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Outcomes of Hip Arthroscopy in Patients with Femoroacetabular Impingement and Concomitant Tönnis Grade II Osteoarthritis or Greater: Protocol for a Systematic Review. 髋关节镜治疗股髋臼撞击合并Tönnis II级或以上骨关节炎的结果:系统评价方案
IF 0.9 Q3 SURGERY Pub Date : 2021-03-16 DOI: 10.29337/ijsp.26
Octavian Andronic, Leica Claydon, Rachael Cubberley, Karadi Hari Sunil-Kumar, Vikas Khanduja

Introduction: Outcomes of hip arthroscopy for femoroacetabular impingement and concomitant moderate- to advanced hip osteoarthritis (Tönnis Grade II or greater) is still a matter of debate as findings in the literature are controversial. This study aims to investigate whether hip arthroscopy is effective in treating patients with femoroacetabular impingement and Tönnis hip osteoarthritis Grade II or greater.

Methods and analysis: The protocol follows the PRISMA-P guidelines. The systematic review is registered in the International Prospective Register for Systematic Reviews and Meta-analysis (PROSPERO) under the registration number: CRD42020210936. The search will include multiple databases: MEDLINE, EMBASE, Web of Science Core Collection and Cochrane library. The screening and selection process will be performed by two independent researchers based on predefined criteria. All studies published in English or German from inception to 1st of December 2020 that investigated outcomes of hip arthroscopy in patients with Tönnis grade II or greater of hip osteoarthritis will be considered eligible. The risk of bias and quality of articles will be assessed using the MINORS tool. Methodological inconsistency and heterogeneity will be explored using the I2 test. This assessment will be used to provide recommendations using the GRADE system.

Ethics and dissemination: Separate ethical approval is not required. This study will be a comprehensive and rigorous systematic review on all published articles reporting on outcomes of hip arthroscopy for femoroacetabular impingement and concomitant hip osteoarthritis Tönnis Grade II or greater. It will explore patient reported outcomes as well as radiological outcomes, complications, rates of revision surgery and rates of conversion to total hip replacement (THR). Results of the current review will be published in a peer-reviewed scientific journal and disseminated on research platforms according to copyright rules and rights.

Highlights: Hip arthroscopy is used to treat femoroacetabular impingement and is effective in patients that have concomitant hip osteoarthritis Tönnis Grade 0 or 1.Outcomes of hip arthroscopy in patients with femoroacetabular impingement and in moderate to advanced osteoarthritis - Tönnis Grade 2 or greater, is a matter of debate.The purpose of the current systematic review is to elucidate, stratify and critical appraise the current evidence on outcomes in this patient subpopulation.

导读:髋关节镜治疗股髋臼撞击并伴有中晚期髋关节骨关节炎(Tönnis II级或以上)的结果仍然是一个有争议的问题,因为文献中的发现是有争议的。本研究旨在探讨髋关节镜治疗股髋臼撞击合并Tönnis II级及以上髋关节骨性关节炎患者是否有效。方法和分析:该方案遵循PRISMA-P指南。该系统评价已在国际前瞻性系统评价和荟萃分析注册(PROSPERO)中注册,注册号为CRD42020210936。搜索将包括多个数据库:MEDLINE, EMBASE, Web of Science Core Collection和Cochrane library。筛选和选择过程将由两名独立的研究人员根据预先确定的标准进行。从开始到2020年12月1日,所有以英语或德语发表的研究调查Tönnis II级或以上髋关节骨关节炎患者髋关节镜检查结果的研究将被认为符合条件。偏倚风险和文章质量将使用未成年人工具进行评估。方法学上的不一致和异质性将使用I2检验进行探讨。该评估将用于使用GRADE系统提供建议。伦理和传播:不需要单独的伦理批准。本研究将对所有已发表的关于髋关节镜治疗股髋臼撞击和伴发髋关节骨性关节炎Tönnis II级或以上的结果的文章进行全面、严格的系统综述。它将探讨患者报告的结果以及放射学结果、并发症、翻修手术率和转换为全髋关节置换术(THR)的率。本次评审的结果将在同行评审的科学期刊上发表,并根据版权规则和权利在研究平台上传播。重点:髋关节镜用于治疗股髋臼撞击,对伴有髋关节骨性关节炎Tönnis 0级或1级的患者有效。股骨髋臼撞击和中晚期骨关节炎(Tönnis 2级或以上)患者的髋关节镜检查结果存在争议。本系统综述的目的是阐明、分层和批判性评价该患者亚群的结果的现有证据。
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引用次数: 5
Protocol for a Systematic Review Assessing Surgery versus Primary Endocrine Therapy in Operable Breast Cancer. Prep for Pandemic 评估手术与原发性内分泌治疗在可手术乳腺癌中的系统评价方案。为大流行做准备
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.10.003
Sacha Roberts, Aram Rojas, Mahir Gachabayov, Maria Castaldi

Introduction

In COVID-19 pandemic epicenters cancer care was severely impacted. All elective and semi-elective procedures, as well as select urgent cases, were postponed in order to preserve resources and protect patients and staff from SARS-CoV-2 exposure. Structured decision making for breast cancer treatment resulted in deferment of surgery with initiation of endocrine therapy. Moreover, the waitlist for elective breast cancer procedures after mitigation is a challenge for prioritization.

