International Journal of Surgery Protocols最新文献

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The use of intra-operative tranexamic acid in shoulder surgery: Protocol for a systematic review and meta-analysis 肩关节手术中术中氨甲环酸的使用:系统回顾和荟萃分析方案
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.06.003
Alexander W. Hartland , Kar H. Teoh , Mustafa S. Rashid
{"title":"The use of intra-operative tranexamic acid in shoulder surgery: Protocol for a systematic review and meta-analysis","authors":"Alexander W. Hartland ,&nbsp;Kar H. Teoh ,&nbsp;Mustafa S. Rashid","doi":"10.1016/j.isjp.2020.06.003","DOIUrl":"10.1016/j.isjp.2020.06.003","url":null,"abstract":"<div><h3>Introduction</h3><p>Blood loss is an important consideration in all types of shoulder surgery. Excessive bleeding is associated with increased morbidity. Tranexamic acid (TXA) is an antifibrinolytic agent. It has been demonstrated to be effective in reducing blood loss across multiple surgical specialties. The aim of this systematic review and meta-analysis is to review the literature evaluating clinical outcomes associated with the use of TXA in shoulder surgery.</p></div><div><h3>Methods</h3><p>The study protocol was designed and registered prospectively on PROSPERO (International prospective register for systematic reviews). Literature search will include the MEDLINE, EMBASE, PsycINFO, and Cochrane Library databases. Randomised controlled trials (RCTs) evaluating the use of TXA against placebo, in all types of shoulder surgery, will be included. Our primary outcome is total blood loss (ml). Secondary outcomes include patient-reported outcome measures (PROMs), adverse events, and number of blood transfusions required. Risk of bias will be assessed within each study using The Cochrane Risk of Bias Tool 2.0 and the Jadad score. Inconsistency and bias across included studies will be assessed statistically. Data from comparable outcomes will be pooled and analysed quantitatively or descriptively as appropriate.</p></div><div><h3>Ethics and dissemination</h3><p>No ethical clearances required for this study. This systematic review and meta-analysis will be published in a peer-reviewed journal. It will be presented a various 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.2020.06.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38157489","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
IDENTIFY: The investigation and detection of urological neoplasia in patients referred with suspected urinary tract cancer: A multicentre cohort study 鉴别:对疑似尿路癌患者泌尿系统肿瘤的调查和检测:一项多中心队列研究
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.02.002
Sinan Khadhouri , Kevin M Gallagher , Kenneth MacKenzie , Taimur T Shah , Chuanyu Gao , Sacha Moore , Eleanor Zimmermann , Eric Edison , Matthew Jefferies , Arjun Nambiar , Graeme MacLennan , John S McGrath , Veeru Kasivisvanathan
{"title":"IDENTIFY: The investigation and detection of urological neoplasia in patients referred with suspected urinary tract cancer: A multicentre cohort study","authors":"Sinan Khadhouri ,&nbsp;Kevin M Gallagher ,&nbsp;Kenneth MacKenzie ,&nbsp;Taimur T Shah ,&nbsp;Chuanyu Gao ,&nbsp;Sacha Moore ,&nbsp;Eleanor Zimmermann ,&nbsp;Eric Edison ,&nbsp;Matthew Jefferies ,&nbsp;Arjun Nambiar ,&nbsp;Graeme MacLennan ,&nbsp;John S McGrath ,&nbsp;Veeru Kasivisvanathan","doi":"10.1016/j.isjp.2020.02.002","DOIUrl":"10.1016/j.isjp.2020.02.002","url":null,"abstract":"","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.2020.02.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37862066","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: 7
Intraoperative evaluation of hepatic artery blood flow during pancreatoduodenectomy (HEPARFLOW): Protocol of an exploratory study 胰十二指肠切除术中肝动脉血流的术中评价(HEPARFLOW):一项探索性研究的方案
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.03.003
Mohammed Al-Saeedi , Leonie Frank-Moldzio , Miriam Klauß , Philipp Mayer , Tom Bruckner , Elias Khajeh , Mohammad Golriz , Arianeb Mehrabi , Phillip Knebel , Markus K. Diener , Markus W. Büchler , Oliver Strobel
{"title":"Intraoperative evaluation of hepatic artery blood flow during pancreatoduodenectomy (HEPARFLOW): Protocol of an exploratory study","authors":"Mohammed Al-Saeedi ,&nbsp;Leonie Frank-Moldzio ,&nbsp;Miriam Klauß ,&nbsp;Philipp Mayer ,&nbsp;Tom Bruckner ,&nbsp;Elias Khajeh ,&nbsp;Mohammad Golriz ,&nbsp;Arianeb Mehrabi ,&nbsp;Phillip Knebel ,&nbsp;Markus K. Diener ,&nbsp;Markus W. Büchler ,&nbsp;Oliver Strobel","doi":"10.1016/j.isjp.2020.03.003","DOIUrl":"10.1016/j.isjp.2020.03.003","url":null,"abstract":"<div><h3>Introduction</h3><p>Pancreatoduodenectomy is the treatment of choice for a range of benign and malignant diseases. The pancreatic head must be separated from its supplying vessels, especially the gastroduodenal artery, during this operation. However, dissection of the gastroduodenal artery can disturb blood supply to the liver and result in liver ischemia. There is currently no well-established algorithm to evaluate and ensure sufficient blood flow in patients with altered hepatic artery blood flow. To address this important issue, this study aims to establish a basis for assessing liver blood supply during pancreatoduodenectomy. Furthermore, factors influencing arterial blood flow and related postoperative complications will be evaluated.