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Evaluating current acute aortic syndrome pathways: Collaborative Acute Aortic Syndrome Project (CAASP). 评估当前的急性主动脉综合征路径:急性主动脉综合征合作项目(CAASP)。
IF 3.5 3区 医学 Q1 SURGERY Pub Date : 2024-09-03 DOI: 10.1093/bjsopen/zrae096
Jim Zhong, Aminder A Singh, Nawaz Z Safdar, Sandip Nandhra, Ganesh Vigneswaran

Background: Diagnosis of acute aortic syndrome is challenging and associated with high perihospital mortality rates. The study aim was to evaluate current pathways and understand the chronology of acute aortic syndrome patient care.

Method: Consecutive patients with acute aortic syndrome imaging diagnosis between 1 January 2018 and 1 June 2021 were identified using a predetermined search strategy and followed up for 6 months through retrospective case note review. The UK National Interventional Radiology Trainee Research and Vascular and Endovascular Research Network co-ordinated the study.

Results: From 15 UK sites, 620 patients were enrolled. The median age was 67 (range 25-98) years, 62.0% were male and 92.9% Caucasian. Type-A dissection (41.8%) was most common, followed by type-B (34.5%); 41.2% had complicated acute aortic syndrome. Mode of presentation included emergency ambulance (80.2%), self-presentation (16.2%), and primary care referral (3.6%). Time (median (i.q.r.)) to hospital presentation was 3.1 (1.8-8.6) h and decreased by sudden onset chest pain but increased with migratory pain or hypertension. Time from hospital presentation to imaging diagnosis was 3.2 (1.3-6.5) h and increased by family history of aortic disease and decreased by concurrent ischaemic limb. Time from diagnosis to treatment was 2 (1.0-4.3) h with interhospital transfer causing delay. Management included conservative (60.2%), open surgery (32.2%), endovascular (4.8%), hybrid (1.4%) and palliative (1.4%). Factors associated with a higher mortality rate at 30 days and 6 months were acute aortic syndrome type, complicated disease, no critical care admission and age more than 70 years (P < 0.05).

Conclusions: This study presents a longitudinal data set linking time-based delays to diagnosis and treatment with clinical outcomes. It can be used to prioritize research strategies to streamline patient care.

背景:急性主动脉综合征的诊断具有挑战性,且与较高的院周死亡率相关。研究旨在评估当前的路径,了解急性主动脉综合征患者护理的时序:采用预先确定的搜索策略,对2018年1月1日至2021年6月1日期间影像诊断为急性主动脉综合征的连续患者进行识别,并通过回顾性病例记录审查进行为期6个月的随访。英国国家介入放射学受训者研究和血管及血管内研究网络对该研究进行了协调:英国 15 个研究机构共招募了 620 名患者。中位年龄为 67 岁(25-98 岁不等),62.0% 为男性,92.9% 为白种人。最常见的是A型夹层(41.8%),其次是B型(34.5%);41.2%的患者患有复杂的急性主动脉综合征。就诊方式包括急诊救护车(80.2%)、自行就诊(16.2%)和基层医疗机构转诊(3.6%)。到医院就诊的时间(中位数)为 3.1(1.8-8.6)小时,突发胸痛缩短了就诊时间,而移动性疼痛或高血压则延长了就诊时间。从入院到影像学诊断的时间为 3.2(1.3-6.5)小时,有主动脉疾病家族史的患者所需时间增加,同时患有缺血性肢体疾病的患者所需时间减少。从诊断到治疗的时间为2(1.0-4.3)小时,医院间转院导致了时间延误。治疗方法包括保守治疗(60.2%)、开放手术(32.2%)、血管内治疗(4.8%)、混合治疗(1.4%)和姑息治疗(1.4%)。30天和6个月内死亡率较高的相关因素是急性主动脉综合征类型、病情复杂、未入住重症监护室和年龄超过70岁(P<0.05):本研究提供了一个纵向数据集,将诊断和治疗的时间延迟与临床结果联系起来。结论:该研究提供的纵向数据集将诊断和治疗的时间延误与临床结果联系起来,可用于确定研究策略的优先次序,以简化患者护理。
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引用次数: 0
Risk factors and development of machine learning diagnostic models for lateral lymph node metastasis in rectal cancer: multicentre study. 直肠癌侧淋巴结转移的风险因素和机器学习诊断模型的开发:多中心研究。
IF 3.5 3区 医学 Q1 SURGERY Pub Date : 2024-07-02 DOI: 10.1093/bjsopen/zrae073
Shunsuke Kasai, Akio Shiomi, Hideyuki Shimizu, Monami Aoba, Yusuke Kinugasa, Takuya Miura, Kay Uehara, Jun Watanabe, Kazushige Kawai, Yoichi Ajioka

