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Usefulness of Glucose Measurement To Assess Tissue Perfusion of the Nipple-Areola Complex in Conservative Mastectomy: A Prospective Cohort Study Protocol. 葡萄糖测量评估保守乳房切除术中乳头-乳晕复体组织灌注的有效性:一项前瞻性队列研究方案。
IF 0.9 Q3 Medicine Pub Date : 2022-08-01 eCollection Date: 2022-01-01 DOI: 10.29337/ijsp.178
Robertino B Basso, Breyner Garcia Rodriguez, René M Palacios Huatuco, Alejandro Coloccini, Mariano F Ramírez, Horacio F Mayer

In recent decades, the mastectomy technique has undergone progressive adaptations in order to preserve the integrity of the breast structure and the nipple-areola complex (NAC), allowing reconstruction to be performed immediately after ablation. However, mastectomy flap necrosis or NAC has become a common complication, with an incidence between 2% and 22.3%. Blood glucose measurement to monitor microsurgical flaps has been reported as a simple method for the early detection of venous compromise. In this scenario, we propose the need to use an alternative, cost-effective method to assess the vitality of NAC in conservative oncological mastectomies. This protocol describes a prospective cohort study and was approved by the Research Protocols Ethics Committee of our institution. Patients will be included after signing informed consent. The anonymity and confidentiality of the information collected will be respected according to the Declaration of Helsinki and according to local and national guidelines.

Highlights: The rate of flap necrosis or nipple-areola complex (NAC) after mastectomy with reconstruction ranges from 2% to 22.3%.Glucose measurement has been reported in microsurgical flaps.This protocol seeks to determine the use of glucose as an early predictor of NAC necrosis.Participants will be recruited from a high-volume breast pathology hospital.

近几十年来,为了保持乳房结构和乳头乳晕复合体(NAC)的完整性,乳房切除术技术经历了不断的调整,允许在消融后立即进行重建。然而,乳房切除术皮瓣坏死或NAC已成为常见的并发症,发生率在2%至22.3%之间。血糖测量监测显微外科皮瓣已被报道为一种简单的方法,早期发现静脉妥协。在这种情况下,我们建议需要使用一种替代的,具有成本效益的方法来评估保守性肿瘤乳房切除术中NAC的活力。本方案描述了一项前瞻性队列研究,并经本机构研究方案伦理委员会批准。患者将在签署知情同意书后纳入研究。所收集信息的匿名性和保密性将根据《赫尔辛基宣言》以及地方和国家准则予以尊重。重点:乳房切除术重建后皮瓣坏死或乳头乳晕复合(NAC)的发生率为2%至22.3%。显微外科皮瓣中葡萄糖测量已被报道。本方案旨在确定使用葡萄糖作为NAC坏死的早期预测因子。参与者将从一家规模较大的乳腺病理医院招募。
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引用次数: 0
Evaluation of the Introduction of a Colorectal Bundle in Left Sided Colorectal Resections (EvaCol): Study Protocol of a Multicentre, Observational Trial. 评估在左侧结肠直肠切除术中引入结肠直肠束 (EvaCol):一项多中心观察性试验的研究方案。
IF 1.1 Q3 SURGERY Pub Date : 2022-07-14 eCollection Date: 2022-01-01 DOI: 10.29337/ijsp.177
Benjamin Wiesler, Jörn-Markus Gass, Carsten Th Viehl, Alexandra Müller, Jürg Metzger, Mark Hartel, Christian Nebiker, Robert Rosenberg, Raffaele Galli, Urs Zingg, Alex Ochsner, Lukas Eisner, Martina Pabst, Mathias Worni, Mark Henschel, Markus von Flüe, Markus Zuber, Marco von Strauss Und Torney

Purpose: Overall complication and leak rates in colorectal surgery showed only minor improvements over the last years and remain still high. While the introduction of the WHO Safer Surgery Checklist has shown a reduction of overall operative mortality and morbidity in general surgery, only minor attempts have been made to improve outcomes by standardizing perioperative processes in colorectal surgery. Nevertheless, a number of singular interventions have been found reducing postoperative complications in colorectal surgery. The aim of the present study is to combine nine of these measures to a catalogue called colorectal bundle (CB). This will help to standardize pre-, intra-, and post-operative processes and therefore eventually reduce complication rates after colorectal surgery.