Objective and significance

We aim to summarize the current body of evidence, comparatively evaluate oncological outcomes of surgery versus primary endocrine therapy (PET), and determine whether PET is a viable long-term alternative to surgery in the context of crisis management strategy for early, operable hormone receptor positive (HRP) breast cancer. PET could potentially be an acceptable bridging or maintenance therapy in select patients during pandemic crisis or for those choosing to forgo surgery in the treatment of breast cancer.

Methods and analysis

The database search includes PubMed, EMBASE, and MEDLINE (via Ovid). This systematic review includes women 18 years or older undergoing one of two interventions for HRP breast cancer: surgery (with or without endocrine therapy post-surgery) or solely PET. Studies comparing one of the two interventions of interest to a non-relevant intervention and studies reporting only descriptive data will not be included in the quantitative synthesis of data. After selection of eligible studies based on title and abstract, these studies will be further screened through full text articles by two independent reviewers, with a third as an arbitrator. Eligible studies will be critically appraised at the study level for methodological quality. Cochrane methodology will be utilized for meta-analysis.

Ethics and dissemination

This study does not require an institutional review board approval given its summary design nature. Findings of this systematic review will be published in a peer-reviewed journal.

在COVID-19大流行中心,癌症治疗受到严重影响。所有选择性和半选择性手术以及部分紧急病例都被推迟,以保留资源并保护患者和工作人员免受SARS-CoV-2暴露。乳腺癌治疗的结构化决策导致手术延迟开始内分泌治疗。此外,缓解后的选择性乳腺癌手术的等待名单是优先排序的挑战。目的和意义我们旨在总结目前的证据,比较评估手术与原发性内分泌治疗(PET)的肿瘤学结果,并确定在早期可手术的激素受体阳性(HRP)乳腺癌的危机管理策略中,PET是否是一种可行的长期替代手术。在大流行危机期间,PET可能是一种可接受的桥接或维持治疗,对于那些选择放弃手术治疗乳腺癌的患者。方法与分析数据库检索包括PubMed, EMBASE和MEDLINE(通过Ovid)。本系统综述包括18岁或以上接受两种干预措施之一治疗HRP乳腺癌的妇女:手术(术后伴或不伴内分泌治疗)或单纯PET。将两种相关干预措施中的一种与非相关干预措施进行比较的研究以及仅报告描述性数据的研究将不包括在数据的定量综合中。在根据标题和摘要选出符合条件的研究后,这些研究将由两名独立审稿人进一步通过全文文章进行筛选,第三名作为仲裁员。合格的研究将在研究水平上对方法学质量进行严格评价。meta分析将采用Cochrane方法学。伦理和传播考虑到其概要设计的性质,本研究不需要机构审查委员会的批准。本系统综述的结果将发表在同行评议的期刊上。
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引用次数: 1
Adult cardiac surgical cost variation around the world: Protocol for a systematic review 世界各地成人心脏手术费用变化:系统评价方案
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.07.004
Dominique Vervoort , Camila R. Guetter , Lena Trager , Priyansh Shah , Carlos Eduardo Diaz-Castrillon , Eric W. Etchill , Rawn Salenger

Introduction

Globally, over one million cardiac operations occur each year, whereas cardiac surgery is expensive and largely inaccessible without insurance or philanthropic support. Substantial cost variation has been reported within cardiac surgery in the United States and among non-cardiac surgical procedures globally, but little is known on the global procedural cost variation for common adult cardiac surgical procedures.

Objectives and significance

This review seeks to assess variation in procedural costs of coronary artery bypass grafting (CABG), mitral valve repair, mitral valve replacement, aortic valve repair, aortic valve replacement, and combined CABG-mitral or CABG-aortic valve procedures between and within countries. Results may give insights in the scope and drivers of cost variation around the world, posing cost reduction lessons. Results may further inform the potential of economies of scale in reducing procedural costs, benefiting patients, hospitals, governments, and insurers.

