity, internal consistency, internal validity and confirmatory analyses. One thousand patients will be enrolled for the analyses. The questionnaire will be initially administered to the first 100 patients to verify the adequacy and degree of comprehension of the questions. Then reproducibility will be investigated by a test–retest procedure in the following 400 patients.

An analysis will be conducted to determine the correlation between the LARS score and the Quality of Life Questionnaire (QLQ; European Organization for Treatment and Research of Cancer’s QLQ-C30, QLQ-CR29). Risk factors linked to QoL deterioration will be identified and their impact will be measured. This study will meet the need for a validated tool to improve patient care and QoL.

Ethics and dissemination

The institutional review board of the University Hospital of Caen and the ethics committee (CPP Nord Ouest I, 25 January 2019) approved the study.

Trial registration number

NCT03569488.

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<![CDATA[Development of screening tools to predict the risk of recurrence and related complications following anal fistula surgery: protocol for a prospective cohort study]]> https://www.researchpad.co/article/N205cd24a-aadf-4741-995d-951e86560b7b

Introduction

Postoperative recurrence and related complications are common and related to poor outcomes in patients with anal fistula (AF). Due to being associated with short-term and long-term cure rates, perioperative complications have received widespread attention following AF surgery. This study aims to identify a set of predictive factors to develop risk prediction models for recurrence and related complications following AF surgery. We plan to develop and validate risk prediction models, using information collected through a WeChat patient-reported questionnaire system combined with clinical, laboratory and imaging findings from the perioperative period until 3–6 months following AF surgery.

Methods and analysis

This is a prospective hospital-based cohort study using a linked database of collected health data as well as the follow-up outcomes for all adult patients who suffered from AF at a tertiary referral hospital in Shanghai, China. We will perform logistic regression models to predict anal fistula recurrence (AFR) as well as related complications (eg, wound haemorrhage, faecal impaction, urinary retention, delayed wound healing and unplanned hospitalisation) during and after AF surgery, and machine learning approaches will also be applied to develop risk prediction models. This prospective study aims to develop the first risk prediction models for AFR and related complications using multidimensional variables. These tools can be used to warn, motivate and empower patients to avoid some modifiable risk factors to prevent postoperative complications early. This study will also provide alternative tools for the early screening of high-risk patients with AFR and related complications, helping surgeons better understand the aetiology and outcomes of AF in an earlier stage.

Ethics and dissemination

The study was approved by the Institutional Review Board of Shuguang Hospital affiliated with Shanghai University of Traditional Chinese Medicine (approval number: 2019-699-54-01). The results of this study will be submitted to international scientific peer-reviewed journals or conferences in surgery, anorectal surgery or anorectal diseases.

Trial registration number

ChiCTR1900025069; Pre-results.

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<![CDATA[Robotic versus laparoscopic gastrectomy for gastric cancer: protocol for umbrella review of systematic reviews and meta-analyses]]> https://www.researchpad.co/article/Ne99be3af-691f-40ff-81fa-7b2e993a975a

Introduction

Laparoscopic surgery has been adopted in some parts of the world as an innovative approach to the resection of gastric cancers. However, in the modern era of surgical oncology, to overcome intrinsic limitations of the traditional laparoscopy, the robotic approach is advocated as able to facilitate the lymph node dissection and complex reconstruction after gastrectomy, to assure oncologic safety also in advanced gastric cancer patients. Previous meta-analyses highlighted a lower complication rate as well as bleeding in the robotic approach group when compared with the laparoscopic one. This potential benefit must be balanced against an increased time of intervention. The aim of this umbrella review is to provide a comprehensive overview of the literature for surgeons and policymakers in order to evaluate the potential benefits and harms of robotic gastrectomy (RG) compared with the laparoscopic approach for gastric cancer.