Methods: The study will be performed among nine contributing hospitals in the extended north-western part of Switzerland. In the 6-month lasting control period the patients will be treated according to the local standard of each contributing hospital. After a short implementation phase all patients will be treated according to the CB for another 6 months. Afterwards complication rates before and after the implementation of the CB will be compared.

Discussion: The overall complication rate in colorectal surgery is still high. The fact that only little progress has been made in recent years underlines the relevance of the current project. It has been shown for other areas of surgery that standardization is an effective measure of reducing postoperative complication rates. We hypothesize that the combination of effective, individual components into the CB can reduce the complication rate.

Trial registration: Registered in ClinicalTrials.gov on 11/03/2020; NCT04550156.

Highlights: Purpose: Overall complications in colorectal surgery remain still highStandardizing can reduce overall operative mortality and morbidityOnly minor attempts have been made to standardize perioperative processes in colorectal surgerySingular interventions have been found reducing postoperative complicationsThe aim is to combine nine of these measures to a colorectal bundle (CB)The CB will help to reduce complication rates after colorectal surgery Methods: The observational study will be performed among nine hospitals in SwitzerlandSix month the patients will be treated according to the local standardsAfterwards patients will be treated according to the CB for another six monthsComplication rates before and after the implementation of the CB will be compared Discussion: Only little progress has been made to reduce complication rate in colorectal surgeryStandardization is an effective measure of reducing complication ratesThe combination of effective, individual components into the CB can reduce the complication rate.

目的:在过去几年中,结直肠手术的总体并发症和漏诊率仅略有改善,仍然居高不下。世卫组织《更安全手术清单》的引入表明,普外科手术的总体死亡率和发病率有所下降,但通过规范结直肠手术围手术期流程来改善手术效果的尝试还很有限。尽管如此,一些单一的干预措施还是减少了结直肠手术的术后并发症。本研究的目的是将其中九项措施合并到一个名为结直肠束(CB)的目录中。这将有助于实现术前、术中和术后流程的标准化,从而最终降低结直肠手术后的并发症发生率:研究将在瑞士西北部的九家医院中进行。在为期 6 个月的持续对照期内,患者将按照各参与医院的当地标准接受治疗。经过短暂的实施阶段后,所有患者将再接受 6 个月的 CB 治疗。之后,将对实施 CB 前后的并发症发生率进行比较:讨论:结直肠手术的总体并发症发生率仍然很高。讨论:结直肠手术的总体并发症发生率仍然很高,近年来进展甚微,这凸显了本项目的重要性。其他外科领域的研究表明,标准化是降低术后并发症发生率的有效措施。我们假设,将有效的单个组件组合到 CB 中可以降低并发症发生率:试验注册:2020 年 3 月 11 日在 ClinicalTrials.gov 注册;NCT04550156:目的:结直肠手术的总体并发症仍居高不下标准化可降低总体手术死亡率和发病率结直肠手术围手术期流程标准化方面的尝试还很少已经发现了可减少术后并发症的单项干预措施目的是将其中九项措施合并为结直肠捆绑包(CB)CB将有助于降低结直肠手术后的并发症发生率方法:观察性研究将在结直肠手术患者中进行:在瑞士的九家医院中开展观察研究,根据当地标准对患者进行为期六个月的治疗:标准化是降低并发症发生率的有效措施。
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引用次数: 0
Secondary Flexor Tendon Reconstruction: Protocol for a Systematic Review and Meta-Analysis. 二次屈肌腱重建:系统回顾和荟萃分析方案。
IF 0.9 Q3 Medicine Pub Date : 2022-07-04 eCollection Date: 2022-01-01 DOI: 10.29337/ijsp.176
Rituja Kamble, Rushabh Shah, Ailbhe L Kiely, Grant S Nolan, Jason Wong

Introduction: Flexor tendon injuries of the hand and wrist involve complete or partial severance of the tendon, and primary repair is standard treatment. In cases of significantly delayed presentation, rupture of the repair or segmental tendon loss may require 1- or 2-stage secondary tendon reconstruction where a tendon graft is used. There is a risk of poor functional outcome due to stiffness and reduced range of motion which may affect patient's employment and activities of daily living. This study seeks to systematically evaluate the current evidence to determine outcomes of secondary flexor tendon reconstruction in terms of functional outcomes, complications, patient-reported outcome measures (PROMS) and costs.

