International Journal of Surgery Protocols最新文献

{"title":"Clinical Effectiveness of Various Surgical Procedures Addressing Long Head of Biceps Pathology: Protocol for a Systematic Review and Meta-Analysis.","authors":"Alexander W Hartland,&nbsp;Raisa Islam,&nbsp;Kar H Teoh,&nbsp;Mustafa S Rashid","doi":"10.29337/ijsp.139","DOIUrl":"https://doi.org/10.29337/ijsp.139","url":null,"abstract":"<p><strong>Introduction: </strong>The long head of biceps tendon is a common source of anterior shoulder pain and impaired function. Multiple surgical procedures are available as treatment options, but the optimal procedure is not known. The aim of this systematic review and meta-analysis is to review the literature to assess the clinical effectiveness of various surgical procedures to treat pain arising from the long head of biceps.</p><p><strong>Methods: </strong>The study protocol was designed and registered prospectively on PROSPERO (International prospective register for systematic reviews). Electronic databases used for the literature search will include MEDLINE, EMBASE, PsycINFO, and The Cochrane Library. Randomised controlled trials (RCTs) evaluating surgical procedures on the long head of biceps will be included. Our primary outcome is any functional patient-reported outcome measure related to the shoulder. Secondary outcomes will include the rate of 'Popeye' deformity, the rate of biceps cramping pain, the rate of complications, objective measurements of strength testing such as dynamometer, and other patient-reported outcome measures not specific to the shoulder such as the Visual-Analog Scale (VAS) for pain. Methodological quality of included studies will be assessed using The Cochrane Risk of Bias Tool 2.0 and the Jadad score. Inconsistency and bias across included studies will be assessed statistically. Comparable outcome data will be pooled and analysed quantitatively or qualitatively as appropriate.</p><p><strong>Ethics and dissemination: </strong>No ethical clearances required for this study. We plan to publish this systematic review and meta-analysis in a peer-reviewed journal. It will also be presented at various national and international conferences.</p><p><strong>Highlights: </strong>Evaluating the clinical effectiveness of surgical procedures for long head of biceps pathology.Randomised controlled trials.Biceps tenodesis and biceps tenotomy.Systematic review compliant with the PRISMA guideline.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"21-25"},"PeriodicalIF":0.9,"publicationDate":"2021-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114843/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38930286","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}

{"title":"Factors Associated with Foot Lesions in Diabetic Patients at Saint-Louis Hospital (Senegal): A Case-Control Study Protocol.","authors":"A Ndong,&nbsp;B Konta,&nbsp;J N Tendeng,&nbsp;D G Dia,&nbsp;A D Dia,&nbsp;M L Diao,&nbsp;A C Diallo,&nbsp;S Diop,&nbsp;B M Gouamba,&nbsp;D A Dia,&nbsp;M Diedhiou,&nbsp;M Dieng,&nbsp;M L Fall,&nbsp;P M Ma Nyemb,&nbsp;I Konaté","doi":"10.29337/ijsp.141","DOIUrl":"https://doi.org/10.29337/ijsp.141","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetes prevalence has increased over the past years. In Senegal, this prevalence is 4% in the general population. However, the region of Saint-Louis (in the north of the country) has the highest rate with 10.4%. The main prognosis problem is the occurrence foot lesions that can lead to lower-limbs amputation. Diabetic foot is a real public health issue, due to its economic burden and its serious repercussions on patients, leading to poor quality of life. The objective of this case-control study is to identify factors associated with foot lesions in diabetic patients.</p><p><strong>Methods and analysis: </strong>It will be a case-control study from January to December 2021. The patients will be recruited from the departments of general surgery, internal medicine, and emergency. An univariate then multivariate analysis (logistic regression) will allow us to select the variables associated with foot lesions in our study population. The parameters included in the logistic regression will be those with a p < 0.20 in the univariate analysis. Finally, a binary logistic regression analysis (with the calculation of Odds Ratios (OR) with confidence intervals (CI)) according to the backward stepwise method will identify the factors independently associated to foot lesions in diabetic patients.</p><p><strong>Ethics and dissemination: </strong>This research protocol will be submitted to the Ethics Committee of our institution for approval. The knowledge of factors causing diabetic foot will help to communicate with policymakers to raise the awareness in our community. Finally, it will help to prevent lower limb amputations.</p><p><strong>Highlights: </strong>Diabetes is the leading cause of non-traumatic lower-limb amputation in the world.The region of Saint-Louis (Senegal) has the highest prevalence of diabetes.Controlling factors associated with foot lesions in diabetic patients can prevent from amputation.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"16-20"},"PeriodicalIF":0.9,"publicationDate":"2021-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114845/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38918219","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}

