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The Impact of Trauma System Implementation on Patient Quality of Life and Economic Burden: A Systematic Review Study Protocol. 创伤系统实施对患者生活质量和经济负担的影响:系统回顾研究协议》。
IF 1.1 Q3 SURGERY Pub Date : 2023-02-09 eCollection Date: 2023-01-01 DOI: 10.29337/ijsp.187
Michael F Bath, Katharina Kohler, Laura Hobbs, Isla Kuhn, William M Nabulyato, Arthur Kwizera, Laura E Walker, Tom Wilkins, Daniel Stubbs, Sara Halimah, Rowan Burnstein, Angelos G Kolias, Peter Hutchinson, John Clarkson, Tom Bashford

Background: Trauma accounts for 10% of global mortality, with increasing rates disproportionally affecting low- and middle-income countries. In an attempt to improve clinical outcomes after injury, trauma systems have been implemented in multiple countries over recent years. However, whilst many studies have subsequently demonstrated improvements in overall mortality outcomes, less is known about the impact trauma systems have on morbidity, quality of life, and economic burden. This systematic review seeks to assess the existing evidence base for trauma systems with these outcome measures.

Methods: This review will include any study that assesses the impact implementation of a trauma system has on patient morbidity, quality of life, or economic burden. Any comparator study, including cohort, case-control, and randomised controlled studies, will be included, both retrospective or prospective in nature. Studies conducted from any region in the world and involving any age of patient will be included. We will collect data on any morbidity outcomes, health-related quality of life measures, or health economic assessments reported. We predict a high heterogeneity in these outcomes used and will therefore keep inclusion criteria broad.

Discussion: Previous reviews have shown the significant improvements that can be achieved in mortality outcomes with the implementation of an organised trauma system, however the wider impact they can have on morbidity outcomes, quality of life measures, and the economic burden of trauma, is less well described. This systematic review will present all available data on these outcomes, helping to better characterise both the societal and economic impact of trauma system implementation.

Highlights: Trauma systems are known to improve mortality rates, however less in known on the impact they have on morbidity outcomes, quality of life, and economic burdenWe aim to perform a systematic review to identify any comparator study that assesses the impact implementation of a trauma system on these outcomesUnderstanding the impact trauma systems can have on wider parameters, such as economic and quality of life outcomes, is crucial to allow governments globally to appropriately allocate often limited healthcare resources.PROSPERO registration number: CRD42022348529.

背景:创伤占全球死亡率的 10%,中低收入国家的创伤率不断上升,影响尤为严重。为了改善受伤后的临床治疗效果,近年来多个国家实施了创伤系统。然而,尽管许多研究随后证明总体死亡率结果有所改善,但人们对创伤系统对发病率、生活质量和经济负担的影响却知之甚少。本系统性综述旨在评估创伤系统对这些结果衡量的现有证据基础:本综述将包括任何评估创伤系统的实施对患者发病率、生活质量或经济负担的影响的研究。任何对比研究,包括队列研究、病例对照研究和随机对照研究,无论是回顾性研究还是前瞻性研究,都将包括在内。全球任何地区进行的、涉及任何年龄段患者的研究都将包括在内。我们将收集有关任何发病率结果、与健康相关的生活质量测量或健康经济评估报告的数据。我们预测这些结果的异质性很高,因此将保持广泛的纳入标准:讨论:以往的综述表明,通过实施有组织的创伤系统,死亡率可得到明显改善,但这些系统对发病率、生活质量和创伤经济负担所产生的更广泛影响却没有得到很好的描述。本系统综述将介绍有关这些结果的所有可用数据,以帮助更好地描述创伤系统的实施对社会和经济的影响:我们的目标是开展一项系统性综述,以确定任何评估创伤系统的实施对这些结果的影响的比较研究。了解创伤系统对经济和生活质量结果等更广泛参数的影响对于全球各国政府合理分配往往有限的医疗资源至关重要:CRD42022348529。
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引用次数: 0
Effect of Chewing Gum on Duration of Postoperative Ileus Following Laparotomy for Gastroduodenal Perforations: Protocol for a Randomized Controlled Trial. 咀嚼口香糖对胃十二指肠穿孔腹腔手术后回肠梗阻持续时间的影响:随机对照试验方案》。
IF 1.1 Q3 SURGERY Pub Date : 2023-02-06 eCollection Date: 2023-01-01 DOI: 10.29337/ijsp.188
Joshua Muhumuza, Selamo Fabrice Molen, William Mauricio, Jorge Soria La O, Jethro Atumanyire, Nyenke Bassara Godefroy, Musa Abbas Waziri, Stephen Mbae Kithinji, Kiyaka Magugu Sonye, Mugisho Munyerenkana Leocadie, Franck Katembo Sikakulya, ByaMungu Pahari Kagenderezo, Musafiri Simba Lionel, Mumin Farah, Herman Lule

Background: Prolonged post-operative ileus is associated with increased risk of other complications, length of hospital stays and health care related costs. Chewing gum has been shown to reduce duration of ileus in many elective surgeries, but there is a paucity of randomised controlled trials (RCTs) on its effect on duration of ileus among patients undergoing emergency surgery, specifically patients with peritonitis. The aim of this study is to determine the effect of chewing gum on duration of postoperative ileus following laparotomy for gastroduodenal perforations.

