International Journal of Surgery Protocols最新文献

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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
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.10.003
Sacha Roberts, Aram Rojas, Mahir Gachabayov, Maria Castaldi
{"title":"Protocol for a Systematic Review Assessing Surgery versus Primary Endocrine Therapy in Operable Breast Cancer. Prep for Pandemic","authors":"Sacha Roberts,&nbsp;Aram Rojas,&nbsp;Mahir Gachabayov,&nbsp;Maria Castaldi","doi":"10.1016/j.isjp.2020.10.003","DOIUrl":"10.1016/j.isjp.2020.10.003","url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Objective and significance</h3><p>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<strong>-</strong>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.</p></div><div><h3>Methods and analysis</h3><p>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.</p></div><div><h3>Ethics and dissemination</h3><p>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.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.10.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38689866","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: 1
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
International Journal of Surgery Protocols 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
{"title":"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","authors":"Faith Hyun Kyung Jeon ,&nbsp;Michelle Griffin ,&nbsp;Christopher Paul Denton ,&nbsp;Peter Edward Michael Butler","doi":"10.1016/j.isjp.2020.07.002","DOIUrl":"10.1016/j.isjp.2020.07.002","url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Methods and analysis</h3><p>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.</p></div><div><h3>Ethics and dissemination</h3><p>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.</p></div><div><h3>Trial registration</h3><p>Registered on ISRCTN registry (ISRCTN17793055).</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.07.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38270012","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: 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
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.10.004
Bahareh Mothaghi Dastenaei , Fereshteh Aein , Faranak Safdari , Zohreh Karimiankakolaki
{"title":"Designing an intervention program over the effects of Pilates on pregnancy outcomes among the pregnant women: A protocol study","authors":"Bahareh Mothaghi Dastenaei ,&nbsp;Fereshteh Aein ,&nbsp;Faranak Safdari ,&nbsp;Zohreh Karimiankakolaki","doi":"10.1016/j.isjp.2020.10.004","DOIUrl":"10.1016/j.isjp.2020.10.004","url":null,"abstract":"<div><h3>Background</h3><p>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<strong>.</strong> Therefore, the present study targeted at designing an intervention program over the effects of Pilates on pregnancy outcomes among the pregnant women.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Discussions</h3><p>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.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.10.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38304441","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: 4
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
International Journal of Surgery Protocols 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
{"title":"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","authors":"Praveen Kumar Kandakurti ,&nbsp;Sukumar Shanmugam ,&nbsp;Shaikh Altaf Basha ,&nbsp;Sampath Kumar Amaravadi ,&nbsp;Prathap Suganthirababu ,&nbsp;Kumaraguruparan Gopal ,&nbsp;Geovinson Stephen George","doi":"10.1016/j.isjp.2020.11.001","DOIUrl":"10.1016/j.isjp.2020.11.001","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methodology</h3><p>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-<em>U</em> tests will be performed to report the within and between groups timeline differences.</p></div><div><h3>Discussion</h3><p>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.</p></div><div><h3>Dissemination</h3><p>We plan to publish this review in a peer-reviewed journal. We may also present this review at local and/or national conferences.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.11.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38707496","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: 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
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.06.001
Walid El Ansari , Brijesh Sathian , Ayman El-Menyar
{"title":"Venous thromboembolic events after bariatric surgery: Protocol for a systematic review and meta-analysis","authors":"Walid El Ansari ,&nbsp;Brijesh Sathian ,&nbsp;Ayman El-Menyar","doi":"10.1016/j.isjp.2020.06.001","DOIUrl":"10.1016/j.isjp.2020.06.001","url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Methods and analysis</h3><p>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.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.06.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38109036","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: 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
International Journal of Surgery Protocols 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