{"title":"Pre-Emptive Endoluminal Negative Pressure Therapy at the Anastomotic Site in Minimally Invasive Transthoracic Esophagectomy (the preSPONGE Trial): Study Protocol for a Multicenter Randomized Controlled Trial.","authors":"Philip C Müller,&nbsp;Diana Vetter,&nbsp;Joshua R Kapp,&nbsp;Christoph Gubler,&nbsp;Bernhard Morell,&nbsp;Dimitri A Raptis,&nbsp;Christian A Gutschow","doi":"10.29337/ijsp.24","DOIUrl":"https://doi.org/10.29337/ijsp.24","url":null,"abstract":"<p><strong>Introduction: </strong>Anastomotic leakage (AL) accounts for a significant proportion of morbidity following oesophagectomy. Endoluminal negative pressure (ENP) therapy via a specifically designed polyurethane foam (EsoSponge^®, B.Braun Medical, Melsungen, Germany) has become the standard of care for AL in many specialized centres. The prophylactic (pENP) application of this technique aims to reduce postoperative morbidity and is a novel approach which has not yet been investigated in a prospective study. The aim of this study is therefore to assess the effect of pENP at the anastomotic site in high-risk patients undergoing minimally invasive transthoracic Ivor Lewis oesophagectomy.</p><p><strong>Methods and analysis: </strong>The study design is a prospective, multi-centre, two-arm, parallel-group, randomised controlled trial and will be conducted in two phases. Phase one is a randomised feasibility and safety pilot trial involving 40 consecutive patients. After definitive sample size calculation, additional patients will be included accordingly during phase two. The primary outcome of the study will be the postoperative length of hospitalization until reaching previously defined \"fit for discharge criteria\". Secondary outcomes will include postoperative morbidity, mortality and postoperative AL-rates based on 90-day follow-up. A confirmatory analysis based on intention-to-treat will be performed.</p><p><strong>Ethics and dissemination: </strong>The ethics committee of the University of Zurich approved this study (2019-00562), which has been registered with <i>ClinicalTrials.gov</i> on 14.11.2019 (NCT04162860) and the Swiss National Clinical Trials Portal (SNCTP000003524). The results of the study will be published and presented at appropriate conferences.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"7-15"},"PeriodicalIF":0.9,"publicationDate":"2021-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38918218","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}

{"title":"Outcomes of Hip Arthroscopy in Patients with Femoroacetabular Impingement and Concomitant Tönnis Grade II Osteoarthritis or Greater: Protocol for a Systematic Review.","authors":"Octavian Andronic,&nbsp;Leica Claydon,&nbsp;Rachael Cubberley,&nbsp;Karadi Hari Sunil-Kumar,&nbsp;Vikas Khanduja","doi":"10.29337/ijsp.26","DOIUrl":"https://doi.org/10.29337/ijsp.26","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods and analysis: </strong>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 1^st 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.</p><p><strong>Ethics and dissemination: </strong>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.</p><p><strong>Highlights: </strong>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.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"1-6"},"PeriodicalIF":0.9,"publicationDate":"2021-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8114840/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38918217","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}

{"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":"24 ","pages":"Pages 36-38"},"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}

{"title":"Adult cardiac surgical cost variation around the world: Protocol for a systematic review","authors":"Dominique Vervoort ,&nbsp;Camila R. Guetter ,&nbsp;Lena Trager ,&nbsp;Priyansh Shah ,&nbsp;Carlos Eduardo Diaz-Castrillon ,&nbsp;Eric W. Etchill ,&nbsp;Rawn Salenger","doi":"10.1016/j.isjp.2020.07.004","DOIUrl":"10.1016/j.isjp.2020.07.004","url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Objectives and significance</h3><p>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.</p></div><div><h3>Methods and analysis</h3><p>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.</p></div><div><h3>Ethics and dissemination</h3><p>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.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"23 ","pages":"Pages 11-14"},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.07.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38269949","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}

{"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}

{"title":"The B-MaP-C study: Breast cancer management pathways during the COVID-19 pandemic. Study protocol","authors":"Alona Courtney ,&nbsp;Rachel O'Connell ,&nbsp;Tim Rattay ,&nbsp;Baek Kim ,&nbsp;Ramsey I. Cutress ,&nbsp;Cliona C. Kirwan ,&nbsp;Ashu Gandhi ,&nbsp;Patricia Fairbrother ,&nbsp;Nisha Sharma ,&nbsp;Christopher W.J. Cartlidge ,&nbsp;Kieran Horgan ,&nbsp;Stuart A. McIntosh ,&nbsp;Daniel R. Leff ,&nbsp;Raghavan Vidya ,&nbsp;Shelley Potter ,&nbsp;Chris Holcombe ,&nbsp;Ellen Copson ,&nbsp;Charlotte E. Coles ,&nbsp;Rajiv V. Dave","doi":"10.1016/j.isjp.2020.07.003","DOIUrl":"10.1016/j.isjp.2020.07.003","url":null,"abstract":"<div><h3>Introduction</h3><p>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.</p></div><div><h3>Methods and analysis</h3><p>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.</p></div><div><h3>Ethics and dissemination</h3><p>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.</p></div><div><h3>Registration details</h3><p>Each participating centre received local governance audit registration.</p></div>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"24 ","pages":"Pages 1-5"},"PeriodicalIF":0.9,"publicationDate":"2020-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.isjp.2020.07.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38302944","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}

{"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":"24 ","pages":"Pages 39-44"},"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}

{"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":"23 ","pages":"Pages 6-10"},"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}