Methods: This will be a randomised controlled trial done in 3 hospitals. Fifty-two patients will be randomised to 2 groups. Group A will receive chewing gum in addition to routine care, whereas group B will receive routine care only. The duration of post-operative ileus in the two groups which is the primary outcome, will be compared using the independent samples t-test in SPSS version 22. The length of hospital stay, in-hospital morbidity and mortality will be the secondary outcomes. This trial has been approved by Kampala International University research and Ethics committee (Ref No. KIU-2021-60) and Uganda national council of science and technology (Ref No. HS1665ES). Retrospective registration with the research registry has also been done (UIN: researchregistry8565).

Highlights: Prolonged post-operative ileus significantly contributes to adverse surgical outcomesChewing gum has been shown to reduce duration of ileus in many elective surgeriesThere is paucity of RCTs on role of chewing gum following surgery for peritonitis.

背景:术后回肠梗阻时间过长会增加其他并发症的风险、住院时间和医疗相关费用。在许多择期手术中,咀嚼口香糖已被证明可缩短回肠持续时间,但在接受急诊手术的患者(尤其是腹膜炎患者)中,有关口香糖对回肠持续时间影响的随机对照试验(RCT)却很少。本研究旨在确定口香糖对胃十二指肠穿孔开腹手术后回肠持续时间的影响:方法:这是一项在 3 家医院进行的随机对照试验。52 名患者将被随机分为两组。A 组除常规护理外还将接受口香糖治疗,而 B 组仅接受常规护理。两组患者术后回肠梗阻的持续时间(这是主要结果)将通过 SPSS 22 版的独立样本 t 检验进行比较。住院时间、院内发病率和死亡率将作为次要结果。该试验已获得坎帕拉国际大学研究与伦理委员会(编号:KIU-2021-60)和乌干达国家科学技术委员会(编号:HS1665ES)的批准。此外,还在研究登记处进行了回顾性登记(UIN:researchregistry8565):在许多择期手术中,咀嚼口香糖已被证明可以缩短回肠梗阻的时间。
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引用次数: 0
Availability and Use of Essential Opioid Analgesics in Sub-Saharan Africa: A Scoping Review Protocol. 撒哈拉以南非洲基本阿片类镇痛药的可得性和使用:一项范围审查方案。
IF 1.1 Q3 SURGERY Pub Date : 2023-02-01 eCollection Date: 2023-01-01 DOI: 10.29337/ijsp.184
Jane Yao, Ngo Valery Ngo, Odette D Kibu, Constantine Asahngwa, Hilary M Jasmin, Ronald M Gobina, Denis A Foretia

Introduction: The treatment of acute, peri-operative, and chronic pain by healthcare practitioners and health systems requires appropriate access to and availability of essential opioid medications. While opioids are often oversupplied and overprescribed in high-income countries, there are significant inequities as many low- and middle-income countries (LMICs) experience severe shortages. In fact, while the richest 10% in the world reside in countries receiving almost 90% of all available opioids, 50% of the poorest in the world reside in countries receiving just 1% of all available opioids.Understanding the social, economic, cultural, and regulatory barriers to access essential opioid analgesics in LMICs is critical in delineating and prioritizing appropriate interventions. We aim to conduct a scoping review on the availability and usage of essential opioid analgesics in LMICs, specifically in sub-Saharan Africa, to identify barriers, themes, and knowledge gaps.

Materials and methods: We will utilize the framework for conducting scoping reviews by Arksey and O'Malley. We will perform the search for articles in 3 electronic databases (i.e., SCOPUS, PubMed, Embase) and relevant gray literature. Only articles in English will be included. There will be no restriction on the publication period. All articles will directly involve either the availability and/or the use of essential opioid analgesics. Studies will be restricted to focus on sub-Saharan Africa. We will use a tailored extraction frame to extract relevant information from published articles that meet our inclusion criteria. We will analyze the data using both descriptive statistics and thematic analysis on the main study questions.

Ethics and dissemination: Since we will not be collecting primary data, formal ethical approval is not required.Our study findings will be disseminated through abstracts, conference presentations, and peer-reviewed publications.