</p></div><div><h3>Methods and analysis</h3><p>The HEPARFLOW study is a single institutional single-arm prospective exploratory observational clinical trial. All consecutive patients undergoing elective partial or total pancreatoduodenectomy will be screened for inclusion until 100 patients are enrolled. Blood flow in the proper hepatic artery, gastroduodenal artery, portal vein, and additional vessels supplying the liver will be measured during pancreatoduodenectomy using Doppler flowmetry. All patients will be followed up for 90 days after surgery. At each visit, standard clinical data, postoperative complications and mortality will be recorded.</p></div><div><h3>Discussion</h3><p>This will be the first study to prospectively assess intraoperative flow rates of the hepatic artery and portal vein to evaluate liver blood supply during pancreatoduodenectomy. The preoperative and intraoperative factors influencing blood flow in the hepatic arteries will be identified. This study may also reveal the hemodynamic and clinical relevance of a compression of the celiac axis during pancreatoduodenectomy.</p></div><div><h3>Ethics and dissemination</h3><p>This study was approved by the Ethics Committee of the University of Heidelberg (S-073/2018). The results will be published in a peer-reviewed journal and will be presented at medical meetings.</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.2020.03.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37882522","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
Robotic versus open primary ventral hernia repair: A randomized controlled trial (Robovent Trial) 机器人与开放式腹疝修补术:一项随机对照试验(Robovent试验)
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.03.004
Jonathan Douissard, Jeremy Meyer, Arnaud Dupuis, Andrea Peloso, Julie Mareschal, Christian Toso, Monika Hagen
{"title":"Robotic versus open primary ventral hernia repair: A randomized controlled trial (Robovent Trial)","authors":"Jonathan Douissard,&nbsp;Jeremy Meyer,&nbsp;Arnaud Dupuis,&nbsp;Andrea Peloso,&nbsp;Julie Mareschal,&nbsp;Christian Toso,&nbsp;Monika Hagen","doi":"10.1016/j.isjp.2020.03.004","DOIUrl":"10.1016/j.isjp.2020.03.004","url":null,"abstract":"<div><h3>Background</h3><p>The objective of the present study is to compare the outcomes open PVHR and robotic PVHR.</p></div><div><h3>Methods/Design</h3><p>The present study will be a randomized single-blinded controlled trial with intention-to-treat analysis comparing robotic PVHR to open PVHR in adult patients undergoing elective PVHR with a defect ranging between 1–5 cm. Patient refusing to participate, not able to give informed consent, with history of intra-abdominal surgery contraindicating a robotic surgical approach will be excluded. The intervention will consist in laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical PVHR with closure of fascial defect and non-adsorbable mesh reinforcement. The control will be open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-absorbable mesh reinforcement. The primary outcome will be the incidence of wound-related complication within 1 month. The secondary outcomes will be esthetic satisfaction, pain, pain-killers consumption, general complications, costs, operative time and early hernia recurrence.</p></div><div><h3>Discussion</h3><p>Open PVHR is potentially associated to more wound-related complications, but has the advantages of cost-effectiveness, short operative time and totally extra-peritoneal repair. Laparoscopic PVHR has lower wound-related complications but implies placing the mesh in intra-peritoneal position, requires advanced laparoscopic skills, usually does not allow the closure of the defect, and can lead to excessive pain and pain-killers consumption. Robotic PVHR uses the same laparoscopic access as laparoscopic PVHR, but thanks to the extended range of motion given by the robotic system, allows defect closure, pre-peritoneal placement of the mesh and requires less technical skills.</p><p>In the present randomized controlled trial, we expect to show that robotic PVHR leads to better wound-related outcomes than open PVHR.</p></div><div><h3>Trial registration</h3><p>The present randomized controlled trial was registered into clinicaltrials.gov under registration number NCT04171921.</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.2020.03.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37901767","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