Methods: This is a PROSPERO registered study protocol for systematic review and meta-analysis of comparative and non-comparative studies. Outcomes of intrasynovial versus extrasynovial tendon grafting and seniority of the surgeon will be analysed in addition to comparing graft weaving at the wrist and palm for both single- and two-stage tendon reconstruction. The primary outcome is functional active range of motion. Secondary outcomes are complications, PROMs and resource use. A comprehensive literature search will be conducted from 2000 to present. All studies involving secondary flexor tendon repairs will be involved, without limitation on language, and will be screened by two independent reviewers. Tools to appraise the quality of study methodology and/or bias will be used (e.g., Cochrane Collaborative Risk of Bias tool) and if feasible, a random effects meta-analysis will be conducted.

Ethics and dissemination: Ethical approval was not required for this study. The results of this systematic review and meta-analysis will be published in a peer-reviewed journal, and presented at both national and international conferences involving hand surgeons. The data collected will allow patients to be counselled more accurately by clinicians and may suggest areas where further research could be undertaken.

Systematic review registration: PROSPERO CRD42021296009.

Highlights: Single- or two-stage secondary flexor tendon reconstruction is an important treatment modality in cases unsuitable for primary repair.This study seeks to systematically evaluate the current evidence to determine outcomes of secondary flexor tendon reconstruction in terms of functional. outcomes, complications, patient-reported outcome measures (PROMS) and costs.This is a PROSPERO registered study protocol for systematic review and meta-analysis of comparative and non-comparative studies.Outcomes of intrasynovial versus extrasynovial tendon grafting and seniority of the surgeon will be analysed in addition to comparing graft weaving at the wrist and palm for both single- and two-stage tendon reconstruction.This systematic review aims to evaluate and summarise the be

手部和手腕的屈肌腱损伤涉及肌腱的完全或部分断裂,初级修复是标准治疗。在出现明显延迟的情况下,修复断裂或节段性肌腱丢失可能需要1或2期的二次肌腱重建,并使用肌腱移植物。由于僵硬和活动范围缩小,可能会影响患者的工作和日常生活活动,因此存在功能不良的风险。本研究旨在系统地评估当前的证据,以确定二次屈肌腱重建在功能结果、并发症、患者报告的结果测量(PROMS)和成本方面的结果。方法:这是一项普洛斯彼罗注册的研究方案,用于比较和非比较研究的系统评价和荟萃分析。除了比较腕部和手掌的移植物编织进行单阶段和两阶段肌腱重建外,还将分析滑膜内和滑膜外肌腱移植的结果以及外科医生的资历。主要结果是功能性活动范围。次要结局是并发症、prom和资源使用。将从2000年至今进行全面的文献检索。所有涉及二次屈肌腱修复的研究都将纳入,不受语言的限制,并将由两名独立审稿人进行筛选。将使用评估研究方法质量和/或偏倚的工具(例如,Cochrane协作偏倚风险工具),如果可行,将进行随机效应荟萃分析。伦理与传播:本研究不需要伦理批准。该系统综述和荟萃分析的结果将发表在同行评议的期刊上,并在涉及手外科医生的国内和国际会议上发表。收集的数据将使临床医生能够更准确地向患者提供咨询,并可能提出可以进行进一步研究的领域。系统评价注册:PROSPERO CRD42021296009。重点:单阶段或两阶段的二次屈肌腱重建是不适合初级修复的病例的重要治疗方式。本研究旨在系统地评估目前的证据,以确定二次屈肌腱重建在功能方面的结果。结果、并发症、患者报告的结果测量(PROMS)和费用。这是一个普洛斯彼罗注册的研究方案,用于比较和非比较研究的系统评价和荟萃分析。除了比较腕部和手掌的移植物编织进行单阶段和两阶段肌腱重建外,还将分析滑膜内和滑膜外肌腱移植的结果以及外科医生的资历。本系统综述旨在评估和总结目前最好的文献,以确定二次屈肌腱重建的结果。
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引用次数: 2
Hemocoagulative Modifications after Laparoscopic Surgery at Different Pneumoperitoneum Pressure Settings. 不同气腹压力下腹腔镜手术后凝血功能的改变。
IF 0.9 Q3 Medicine Pub Date : 2022-06-14 eCollection Date: 2022-01-01 DOI: 10.29337/ijsp.173
Intagliata Eva, Vecchio Rosario, Saitta Cesare, Vizzini Clarissa, Lo Presti Federica, Cacciola Rossella Rosaria, Cacciola Emma, Vecchio Veronica