Background: The diagnostic criteria for lateral lymph node metastasis in rectal cancer have not been established. This research aimed to investigate the risk factors for lateral lymph node metastasis and develop machine learning models combining these risk factors to improve the diagnostic performance of standard imaging.

Method: This multicentre prospective study included patients who underwent lateral lymph node dissection without preoperative treatment for rectal cancer between 2017 and 2019 in 15 Japanese institutions. First, preoperative clinicopathological factors and magnetic resonance imaging findings were evaluated using multivariable analyses for their correlation with lateral lymph node metastasis. Next, machine learning diagnostic models for lateral lymph node metastasis were developed combining these risk factors. The models were tested in a training set and in an internal validation cohort and their diagnostic performance was tested using receiver operating characteristic curve analyses.

Results: Of 212 rectal cancers, 122 patients were selected, including 232 lateral pelvic sides, 30 sides of which had pathological lateral lymph node metastasis. Multivariable analysis revealed that poorly differentiated/mucinous adenocarcinoma, extramural vascular invasion, tumour deposit and a short-axis diameter of lateral lymph node ≥ 6.0 mm were independent risk factors for lateral lymph node metastasis. Patients were randomly divided into a training cohort (139 sides) and a test cohort (93 sides) and machine learning models were computed on the basis of a combination of significant features (including: histological type, extramural vascular invasion, tumour deposit, short- and long-axis diameter of lateral lymph node, body mass index, serum carcinoembryonic antigen level, cT, cN, cM, irregular border and mixed signal intensity). The top three models with the highest sensitivity in the training cohort were as follows: support vector machine (sensitivity, 1.000; specificity, 0.773), light gradient boosting machine (sensitivity, 0.950; specificity, 0.918) and ensemble learning (sensitivity, 0.950; specificity, 0.917). The diagnostic performances of these models in the test cohort were as follows: support vector machine (sensitivity, 0.750; specificity, 0.667), light gradient boosting machine (sensitivity, 0.500; specificity, 0.852) and ensemble learning (sensitivity, 0.667; specificity, 0.864).

Conclusion: Machine learning models combining multiple risk factors can contribute to improving diagnostic performance of lateral lymph node metastasis.

背景:直肠癌侧淋巴结转移的诊断标准尚未确立。本研究旨在调查侧淋巴结转移的风险因素,并结合这些风险因素开发机器学习模型,以提高标准成像的诊断性能:这项多中心前瞻性研究纳入了2017年至2019年间在日本15家机构接受侧淋巴结清扫术而未进行术前治疗的直肠癌患者。首先,通过多变量分析评估了术前临床病理因素和磁共振成像结果与侧淋巴结转移的相关性。然后,结合这些风险因素开发了侧淋巴结转移的机器学习诊断模型。这些模型在训练集和内部验证组中进行了测试,并通过接收器操作特征曲线分析检验了它们的诊断性能:结果:在212例直肠癌中,有122例患者被选中,包括232例盆腔侧位癌,其中30例有病理侧位淋巴结转移。多变量分析显示,分化差/粘液腺癌、壁外血管侵犯、肿瘤沉积和侧淋巴结短轴直径≥6.0毫米是侧淋巴结转移的独立危险因素。患者被随机分为训练组(139例)和测试组(93例),并根据重要特征(包括:组织学类型、壁外血管侵犯、肿瘤沉积、侧淋巴结短轴和长轴直径、体重指数、血清癌胚抗原水平、cT、cN、cM、不规则边界和混合信号强度)的组合计算机器学习模型。训练队列中灵敏度最高的前三个模型如下:支持向量机(灵敏度 1.000;特异性 0.773)、轻梯度提升机(灵敏度 0.950;特异性 0.918)和集合学习(灵敏度 0.950;特异性 0.917)。这些模型在测试队列中的诊断表现如下:支持向量机(灵敏度,0.750;特异性,0.667)、轻梯度提升机(灵敏度,0.500;特异性,0.852)和集合学习(灵敏度,0.667;特异性,0.864):结合多种风险因素的机器学习模型有助于提高侧淋巴结转移的诊断性能。
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引用次数: 0
Remote ischaemic preconditioning on gene expression and circulating proteins after subacute laparoscopic cholecystectomy: randomized clinical trial. 亚急性腹腔镜胆囊切除术后远程缺血预处理对基因表达和循环蛋白的影响:随机临床试验。
IF 3.5 3区 医学 Q1 SURGERY Pub Date : 2024-07-02 DOI: 10.1093/bjsopen/zrae067
Kirsten L Wahlstrøm, Lukas Balsevicius, Hannah F Hansen, Madeline Kvist, Jakob Burcharth, Gry Skovsted, Jens Lykkesfeldt, Ismail Gögenur, Sarah Ekeloef