{"title":"Management and outcomes following emergency surgery for traumatic brain injury – A multi-centre, international, prospective cohort study (the Global Neurotrauma Outcomes Study)","authors":"David Clark ,&nbsp;Alexis Joannides ,&nbsp;Omar Ibrahim Abdallah ,&nbsp;Amos Olufemi Adeleye ,&nbsp;Abdul Hafid Bajamal ,&nbsp;Tom Bashford ,&nbsp;Arnold Bhebhe ,&nbsp;Hagos Biluts ,&nbsp;Natalia Budohoska ,&nbsp;Karol Budohoski ,&nbsp;Iype Cherian ,&nbsp;Niklas Marklund ,&nbsp;Rocio Fernandez Mendez ,&nbsp;Tony Figaji ,&nbsp;Deepak Kumar Gupta ,&nbsp;Corrado Iaccarino ,&nbsp;Ali Ilunga ,&nbsp;Mathew Joseph ,&nbsp;Tariq Khan ,&nbsp;Tsegazeab Laeke ,&nbsp;Peter Hutchinson","doi":"10.1016/j.isjp.2020.02.001","DOIUrl":"10.1016/j.isjp.2020.02.001","url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Methods and analysis</h3><p>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.</p></div><div><h3>Ethics and dissemination</h3><p>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.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.02.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37770263","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: 9
Face, content, construct validity and training effect of touch surgery™ as a surgical decision-making trainer for novices in open appendicectomy touch surgery™作为开放性阑尾切除术新手手术决策培训课程的内容、内容、结构效度及培训效果
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.05.002
Chi Lap Nicholas Tsang , Jerry Cao , Kapil Sugand , Jacqui Chiu , Franz Casper Pretorius
{"title":"Face, content, construct validity and training effect of touch surgery™ as a surgical decision-making trainer for novices in open appendicectomy","authors":"Chi Lap Nicholas Tsang ,&nbsp;Jerry Cao ,&nbsp;Kapil Sugand ,&nbsp;Jacqui Chiu ,&nbsp;Franz Casper Pretorius","doi":"10.1016/j.isjp.2020.05.002","DOIUrl":"10.1016/j.isjp.2020.05.002","url":null,"abstract":"<div><h3>Background</h3><p>Laparoscopic surgery has become the gold standard for many operations with significant benefits in morbidity and hospital recovery time. One such procedure is appendicectomy, which is overwhelmingly performed using the laparoscopic approach in the modern era. This has also meant that the number of cases involving traditional open appendicectomy has declined despite surgeons being expected to be able to convert to the open technique if required. One method to rehearse for theatre is the use of software applications. This paper investigates the validity of Touch Surgery™ as an education tool for surgical decision-making for novices, as well as its training effect in open appendicectomy.</p></div><div><h3>Method</h3><p>70 participants will be recruited, consisting of 60 medical students (novices) and 10 surgical consultants (experts). For face, content, and construct validity, first attempt scores on the Touch Surgery™ Open Appendicectomy Test Module will be compared between novices and experts. For the training effect and knowledge decline elements of the study, novices will be further randomised into either the low intervention (control) group who will complete the simulation once, or to the high intervention group who will complete the simulation six times, with both novice groups asked to repeat the test one week later. All participants will also be requested to complete questionnaires regarding the stimulation.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.05.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38157388","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: 2
Efficacy of goal-directed minimally invasive surgery simulation training with the Lübeck Toolbox-Curriculum prior to first operations on patients: Study protocol for a multi-centre randomized controlled validation trial (NOVICE) 患者首次手术前使用l<s:1> beck工具箱课程进行目标导向微创手术模拟训练的效果:一项多中心随机对照验证试验的研究方案(新手)
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.02.004
Michael Thomaschewski , Tilman Laubert , Markus Zimmermann , Hamed Esnaashari , Reinhard Vonthein , Tobias Keck , Claudia Benecke
{"title":"Efficacy of goal-directed minimally invasive surgery simulation training with the Lübeck Toolbox-Curriculum prior to first operations on patients: Study protocol for a multi-centre randomized controlled validation trial (NOVICE)","authors":"Michael Thomaschewski ,&nbsp;Tilman Laubert ,&nbsp;Markus Zimmermann ,&nbsp;Hamed Esnaashari ,&nbsp;Reinhard Vonthein ,&nbsp;Tobias Keck ,&nbsp;Claudia Benecke","doi":"10.1016/j.isjp.2020.02.004","DOIUrl":"10.1016/j.isjp.2020.02.004","url":null,"abstract":"<div><h3>Background</h3><p>Minimally invasive surgery (MIS) procedures require special psychomotoric skills. Learning of these MIS basic skills is often performed in the operating room (OR). This is economically inefficient and could be improved in terms of patient safety. Against the background of this problem, various MIS simulators have been developed to train MIS basic skills outside the OR. Aim of this study is to evaluate to what extent MIS training programs and simulators improve the residents’ skills in performing their first MIS procedures on patients.</p></div><div><h3>Method</h3><p>The current multicentric RCT will be performed with surgical residents without prior active experience in MIS (n = 14). After the participants have completed their first laparoscopic cholecystectomy as baseline evaluation (CHE I), they will be randomized into two groups: 1) The intervention group will perform the <em>Lübeck Toolbox curriculum</em>, whereas 2) the control group will not undergo any MIS training. After 6 weeks, both groups will perform the second laparoscopic CHE (CHE II). Changes or improvements in operative performance (between CHE I and CHE II) will be analyzed and evaluated according to the <em>Global Operative Assessment of Laparoscopic Skill</em> (GOALS) Score (<em>primary endpoint</em>).</p></div><div><h3>Discussion</h3><p>The multicentric randomized controlled trial will help to determine the value of MIS training outside the operation room. Proof of effectiveness in practice transfer could be of considerable relevance with regard to an integration of MIS training programs into surgical education.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.02.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37862067","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: 1