Effectiveness of home-based rehabilitation program in minimizing disability and secondary falls after a hip fracture: Protocol for a randomized controlled trial 家庭康复计划在减少髋部骨折后残疾和继发跌倒方面的有效性: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.2020.06.002
Anum Sadruddin Pidani , Saniya Sabzwari , Khabir Ahmad , Ata Mohammed , Shahryar Noordin
{"title":"Effectiveness of home-based rehabilitation program in minimizing disability and secondary falls after a hip fracture: Protocol for a randomized controlled trial","authors":"Anum Sadruddin Pidani ,&nbsp;Saniya Sabzwari ,&nbsp;Khabir Ahmad ,&nbsp;Ata Mohammed ,&nbsp;Shahryar Noordin","doi":"10.1016/j.isjp.2020.06.002","DOIUrl":"10.1016/j.isjp.2020.06.002","url":null,"abstract":"<div><h3>Introduction</h3><p>Hip fractures are a major health problem globally and are associated with increased morbidity, mortality, and substantial economic costs. Successful operative treatment of hip fracture patients is necessary for the optimization of post-op mobility and functional recovery of the patient. Rehabilitation after surgical stabilization of a hip fracture is crucial in order to restore pre-fracture function and to avoid long-term institutionalization. In particular ongoing exercise which targets balance can prevent up to 40% of falls. Therefore, we have designed a post-discharge home-based physical rehabilitation intervention program to minimize disability and falls in this high-risk elderly population.</p></div><div><h3>Methods and analysis</h3><p>The study will be an open label, simple randomized controlled trial at a single hospital. The two arms will be equally allocated on a 1:1 ratio into intervention and control groups. The control arm will receive the usual standard postoperative rehabilitation. The intervention group will receive an extended home-based rehabilitation program twice a week continued for 3 months (12 weeks) after discharge. The Primary outcome of the study is occurrence of falls. Falls will be measured at 3, 6, 12, and 24 months by research-assistant follow-up telephone calls for both the groups. Mobility-related disability will be measured with a self-reported test at every routine follow-up for up to two years using a performance-based short battery tool. Negative binomial regression model will be used to compare number of falls in both the groups by computing incidence ratio rates.</p></div><div><h3>Ethics and dissemination</h3><p>Approval for the conduction of this study has been taken from the Ethical Review Committee (ERC) of the institution. Evidences which will be obtained from this study will facilitate to propose changes in existing guidelines and policies for treating fall and hip fracture patients.</p><p>Trial registration</p><p>This trial is registered on clinicaltrials.gov ID: NCT04108793.</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.2020.06.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38186707","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
Protocol for a modified vaginal pipe for total laparoscopic hysterectomies: Experimental research 改良阴道管用于腹腔镜全子宫切除术的方案:实验研究
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.02.003
Fumitake Ito, Tetsuya Kokabu, Hiroshi Matsushima, Akemi Koshiba, Taisuke Mori, Izumi Kusuki, Jo Kitawaki
{"title":"Protocol for a modified vaginal pipe for total laparoscopic hysterectomies: Experimental research","authors":"Fumitake Ito,&nbsp;Tetsuya Kokabu,&nbsp;Hiroshi Matsushima,&nbsp;Akemi Koshiba,&nbsp;Taisuke Mori,&nbsp;Izumi Kusuki,&nbsp;Jo Kitawaki","doi":"10.1016/j.isjp.2020.02.003","DOIUrl":"10.1016/j.isjp.2020.02.003","url":null,"abstract":"<div><h3>Background</h3><p>The Vagi-Pipe® is a useful device for performing a total laparoscopic hysterectomy. The conventional model of the Vagi-Pipe® is unable to grasp the uterus during colpotomy for recovery of the resected uterus. However, the modified C-Type Vagi-Pipe® model has a shape that allows insertion into the vagina without removing the uterus manipulator. In this study, we will prospectively investigate the safety and efficacy of the C-Type Vagi-Pipe® in total laparoscopic hysterectomies.</p></div><div><h3>Materials and methods</h3><p>In total, 25 female subjects aged between 20 and 60 years with uterine fibroids or adenomyosis will be included. Patients with complications regarded as unsuitable for this study by the investigators will be excluded. The C-Type Vagi-Pipe® will be used rather than the conventional Vagi-Pipe® when performing a total laparoscopic hysterectomy. The primary endpoint will be safety and the secondary endpoints will be operation time, bleeding volume, and presence of complications.</p></div><div><h3>Ethics and dissemination</h3><p>The protocol was approved by the institutional review boards. Written informed consent will be obtained from all patients before registration in accordance with the Declaration of Helsinki. Results of the study will be disseminated via publications in peer-reviewed journals.</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.2020.02.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37811488","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