Background: Many of the effects of pneumoperitoneum on cardiovascular, respiratory and metabolic systems have been discussed in Literature, but very little is known about the variations of the hemocoagulative parameters in patients undergoing laparoscopic surgery. The purpose of this study is to analyze the variations of the hemocoagulative parameters in patients undergoing elective laparoscopic cholecystectomy for symptomatic gallbladder stones. An eventual statistically significant difference linked to different pressure settings of pneumoperitoneum will allow selecting a specific intrabdominal pressure for a more adequate treatment with a lower incidence of pneumoperitoneum related complications.

Materials and methods: The clinical trial was conducted on 43 patients assigned in two groups based on the intra-abdominal pressure: group A, 27 patients, 12 mmHg, and group B, 16 patients, 8 mmHg. Hemoglobin, hematocrit, platelets count, PT ratio, aPTT, Fibrinogen, D-dimer, Von Willebrand factor, Factor II, Lupus Anticoagulant, Antithrombin III, Protein C, Protein S, Anticardiolipin IgG and IgM, anti-beta 2-Glicoprotein IgG and IgM were evaluated.

Results: For group A, patient's variations were observed for D-dimer, Factor II, von Willembrand factor and protein C reactive, while for patients belonging to group B the parameters most affected were PT ratio, anti-thrombin III and protein C reactive.D-dimer values increased significantly in group A, a statistically significant decrease in anti-thrombin III levels was detected in group B, and a statistically significant difference in PT ratio in patients belonging to group B was observed.

Conclusion: The statistical analysis showed no significant difference in the post-operative parameters when comparing the two groups of patients. Alterations of the coagulation parameters were present between pre- and post-operative data within the same group, namely a higher abdominal pressure is linked to a prothrombotic state. The question is worthy of further studies.

Highlights: - Variations of the hemocoagulative parameters in patients undergoing laparoscopy are still a matter of study;- Pneumoperitoneum seems to cause alterations in the hemocoagulative parameters, which could be influenced by the pneumoperitoneum pressure;- An eventual statistically significant difference linked to different pressure settings of pneumoperitoneum will allow selecting a specific intrabdominal pressure for a more adequate surgical treatment with a lower incidence of pneumoperitoneum related complications.