Background: Surgical stress may lead to postsurgical hypercoagulability, endothelial dysfunction and systemic inflammation, which can impact on patient recovery. Remote ischaemic preconditioning is a procedure that activates the body's endogenous defences against ischaemia and reperfusion injury. Studies have suggested that remote ischaemic preconditioning has antithrombotic, antioxidative and anti-inflammatory effects. The hypothesis was that remote ischaemic preconditioning reduces surgery-induced systemic stress response.

Method: During a 24-month period (2019-2021), adult patients undergoing subacute laparoscopic cholecystectomy due to acute cholecystitis were randomized to remote ischaemic preconditioning or control. Remote ischaemic preconditioning was performed less than 4 h before surgery on the upper arm. It consisted of four cycles of 5 min ischaemia and 5 min reperfusion. The gene expression of 750 genes involved in inflammatory processes, oxidative stress and endothelial function was investigated preoperatively and 2-4 h after surgery in both groups. In addition, changes in 20 inflammation- and vascular trauma-associated proteins were assessed preoperatively, 2-4 h after surgery and 24 h after surgery.

Results: A total of 60 patients were randomized. There were no statistically significant differences in gene expression 2-4 h after surgery between the groups (P > 0.05). Remote ischaemic preconditioning did not affect concentrations of circulating proteins up to 24 h after surgery (P > 0.05).

Conclusion: The study did not demonstrate any effect of remote ischaemic preconditioning on expression levels of the chosen genes or in circulating immunological cytokines and vascular trauma-associated proteins up to 24 h after subacute laparoscopic cholecystectomy in patients with acute cholecystitis.