Methods and analysis

We will perform a comprehensive search of the PubMed, Cochrane and Embase databases for all articles published up to May 2019 and reference list of relevant publications for systematic review and meta-analyses comparing the outcomes of RG and laparoscopic gastrectomy in patients with gastric cancer. Studies will be selected by two independent reviewers based on prespecified eligibility criteria and the quality will be assessed according to AMSTAR (A MeaSurement Tool to Assess systematic Reviews) checklist. All information will be collected using piloted and standardised data-extraction forms in DistillerSR developed following the Joanna Briggs Institute’s recommended extraction items.

Ethics and dissemination

This umbrella review will inform clinical and policy decisions regarding the benefits and harms of RG for treating gastric cancer. The results will be disseminated through a peer-reviewed publication, conference presentations and the popular press. Formal ethical approval is not required as primary data will not be collected.

PROSPERO registration number

CRD42019139906.

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<![CDATA[CORE-Kids: a protocol for the development of a core outcome set for childhood fractures]]> https://www.researchpad.co/article/N91a8739a-680e-4c3d-9be6-957d29f98a78

Introduction

Limb fractures in children are common yet there are few trials that compare treatments for these injuries. There is significant heterogeneity in the outcomes reported in the paediatric orthopaedic literature, which limits the ability to compare study results and draw firm conclusions. The aim of the CORE-Kids Study is to develop a core outcome set for use in research studies of childhood limb fractures. A core outcome set will provide a minimum set of outcomes to be measured in all trials to minimise the heterogeneity of outcomes reported and minimise reporting bias. A core outcome set ensures that outcomes are reported that are relevant to families as well as clinicians. The core outcome set will include additional upper and lower limb modules.

Methods

The development of the core outcome set will require four phases to evaluate:

  1. What are the outcomes that are relevant to professionals?

  2. What are the outcomes that are relevant to families?

  3. What are the most important of these outcomes?

  4. Which outcomes should be included in the core outcome set?

This will be completed through a systematic review of trials to identify the outcomes domains that are relevant to trialists. A series of semi-structured interviews will be completed with families to identify the outcome domains that are relevant to families. These outcome domains will be used in a three-round Delphi Study to analyse the importance of these outcome domains to a range of stakeholders including parents, clinicians and researchers. Following this, the core outcome set will be decided at a consensus meeting.

Ethics and dissemination

Ethical approval has been awarded HRA/REC IRAS number 262503. Date of approval 06/08/2019. Dissemination will be through scientific literature and international societies.

Trial registration

Core Outcome Measures in Effectiveness Trials Initiative, registration number: 1274. Date of registration 13/12/2018.

PROSPERO registration number

CRD42018106605.

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<![CDATA[Improving the quality of life of patients with breast cancer-related lymphoedema by lymphaticovenous anastomosis (LVA): study protocol of a multicentre randomised controlled trial]]> https://www.researchpad.co/article/N1e77a125-f043-4f59-b4e8-2725b2355c79

Introduction

Early breast cancer detection and advancements in treatment options have resulted in an increase of breast cancer survivors. An increasing number of women are living with the long-term effects of breast cancer treatment, making the quality of survivorship an increasingly important goal. Breast cancer-related lymphoedema (BCRL) is one of the most underestimated complications of breast cancer treatment with a reported incidence of 20%. A microsurgical technique called lymphaticovenous anastomosis (LVA) might be a promising treatment modality for patients with BCRL. The main objective is to assess whether LVA is more effective than the current standard therapy (conservative treatment) in terms of improvement in quality of life and weather it is cost-effective.

Methods and analysis

A multicentre, randomised controlled trial, carried out in two academic and two community hospitals in the Netherlands. The study population includes 120 women over the age of 18 who have undergone treatment for breast cancer including axillary treatment (sentinel lymph node biopsy or axillary lymph node dissection) and/or axillary radiotherapy, presenting with an early stage lymphoedema of the arm, viable lymphatic vessels and received at least 3 months conservative treatment. Sixty participants will undergo the LVA operation and the other sixty will continue their regular conservative treatment, both with a follow-up of 24 months. The primary outcome is the health-related quality of life. Secondary outcomes are societal costs, quality adjusted life years, cost-effectiveness ratio, discontinuation rate of conservative treatment and excess limb volume.