背景:文献中已经讨论了气腹对心血管、呼吸和代谢系统的许多影响,但对腹腔镜手术患者凝血参数的变化知之甚少。本研究的目的是分析择期腹腔镜胆囊切除术治疗症状性胆囊结石患者凝血参数的变化。与气腹不同压力设置相关的最终统计显着差异将允许选择特定的腹内压力进行更充分的治疗,并降低气腹相关并发症的发生率。材料与方法:临床试验纳入43例患者,根据腹内压分为两组:A组27例,12 mmHg, B组16例,8 mmHg。检测血红蛋白、红细胞压积、血小板计数、PT比值、aPTT、纤维蛋白原、d -二聚体、血管性血友病因子、因子II、狼疮抗凝血剂、抗凝血酶III、蛋白C、蛋白S、抗心磷脂IgG和IgM、抗β 2-糖蛋白IgG和IgM。结果:A组患者d -二聚体、因子II、血管性血友病因子、蛋白C反应发生变化,B组患者PT比值、抗凝血酶III、蛋白C反应受影响最大。A组d -二聚体值明显升高,B组抗凝血酶III水平明显降低,B组患者PT比值差异有统计学意义。结论:经统计学分析,两组患者术后各项参数差异无统计学意义。在同一组中,凝血参数在术前和术后数据之间存在变化,即较高的腹压与血栓形成前状态有关。这个问题值得进一步研究。亮点:-腹腔镜患者的凝血参数变化仍是一个研究问题;-气腹似乎引起凝血参数的改变。与气腹不同压力设置相关的最终统计显着差异将允许选择特定的腹内压力进行更适当的手术治疗,并降低气腹相关并发症的发生率。
{"title":"Hemocoagulative Modifications after Laparoscopic Surgery at Different Pneumoperitoneum Pressure Settings.","authors":"Intagliata Eva,&nbsp;Vecchio Rosario,&nbsp;Saitta Cesare,&nbsp;Vizzini Clarissa,&nbsp;Lo Presti Federica,&nbsp;Cacciola Rossella Rosaria,&nbsp;Cacciola Emma,&nbsp;Vecchio Veronica","doi":"10.29337/ijsp.173","DOIUrl":"https://doi.org/10.29337/ijsp.173","url":null,"abstract":"<p><strong>Background: </strong>Many of the effects of pneumoperitoneum on cardiovascular, respiratory and metabolic systems have been discussed in Literature, but very little is known about the variations of the hemocoagulative parameters in patients undergoing laparoscopic surgery. The purpose of this study is to analyze the variations of the hemocoagulative parameters in patients undergoing elective laparoscopic cholecystectomy for symptomatic gallbladder stones. An eventual statistically significant difference linked to different pressure settings of pneumoperitoneum will allow selecting a specific intrabdominal pressure for a more adequate treatment with a lower incidence of pneumoperitoneum related complications.</p><p><strong>Materials and methods: </strong>The clinical trial was conducted on 43 patients assigned in two groups based on the intra-abdominal pressure: group A, 27 patients, 12 mmHg, and group B, 16 patients, 8 mmHg. Hemoglobin, hematocrit, platelets count, PT ratio, aPTT, Fibrinogen, D-dimer, Von Willebrand factor, Factor II, Lupus Anticoagulant, Antithrombin III, Protein C, Protein S, Anticardiolipin IgG and IgM, anti-beta 2-Glicoprotein IgG and IgM were evaluated.</p><p><strong>Results: </strong>For group A, patient's variations were observed for D-dimer, Factor II, von Willembrand factor and protein C reactive, while for patients belonging to group B the parameters most affected were PT ratio, anti-thrombin III and protein C reactive.D-dimer values increased significantly in group A, a statistically significant decrease in anti-thrombin III levels was detected in group B, and a statistically significant difference in PT ratio in patients belonging to group B was observed.</p><p><strong>Conclusion: </strong>The statistical analysis showed no significant difference in the post-operative parameters when comparing the two groups of patients. Alterations of the coagulation parameters were present between pre- and post-operative data within the same group, namely a higher abdominal pressure is linked to a prothrombotic state. The question is worthy of further studies.</p><p><strong>Highlights: </strong>- Variations of the hemocoagulative parameters in patients undergoing laparoscopy are still a matter of study;- Pneumoperitoneum seems to cause alterations in the hemocoagulative parameters, which could be influenced by the pneumoperitoneum pressure;- An eventual statistically significant difference linked to different pressure settings of pneumoperitoneum will allow selecting a specific intrabdominal pressure for a more adequate surgical treatment with a lower incidence of pneumoperitoneum related complications.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9205367/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40570100","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
Topical Treatments in Reducing Propionibacterium Acnes Infection in Shoulder Surgery: Protocol for a Systematic Review and Meta-analysis. 减少肩部手术中痤疮丙酸杆菌感染的局部治疗:系统回顾和元分析协议》。
IF 1.1 Q3 SURGERY Pub Date : 2022-06-09 eCollection Date: 2022-01-01 DOI: 10.29337/ijsp.174
Yash Sewpaul, Brook Leung, Alexander W Hartland, Sandeep Krishan Nayar, Mustafa S Rashid

Introduction: Propionibacterium acnes is a gram-positive anaerobe that is found on the dermis and epidermis of the shoulder and is the most commonly identifiable cause of periprosthetic shoulder joint infection. Various topical strategies have been investigated to reduce the prevalence of P acnes, with several demonstrating efficacy in reducing the positive culture. The aim of this systematic review and meta-analysis is to review the literature to assess the effectiveness of topical preparations in reducing the prevalence of P acnes in shoulder surgery.