Highlights: 50 percent of the poorest in the world reside in countries receiving just 1 percent of all available opioidsThere is a paucity of data analyzing the inequitable distribution of essential opioid analgesics worldwideOur scoping review will identify barriers, themes, and knowledge gaps on the availability and use of essential opioids in SSAIt will identify areas for further research and potential policy initiatives.

卫生保健从业人员和卫生系统对急性、围手术期和慢性疼痛的治疗需要适当获取和提供基本阿片类药物。虽然阿片类药物在高收入国家往往供应过剩和处方过度,但由于许多低收入和中等收入国家严重短缺,存在严重的不公平现象。事实上,虽然世界上最富有的10%居住在接收所有可用阿片类药物几乎90%的国家,但世界上最贫穷的50%居住在仅接收所有可用阿片类药物1%的国家。了解中低收入国家获得基本阿片类镇痛药的社会、经济、文化和监管障碍,对于划定和优先考虑适当的干预措施至关重要。我们的目标是对中低收入国家,特别是撒哈拉以南非洲国家基本阿片类镇痛药的可得性和使用情况进行范围审查,以确定障碍、主题和知识差距。材料和方法:我们将利用Arksey和O'Malley的框架进行范围审查。我们将在3个电子数据库(即SCOPUS, PubMed, Embase)和相关的灰色文献中进行检索。只收录英文文章。出版期限将不受限制。所有文章将直接涉及基本阿片类镇痛药的可得性和/或使用。研究将仅限于撒哈拉以南非洲地区。我们将使用定制的提取框架从符合纳入标准的已发表文章中提取相关信息。我们将使用描述性统计和对主要研究问题的专题分析来分析数据。伦理和传播:由于我们不会收集原始数据,因此不需要正式的伦理批准。我们的研究结果将通过摘要、会议报告和同行评议的出版物进行传播。重点:世界上50%的最贫困人口居住在仅占所有可用阿片类药物1%的国家。全球缺乏分析基本阿片类镇痛药不公平分布的数据。我们的范围审查将确定ssai中基本阿片类药物的可获得性和使用方面的障碍、主题和知识差距。它将确定进一步研究和潜在政策举措的领域。
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引用次数: 0
Epidemiology of Digestive Surgical Emergencies in a Sub-Saharan African Country: A Multicentre Pilot Study Protocol. 撒哈拉以南非洲国家消化外科急诊流行病学:一项多中心试点研究方案。
IF 0.9 Q3 SURGERY Pub Date : 2023-01-01 DOI: 10.29337/ijsp.186
Maguatte Faye, Adja Coumba Diallo, Mamadou Ndiaye, Papa Mamadou Faye, Abdourahmane Ndong, Mamadou Cisse

Introduction: Digestive surgical emergencies remains one of the main general surgery activities. Despite the associated mortality rate in low income countries, epidemiologic data about this subject is rare and multicenter studies are even more. We aimed to study an epidemiology of digestive surgical emergencies in Senegal by multicenter protocol.

Methods and analysis: it will a prospective multicenter pilot study from May to July 2022. The patients were from General surgery departments of these teaching hospital in Senegal: Dakar Principal Hospital, Aristide le Dantec Hospital, Dalal Jamm hospital and Saint-Louis Regional Hospital. The Schwartz formula was used. We used a proportion of abdominal surgical emergency of 20%. We had a sample size of 246 patients.

Ethics and dissemination: this research protocol will be submitted to Ethics committee of four hospital that included. The results of this study can help to get better the management of our digestives emergencies and at the same time improve mortality rate.

Highlights: Digestive surgical emergencies is a public health issueBecause of high mortality rate in poorest countries, epidemiological data in Senegal must be knownThese information can help to lower associated mortality.

消化外科急诊仍然是普通外科的主要活动之一。尽管在低收入国家有相关的死亡率,但关于这一主题的流行病学数据很少,多中心研究甚至更多。我们的目的是通过多中心协议研究塞内加尔消化外科急诊的流行病学。方法与分析:该研究将于2022年5月至7月进行前瞻性多中心试点研究。患者来自塞内加尔这些教学医院的普通外科:达喀尔主要医院、阿里斯蒂德·勒丹特克医院、达拉尔·贾姆医院和圣路易斯地区医院。使用了施瓦兹公式。我们使用了20%的腹部外科急诊。我们的样本量为246名患者。伦理与传播:本研究方案将提交给四家医院伦理委员会。本研究的结果可以帮助我们更好地处理消化紧急情况,同时降低死亡率。重点:消化外科急诊是一个公共卫生问题,因为最贫穷国家的死亡率很高,必须了解塞内加尔的流行病学数据,这些信息有助于降低相关死亡率。
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引用次数: 0
NANOTEX BONE Graft along with Fibula Flap in the Reconstruction of Segmental Mandibular Defect: Protocol for Pilot Clinical Trial. NANOTEX骨移植联合腓骨瓣重建下颌骨节段性缺损:初步临床试验方案。
IF 0.9 Q3 SURGERY Pub Date : 2023-01-01 DOI: 10.29337/ijsp.185
Anna Serene Babu, R Rashmi, V Manju, Pramod Subash, Arjun Krishnadas, Manitha Nair, Subramania Iyer