背景:手术应激可能导致术后高凝状态、内皮功能障碍和全身炎症,从而影响患者的康复。远程缺血预处理是一种激活机体内源性防御缺血和再灌注损伤的程序。研究表明,远程缺血预处理具有抗血栓、抗氧化和抗炎作用。假设远程缺血预处理可降低手术引起的全身应激反应:在为期24个月(2019-2021年)的时间里,因急性胆囊炎接受亚急性腹腔镜胆囊切除术的成年患者被随机分配到远程缺血预处理或对照组。远程缺血预处理在手术前不到4小时在上臂进行。它包括 5 分钟缺血和 5 分钟再灌注的四个周期。对两组患者术前和术后 2-4 小时内涉及炎症过程、氧化应激和内皮功能的 750 个基因的表达进行了调查。此外,还评估了术前、术后 2-4 小时和术后 24 小时 20 种炎症和血管创伤相关蛋白的变化:结果:共有 60 名患者接受了随机治疗。两组患者术后 2-4 小时的基因表达差异无统计学意义(P>0.05)。远程缺血预处理对术后 24 小时内的循环蛋白浓度没有影响(P > 0.05):结论:该研究未显示远程缺血预处理对急性胆囊炎患者亚急性腹腔镜胆囊切除术后24小时内所选基因的表达水平或循环免疫细胞因子和血管创伤相关蛋白有任何影响。
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引用次数: 0
Comment on: Portal vein embolization versus dual vein embolization for management of the future liver remnant in patients undergoing major hepatectomy: meta-analysis. 评论门静脉栓塞与双静脉栓塞治疗肝脏大部切除术患者未来残余肝脏:荟萃分析。
IF 3.5 3区 医学 Q1 SURGERY Pub Date : 2024-07-02 DOI: 10.1093/bjsopen/zrae057
Hani Oweira, Bassem Krimi, Amine Gouader, Ian Seiller, Mohamed Ali Chaouch
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引用次数: 0
Erratum to: Complications and adverse events in lymphadenectomy of the inguinal area: worldwide expert consensus. 勘误:腹股沟区淋巴腺切除术的并发症和不良事件:全球专家共识。
IF 3.5 3区 医学 Q1 SURGERY Pub Date : 2024-07-02 DOI: 10.1093/bjsopen/zrae112
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引用次数: 0
Attribution of smoking to healthcare costs in the postoperative interval. 吸烟对术后间歇期医疗成本的影响。
IF 3.5 3区 医学 Q1 SURGERY Pub Date : 2024-07-02 DOI: 10.1093/bjsopen/zrae090
Helene L Gräsbeck, Aleksi R P Reito, Heikki J Ekroos, Juhani A Aakko, Olivia Hölsä, Tuula M Vasankari
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引用次数: 0
Survival outcomes after breast cancer surgery among older women with early invasive breast cancer in England: population-based cohort study. 英国早期浸润性乳腺癌老年妇女乳腺癌手术后的生存结果:基于人群的队列研究。
IF 3.5 3区 医学 Q1 SURGERY Pub Date : 2024-07-02 DOI: 10.1093/bjsopen/zrae062
Katie Miller, Melissa Ruth Gannon, Jibby Medina, Karen Clements, David Dodwell, Kieran Horgan, Min Hae Park, David Alan Cromwell

Background: This study assessed the influence of age, co-morbidity and frailty on 5-year survival outcomes after breast conservation surgery (BCS) with radiotherapy (RT) versus mastectomy (with or without RT) in women with early invasive breast cancer.

Methods: Women aged over 50 years with early invasive breast cancer diagnosed in England (2014-2019) who had breast surgery were identified from Cancer Registry data. Survival estimates were calculated from a flexible parametric survival model. A competing risk approach was used for breast cancer-specific survival (BCSS). Standardized survival probabilities and cumulative incidence functions for breast cancer death were calculated for each treatment by age.

Results: Among 101 654 women, 72.2% received BCS + RT and 27.8% received mastectomy. Age, co-morbidity and frailty were associated with overall survival (OS), but only age and co-morbidity were associated with BCSS. Survival probabilities for OS were greater for BCS + RT (90.3%) versus mastectomy (87.0%), and the difference between treatments varied by age (50 years: 1.9% versus 80 years: 6.5%). Cumulative incidence functions for breast cancer death were higher after mastectomy (5.1%) versus BCS + RT (3.9%), but there was little change in the difference by age (50 years: 0.9% versus 80 years: 1.2%). The results highlight the change in baseline mortality risk by age for OS compared to the stable baseline for BCSS.

Conclusion: For OS, the difference in survival probabilities for BCS + RT and mastectomy increased slightly with age. The difference in cumulative incidence functions for breast cancer death by surgery type was small regardless of age. Evidence on real-world survival outcomes among older populations with breast cancer is informative for treatment decision-making.