Ethics and dissemination

The study was approved by the Ethics Committee of Maastricht University Medical Center (METC) on 19 December 2018 (NL67059.068.18). The results of this study will be disseminated in presentations at academic conferences, publications in peer-reviewed journals and other news media.

Trial registration number

NCT02790021; Pre-results.

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<![CDATA[Multicentre randomised controlled trial of balloon pulmonary angioplasty and riociguat in patients with chronic thromboembolic pulmonary hypertension: protocol for the MR BPA study]]> https://www.researchpad.co/article/Ndfec9d13-f056-4d33-83d6-8caafed545cb

Introduction

Management of inoperable chronic thromboembolic pulmonary hypertension (CTEPH) remains a clinical challenge. Currently, medical treatment involving pulmonary vasodilators (such as soluble guanylate-cyclase stimulators) is recommended, primarily for ameliorating symptoms. More recently, balloon pulmonary angioplasty (BPA) has been developed as alternative treatment for inoperable CTEPH. This study aimed to compare the efficacy and safety of BPA and riociguat (a soluble guanylate-cyclase stimulator) as treatments for inoperable CTEPH.

Methods and analysis

This study is a multicentre randomised controlled trial. Subjects with inoperable CTEPH were randomised (1:1) into either a BPA or riociguat group, and observed for 12 months after initiation of treatment. The primary endpoint will be the change in mean pulmonary arterial pressure from baseline to 12 months after initiation of treatment. For primary analysis, we will estimate the least square means difference and 95% CI for the change of pulmonary arterial pressure between the groups at 12 months using the analysis of covariance adjusted for allocation factors.

Ethics and dissemination

This study and its protocols were approved by the institutional review board of Keio University School of Medicine and each participating institution. Written informed consent was obtained from all participants. Results will be disseminated at medical conferences and in journal publications.

Trial registration number

University Hospital Medical Information Network Clinical Trial Registry (UMIN000019549); Pre-results.

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<![CDATA[Clinical evaluation of percutaneous transforaminal endoscopic discectomy (PTED) and paraspinal minitubular microdiscectomy (PMTM) for lumbar disc herniation: study protocol for a randomised controlled trial]]> https://www.researchpad.co/article/N6b68084b-14b8-4e2a-871c-63372d6fe2f0

Introduction

For sciatica caused by lumbar disc herniation (LDH), the standard surgical technique is conventional microdiscectomy. In recent years, minimally invasive techniques (eg, percutaneous transforaminal endoscopic discectomy (PTED), paraspinal minitubular microdiscectomy (PMTM)) have gained increasing interest. PTED and PMTM are considered alternative minimally invasive techniques for the treatment of LDH. Due to insufficient evidence, the differences in efficacy between PTED and PMTM have been debated. A pragmatic, multicentre, non-inferiority, randomised controlled trial has been designed to determine the efficacy and cost-effectiveness of PTED versus PMTM for the treatment of LDH.

Methods and analysis

A total of 280 patients (18–70 years) presenting with significant symptoms of sciatica and failure after 3 months of conservative treatment will be recruited. Patients must have an indication for surgery based on MRI demonstrating LDH with nerve root compression. Patients will be randomised to PTED or PMTM treatment. The primary outcome is Oswestry Disability Index scores. Secondary outcomes include Visual Analogue Scale scores, Short Form 36 health survey scores, physical examination, length of hospital stay, costs and complications. Outcomes will be measured the day following surgery, at 1 week, and at 1, 3, 6, 12 and 24 months after surgical treatment. Physical examination will be conducted at 1 week, 1 month and 12 months after surgery. The non-inferiority margin for the primary outcome is 5.

Ethics and dissemination

Ethical approval has been granted by the Ethics Committee of Fujian Medical University Union Hospital, Fuzhou, China (2018YF010-02). Results of the research will be published in an international peer-reviewed scientific journal and disseminated through presentation at scientific conferences.