Introduction and objectives: Mandible reconstruction with vascularized fibula flap is the standard treatment for segmental mandibulectomy in patients with tumor or trauma. But the height of the fibula graft is insufficient for dental implant placement and prosthetic rehabilitation to replace the missing teeth, which in turn will compromise the functional efficiency and aesthetics of the patient. Although the bone height can be augmented through onlay grafting with iliac crest, it is associated with limitations like donor site morbidity and fast resorbability. This suggests the need for a synthetic biomaterial for vertical bone augmentation in implant dentistry.We have developed a biomimetic, porous, mechanically stable, and biodegradable nanocomposite named "NANOTEX BONE Graft" and its bone regeneration potential was evaluated in pre-clinical animal models. In this clinical trial, the safety as well as the efficacy of NANOTEX to augment new bone over fibula and further its ability to integrate with dental implants will be studied. The study has received the approval of the Ethics Committee of Amrita Institute of Medical Sciences and Central Drugs Standard Control Organization (CDSCO), India.

Methods: We have designed a prospective, single-center, non-randomized pilot clinical study. Patients with benign tumor or trauma indicated for mandibular reconstruction followed by implant rehabilitation will be included in the study. Eligible patients will be enrolled after obtaining informed consent. The study will be initiated and followed up as per defined timelines.

Highlights: Resection of benign mandibular tumours necessitates surgical removal of jaw bone and adjacent affected areas.The segmental mandibulectomy leaves the patient with functional impairments and aesthetic defects which in turn affect the quality of life.The standard treatment of reconstruction with vascularized fibula flap has challenge in achieving sufficient vertical bone height for implant placement and prosthetic rehabilitation.Alternate surgical techniques cause donor site morbidity and surgical complications.There is need for a synthetic biomaterial to be grafted over fibula for vertical bone augmentation.NANOTEX BONE Graft, a nanofibrous composite scaffold that mimics native bone, promote cell infiltration, neo-angiogenesis and new bone formation.Preclinical studies of NANOTEX in animal models showed bone tissue regeneration, better biodegradation in critical sized defects and efficient integration with dental implants.This clinical study propose to evaluate the safety and efficacy of NANOTEX bone graft augmented over fibula in bone regeneration and Titanium dental implant integration.

前言与目的:带血管腓骨皮瓣重建下颌骨是肿瘤或创伤下颌骨切除术的标准治疗方法。但是腓骨移植物的高度不足以用于牙种植体的植入和假体康复来替代缺失的牙齿,这反过来又会损害患者的功能效率和美观。虽然骨高度可以通过髂骨移植来增加,但它有局限性,如供体部位发病率和快速可吸收性。这表明需要一种人工合成的生物材料用于种植牙科的垂直骨增强。我们开发了一种仿生的、多孔的、机械稳定的、可生物降解的纳米复合材料,命名为“NANOTEX骨移植”,并在临床前动物模型中评估了其骨再生潜力。在这项临床试验中,将研究NANOTEX在腓骨上增加新骨的安全性和有效性,并进一步研究其与种植体结合的能力。这项研究已经得到了印度Amrita医学科学研究所和中央药物标准控制组织(CDSCO)伦理委员会的批准。方法:我们设计了一项前瞻性、单中心、非随机的先导临床研究。有良性肿瘤或创伤的患者需要进行下颌骨重建并进行种植体康复。符合条件的患者将在获得知情同意后入组。该研究将按照规定的时间表启动和跟进。重点:切除良性下颌骨肿瘤需要手术切除颌骨和邻近受影响的区域。节段性下颌骨切除术会给患者留下功能障碍和审美缺陷,进而影响患者的生活质量。带血管腓骨瓣重建的标准治疗在获得足够的垂直骨高度以进行种植体植入和假体康复方面存在挑战。替代手术技术导致供体部位发病率和手术并发症。需要一种人工合成的生物材料在腓骨上进行垂直骨增强。NANOTEX骨移植,一种纳米纤维复合支架,模拟天然骨,促进细胞浸润,新血管生成和新骨形成。在动物模型上的临床前研究表明,NANOTEX可以再生骨组织,在临界尺寸的缺陷中具有更好的生物降解能力,并与种植体有效结合。本临床研究旨在评价NANOTEX骨移植在腓骨骨再生和钛牙种植体整合中的安全性和有效性。
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引用次数: 0
Recommendations for Intraoperative Adverse Events Data Collection in Clinical Studies and Study Protocols. An ICARUS Global Surgical Collaboration Study. 临床研究和研究方案中术中不良事件数据收集的建议。ICARUS全球外科合作研究。
IF 0.9 Q3 SURGERY Pub Date : 2023-01-01 DOI: 10.29337/ijsp.183
Giovanni E Cacciamani, Michael Eppler, Aref S Sayegh, Tamir Sholklapper, Muneeb Mohideen, Gus Miranda, Mitch Goldenberg, Rene J Sotelo, Mihir M Desai, Inderbir S Gill