Methods and analysis

A systematic review will be performed using the EconLit, Embase, PubMed/MEDLINE, Web of Science, and WHO Global Index Medicus databases to identify articles published between January 1, 2000 and June 1, 2020. Studies describing procedural costs for CABG, mitral valve repair, mitral valve replacement, aortic valve repair, aortic valve replacement, and combined CABG-mitral or CABG-aortic valve procedures will be identified. Articles describing other types of cardiac surgery, concomitant aortic surgery, only describing costs related to non-surgical care, or with incomplete cost data will be excluded from the analysis. No exclusion will be based solely on article type or language. Identified costs will be converted to 2019 USD to account for local currency unit inflation and exchange fluctuations.

Ethics and dissemination

This study protocol has been prospectively registered on the International Platform of Registered Systematic Review and Meta-analysis Protocols. This review requires no institutional review board approval. Results of this study will be summarized and disseminated in a peer-review journal.

在全球范围内,每年有超过100万例心脏手术,而心脏手术是昂贵的,而且在没有保险或慈善支持的情况下,大部分人无法进行心脏手术。据报道,美国心脏手术和全球非心脏手术的成本差异很大,但对普通成人心脏手术的全球成本差异知之甚少。目的和意义本综述旨在评估各国之间冠状动脉旁路移植术(CABG)、二尖瓣修复、二尖瓣置换术、主动脉瓣修复、主动脉瓣置换术以及冠状动脉-二尖瓣或冠状动脉-主动脉瓣联合手术的手术成本差异。结果可能会对世界各地成本变化的范围和驱动因素提供见解,提出降低成本的经验教训。结果可能进一步说明规模经济在降低程序成本方面的潜力,使患者、医院、政府和保险公司受益。方法和分析将使用EconLit、Embase、PubMed/MEDLINE、Web of Science和WHO Global Index Medicus数据库进行系统评价,以确定2000年1月1日至2020年6月1日期间发表的文章。研究将描述冠状动脉搭桥、二尖瓣修复、二尖瓣置换术、主动脉瓣修复、主动脉瓣置换术以及冠状动脉搭桥-二尖瓣或冠状动脉搭桥-主动脉瓣联合手术的手术成本。描述其他类型心脏手术、合并主动脉手术、仅描述与非手术护理相关的费用或费用数据不完整的文章将被排除在分析之外。排除将不会仅仅基于文章类型或语言。已确定的费用将转换为2019年美元,以考虑当地货币单位通货膨胀和汇率波动。伦理和传播本研究方案已在国际系统评价和荟萃分析方案注册平台上前瞻性注册。这项审查不需要机构审查委员会的批准。本研究结果将在同行评议期刊上进行总结和传播。
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引用次数: 0
CRC COVID: Colorectal cancer services during COVID-19 pandemic. Study protocol for service evaluation CRC COVID: COVID-19大流行期间的结直肠癌服务。服务评估的研究方案
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.07.005
Alona Courtney , Ann-Marie Howell , Najib Daulatzai , Nicos Savva , Oliver Warren , Sarah Mills , Shahnawaz Rasheed , Goel Milind , Nicholas Tekkis , Matthew Gardiner , Tinglong Dai , Bashar Safar , Jonathan E Efron , Ara Darzi , Paris Tekkis , Christos Kontovounisios

Introduction

COVID-19 has had an impact on the provision of colorectal cancer care. The aim of the CRC COVID study is to describe the changes in colorectal cancer services in the UK and USA in response to the pandemic and to understand the long-term impact.

Methods and analysis

This study comprises 4 phases. Phase 1 is a survey of colorectal units that aims to evaluate adherences and deviations from the best practice guidelines during the COVID-19 pandemic. Phase 2 is a monthly prospective data collection of service provision that aims to determine the impact of the service modifications on the long-term cancer specific outcomes compared to the national standards. Phase 3 aims to predict costs attributable to the modifications of the CRC services and additional resources required to treat patients whose treatment has been affected by the pandemic. Phase 4 aims to compare the impact of COVID-19 on the NHS and USA model of healthcare in terms of service provision and cost, and to propose a standardised model of delivering colorectal cancer services for future outbreaks.

Ethics and dissemination

This study is a service evaluation and does not require HRA Approval or Ethical Approval in the UK. Local service evaluation registration is required for each participating centre. In the USA, Ethical Approval was granted by the Research and Development Committee. The results of this study will be disseminated to stakeholders, submitted for peer review publications, conference presentations and circulated via social media.