Methods: The study protocol was designed and registered prospectively on PROSPERO (International prospective register for systematic reviews). Databases used for the literature search will include MEDLINE, EMBASE, PsycINFO, and The Cochrane Library. Randomised controlled trials (RCTs) evaluating the use of any topical preparation against placebo, in all types of shoulder surgery, will be included. Our primary outcome is the number of colony forming units of P acnes. Secondary outcomes will include adverse events such as skin irritation, wound dehiscence, and the incidence of revision surgery due to infection. The Cochrane Risk of Bias Tool 2.0 and Jadad score will be used to assess the quality of methodology of the studies. Statistical analysis will be used to assess inconsistency and bias across included studies. Comparable outcome data will be pooled and analysed quantitatively or qualitatively as appropriate.

Ethics and dissemination: No ethical clearances required for this study. This systematic review and meta-analysis will be published in a peer-reviewed journal.

Highlights: Various topical strategies have been investigated to reduce the prevalence of P acnes, the most common identifiable cause of periprosthetic shoulder joint infection, with several demonstrating efficacy in reducing the positive culture.This systematic review and meta-analysis evaluates the effectiveness of topical preparations in reducing the prevalence of P acnes in shoulder surgery.Our primary outcome is the number of colony forming units of P acnes.

Registration: PROSPERO 2022 CRD42022310312.

导言:痤疮丙酸杆菌是一种革兰氏阳性厌氧菌,存在于肩部的真皮层和表皮层,是造成肩关节周围感染的最常见原因。为了降低痤疮丙酸杆菌的感染率,研究人员采用了多种外用药策略,其中有几种策略在降低阳性培养物方面效果显著。本系统综述和荟萃分析旨在回顾文献,评估外用制剂在降低肩关节手术中痤疮丙酸杆菌感染率方面的有效性:研究方案已设计完成,并在 PROSPERO(国际系统综述前瞻性注册系统)上进行了前瞻性注册。用于文献检索的数据库包括 MEDLINE、EMBASE、PsycINFO 和 Cochrane Library。将纳入对所有类型肩部手术中使用任何外用制剂与安慰剂进行评估的随机对照试验(RCT)。我们的主要结果是痤疮丙酸杆菌的菌落形成单位数。次要结果包括皮肤刺激、伤口开裂等不良事件,以及因感染而进行翻修手术的发生率。将使用 Cochrane 偏倚风险工具 2.0 和 Jadad 评分来评估研究方法的质量。统计分析将用于评估纳入研究的不一致性和偏倚性。可比较的结果数据将集中起来,并酌情进行定量或定性分析:本研究无需通过伦理审查。本系统综述和荟萃分析将在同行评审期刊上发表:本系统综述和荟萃分析评估了外用制剂在降低肩关节手术中痤疮丙酸杆菌感染率方面的有效性。我们的主要结果是痤疮丙酸杆菌的菌落形成单位数:ProCOMPRO 2022 CRD42022310312.
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引用次数: 0
Robotic Versus Conventional Minimal-Invasive Inguinal Hernia Repair: Study Protocol for a Prospective, Randomized and Blinded Clinical Trial. 机器人与传统微创腹股沟疝修补:一项前瞻性、随机和盲法临床试验的研究方案。
IF 0.9 Q3 Medicine Pub Date : 2022-06-06 eCollection Date: 2022-01-01 DOI: 10.29337/ijsp.175
Fiorenzo V Angehrn, Kerstin J Neuschütz, Johannes Baur, Romano Schneider, Alexander Wilhelm, Lea Stoll, Julian Süsstrunk, Markus von Flüe, Martin Bolli, Daniel C Steinemann

Introduction: Inguinal hernia repairs are commonly performed procedures. The surgical techniques vary from open procedures to minimally invasive and robotic-assisted surgeries and include totally extra-peritoneal hernia repairs (TEP) and robotic transabdominal pre-peritoneal hernia repairs (rTAPP). So far, there is no randomized and blinded clinical trial comparing these two surgical approaches. Our objective is to investigate whether rTAPP is associated with a decreased postoperative level of pain.

Methods: This is a prospective, single center, randomized and blinded clinical trial. Patients will receive either rTAPP or TEP for uni- or bilateral inguinal hernias. All patients and assessors of the study are blinded to the randomization. The perioperative setting is standardized, and all surgeons will perform both rTAPP and TEP to eliminate surgeons` bias. Primary endpoint is the assessment of pain while coughing 24 hours after surgery using the numeric rating scale (NRS). Secondary endpoints include the assessment of multiple pain and quality of life questionnaires at several defined times according to the study schedule. Furthermore, intra- and postoperative complications, duration until discharge, procedure time, duration of postoperative sick leave and the recurrence rate will be evaluated.