Introduction: Intraoperative adverse events (iAEs) occur and have the potential to impact the postoperative course. However, iAEs are underreported and are not routinely collected in the contemporary surgical literature. There is no widely utilized system for the collection of essential aspects of iAEs, and there is no established database for the standardization and dissemination of this data that likely have implications for outcomes and patient safety. The Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) Global Surgical Collaboration initiated a global effort to address these shortcomings, and the establishment of an adverse event data collection system is an essential step. In this study, we present the core-set variables for collecting iAEs that were based on the globally validated ICARUS criteria for surgical/interventional and anesthesiologic intraoperative adverse event collection and reporting.

Material and methods: This article includes three tools to capture the essential aspects of iAEs. The core-set variables were developed from the globally validated ICARUS criteria for reporting iAEs (item 1). Next, the summary table was developed to guide researchers in summarizing the accumulated iAE data in item 1 (item 2). Finally, this article includes examples of the method and results sections to include in a manuscript reporting iAE data (item 3). Then, 5 scenarios demonstrating best practices for completing items 1-3 were presented both in prose and in a video produced by the ICARUS collaboration.

Dissemination: This article provides the surgical community with the tools for collecting essential iAE data. The ICARUS collaboration has already published the 13 criteria for reporting surgical adverse events, but this article is unique and essential as it actually provides the tools for iAE collection. The study team plans to collect feedback for future directions of adverse event collection and reporting.

Highlights: This article represents a novel, fully-encompassing system for the data collection of intraoperative adverse events.The presented core-set variables for reporting intraoperative adverse events are not based solely on our opinion, but rather are synthesized from the globally validated ICARUS criteria for reporting intraoperative adverse events.Together, the included text, figures, and ICARUS collaboration-produced video should equip any surgeon, anesthesiologist, or nurse with the tools to properly collect intraoperative adverse event data.Future directions include translation of this article to allow for the widest possible adoption of this important collection system.

术中不良事件(iae)的发生并有可能影响术后过程。然而,在当代外科文献中,iae被低估,并且没有被常规收集。目前还没有广泛使用的系统来收集iae的基本方面,也没有建立数据库来标准化和传播这些可能对结果和患者安全产生影响的数据。采用通用标准的术中并发症评估和报告(ICARUS)全球外科合作组织发起了一项全球性的努力来解决这些缺点,建立不良事件数据收集系统是必不可少的一步。在这项研究中,我们提出了收集iae的核心变量,这些变量基于全球验证的ICARUS标准,用于收集和报告手术/介入和麻醉术中不良事件。材料和方法:本文包括三个工具,用于捕获iae的基本方面。根据全球验证的iAE报告ICARUS标准(项目1)开发核心集变量。接下来,开发汇总表,指导研究人员总结项目1(项目2)中积累的iAE数据。最后,本文包括方法示例和结果部分,用于报告iAE数据的稿件(项目3)。在ICARUS合作组织制作的视频中,以散文形式展示了完成项目1-3的5个最佳实践方案。传播:本文为外科社区提供了收集基本iAE数据的工具。ICARUS合作已经公布了13项报告手术不良事件的标准,但这篇文章是独特而重要的,因为它实际上为iAE收集提供了工具。研究小组计划收集反馈意见,以指导未来不良事件的收集和报告。重点:这篇文章代表了一个新颖的、全面的系统,用于收集术中不良事件的数据。所提出的报告术中不良事件的核心变量集并不仅仅基于我们的观点,而是根据全球有效的报告术中不良事件的ICARUS标准综合而成的。所包含的文本、图表和ICARUS合作制作的视频应使任何外科医生、麻醉师或护士掌握正确收集术中不良事件数据的工具。未来的方向包括翻译这篇文章,以便尽可能广泛地采用这一重要的收集系统。
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引用次数: 3
Development of Surgical Error Reduction System (SERS) for Laparoscopic Appendectomy by using Observational Human Reliability Analysis (OCHRA) model and to analyse its impact on patient outcomes. 应用观察性人类可靠性分析(OCHRA)模型开发腹腔镜阑尾切除术手术差错减少系统(SERS),并分析其对患者预后的影响。
IF 0.9 Q3 SURGERY Pub Date : 2022-09-21 eCollection Date: 2022-01-01 DOI: 10.29337/ijsp.181
Girivasan Muthukumarasamy, Samer Zino, Benjie Tang, Pradeep Patil

This project is to develop a surgical error reduction system (SERS) for laparoscopic appendectomy by using observational Human Reliability Analysis (OCHRA) model and to analyse it impact on patient's outcome.