Precave: Immediate neoadjuvant instillation of chemotherapy for the prevention of non-muscle invasive bladder carcinoma recurrence: A prospective randomized clinical trial protocol 预防:立即新辅助灌注化疗预防非肌性浸润性膀胱癌复发:一项前瞻性随机临床试验方案
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.10.001
Diego M. Carrion, Juan Gómez Rivas, Cristina Ballesteros Ruiz, Mario Alvarez-Maestro, Alfredo Aguilera Bazán, Luis Martínez-Piñeiro
{"title":"Precave: Immediate neoadjuvant instillation of chemotherapy for the prevention of non-muscle invasive bladder carcinoma recurrence: A prospective randomized clinical trial protocol","authors":"Diego M. Carrion,&nbsp;Juan Gómez Rivas,&nbsp;Cristina Ballesteros Ruiz,&nbsp;Mario Alvarez-Maestro,&nbsp;Alfredo Aguilera Bazán,&nbsp;Luis Martínez-Piñeiro","doi":"10.1016/j.isjp.2020.10.001","DOIUrl":"10.1016/j.isjp.2020.10.001","url":null,"abstract":"<div><h3>Introduction and objectives</h3><p>Recurrence rates for patients presenting with non-muscle invasive bladder carcinoma (NMIBC) can be as high as 60% during the first year after a transurethral resection of bladder tumor (TURBT). Currently, an immediate postoperative instillation of chemotherapy (IPOIC) is recommended for the prevention of recurrences in patients with low to intermediate risk disease. Although in real clinical practice this specific instillation of chemotherapy has many difficulties to be standardized, including its contraindications (suspected or confirmed bladder perforation, wide or extensive resection and, continuous bladder irrigation requirement), which will only make it feasible for around 30% of patients.</p><p>We propose in this controlled study, to administer an immediate neoadjuvant instillation of chemotherapy (INAIC), which can be applied technically to all patients, no matter the surgical outcomes and compare it with a control group. We expect to find a reduction in the recurrence rate in the experimental group of at least 15%.</p></div><div><h3>Methods</h3><p>We designed a phase IV, randomized, controlled, open label clinical trial. Main inclusion criteria are: patients with a clinical diagnosis of localized, papillary-type bladder cancer (suspected low to intermediate risk) with a disease-free interval of at least 6 months. Eligible patients will be allocated into group A (INAIC plus TURBT) or group B (TURBT) using a computer-generated block randomization sequence/ratio 1:1. Time to recurrence of both groups will be analyzed and compared using Kaplan-Meier estimates, log-rank tests and, Cox-regression. Univariate and multivariate analyzes will be performed to determine factors which influence recurrence. The study has received the approval of the Ethics Committee for Drug Research (CEIm) of La Paz University Hospital and the Spanish Agency for Medicines and Health Products.</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.2020.10.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"38615944","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
Evaluation of the completeness of interventions reported in published randomized controlled trials in plastic surgery: A cross-sectional review protocol 在已发表的整形外科随机对照试验中报道的干预措施的完整性评价:一项横断面审查方案
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2019.12.001
Sheridan Evans , Shelby Rauh , Samuel Jellison , Brian Diener , Riaz Agha , Matt Vassar
{"title":"Evaluation of the completeness of interventions reported in published randomized controlled trials in plastic surgery: A cross-sectional review protocol","authors":"Sheridan Evans ,&nbsp;Shelby Rauh ,&nbsp;Samuel Jellison ,&nbsp;Brian Diener ,&nbsp;Riaz Agha ,&nbsp;Matt Vassar","doi":"10.1016/j.isjp.2019.12.001","DOIUrl":"10.1016/j.isjp.2019.12.001","url":null,"abstract":"<div><h3>Background</h3><p>Randomized controlled trials (RCTs) are critical in developing new therapeutic approaches. Historically, in plastic surgery, RCTs are uncommon as they make up less than 2% of all publications. However there has recently been an increase in RCTs appearing in plastic surgery but the quality of these articles has yet to be assessed. We aim to determine the completeness of intervention reporting in plastic surgery RCTs using the TIDieR checklist.