Oral cancer screening using mobile phone-based(mHealth) approach versus conventional oral examination approach, protocol of a cluster randomized study with cost-effectiveness analysis 使用基于移动电话的(mHealth)方法与传统口腔检查方法进行口腔癌筛查,具有成本-效果分析的聚类随机研究方案
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.07.001
Krishnakumar Thankappan , Praveen Birur , Manu Raj , Sandjar Djalalov , Sujha Subramanian , Subramania Iyer , Moni Abraham Kuriakose
{"title":"Oral cancer screening using mobile phone-based(mHealth) approach versus conventional oral examination approach, protocol of a cluster randomized study with cost-effectiveness analysis","authors":"Krishnakumar Thankappan ,&nbsp;Praveen Birur ,&nbsp;Manu Raj ,&nbsp;Sandjar Djalalov ,&nbsp;Sujha Subramanian ,&nbsp;Subramania Iyer ,&nbsp;Moni Abraham Kuriakose","doi":"10.1016/j.isjp.2020.07.001","DOIUrl":"10.1016/j.isjp.2020.07.001","url":null,"abstract":"<div><h3>Introduction</h3><p>Oral cancer is a significant health problem in India. Diagnosis is often delayed. The effectiveness of conventional oral screening has been shown in the Trivandrum oral cancer screening study. The present study will be a step forward to test a mobile phone-based (the mHealth approach) comparing it with the conventional approach. The purpose of this paper is to report the protocol for this study. The primary objective will be to compare both methods in diagnosing oral potentially malignant disorders and cancers. The secondary objective would be to study the cost-effectiveness.</p></div><div><h3>Methods and analysis</h3><p>This will be a cluster-randomized clinical trial of the population in Ernakulam district of Kerala state in India. They will undergo oral cancer screening by community health workers, who will be pre-assigned to the randomly allotted intervention (mHealth) or control (conventional method) clusters. We will enrol a minimum of 9696 subjects from all 6 clusters over 18 months. The cost-effectiveness of the two strategies for oral screening will be determined using data from this randomized controlled trial. The incremental cost per oral cancer/high-risk dysplasia detected, and the incremental cost per life saved will be reported. We will conduct sensitivity and scenario analysis to evaluate the robustness of the findings.</p></div><div><h3>Ethics and dissemination</h3><p>When completed, this will be the first cluster randomized population-based study to test the technology-based approach in India. The knowledge from this study will indicate whether specialists can make a remote diagnosis of oral lesions accurately based on the information gathered using a mobile phone health application and whether the mHealth strategy will be cost-effective in Oral cancer screening. The study will follow the ethical guidelines and will be published in an indexed journal.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.07.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38215916","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: 4
Effectiveness of proprioceptive training versus conventional exercises on postural sway in patients with early knee osteoarthritis – A randomized controlled trial protocol 本体感觉训练与常规运动对早期膝关节骨关节炎患者体位摇摆的有效性-一项随机对照试验方案。
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.09.002
Ashish John Prabhakar , Abraham M. Joshua , Srikanth Prabhu , Yogeesh Dattakumar Kamat
{"title":"Effectiveness of proprioceptive training versus conventional exercises on postural sway in patients with early knee osteoarthritis – A randomized controlled trial protocol","authors":"Ashish John Prabhakar ,&nbsp;Abraham M. Joshua ,&nbsp;Srikanth Prabhu ,&nbsp;Yogeesh Dattakumar Kamat","doi":"10.1016/j.isjp.2020.09.002","DOIUrl":"10.1016/j.isjp.2020.09.002","url":null,"abstract":"<div><h3>Introduction</h3><p>In recent times, ‘early osteoarthritis’ (EOA) has achieved recognition as a disease entity. The importance of defining EOA is in the fact that a variety of joint preservation treatments are available. Development of the sense of proprioception is a known vital element of most exercise rehabilitation programmes. Postural sways have been found to be prevalent in arthritic patients. It follows therefore that correction of early postural aberrations should help patients with EOA. The current study aims to determine the effectiveness of such proprioceptive training versus conventional exercises in patients with EOA.</p></div><div><h3>Method</h3><p>This study is a randomized controlled trial. A total of 100 participants between the age of 20–45 years will be recruited. Participants will be randomly assigned to conventional or interventional group. Participants in both the groups will receive 12 session of treatment over a period of four weeks. Outcome measure considered are center of pressure excursion, joint position sense, hand held dynamometer, visual analog scale and knee injury and osteoarthritis Outcome Score for functional outcome.</p></div><div><h3>Results</h3><p>Data collected will be analyzed by mean, SD and 2 factor ANOVA for repeated measure, followed by Bonferroni post hoc analysis. Data will be analyzed using SPSS package version 17.0, p &lt; 0.05 will be considered as significant.</p></div><div><h3>Conclusion</h3><p>The authors hope to determine whether proprioceptive training improves outcome better than conventional exercise therapy and hope to contribute to an improved targeted treatment for patients with Early osteoarthritis.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.09.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38517205","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: 8
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