Trial registration number

ChiCTR1800015727; Pre-results.

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<![CDATA[CRISTAL: protocol for a cluster randomised, crossover, non-inferiority trial of aspirin compared to low molecular weight heparin for venous thromboembolism prophylaxis in hip or knee arthroplasty, a registry nested study]]> https://www.researchpad.co/article/N03a63e74-ac67-4fd4-b948-65b64dd57b2f

Introduction

Venous thromboembolism (VTE) is a serious complication following hip arthroplasty (HA) and knee arthroplasty (KA). This study aims to determine whether aspirin is non-inferior to low molecular weight heparin (LMWH) in preventing symptomatic VTE following HA and KA.

Methods and analysis

This is a cluster randomised, crossover, non-inferiority, trial nested within the Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR). The clusters will consist of Australian hospitals performing at least 250 HA and/or KA procedures per annum. All adult patients undergoing HA or KA will be included. The intervention will be aspirin, orally, 85–150 mg daily. The comparator will be LMWH (enoxaparin) 40 mg, subcutaneously, daily. Both drugs will commence within 24 hours postoperatively and continue for 35 days after HA and 14 days after KA. Each hospital will be randomised to commence with aspirin or LMWH and then crossover to the alternative treatment after meeting the recruitment target. Data will be collected through the AOANJRR via patient-reported surveys. The primary outcome is symptomatic VTE within 90 days post surgery, verified by AOANJRR staff. The primary analysis will include only patients undergoing elective primary total hip arthroplasty and total knee arthroplasty for osteoarthritis. Secondary outcomes will include symptomatic VTE for all HA and KA (including partial and revision) within 90 days, readmission, reoperation, major bleeding and death within 90 days and reoperation, death and patient-reported pain, function and health status at 6 months. If aspirin is found to be inferior, a cost-effectiveness analysis will be conducted. The study will aim to recruit 15 562 patients from 31 hospitals.

Ethics and dissemination

Ethics approval has been granted. Trial results will be submitted for publication. The trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12618001879257, pre-results) and is endorsed by the Australia and New Zealand Musculoskeletal Clinical Trials Network.

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<![CDATA[Perineural local anaesthetic catheter after major lower limb amputation trial (PLACEMENT): results from a randomised controlled feasibility trial]]> https://www.researchpad.co/article/Naeec64ca-bd61-401d-b2ab-335347634a89

Objectives

To determine the feasibility of undertaking a randomised controlled effectiveness trial evaluating the use of a perineural catheter (PNC) after major lower limb amputation with postoperative pain as the primary outcome.

Design

Randomised controlled feasibility trial.

Setting

Two vascular Centres in South Wales, UK.

Participants

50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease.

Interventions

The treatment arm received a PNC placed adjacent to the sciatic or tibial nerve at the time of surgery, with continuous infusion of levobupivacaine hydrochloride 0.125% for up to 5 days. The control arm received neither local anaesthetic nor PNC. Both arms received usual perioperative anaesthesia and postoperative analgesia.

Primary and secondary outcome measures

The primary outcomes were the proportion of eligible patients who were randomised and the proportion of recruited patients who provided primary effectiveness outcome data. Secondary outcomes were: the proportion of recruited patients reaching 2 and 6 month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain.

Results

Seventy-six of 103 screened patients were deemed eligible over a 10 month period. Fifty (64.5%) of these patients were randomised, with one excluded in the perioperative period. Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation. Attrition rates were high; 18 patients supplied data at 6 month follow-up. Costs were dominated by length of hospital stay. Patients and healthcare professionals reported that trial processes were acceptable.

Conclusions

Recruitment of patients into a trial comparing PNC use to usual care after major lower limb amputation with postoperative pain measured on a 4-point verbal rating scale is feasible. Evaluation of longer-term symptoms is difficult.

Trial registration number

ISRCTN: 85 710 690. EudraCT: 2016-003544-37.