本项目旨在应用观察性人类可靠性分析(OCHRA)模型,开发腹腔镜阑尾切除术的手术差错减少系统(SERS),并分析其对患者预后的影响。
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引用次数: 0
Clinical Effectiveness of Various Surgical Reconstruction Modalities for Acute ACJ Separation: Protocol for a Systematic Review and Meta-Analysis 不同手术重建方式治疗急性ACJ分离的临床效果:系统回顾和荟萃分析方案
IF 0.9 Q3 SURGERY Pub Date : 2022-03-03 DOI: 10.29337/ijsp.172
A. Hartland, S. Nayar, K. H. Teoh, M. Rashid
Introduction: Acute acromioclavicular joint separation is a common injury to the shoulder. Various surgical reconstruction methods exist when operative management is required, 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 reconstruction modalities used for acute ACJ separation. Methods: The study protocol was designed and registered prospectively on PROSPERO (International prospective register for systematic reviews). Literature search will include MEDLINE, EMBASE, PsycINFO, and The Cochrane Library electronic databases. Randomised controlled trials (RCTs) evaluating surgical procedures for acute acromioclavicular joint (ACJ) separation will be included. Our primary outcome is any functional patient-reported outcome measure related to the shoulder. Secondary outcomes may include radiological measurements, objective measurements of strength testing, range of motion, other patient-reported outcome measures not specific to the shoulder such as the Visual-Analog Scale (VAS) for pain, timelines for return to sport or work, and rate of complications. 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. Comparable outcome data will be pooled and analysed quantitatively or qualitatively as appropriate. Ethics and dissemination: This study did not require ethical clearance. We plan to publish this systematic review and meta-analysis in a peer-reviewed journal and present the results at various national and international conferences. Highlights There is currently variation in surgical synthetic ligament reconstruction techniques for acute acromioclavicular separation, with no clear consensus established. This systematic review evaluates the clinical effectiveness of various surgical reconstruction modalities used for acute ACJ separation. Our primary outcome is any functional patient-reported outcome measure related to the shoulder.
摘要急性肩锁关节分离是一种常见的肩部损伤。当需要手术治疗时,存在各种手术重建方法,但最佳程序尚不清楚。本系统综述和荟萃分析的目的是回顾文献,以评估用于急性ACJ分离的各种手术重建方式的临床有效性。方法:设计研究方案,并在PROSPERO(国际前瞻性系统评价注册系统)上进行前瞻性注册。文献检索将包括MEDLINE, EMBASE, PsycINFO和Cochrane图书馆的电子数据库。将纳入评估急性肩锁关节(ACJ)分离手术方法的随机对照试验(RCTs)。我们的主要终点是任何功能性患者报告的与肩部相关的终点测量。次要结果可能包括放射学测量、力量测试的客观测量、活动范围、其他患者报告的非特定于肩部的结果测量,如疼痛的视觉模拟量表(VAS)、恢复运动或工作的时间以及并发症的发生率。将使用Cochrane Risk of bias Tool 2.0和Jadad评分评估每项研究的偏倚风险。纳入研究的不一致性和偏倚将进行统计学评估。将汇集可比较的结果数据,并酌情进行定量或定性分析。伦理与传播:本研究不需要伦理许可。我们计划在同行评议的期刊上发表这一系统综述和荟萃分析,并在各种国内和国际会议上发表结果。目前对于急性肩锁分离的手术合成韧带重建技术存在差异,并没有明确的共识。本系统综述评估了用于急性ACJ分离的各种手术重建方式的临床效果。我们的主要终点是任何功能性患者报告的与肩部相关的终点测量。
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引用次数: 0
Diagnostic Inflammation Biomarkers for Prediction of 30-Day Mortality Rate in Acute Cholangitis 诊断性炎症生物标志物预测急性胆管炎30天死亡率
IF 0.9 Q3 SURGERY Pub Date : 2022-03-02 DOI: 10.29337/ijsp.170
Omer Al-Yahri, R. Al‐Zoubi, Azza Alam Elhuda, Amina Ahmad, M. Al Dhaheri, S. Abdelaziem, M. Alwani, A. Al-Qudimat, Ahmad Zarour