Registration details

Nil.

covid -19对结直肠癌护理的提供产生了影响。CRC COVID研究的目的是描述英国和美国应对大流行的结直肠癌服务的变化,并了解其长期影响。方法与分析本研究分为四个阶段。第一阶段是对结直肠单位的调查,旨在评估在COVID-19大流行期间遵守和偏离最佳实践指南的情况。第二阶段是每月收集服务提供的前瞻性数据,旨在确定与国家标准相比,服务修改对长期癌症特定结果的影响。第三阶段的目的是预测由于CRC服务的改变而产生的费用,以及治疗受大流行影响的患者所需的额外资源。第4阶段旨在比较COVID-19对NHS和美国医疗保健模式在服务提供和成本方面的影响,并提出一种为未来疫情提供结直肠癌服务的标准化模式。伦理和传播本研究是一项服务评估,在英国不需要HRA批准或伦理批准。每个参与中心都需要进行本地服务评估注册。在美国,研究与发展委员会批准了伦理批准。这项研究的结果将分发给利益相关者,提交同行评审出版物、会议报告,并通过社交媒体传播。登记detailsNil。
{"title":"CRC COVID: Colorectal cancer services during COVID-19 pandemic. Study protocol for service evaluation","authors":"Alona Courtney ,&nbsp;Ann-Marie Howell ,&nbsp;Najib Daulatzai ,&nbsp;Nicos Savva ,&nbsp;Oliver Warren ,&nbsp;Sarah Mills ,&nbsp;Shahnawaz Rasheed ,&nbsp;Goel Milind ,&nbsp;Nicholas Tekkis ,&nbsp;Matthew Gardiner ,&nbsp;Tinglong Dai ,&nbsp;Bashar Safar ,&nbsp;Jonathan E Efron ,&nbsp;Ara Darzi ,&nbsp;Paris Tekkis ,&nbsp;Christos Kontovounisios","doi":"10.1016/j.isjp.2020.07.005","DOIUrl":"10.1016/j.isjp.2020.07.005","url":null,"abstract":"<div><h3>Introduction</h3><p>COVID-19 has had an impact on the provision of colorectal cancer care. The aim of the CRC COVID study is to describe the changes in colorectal cancer services in the UK and USA in response to the pandemic and to understand the long-term impact.</p></div><div><h3>Methods and analysis</h3><p>This study comprises 4 phases. Phase 1 is a survey of colorectal units that aims to evaluate adherences and deviations from the best practice guidelines during the COVID-19 pandemic. Phase 2 is a monthly prospective data collection of service provision that aims to determine the impact of the service modifications on the long-term cancer specific outcomes compared to the national standards. Phase 3 aims to predict costs attributable to the modifications of the CRC services and additional resources required to treat patients whose treatment has been affected by the pandemic. Phase 4 aims to compare the impact of COVID-19 on the NHS and USA model of healthcare in terms of service provision and cost, and to propose a standardised model of delivering colorectal cancer services for future outbreaks.</p></div><div><h3>Ethics and dissemination</h3><p>This study is a service evaluation and does not require HRA Approval or Ethical Approval in the UK. Local service evaluation registration is required for each participating centre. In the USA, Ethical Approval was granted by the Research and Development Committee. The results of this study will be disseminated to stakeholders, submitted for peer review publications, conference presentations and circulated via social media.</p></div><div><h3>Registration details</h3><p>Nil.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"23 ","pages":"Pages 15-19"},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.07.005","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38295734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The B-MaP-C study: Breast cancer management pathways during the COVID-19 pandemic. Study protocol B-MaP-C研究:COVID-19大流行期间乳腺癌管理途径研究协议
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.07.003
Alona Courtney , Rachel O'Connell , Tim Rattay , Baek Kim , Ramsey I. Cutress , Cliona C. Kirwan , Ashu Gandhi , Patricia Fairbrother , Nisha Sharma , Christopher W.J. Cartlidge , Kieran Horgan , Stuart A. McIntosh , Daniel R. Leff , Raghavan Vidya , Shelley Potter , Chris Holcombe , Ellen Copson , Charlotte E. Coles , Rajiv V. Dave

Introduction

Approximately 55,000 women in the United Kingdom are diagnosed with new breast cancer annually. Since emerging in December 2019, SARS-CoV-2 (coronavirus disease 2019, COVID-19) has become a global pandemic, affecting healthcare delivery worldwide. In response to the pandemic, multiple guidelines were issued to assist with rationalising breast cancer care. The primary aim of the B-MaP-C study is to audit and describe breast cancer management of patients newly diagnosed with breast cancer during the COVID-19 pandemic against pre-COVID-19 management practice in the UK. The implications of changes to management will be determined and the impact of a COVID-19 diagnosis on the patient’s breast cancer management will be determined.