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<![CDATA[Inequality of trauma care under a single-payer universal coverage system in Taiwan: a nationwide cohort study from the National Health Insurance Research Database]]> https://www.researchpad.co/article/Nd5de0077-5e01-4c37-bc8d-9bbb0d21ea8b

​Objectives

To assess the impact of lower socioeconomic status on the outcome of major torso trauma patients under the single-payer system by the National Health Insurance (NHI) in Taiwan.

​Design

A nationwide, retrospective cohort study.

​Setting

An observational study from the NHI Research Database (NHIRD), involving all the insurees in the NHI.

​Participants

Patients with major torso trauma (injury severity score ≥16) from 2003 to 2013 in Taiwan were included. International Classification of Disease, Ninth Revision, Clinical Modification codes were used to identify trauma patients. A total of 64 721 patients were initially identified in the NHIRD. After applying the exclusion criteria, 20 009 patients were included in our statistical analysis.

​Primary and secondary outcome measures

The primary outcome measure was in-hospital mortality, and we analysed patients with different income levels and geographic regions. Multiple logistic regression was used to control for confounding variables.

​Results

In univariate analysis, geographic disparities and low-income level were both risk factors for in-hospital mortality for patients with major torso trauma (p=0.002 and <0.001, respectively). However, in multivariate analysis, only a low-income level remained an independent risk factor for increased in-hospital mortality (p<0.001).

​Conclusion

Even with the NHI, wealth inequity still led to different outcomes for major torso trauma in Taiwan. Health policies must focus on this vulnerable group to eliminate inequality in trauma care.

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<![CDATA[(Cost-)effectiveness of lower extremity nerve decompression surgery in subjects with diabetes: the DeCompression (DECO) trial—study protocol for a randomised controlled trial]]> https://www.researchpad.co/article/N76a4e072-d24e-4d32-a937-c879ab47f286

Introduction

The peripheral nerves of patients with diabetes are often pathologically swollen, which results in entrapment at places of anatomical narrowing. This results in nerve dysfunction. Surgical treatment of compression neuropathies in the lower extremities (lower extremity nerve decompression (LEND)) results in relief of symptoms and gain in peripheral nerve function, which may lead to less sensory loss (short term) and less associated detrimental effects including foot ulceration and amputations, and lower costs (long term). The aim of the DeCompression trial is to evaluate the effectiveness and (cost-)effectiveness of surgical decompression of compressed lower extremity nerves (LEND surgery) compared with patients treated with conventional (non-surgical) care.

Methods and analysis

A stratified randomised (1 to 1) controlled trial comparing LEND surgery (intervention) with conventional non-surgical care (control strategy) in subjects with diabetes with problems of neuropathy due to compression neuropathies in the lower extremity. Randomisation is stratified for participating hospital (n=11) and gender. Patients and controls have the same follow-up at 1.5, 3, 6, 9, 12, 18, 24 and 48 months. Participants (n=344) will be recruited in 12 months and enrolled in all affiliated hospitals in which they receive both the intervention or conventional non-surgical care and follow-up. Outcome assessors are blinded to group assignment. Primary outcome: disease-specific quality of life (Norfolk Quality of Life Questionnaire—Diabetic Neuropathy). Secondary outcomes: health-related quality of life (EuroQoL 5-dimension 5-level (EQ-5D5L), 36-item Short Form (SF-36)), plantar sensation (Rotterdam Diabetic Foot Test Battery), incidence of ulcerations/amputations, resource use and productivity loss (Medical Cost Questionnaire, Productivity Cost Questionnaire) during follow-up. The incremental cost-effectiveness ratio will be estimated on the basis of the collected empirical data and a cost-utility model.

Ethics and dissemination

Ethics approval has been granted by the Medical Research Ethics Committee of Utrecht University Medical Center (reference: NL68312.041.19v5, protocol number: 19-335/M). Dissemination of results will be via journal articles and presentations at national and international conferences.