Registry: The trial has been registered at ClinicalTrials.gov under the registry number NCT05216276.

Highlights: Trial comparing robotic and conventional minimal-invasive inguinal hernia repairRandomized and patient/assessor blinded trialEarly postoperative pain as primary outcome (24 hours)Secondary patient outcomes include pain and quality of life scores up to one yearFurther secondary outcomes: complications, costs, surgeon's stress level.

腹股沟疝修补是常用的手术。手术技术多种多样,从开放手术到微创手术和机器人辅助手术,包括完全腹膜外疝修补术(TEP)和机器人经腹腹膜前疝修补术(rTAPP)。到目前为止,还没有比较这两种手术入路的随机盲法临床试验。我们的目的是研究rTAPP是否与术后疼痛程度的降低有关。方法:前瞻性、单中心、随机、盲法临床试验。单侧或双侧腹股沟疝患者可接受rTAPP或TEP治疗。该研究的所有患者和评估人员均对随机分组不知情。围手术期设置标准化,所有外科医生将同时进行rTAPP和TEP,以消除外科医生的偏见。主要终点是使用数字评定量表(NRS)评估术后24小时咳嗽疼痛。次要终点包括根据研究计划在几个确定的时间对多个疼痛和生活质量问卷进行评估。此外,还将评估手术内和术后并发症、出院时间、手术时间、术后病假时间和复发率。注册:该试验已在ClinicalTrials.gov注册,注册号为NCT05216276。重点:比较机器人和传统微创腹股沟疝修补术的试验随机和患者/评估者盲法试验术后早期疼痛作为主要结局(24小时),患者的次要结局包括疼痛和长达一年的生活质量评分,进一步的次要结局:并发症,费用,外科医生的压力水平。
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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 Medicine 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 Medicine 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 Medicine 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
Management and Outcomes of Low-Grade Gliomas in Africa: A Scoping Review Protocol. 非洲低级别胶质瘤的治疗和结果:一项范围审查方案。
IF 0.9 Q3 Medicine Pub Date : 2022-02-02 eCollection Date: 2022-01-01 DOI: 10.29337/ijsp.171
Setthasorn Zhi Yang Ooi, Rosaline de Koning, Abdullah Egiz, David Ulrich Dalle, Moussa Denou, Marvin Richie Dongmo Tsopmene, Mehdi Khan, Régis Takoukam, Jay Kotecha, Dawin Sichimba, Yao Christian Hugues Dokponou, Ulrick Sidney Kanmounye, Nourou Dine Adeniran Bankole

Background: Over the last decade, many advancements have been made in the management of low-grade gliomas (LGGs). Overall survival outcomes are correlated with factors such as postoperative residual volumes and specific tumor biomolecular profiles such as IDH mutation status. It is unclear whether these advancements have benefited LGG patients in Africa. This scoping review protocol outlines how the authors will evaluate the epidemiology, presentations, management and outcomes of LGGs in Africa.

Methods: MEDLINE, Embase and African Journals Online will be searched from database inception to date in order to identify the relevant studies. Patients of all ages with histologically and/or radiologically confirmed LGGs that were managed in an African country will be included. Surgical and chemoradiation management of LGG tumours will be considered. Original research, reviews, commentaries, editorials and case reports will be included.

Results: Primary outcomes of the review will include LGG management, morbidity and mortality. Secondary outcomes include epidemiology and recurrence of LGGs.

Discussion: This scoping review will be the first to evaluate the current landscape of LGG management and outcomes in Africa, highlighting pertinent themes that may be used to guide further research as well as health system strengthening efforts by policymakers and stakeholders.

Scoping review registration: The protocol has been registered on the Open Science Framework (OSF; registration link: https://doi.org/10.17605/OSF.IO/E732G).

Highlights: LGGs account for 17% to 22% of total brain tumours and have a median survival time between 5.6 and 13.3 years.Despite many recent advancements in the management of LGGs, there is a paucity in the data within the African landscape.This scoping review will be the first to evaluate the current landscape of LGG management and outcomes in Africa, highlighting pertinent themes that may be used to guide further research and policymaking efforts.