</p></div><div><h3>Methods</h3><p>A search of Pubmed for RCTs published in the top 10 plastic surgery journals as determined by the Google h5-index will be performed by two investigators. All identified articles will be isolated and a random selection of 300 articles will be screened for inclusion in the study by two different investigators. All types of RCTs will be included in this study. Articles will be excluded if they are nonrandomized, observational, follow-up studies, or secondary analyses. Full exclusion criteria can be found within this protocol. Extracted data includes all 12 points of the TIDieR checklist, journal, intervention type, sample size, and funding source. A complete list of what data will be extracted is listed within this protocol. All data extraction will be performed by two independent investigators. All work will be verified by the two investigators and any discrepancies will be resolved via consensus between investigators or with third party adjudication.</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.2019.12.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37616124","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: 3
Characteristics, results, and reporting of contemporary surgical trials: A systematic review and analysis 当代外科试验的特点、结果和报告:系统回顾和分析
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.03.002
N. Bryce Robinson , Ajita Naik , Irbaz Hameed , Yongle Ruan , Mohamed Rahouma , Viola Weidenmann , Marco A. Zenati , Deepak L. Bhatt , Leonard N. Girardi , Paul Kurlansky , Shahzad G. Raja , David Moher , Stephen Fremes , Joanna Chikwe , Mario Gaudino
{"title":"Characteristics, results, and reporting of contemporary surgical trials: A systematic review and analysis","authors":"N. Bryce Robinson ,&nbsp;Ajita Naik ,&nbsp;Irbaz Hameed ,&nbsp;Yongle Ruan ,&nbsp;Mohamed Rahouma ,&nbsp;Viola Weidenmann ,&nbsp;Marco A. Zenati ,&nbsp;Deepak L. Bhatt ,&nbsp;Leonard N. Girardi ,&nbsp;Paul Kurlansky ,&nbsp;Shahzad G. Raja ,&nbsp;David Moher ,&nbsp;Stephen Fremes ,&nbsp;Joanna Chikwe ,&nbsp;Mario Gaudino","doi":"10.1016/j.isjp.2020.03.002","DOIUrl":"10.1016/j.isjp.2020.03.002","url":null,"abstract":"<div><h3>Introduction</h3><p>The complexities and risks inherent to the field of surgery and surgical interventions present unique challenges to the design and analysis of surgical randomized controlled trials (RCT). Prior studies have investigated the practical and methodologic challenges posed by surgical RCTs. To date, however, a comprehensive analysis of the contemporary literature across multiple surgical subspecialties does not exist. In this descriptive analysis, we set out to characterize surgical RCTs over the past 10 years across six major surgical specialties.</p></div><div><h3>Methods and analysis</h3><p>A literature search by a medical librarian will be performed to identify all surgical randomized clinical trials published between January 2009 and December 2019 in the two journals with the highest impact factor for six surgical specialties as well as two large general medicine journals. Two reviewers will independently screen the citations retrieved from the literature search and extract data according to a previously described protocol via a pre-defined data collection form. Categorical variables will be reported as counts and percentages. Following assessment of normality, continuous variables will be reported as mean (standard deviation) or median (inter-quartile range). Based on normality of data, independent t-test or the Mann-Whitney U test will be used to compare continuous variables and chi-square and Fisher’s exact tests to compare categorical variables. Comparisons across multiple sets will be performed using ANOVA or Kruskak-Wallis tests. Two-sided significance testing will be used and a p-value &lt;0.05 will be considered significant without adjustment for multiple testing. All analyses will be performed using SPSS version 24 and R within RStudio. PROSPERO (ID number: 162797).</p></div><div><h3>Ethics and dissemination</h3><p>There are no ethical concerns directly pertinent to this systematic review. The retrieved data will be made available upon request. The study will be written in English and submitted for publication 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.2020.03.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"37811487","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
Erratum to “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)” [Int. J. Surg. Protoc. 21 (2020) 13–20] 在患者首次手术前使用l<s:1>贝克工具箱课程进行目标导向的微创手术模拟训练的有效性:一项多中心随机对照验证试验的研究方案(新手)。中华外科杂志。21 (2020):13-20]
IF 0.9
International Journal of Surgery Protocols Pub Date : 2020-01-01 DOI: 10.1016/j.isjp.2020.11.002
Michael Thomaschewski , Tilman Laubert , Markus Zimmermann , Hamed Esnaashari , Reinhard Vonthein , Tobias Keck , Claudia Benecke
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