研究背景本研究评估了早期浸润性乳腺癌女性患者在接受乳房保护手术(BCS)加放疗(RT)与乳房切除术(加或不加放疗)后,年龄、并发症和虚弱程度对5年生存结果的影响:从癌症登记数据中识别出在英格兰(2014-2019年)确诊患有早期浸润性乳腺癌且接受过乳房手术的50岁以上女性。通过灵活的参数生存模型计算出生存期估计值。乳腺癌特异性生存率(BCSS)采用竞争风险法。按年龄计算了每种治疗方法的标准化生存概率和乳腺癌死亡累积发生率函数:在 101 654 名妇女中,72.2% 接受了 BCS + RT,27.8% 接受了乳房切除术。年龄、并发症和体弱与总生存率(OS)有关,但只有年龄和并发症与BCSS有关。BCS+RT(90.3%)与乳房切除术(87.0%)相比,OS的生存概率更高,不同年龄的患者接受不同治疗的差异也不同(50岁:1.9%;80岁:6.5%)。乳房切除术(5.1%)与BCS+RT(3.9%)相比,乳腺癌死亡累积发病率较高,但不同年龄段的差异变化不大(50 岁:0.9% 对 80 岁:1.2%)。结果突出表明,与 BCSS 的稳定基线相比,OS 的基线死亡风险随年龄而变化:就OS而言,随着年龄的增长,BCS+RT和乳房切除术的生存概率差异略有增加。无论年龄如何,按手术类型划分的乳腺癌死亡累积发生率函数差异很小。有关老年乳腺癌患者实际生存结果的证据对治疗决策具有参考价值。
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引用次数: 0
Margin clearance greater than 1 mm in nodal-positive pancreatic adenocarcinoma patients: multicentre retrospective analysis. 结节阳性胰腺癌患者边缘间隙大于 1 毫米:多中心回顾性分析。
IF 3.5 3区 医学 Q1 SURGERY Pub Date : 2024-07-02 DOI: 10.1093/bjsopen/zrae076
Reea P Ahola, Eline S Zwart, Benediktas Kurlinkus, Asif Halimi, Bengi S Yilmaz, Giulio Belfiori, Keith Roberts, Rupaly Pande, Hasan A Al-Saffar, Patrick Maisonneuve, Güralp O Ceyhan, Johanna Laukkarinen

Background: The introduction of the 1 mm cut-off for resection margin according to the Leeds Pathology Protocol has transformed the concept of surgical radicality. Its impact on nodal-positive resected pancreatic ductal adenocarcinoma patients is unclear. The aim of this study was to analyse the effect of margin clearance on survival among resected, nodal-positive pancreatic ductal adenocarcinoma patients whose specimens were analysed according to the Leeds Pathology Protocol.

Methods: Data were collected retrospectively from multicentre clinical databases. Resected patients with nodal involvement were included. Overall survival and disease-free survival were analysed according to minimum reported margin clearances of 0, 0.5, 1, and 2 mm. The results are reported separately for patients who had not undergone venous resection and for patients for whom data were available regarding the superior mesenteric vein-facing margin or the vein specimen. The eighth edition of TNM classification by the AJCC was used.

Results: The study comprised 290 stage IIB patients and 215 stage III patients without venous resection. The superior mesenteric vein margin analysis comprised 127 stage IIB patients and 198 stage III patients. The different resection margin distances were not associated with overall survival and disease-free survival among patients without venous resection (P > 0.050). Receiving adjuvant therapy was associated with longer overall survival among stage IIB patients (P = 0.034) and stage III patients (P = 0.003) and with longer disease-free survival among stage III patients (P < 0.001).

Conclusions: In this study, a margin clearance greater than 1 mm showed no clear effect on overall survival in pancreatic ductal adenocarcinoma patients with nodal involvement, whereas adjuvant therapy was confirmed to be essential to ensure longer overall survival.

背景:根据《利兹病理学协议》(Leeds Pathology Protocol),切除边缘的临界值为 1 毫米,这改变了手术根治性的概念。其对结节阳性胰腺导管腺癌切除患者的影响尚不明确。本研究的目的是分析根据利兹病理学方案分析标本的切除、结节阳性胰腺导管腺癌患者的边缘清除率对生存率的影响:从多中心临床数据库中回顾性收集数据。包括结节受累的切除患者。根据报告的最小边缘净度 0、0.5、1 和 2 毫米对总生存率和无病生存率进行分析。对于未进行静脉切除术的患者和有肠系膜上静脉切缘或静脉标本数据的患者,结果将分别进行报告。采用的是 AJCC 的第八版 TNM 分类法:研究包括 290 例 IIB 期患者和 215 例未进行静脉切除的 III 期患者。肠系膜上静脉切缘分析包括 127 例 IIB 期患者和 198 例 III 期患者。在未进行静脉切除的患者中,不同的切除边缘距离与总生存率和无病生存率无关(P > 0.050)。接受辅助治疗与IIB期患者(P = 0.034)和III期患者(P = 0.003)较长的总生存期有关,与III期患者较长的无病生存期有关(P < 0.001):在这项研究中,边缘间隙大于1毫米对结节受累的胰腺导管腺癌患者的总生存率没有明显影响,而辅助治疗被证实对确保延长总生存率至关重要。
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引用次数: 0
Japanese living donor liver transplantation criteria for hepatocellular carcinoma: nationwide cohort study. 日本肝细胞癌活体肝移植标准:全国性队列研究。
IF 3.5 3区 医学 Q1 SURGERY Pub Date : 2024-07-02 DOI: 10.1093/bjsopen/zrae079
Masahiro Ohira, Gaku Aoki, Yasushi Orihashi, Kenichi Yoshimura, Takeo Toshima, Etsuro Hatano, Susumu Eguchi, Taizo Hibi, Kiyoshi Hasegawa, Yuzo Umeda, Takuya Hashimoto, Yasushi Hasegawa, Shuji Nobori, Yasuhiro Ogura, Hiroyuki Nitta, Hiroto Egawa, Hidetoshi Eguchi, Yasutsugu Takada, Yoshihide Ueda, Mureo Kasahara, Shigeyuki Kawachi, Yuji Soejima, Katsutoshi Tokushige, Hiroaki Nagano, Hironori Haga, Takumi Fukumoto, Satoshi Mochida, Koji Umeshita, Hideki Ohdan