Methods and analysis

This is a multi-centre collaborative audit of consecutive breast cancer patients undergoing treatment decisions during the acute and recovery phases of the COVID-19 pandemic. All patients with newly diagnosed primary breast cancer, whose treatment was decided in a multidisciplinary meeting from the 16th March 2020, are eligible for inclusion.

Ethics and dissemination

As this is an audit ethical approval is not required. Each participating centre is required to register the study locally and obtain local governance approvals prior to commencement of data collection. Local audit data will be available to individual participating units for governance purposes. The results of the data analysis will be submitted for publication, as well as disseminated via the ABS newsletter and a webinar. All data will be presented at national and international conferences, circumstances permitting.

Registration details

Each participating centre received local governance audit registration.

在英国,每年大约有55,000名女性被诊断为新发乳腺癌。自2019年12月出现以来,SARS-CoV-2(2019冠状病毒病,COVID-19)已成为全球大流行,影响了全球的医疗保健服务。为应对这一流行病,发布了多项准则,以协助使乳腺癌护理合理化。B-MaP-C研究的主要目的是审计和描述在2019冠状病毒病大流行期间新诊断为乳腺癌的患者的乳腺癌管理与英国COVID-19前的管理实践。将确定管理变化的影响,并确定COVID-19诊断对患者乳腺癌管理的影响。方法和分析这是一项对2019冠状病毒病大流行急性期和恢复期连续接受治疗决策的乳腺癌患者的多中心协作审计。所有在2020年3月16日起的多学科会议上决定治疗的新诊断原发性乳腺癌患者都有资格纳入研究。道德和传播由于这是审计,不需要道德批准。每个参与中心都必须在当地注册研究,并在开始数据收集之前获得当地政府的批准。本地审计数据将提供给各个参与单位用于治理目的。数据分析的结果将提交出版,并通过ABS通讯和网络研讨会进行传播。如果情况允许,所有数据将在国家和国际会议上提交。各参与中心已接受本地管治审核注册。
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引用次数: 6
The effectiveness of low-level laser therapy combined with facial expression exercises in patients with moderate-to-severe Bell's palsy: A study protocol for a randomised controlled trial 低水平激光治疗结合面部表情练习对中重度贝尔氏麻痹患者的有效性:一项随机对照试验的研究方案
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.11.001
Praveen Kumar Kandakurti , Sukumar Shanmugam , Shaikh Altaf Basha , Sampath Kumar Amaravadi , Prathap Suganthirababu , Kumaraguruparan Gopal , Geovinson Stephen George

Background

Even though corticosteroid therapy and facial expression exercises were found to be effective, still 30% of participants with bell’s palsy achieve incomplete recovery from the facial paralysis. The study objective was to evaluate the effectiveness of low-level laser therapy (LLLT) combined with progressive facial expression exercises in participants with moderate to severe bell’s palsy.

Methodology

A total of 120 participants with idiopathic bell’s palsy to be equally allocated in three groups. LLLT, electrical stimulation and corticosteroid/antiviral therapy will be performed respectively in the group I, group II and Group III and facial expression exercises as a common intervention. First two groups to be treated with respective interventions weekly 3 days for 6 consecutive weeks and third group will receive prescribed doses of medications and facial expression exercise for 6 weeks. The functional recovery will be assessed at baseline, 3 weeks, 6 weeks, and 12 weeks using the Facial Disability Index and House-Brackmann Scale. The overall within and between group differences in the clinical outcomes to be reported based on the Friedman Repeated Measures ANOVA and Kruskal-Wallis test. Whereas Wilcoxon Signed Rank and Mann-Whitney-U tests will be performed to report the within and between groups timeline differences.

Discussion

Based on the dearth of evidence for the effective treatment of moderate to severe bell’s palsy, we framed a most appropriate LLLT dosage along with facial expression exercises. Our study’s intervention protocol designed with equal duration and number of interventions for all three groups. Even the comparator groups such as electrical muscle stimulation and Corticosteroids therapy will be receiving similar facial expression exercises. We believe that this intervention protocol would benefit by promoting the complete facial function recovery in patients with moderate to severe bell’s palsy.

Dissemination

We plan to publish this review in a peer-reviewed journal. We may also present this review at local and/or national conferences.