Trial registration number

NetherlandsTrial Registry NL7664.

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<![CDATA[Patient preferences for venous thromboembolism prophylaxis after injury: a discrete choice experiment]]> https://www.researchpad.co/article/5b440fe1463d7e3345f81d85

Objective

Limited evidence for the optimal venous thromboembolism (VTE) prophylaxis regimen in orthopaedic trauma leads to variability in regimens. We sought to delineate patient preferences towards cost, complication profile, and administration route (oral tablet vs. subcutaneous injection).

Design

Discrete choice experiment (DCE).

Setting

Level 1 trauma center in Baltimore, USA.

Participants

232 adult trauma patients (mean age 47.9 years) with pelvic or acetabular fractures or operative extremity fractures.

Primary and secondary outcome measures

Relative preferences and trade-off estimates for a 1% reduction in complications were estimated using multinomial logit modelling. Interaction terms were added to the model to assess heterogeneity in preferences.

Results

Patients preferred oral tablets over subcutaneous injections (marginal utility, 0.16; 95% CI: 0.11 - 0.21, P<0.0001). Preferences changed in favor of subcutaneous injections with an absolute risk reduction of 6.98% in bleeding, 4.53% in wound complications requiring reoperation, 1.27% in VTE, and 0.07% in death from pulmonary embolism (PE). Patient characteristics (sex, race, type of injury, time since injury) affected patient preferences (P<0.01).

Conclusions

Patients preferred oral prophylaxis and were most concerned about risk of death from PE. Furthermore, the findings estimated the trade-offs acceptable to patients and heterogeneity in preferences for VTE prophylaxis.

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<![CDATA[Non-Invasive Positive airway Pressure thErapy to Reduce Postoperative Lung complications following Upper abdominal Surgery (NIPPER PLUS): protocol for a single-centre, pilot, randomised controlled trial]]> https://www.researchpad.co/article/5c644663d5eed0c484c2bbfe

Introduction

Postoperative pulmonary complications (PPCs) are a common serious complication following upper abdominal surgery leading to significant consequences including increased mortality, hospital costs and prolonged hospitalisation. The primary objective of this study is to detect whether there is a possible signal towards PPC reduction with the use of additional intermittent non-invasive ventilation (NIV) compared with continuous high-flow nasal oxygen therapy alone following high-risk elective upper abdominal surgery. Secondary objectives are to measure feasibility of: (1) trial conduct and design and (2) physiotherapy-led NIV and a high-flow nasal oxygen therapy protocol, safety of NIV and to provide preliminary costs of care information of NIV and high-flow nasal oxygen therapy.

Methods and analysis

This is a single-centre, parallel group, assessor blinded, pilot, randomised trial, with 130 high-risk upper abdominal surgery patients randomly assigned via concealed allocation to either (1) usual care of continuous high-flow nasal oxygen therapy for 48 hours following extubation or (2) usual care plus five additional 30 min physiotherapy-led NIV sessions within the first two postoperative days. Both groups receive standardised preoperative physiotherapy and postoperative early ambulation. No additional respiratory physiotherapy is provided to either group. Outcome measures will assess incidence of PPC within the first 14 postoperative days, recruitment ability, physiotherapy-led NIV and high-flow nasal oxygen therapy protocol adherence, adverse events relating to NIV delivery and costs of providing a physiotherapy-led NIV and a high-flow nasal oxygen therapy service following upper abdominal surgery.

Ethics and dissemination

Ethics approval has been obtained from the relevant institution and results will be published to inform future multicentre trials.

Trial registration number

ACTRN12617000269336; Pre-results.