Background: Acute cholangitis (AC) is an acute inflammation and infection of the biliary tract, a potentially life-threatening infection, which is usually associated with biliary tree obstruction and impairment of bile flow from the liver to the duodenum. AC is classified by severity from mild, moderate to severe infection (grade I to III, respectively). Methods: This study recruited a retrospective cohort from Jan 2015 to July 2018. Overall, 294 patients of age ≥ 18 years with AC were enrolled. The study was conducted according to the World Medical Association Declaration of Helsinki. Demographic and laboratory data were collected for analysis. T-Bilirubin and other laboratory results were collected and analyzed using independent T-test and ANOVA for continuous values and multivariate COX regression for survival analysis for identifying independent factors for early mortality. The cut-off threshold of T-bilirubin was determined by calculating the area under the receiver operating characteristic (ROC) curve. Results: There were 213 male and 81 female patients and mean age ± SD of patients was 49.57 ± 16.1 and 56.12 ± 20.18 respectively. 31.9% patients were found older than 60 years of age and 35% patients were found between 30–45 years of age. T-bilirubin and length of hospital stay (LOS) were found statistically significant (P < 0.05) in relation to mortality in AC patients. The area under ROC curve for T-bilirubin level (P = 0.017, OR = 1.010) was 0.717 (95% CI, 6.25–168.9) and this is consistent with the Cut-off point for more than or equal to 38.6 µmol/L (2.26 mg/dL). Conclusions: In this study, T-bilirubin level is found to be significantly related to short-term mortality in AC. Further studies are still needed with larger cohorts to shed more light on these findings. Highlights: Herein, we report a retrospective observational study aiming to evaluate biomarkers contributing to mortality in AC and to determine the cut-off diagnostic levels that could be easily used in emergency setting. Overall, 294 patients of age ≥ 18 years with AC were enrolled. The study was conducted according to the World Medical Association Declaration of Helsinki and approved by Institutional Review Board (IRB) with approval: MRC-01-20-823 at Hamad Medical Corporation (HMC). Demographic and laboratory data were collected for analysis. Total-Bilirubin and other laboratory results were collected and analyzed using independent T-test and ANOVA for continuous values and multivariate COX regression for survival analysis for identifying independent factors for early mortality. The cut-off threshold of T-bilirubin was determined by calculating the area under the receiver operating characteristic (ROC) curve. There were 213 male and 81 female patients and mean age ± SD of patients was 49.57 ± 16.1 and 56.12 ± 20.18 respectively. 31.9% patients were found older than 60 years of age and 35% patients were found between 30-45 years of age. T-bilirubin and length of hospital stay
背景:急性胆管炎(AC)是一种急性胆道炎症和感染,是一种可能危及生命的感染,通常与胆管树梗阻和胆汁从肝脏流向十二指肠的障碍有关。AC按严重程度分为轻度、中度至重度感染(分别为I级至III级)。方法:本研究招募了2015年1月至2018年7月的回顾性队列。总的来说,294名年龄≥18岁的AC患者被纳入研究。这项研究是根据世界医学协会赫尔辛基宣言进行的。收集人口统计学和实验室数据进行分析。收集并分析T-胆红素和其他实验室结果,使用独立T检验和ANOVA进行连续值分析,使用多变量COX回归进行生存分析,以确定早期死亡率的独立因素。通过计算受试者工作特性(ROC)曲线下的面积来确定T-胆红素的临界阈值。结果:男性213例,女性81例,平均年龄±SD分别为49.57±16.1和56.12±20.18。31.9%的患者年龄超过60岁,35%的患者年龄在30-45岁之间。T胆红素和住院时间(LOS)与AC患者的死亡率有统计学意义(P<0.05)。T-胆红素水平的ROC曲线下面积(P=0.017,OR=1.010)为0.717(95%CI,6.25–168.9),这与大于或等于38.6µmol/L(2.26 mg/dL)的临界点一致。结论:在这项研究中,发现T-胆红素水平与AC的短期死亡率显著相关。仍需要对更大的队列进行进一步研究,以进一步阐明这些发现。要点:在此,我们报告了一项回顾性观察性研究,旨在评估导致AC死亡率的生物标志物,并确定可在紧急情况下轻松使用的临界诊断水平。总的来说,294名年龄≥18岁的AC患者被纳入研究。该研究根据世界医学协会赫尔辛基宣言进行,并由Hamad Medical Corporation(HMC)的机构审查委员会(IRB)批准:MRC-01-20-823。收集人口统计学和实验室数据进行分析。收集总胆红素和其他实验室结果,并使用独立的T检验和ANOVA进行连续值分析,使用多变量COX回归进行生存分析,以确定早期死亡率的独立因素。通过计算受试者工作特性(ROC)曲线下的面积来确定T-胆红素的临界阈值。男性213例,女性81例,平均年龄±SD分别为49.57±16.1和56.12±20.18。31.9%的患者年龄超过60岁,35%的患者年龄在30-45岁之间。T胆红素和住院时间(LOS)与AC患者的死亡率有统计学意义(P<0.05)。T-胆红素水平的ROC曲线下面积(P=0.037,OR=1.010)为0.717(95%CI,6.25–168.9),这与大于或等于38.6μmol/L(2.26 mg/dL)的临界点一致。