尽管皮质类固醇治疗和面部表情练习被发现是有效的,但仍有30%的贝尔氏麻痹患者从面瘫中完全恢复。研究目的是评估低水平激光治疗(LLLT)结合渐进式面部表情练习对中度至重度贝尔氏麻痹患者的有效性。方法将120例特发性铃性麻痹患者平均分为三组。在I组、II组和III组分别进行LLLT、电刺激和皮质类固醇/抗病毒治疗,面部表情练习作为常见干预。前两组采用各自的干预措施,每周3天,连续6周;第三组采用规定剂量的药物治疗和面部表情练习,连续6周。使用面部残疾指数和House-Brackmann量表在基线、3周、6周和12周评估功能恢复情况。根据Friedman重复测量方差分析和Kruskal-Wallis检验报告临床结果的组内和组间总体差异。而Wilcoxon sign Rank和Mann-Whitney-U检验将用于报告组内和组间时间线差异。基于缺乏有效治疗中度至重度贝尔氏麻痹的证据,我们制定了最合适的LLLT剂量以及面部表情练习。本研究的干预方案为三组设计了相同的干预时间和数量。即使是比较组,如肌肉电刺激和皮质类固醇治疗,也将接受类似的面部表情练习。我们相信这种干预方案将有利于促进中度至重度贝尔氏麻痹患者面部功能的完全恢复。我们计划在同行评议的期刊上发表这篇综述。我们也可能在地方和/或国家会议上介绍这篇综述。
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引用次数: 4
Feasibility study of stem-cell enriched autologous lipotransfer to treat oro-facial fibrosis in systemic sclerosis (Sys-Stem): Protocol for open-label randomised controlled trial 干细胞富集自体脂肪移植治疗系统性硬化症(system - stem)患者口面部纤维化的可行性研究:开放标签随机对照试验方案
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.07.002
Faith Hyun Kyung Jeon , Michelle Griffin , Christopher Paul Denton , Peter Edward Michael Butler

Introduction

Oro-facial fibrosis is a common and disabling manifestation of systemic sclerosis (SSc), causing a plethora of functional, aesthetic and social compromise, yet is without effective treatment. Autologous lipotransfer is an established minimally invasive surgical procedure that is postulated to exert anti-fibrotic effects by adipose-derived stem cells, and presents a novel method in the treatment of fibrotic conditions. This study aims to assess the safety and efficacy of autologous lipotransfer for facial involvement in SSc.

Methods and analysis

This is the first randomised controlled study with an open label design to assess autologous lipotransfer for oro-facial involvement in systemic sclerosis. The goals of this study are to assess the feasibility of using a range of quantitative and qualitative outcome measures to effectively measure disease severity and treatment outcome, and to assess patient acceptability for future multi-centre trials. A total of 50 participants will be randomised to a treatment or control group. The treatment group will receive autologous fat transfer to the peri-oral region by a single surgeon. Dermal fibroblasts and adipose-derived stem cells will be isolated from tissue samples. All outcome measures will be taken at baseline, then at 6 weeks, 3 months and 6 months from the time of intervention in the treatment arm, or from baseline in the control arm.

Ethics and dissemination

The study has ethical approval (REC reference 19/LO/0718). Results will be available to patients, patient user groups, clinicians and the public through presentations at national and international rheumatology conferences and published in peer reviewed journals.

Trial registration

Registered on ISRCTN registry (ISRCTN17793055).

面部纤维化是系统性硬化症(SSc)的一种常见且致残的表现,导致过多的功能、美学和社会损害,但目前尚无有效的治疗方法。自体脂肪移植是一种已建立的微创外科手术,被认为可以通过脂肪来源的干细胞发挥抗纤维化作用,是治疗纤维化疾病的一种新方法。本研究旨在评估自体脂肪移植治疗SSc面部受损伤的安全性和有效性。方法和分析:这是首个采用开放标签设计的随机对照研究,旨在评估自体脂肪移植治疗累及全身硬化症患者的口腔-面部。本研究的目的是评估使用一系列定量和定性结果测量来有效测量疾病严重程度和治疗结果的可行性,并评估患者对未来多中心试验的可接受性。总共50名参与者将被随机分配到治疗组或对照组。治疗组由一名外科医生将自体脂肪移植到口腔周围。将从组织样本中分离出真皮成纤维细胞和脂肪来源的干细胞。所有结果测量将在基线时进行,然后在治疗组进行干预后6周、3个月和6个月,或在对照组进行基线时进行。该研究已获得伦理批准(REC参考19/LO/0718)。研究结果将通过在国家和国际风湿病学会议上的报告以及在同行评议期刊上的发表,提供给患者、患者用户群体、临床医生和公众。试验注册在ISRCTN注册表(ISRCTN17793055)上注册。
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引用次数: 4
Designing an intervention program over the effects of Pilates on pregnancy outcomes among the pregnant women: A protocol study 设计普拉提对孕妇妊娠结局影响的干预方案:一项协议研究
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.10.004
Bahareh Mothaghi Dastenaei , Fereshteh Aein , Faranak Safdari , Zohreh Karimiankakolaki

Background

Pregnancy is a pleasure for most women, it is often considered as a stressful period with physiological, anatomical, biochemical, and psychological changes. Pilates exercise improved quality of life in women. Therefore, the present study targeted at designing an intervention program over the effects of Pilates on pregnancy outcomes among the pregnant women.