背景:在过去的十年中,低级别胶质瘤(LGGs)的治疗取得了许多进展。总体生存结果与术后残留体积和特定肿瘤生物分子特征(如IDH突变状态)等因素相关。目前尚不清楚这些进展是否使非洲的LGG患者受益。这份范围审查方案概述了作者将如何评估非洲LGGs的流行病学、介绍、管理和结果。方法:检索MEDLINE、Embase和African Journals Online从数据库建立至今的相关研究。所有年龄的、经组织学和/或放射学证实在非洲国家治疗过的lgg患者将被纳入研究范围。将考虑LGG肿瘤的手术和放化疗管理。原创性研究、评论、评论、社论和病例报告将包括在内。结果:本综述的主要结局将包括LGG管理、发病率和死亡率。次要结局包括流行病学和lgg的复发。讨论:这次范围审查将首次评估非洲LGG管理的现状和成果,突出可用于指导进一步研究以及决策者和利益攸关方加强卫生系统努力的相关主题。范围审查注册:该方案已在开放科学框架(OSF;注册链接:https://doi.org/10.17605/OSF.IO/E732G).Highlights: LGGs占所有脑肿瘤的17%至22%,中位生存时间在5.6至13.3年之间。尽管最近在LGGs管理方面取得了许多进展,但非洲境内的数据仍然缺乏。这一范围审查将首次评估非洲地方政府集团管理的现状和成果,突出可能用于指导进一步研究和决策工作的相关主题。
{"title":"Management and Outcomes of Low-Grade Gliomas in Africa: A Scoping Review Protocol.","authors":"Setthasorn Zhi Yang Ooi,&nbsp;Rosaline de Koning,&nbsp;Abdullah Egiz,&nbsp;David Ulrich Dalle,&nbsp;Moussa Denou,&nbsp;Marvin Richie Dongmo Tsopmene,&nbsp;Mehdi Khan,&nbsp;Régis Takoukam,&nbsp;Jay Kotecha,&nbsp;Dawin Sichimba,&nbsp;Yao Christian Hugues Dokponou,&nbsp;Ulrick Sidney Kanmounye,&nbsp;Nourou Dine Adeniran Bankole","doi":"10.29337/ijsp.171","DOIUrl":"https://doi.org/10.29337/ijsp.171","url":null,"abstract":"<p><strong>Background: </strong>Over the last decade, many advancements have been made in the management of low-grade gliomas (LGGs). Overall survival outcomes are correlated with factors such as postoperative residual volumes and specific tumor biomolecular profiles such as IDH mutation status. It is unclear whether these advancements have benefited LGG patients in Africa. This scoping review protocol outlines how the authors will evaluate the epidemiology, presentations, management and outcomes of LGGs in Africa.</p><p><strong>Methods: </strong>MEDLINE, Embase and African Journals Online will be searched from database inception to date in order to identify the relevant studies. Patients of all ages with histologically and/or radiologically confirmed LGGs that were managed in an African country will be included. Surgical and chemoradiation management of LGG tumours will be considered. Original research, reviews, commentaries, editorials and case reports will be included.</p><p><strong>Results: </strong>Primary outcomes of the review will include LGG management, morbidity and mortality. Secondary outcomes include epidemiology and recurrence of LGGs.</p><p><strong>Discussion: </strong>This scoping review will be the first to evaluate the current landscape of LGG management and outcomes in Africa, highlighting pertinent themes that may be used to guide further research as well as health system strengthening efforts by policymakers and stakeholders.</p><p><strong>Scoping review registration: </strong>The protocol has been registered on the Open Science Framework (OSF; registration link: <i>https://doi.org/10.17605/OSF.IO/E732G</i>).</p><p><strong>Highlights: </strong>LGGs account for 17% to 22% of total brain tumours and have a median survival time between 5.6 and 13.3 years.Despite many recent advancements in the management of LGGs, there is a paucity in the data within the African landscape.This scoping review will be the first to evaluate the current landscape of LGG management and outcomes in Africa, highlighting pertinent themes that may be used to guide further research and policymaking efforts.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2022-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8815446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39642251","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
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International Journal of Surgery Protocols
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