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引用次数: 4
Robotic vs. TaTME Rectal Surgery (ROTA STUDY) Matched Cohort Trial for Mid to Low Rectal Cancer Surgery Evaluation Trial in the Hands of an Experienced Surgeon 机器人与TaTME直肠手术(ROTA研究)由经验丰富的外科医生进行的中低位癌症直肠手术评估试验的配对队列试验
IF 0.9 Q3 SURGERY Pub Date : 2022-02-18 DOI: 10.29337/ijsp.163
R. Jootun, Pedja Cuk, M. Ellebæk, P. V. Andersen, S. Salomon, G. Baatrup, I. Al-Najami, J. Khan
Background: Recent novel surgical techniques for resection of low rectal cancer have been introduced and these approaches have the potential to overcome anatomical limitations like obesity, narrow male pelvis and bulky and low tumours. Two of these procedures are robotic low anterior resection (RLAR) and transanal total mesorectal excision (TaTME). Both approaches have distinct advantages and limitations. There has been no head to head trial comparing RLAR and TaTME for patients with mid to low rectal cancer undergoing surgery by experienced surgeons. Previous studies looking at the oncological outcomes of either TaTME or robotic TME included many centres where the surgeons were on a learning curve and hence the true oncological outcomes and clinical benefits can not be measured accurately. Method: The inclusion criteria include experienced surgeons defined as minimum of 60 prior procedures with RLAR or TaTME. Successful oncological and clinical outcomes are defined as circumferential resection margin (CRM) ≥1 mm with limited postoperative morbidity (absence of Clavien-Dindo grade III–IV complications within 30 days after surgery). Local and distal recurrence rates with DFS over 3 years will be measured as primary outcome. Data will be collected prospectively and entered in a dedicated database. Discussion: The primary objective of this study is to conduct a multicentre prospective trial to investigate clinical outcomes, in particular disease free survival (DFS) in patients undergoing RLAR and TaTME. The additional goal is to investigate other efficacy measures, complications rates, health economic aspects and patient reported health related quality of life. This paper describes an important trial conducted in expert centres to establish the needed knowledge for a detailed comparison of outcomes for TaTME versus RLAR. This trial is the first comparative study, comparing TaTME and RLAR, seeking to establish foothold for tailor-made surgical treatment of low rectal cancer patients. Trial registration: The trial is registered in clinicaltrials.gov September 2019. Clinicaltrials.gov id: NCT04200027.
背景:最近介绍了癌症低位切除术的新手术技术,这些方法有可能克服肥胖、男性骨盆狭窄和肿瘤体积大、体积小等解剖限制。其中两种手术是机器人低位前切除术(RLAR)和经肛门全直肠系膜切除术(TaTME)。这两种方法都有明显的优势和局限性。对于由经验丰富的外科医生进行手术的中低位癌症患者,尚未进行比较RLAR和TaTME的头对头试验。先前对TaTME或机器人TME的肿瘤学结果进行的研究包括许多外科医生处于学习曲线上的中心,因此无法准确测量真正的肿瘤学效果和临床益处。方法:纳入标准包括经验丰富的外科医生,定义为至少60例RLAR或TaTME手术。成功的肿瘤学和临床结果被定义为环切缘(CRM)≥1 mm,术后发病率有限(术后30天内没有Clavien-Dindo III–IV级并发症)。DFS 3年以上的局部和远端复发率将作为主要结果进行测量。将前瞻性地收集数据,并将其输入专用数据库。讨论:本研究的主要目的是进行一项多中心前瞻性试验,以调查接受RLAR和TaTME的患者的临床结果,特别是无病生存率(DFS)。额外的目标是调查其他疗效指标、并发症发生率、健康经济方面和患者报告的健康相关生活质量。本文描述了在专家中心进行的一项重要试验,以建立所需的知识,详细比较TaTME与RLAR的结果。这项试验是第一项比较研究,比较了TaTME和RLAR,旨在为低直肠癌癌症患者的定制手术治疗奠定基础。试验注册:该试验于2019年9月在clinicaltrials.gov上注册。Clinicaltrials.gov id:NCT04200027。
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引用次数: 1
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International Journal of Surgery Protocols
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