Methods

In this protocol, a clinical intervention will be designed in three phases. In the first phase of the study, a researcher-made checklist will be used to evaluate the pregnancy and neonatal outcomes based on the literature review. In the second phase, an intervention program of Pilates exercise will be conducted according to different studies and viewpoints of a panel of reproductive health and physical activity specialists. The exercises will include two sessions of 30 minutes per week for 12 weeks conducted under the supervision of a qualified trainer. The third phase of the intervention will include the pre-test and post-test using a standard questionnaire and a researcher-made checklist for the two intervention groups and one control group.

Discussions

The present study provides useful data regarding the design of a Pilates exercise intervention program for pregnant women with the aim of influencing pregnancy and neonatal outcomes, reducing depression, low back pain and improving maternal mental health. It can also reduce their medical and treatment costs. The strategies of this program could be important and cost effective, and therefore we hope that the success of such a program is a step forward in improving reproductive health status.

怀孕对大多数女性来说是一件快乐的事,它通常被认为是生理、解剖、生化和心理变化的紧张时期。普拉提运动提高了女性的生活质量。因此,本研究旨在设计一个干预方案,以了解普拉提对孕妇妊娠结局的影响。方法本方案将临床干预设计分为三个阶段。在研究的第一阶段,将根据文献综述,使用研究者制作的检查表来评估妊娠和新生儿结局。在第二阶段,将根据一组生殖健康和体育活动专家的不同研究和观点,实施普拉提运动的干预方案。练习将包括在合格教练的监督下进行的每周30分钟的两次练习,为期12周。干预的第三阶段将包括使用标准问卷和研究人员为两个干预组和一个对照组制作的检查表进行前测试和后测试。本研究为孕妇普拉提运动干预方案的设计提供了有用的数据,旨在影响妊娠和新生儿结局,减少抑郁、腰痛和改善产妇心理健康。它还可以减少他们的医疗和治疗费用。这一方案的战略可能是重要的和具有成本效益的,因此我们希望这一方案的成功是在改善生殖健康状况方面向前迈出的一步。
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引用次数: 4
Venous thromboembolic events after bariatric surgery: Protocol for a systematic review and meta-analysis 减肥手术后静脉血栓栓塞事件:系统回顾和荟萃分析的方案
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.06.001
Walid El Ansari , Brijesh Sathian , Ayman El-Menyar

Introduction

Considerably large numbers of bariatric surgery (BS) procedures are undertaken globally, and are projected to increase with the obesity epidemic. Venous thromboembolic events (VTE) comprise an important cause of postoperative morbidity and mortality after BS and an important issue with wide clinical and financial repercussions. Yet, a precise extent of the prevalence of VTE after BS for obesity and its mortality remains uncertain.

Methods and analysis

In order to respond to this knowledge gap, we will conduct a systematic review and meta-analysis of the prevalence of and mortality associated with VTE after BS. This protocol outlines the methodology that will be used and the search strategies and eligibility criteria that will be utilized to identify and select studies, as well as the method by which data from the selected studies will be extracted for analysis. PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), WHO International Clinical Trials Registry Platform, Cochrane Library, MEDLINE, Scopus, clinicaltrials.gov and Google scholar will be searched from 01 January 1990 through 10th April 2020, for original studies written in English that provided prevalence estimates of VTE after BS. Articles will also be searched for mortality estimates of VTE after BS. STROCSS (Strengthening the Reporting of Cohort Studies in Surgery) criteria will evaluate the methodological quality of the selected studies. The use of fixed effect or random effects model will be subject to the findings of the statistical tests for heterogeneity. Publication bias will be visually estimated by inspecting the funnel plots. Pooled estimates will be computed. Th current protocol conforms to the Preferred Reporting Items for Systematic reviews and Meta-Analysis (PRISMA) guidelines and has been submitted to the PROSPERO International Prospective Register of systematic reviews. No ethical clearance is required for this study. This systematic review and meta-analysis will be published in a peer-reviewed journal and presented at national and international conferences.