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<![CDATA[Goal-directed fluid therapy in urgent GAstrointestinal Surgery—study protocol for A Randomised multicentre Trial: The GAS-ART trial]]> https://www.researchpad.co/article/5c19b10dd5eed0c484c4bbf3

Introduction

Intravenous fluid therapy during gastrointestinal surgery is a life-saving part of the perioperative care. Too little fluid may lead to hypovolaemia, decreased organ perfusion and circulatory shock. Excessive fluid administration increases postoperative complications, worsens pulmonary and cardiac function as well as the healing of surgical wounds. Intraoperative individualised goal-directed fluid therapy (GDT) and zero-balance therapy (weight adjusted) has shown to reduce postoperative complications in elective surgery, but studies in urgent gastrointestinal surgery are sparse. The aim of the trial is to test whether zero-balance GDT reduces postoperative mortality and major complications following urgent surgery for obstructive bowel disease or perforation of the gastrointestinal tract compared with a protocolled standard of care.

Methods/analysis

This study is a multicentre, randomised controlled trial with planned inclusion of 310 patients. The randomisation procedure is stratified by hospital and by obstructive bowel disease and perforation of the gastrointestinal tract. Patients are allocated into either ‘the standard group’ or ‘the zero-balance GDT group’. The latter receive intraoperative GDT (guided by a stroke volume algorithm) and postoperative zero-balance fluid therapy based on body weight and fluid charts. The protocolled treatment continues until free oral intake or the seventh postoperative day.

The primary composite outcome is death, unplanned reoperations, life-threatening thromboembolic and bleeding complications, a need for mechanical ventilation or dialysis. Secondary outcomes are additional complications, length of hospital stay, length of stay in the intensive care unit, length of mechanical ventilation, readmissions and time to death. Follow-up is 90 days.

We plan intention-to-treat analysis of the primary outcome.

Ethics and dissemination

The Danish Scientific Ethics Committee approved the GAS-ART trial before patient enrolment (J: SJ-436). Enrolment of patients began in August 2015 and is proceeding. We expect to publish the GAS-ART results in Summer 2019.

Trial registration number

EudraCT 2015-000563-14.

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<![CDATA[Finnish Subacromial Impingement Arthroscopy Controlled Trial (FIMPACT): a protocol for a randomised trial comparing arthroscopic subacromial decompression and diagnostic arthroscopy (placebo control), with an exercise therapy control, in the treatment of shoulder impingement syndrome]]> https://www.researchpad.co/article/5b46c0d6463d7e636e826ab9

Introduction

Arthroscopic subacromial decompression (ASD) is the most commonly performed surgical intervention for shoulder pain, yet evidence on its efficacy is limited. The rationale for the surgery rests on the tenet that symptom relief is achieved through decompression of the rotator cuff tendon passage. The primary objective of this superiority trial is to compare the efficacy of ASD versus diagnostic arthroscopy (DA) in patients with shoulder impingement syndrome (SIS), where DA differs only by the lack of subacromial decompression. A third group of supervised progressive exercise therapy (ET) will allow for pragmatic assessment of the relative benefits of surgical versus non-operative treatment strategies.

Methods and Analysis

Finnish Subacromial Impingement Arthroscopy Controlled Trial is an ongoing multicentre, three-group randomised controlled study. We performed two-fold concealed allocation, first by randomising patients to surgical (ASD or DA) or conservative (ET) treatment in 2:1 ratio and then those allocated to surgery further to ASD or DA in 1:1 ratio. Our two primary outcomes are pain at rest and at arm activity, assessed using visual analogue scale (VAS). We will quantify the treatment effect as the difference between the groups in the change in the VAS scales with the associated 95% CI at 24 months. Our secondary outcomes are functional assessment (Constant score and Simple shoulder test), quality of life (15D and SF-36), patient satisfaction, proportions of responders and non-responders, reoperations/treatment conversions, all at 2 years post-randomisation, as well as adverse effects and complications. We recruited a total of 210 patients from three tertiary referral centres. We will conduct the primary analysis on the intention-to-treat basis.

Ethics and Dissemination

The study was approved by the Institutional Review Board of the Pirkanmaa Hospital District and duly registered at ClinicalTrials.gov. The findings of this study will be disseminated widely through peer-reviewed publications and conference presentations.

Trial registration number

NCT00428870; Pre-results.

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