Background: Validating the expanded criteria for living donor liver transplantation for hepatocellular carcinoma using national data is highly significant. The aim of this study was to evaluate the validity of the new Japanese criteria for living donor liver transplantation for hepatocellular carcinoma patients and identify factors associated with a poor prognosis using the Japanese national data set.

Methods: The study population comprised patients who underwent living donor liver transplantation for hepatocellular carcinoma at 37 centres in Japan between 2010 and 2018. In a nationwide survey, the overall survival and recurrence-free survival rates were evaluated based on the new Japanese criteria for applying the 5-5-500 rule when extending the indication beyond the Milan criteria. Prognostic factors within the Japanese criteria were determined using the Cox proportional hazards model.

Results: Patients within (485 patients) and beyond (31 patients) the Japanese criteria exhibited 5-year overall survival rates of 81% and 58% and 5-year recurrence-free survival rates of 77% and 48% respectively. Patients who met the Milan criteria, but not the 5-5-500 rule, had poorer outcomes. Multivariate analysis for 474 patients identified a neutrophil-to-lymphocyte ratio greater than or equal to 5 and a history of hepatectomy as independent risk factors.

Conclusion: This nationwide survey confirms the validity of the Japanese criteria. The poor prognostic factors within the Japanese criteria include a neutrophil-to-lymphocyte ratio greater than or equal to 5 and previous hepatectomy.

背景:利用全国数据验证肝细胞癌活体肝移植扩大标准意义重大。本研究旨在评估日本肝细胞癌活体肝移植新标准的有效性,并利用日本全国数据集确定与不良预后相关的因素:研究对象包括2010年至2018年期间在日本37个中心接受肝细胞癌活体肝移植的患者。在一项全国范围的调查中,根据日本的新标准,在将适应症扩展到米兰标准之外时应用5-5-500规则,对总生存率和无复发生存率进行了评估。采用考克斯比例危险模型确定了日本标准中的预后因素:结果:符合日本标准的患者(485 例)和超出日本标准的患者(31 例)的 5 年总生存率分别为 81% 和 58%,5 年无复发生存率分别为 77% 和 48%。符合米兰标准但不符合 5-5-500 规则的患者预后较差。对474名患者进行的多变量分析发现,中性粒细胞与淋巴细胞比值大于或等于5以及有肝切除史是独立的风险因素:这项全国性调查证实了日本标准的有效性。日本标准中的不良预后因素包括中性粒细胞与淋巴细胞比值大于或等于 5 以及曾进行过肝切除术。
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引用次数: 0
Comparison of two bundles for reducing surgical site infection in colorectal surgery: multicentre cohort study. 比较两种减少结直肠手术手术部位感染的捆绑方法:多中心队列研究。
IF 3.5 3区 医学 Q1 SURGERY Pub Date : 2024-07-02 DOI: 10.1093/bjsopen/zrae080
Miriam Flores-Yelamos, Aina Gomila-Grange, Josep M Badia, Alexander Almendral, Ana Vázquez, David Parés, Marta Pascual, Enric Limón, Miquel Pujol, Montserrat Juvany

Background: There is controversy regarding the maximum number of elements that can be included in a surgical site infection prevention bundle. In addition, it is unclear whether a bundle of this type can be implemented at a multicentre level.