在全球范围内进行了大量的减肥手术(BS),并且预计随着肥胖的流行而增加。静脉血栓栓塞事件(VTE)是BS术后发病率和死亡率的重要原因,也是一个具有广泛临床和经济影响的重要问题。然而,肥胖BS后静脉血栓栓塞的确切流行程度及其死亡率仍不确定。方法和分析为了应对这一知识空白,我们将对BS后静脉血栓栓塞的患病率和死亡率进行系统回顾和荟萃分析。本方案概述了将用于识别和选择研究的方法学、检索策略和资格标准,以及从所选研究中提取数据进行分析的方法。从1990年1月1日至2020年4月10日,将检索PubMed、Cochrane中央对照试验注册中心(Central)、世卫组织国际临床试验注册平台、Cochrane图书馆、MEDLINE、Scopus、clinicaltrials.gov和Google scholar,以查找提供BS后VTE患病率估计的英文原始研究。文章也将搜索静脉血栓栓塞后BS的死亡率估计。STROCSS(加强外科队列研究报告)标准将评估所选研究的方法学质量。使用固定效应或随机效应模型将取决于异质性的统计检验结果。发表偏倚将通过检查漏斗图进行视觉估计。将计算汇总估计。目前的方案符合系统评价和荟萃分析(PRISMA)指南的首选报告项目,并已提交给普洛斯彼罗国际前瞻性系统评价登记册。本研究不需要伦理许可。这一系统综述和荟萃分析将发表在同行评议的期刊上,并在国家和国际会议上发表。
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引用次数: 2
Management and outcomes following emergency surgery for traumatic brain injury – A multi-centre, international, prospective cohort study (the Global Neurotrauma Outcomes Study) 外伤性脑损伤急诊手术后的处理和结果——一项多中心、国际、前瞻性队列研究(全球神经创伤结局研究)
IF 0.9 Q3 SURGERY Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.02.001
David Clark , Alexis Joannides , Omar Ibrahim Abdallah , Amos Olufemi Adeleye , Abdul Hafid Bajamal , Tom Bashford , Arnold Bhebhe , Hagos Biluts , Natalia Budohoska , Karol Budohoski , Iype Cherian , Niklas Marklund , Rocio Fernandez Mendez , Tony Figaji , Deepak Kumar Gupta , Corrado Iaccarino , Ali Ilunga , Mathew Joseph , Tariq Khan , Tsegazeab Laeke , Peter Hutchinson

Introduction

Traumatic brain injury (TBI) accounts for a significant amount of death and disability worldwide and the majority of this burden affects individuals in low-and-middle income countries. Despite this, considerable geographical differences have been reported in the care of TBI patients. On this background, we aim to provide a comprehensive international picture of the epidemiological characteristics, management and outcomes of patients undergoing emergency surgery for traumatic brain injury (TBI) worldwide.

Methods and analysis

The Global Neurotrauma Outcomes Study (GNOS) is a multi-centre, international, prospective observational cohort study. Any unit performing emergency surgery for TBI worldwide will be eligible to participate. All TBI patients who receive emergency surgery in any given consecutive 30-day period beginning between 1st of November 2018 and 31st of December 2019 in a given participating unit will be included. Data will be collected via a secure online platform in anonymised form. The primary outcome measures for the study will be 14-day mortality (or survival to hospital discharge, whichever comes first). Final day of data collection for the primary outcome measure is February 13th. Secondary outcome measures include return to theatre and surgical site infection.

Ethics and dissemination

This project will not affect clinical practice and has been classified as clinical audit following research ethics review. Access to source data will be made available to collaborators through national or international anonymised datasets on request and after review of the scientific validity of the proposed analysis by the central study team.

外伤性脑损伤(TBI)在世界范围内造成大量死亡和残疾,这一负担主要影响低收入和中等收入国家的个人。尽管如此,据报道,在TBI患者的护理方面存在相当大的地理差异。在此背景下,我们的目标是提供一个全面的国际流行病学特征,管理和世界范围内接受创伤性脑损伤(TBI)急诊手术患者的结局。全球神经创伤结局研究(GNOS)是一项多中心、国际、前瞻性观察队列研究。全球任何进行TBI急诊手术的单位都有资格参加。所有在2018年11月1日至2019年12月31日期间在特定参与单位连续30天内接受紧急手术的TBI患者都将被纳入其中。数据将通过一个安全的在线平台以匿名形式收集。本研究的主要结局指标为14天死亡率(或存活至出院,以先到者为准)。主要结果测量数据收集的最后一天是2月13日。次要结局指标包括返回手术室和手术部位感染。伦理与传播本项目不影响临床实践,在研究伦理审查后已被归类为临床审核。应要求并在中央研究小组审查拟议分析的科学有效性之后,将通过国家或国际匿名数据集向合作者提供对源数据的访问。
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引用次数: 9
期刊
International Journal of Surgery Protocols
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