Methods: A pragmatic, multicentre cohort study was designed to analyse surgical site infection rates in elective colorectal surgery after the sequential implementation of two preventive bundle protocols. Secondary outcomes were to determine compliance with individual measures and to establish their effectiveness, duration of stay, microbiology and 30-day mortality rate.

Results: A total of 32 205 patients were included. A 50% reduction in surgical site infection was achieved after the implementation of two sequential sets of bundles: from 18.16% in the Baseline group to 10.03% with Bundle-1 and 8.19% with Bundle-2. Bundle-2 reduced superficial-surgical site infection (OR 0.74 (95% c.i. 0.58 to 0.95); P = 0.018) and deep-surgical site infection (OR 0.66 (95% c.i. 0.46 to 0.93); P = 0.018) but not organ/space-surgical site infection (OR 0.88 (95% c.i. 0.74 to 1.06); P = 0.172). Compliance increased after the addition of four measures to Bundle-2. In the multivariable analysis, for organ/space-surgical site infection, laparoscopy, oral antibiotic prophylaxis and mechanical bowel preparation were protective factors in colonic procedures, while no protective factors were found in rectal surgery. Duration of stay fell significantly over time, from 7 in the Baseline group to 6 and 5 days for Bundle-1 and Bundle-2 respectively (P < 0.001). The mortality rate fell from 1.4% in the Baseline group to 0.59% and 0.6% for Bundle-1 and Bundle-2 respectively (P < 0.001). There was an increase in Gram-positive bacteria and yeast isolation, and reduction in Gram-negative bacteria and anaerobes in organ/space-surgical site infection.

Conclusions: The addition of measures to create a final 10-measure protocol had a cumulative protective effect on reducing surgical site infection. However, organ/space-surgical site infection did not benefit from the addition. No protective measures were found for organ/space-surgical site infection in rectal surgery. Compliance with preventive measures increased from Bundle-1 to Bundle-2.

背景:关于手术部位感染预防捆绑包中可包含的要素的最大数量存在争议。此外,这种类型的捆绑包能否在多中心水平上实施还不清楚:方法:设计了一项务实的多中心队列研究,分析在依次实施两种预防捆绑方案后,择期结直肠手术的手术部位感染率。次要结果是确定各项措施的依从性,并确定其有效性、住院时间、微生物学和 30 天死亡率:结果:共纳入 32 205 名患者。在连续实施两套捆绑方案后,手术部位感染率降低了 50%:从基线组的 18.16% 降至捆绑方案 1 的 10.03%,捆绑方案 2 的 8.19%。捆绑-2 降低了浅表手术部位感染(OR 0.74 (95% c.i. 0.58 to 0.95); P = 0.018)和深部手术部位感染(OR 0.66 (95% c.i. 0.46 to 0.93); P = 0.018),但没有降低器官/空间手术部位感染(OR 0.88 (95% c.i. 0.74 to 1.06); P = 0.172)。在 Bundle-2 中增加四项措施后,依从性有所提高。在多变量分析中,就器官/空间手术部位感染而言,腹腔镜、口服抗生素预防和机械肠道准备是结肠手术的保护因素,而直肠手术则没有保护因素。随着时间的推移,住院时间明显缩短,Bundle-1 和 Bundle-2 组分别从 7 天和 5 天缩短到 6 天和 5 天(P < 0.001)。死亡率从基线组的 1.4% 降至 Bundle-1 组的 0.59%,Bundle-2 组的 0.6%(P < 0.001)。在器官/空间-手术部位感染中,革兰氏阳性菌和酵母菌分离率上升,革兰氏阴性菌和厌氧菌分离率下降:增加措施以创建最终的 10 项措施方案对减少手术部位感染具有累积保护作用。然而,器官/空间手术部位感染并没有从增加的措施中受益。在直肠手术中没有发现针对器官/空间手术部位感染的保护措施。从 Bundle-1 到 Bundle-2,预防措施的依从性有所提高。
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