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Registry or randomization - must it be evidence or could it be coincidence? 注册或随机化——这是证据还是巧合?
IF 1.2 Q2 SURGERY Pub Date : 2024-06-26 eCollection Date: 2025-06-01 DOI: 10.1515/iss-2022-0028
Olga Radulova, Florian Oehme, Sandra Korn, Christian Praetorius, Marius Distler, Jürgen Weitz

Over the years, clinical registries and randomized controlled trials gained acceptance. With increasing experience, it was possible to obtain knowledge of benefits and limitations in both designs. During the last years, the research focus was placed on new study concepts such as register-based randomized controlled trials intending to merge the benefits of evidence obtained by RCTs and clinical registers. In this review, we aim to provide an overview of the evolution and the present stage of clinical trials. While doing so, we outline past experience and look ahead toward improving models for high-quality clinical trials.

多年来,临床登记和随机对照试验获得了认可。随着经验的增加,有可能了解到这两种设计的优点和局限性。在过去的几年里,研究的重点放在了新的研究概念上,如基于注册的随机对照试验,旨在将随机对照试验和临床注册获得的证据的好处结合起来。在这篇综述中,我们的目的是提供一个发展和目前阶段的临床试验的概述。在此过程中,我们概述了过去的经验,并展望了高质量临床试验的改进模型。
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引用次数: 0
Influence of medical didactic training on the self-efficacy and motivation of clinical teachers. 医学教学培训对临床教师自我效能感和动力的影响。
IF 1.7 Q2 SURGERY Pub Date : 2024-06-21 eCollection Date: 2024-06-01 DOI: 10.1515/iss-2023-0073
Franziska Schydlo, Jasmina Sterz, Maria-Christina Stefanescu, Martina Kadmon, Sarah König, Miriam Rüsseler, Felix Walcher, Farzin Adili

Objectives: Due to increasing workload and rising expectations for both undergraduate and speciality training in medicine, teaching in a clinical environment can be challenging. The "Train the Trainer" course, developed by CAL (Chirurgische Arbeitsgemeinschaft Lehre, Deutsche Gesellschaft für Chirurgie (DGCH)), aims to assist clinical teachers in their task. This study investigates the effect the course has on participants' self-efficacy and teaching motivation.

Methods: Prior to attending the course, participants anonymously completed a 50-question pre-course questionnaire using standardised questions to gather information on biographical data teaching experience, and validated tools measuring teaching motivation and self-efficacy (PRE). Directly after completing the course, participants evaluated it using a 25-question post-course questionnaire (POST1). At least 12 months after the course, participants received a follow-up questionnaire (POST2) by mail. This 44-question form aimed to gather biographical data, review the teaching methods participants had used since their training, and reassess their teaching motivation and self-efficacy.

Results: Between June 2016 and October 2019, 20 TTT courses were held across six German medical faculties. Data were gathered from 241 participants. After the course, 182 POST2 questionnaires were mailed, 61 of which were returned (equals a 39 % return rate). The findings revealed significant increases in teacher self-efficacy (p=0.0025), identified regulation (p=0.0000), and career motivation (p=0.0044). In contrast, there was a significant decrease in introjected regulation (p=0.0048). When comparing the participants to a reference sample selected from literature, significant differences emerged in intrinsic motivation (p=0.0000) and amotivation (p=0.0025).

Conclusions: Course participants already showed strong intrinsic motivation and self-efficacy before taking the course. After completing it, their confidence to meet specific teaching demands based on their abilities had increased. Notably, changes in motivational dimensions identified and introjected regulation point towards a shift in motivational sources, indicating a more self-regulated approach towards participants' teaching activities. Further research is needed to determine how much of this change was due to course participation.

目的:由于工作量不断增加,人们对医学本科生和专科生培训的期望值不断提高,在临床环境中开展教学工作具有挑战性。由 CAL(Chirurgische Arbeitsgemeinschaft Lehre,Deutsche Gesellschaft für Chirurgie (DGCH))开发的 "培训培训师 "课程旨在帮助临床教师完成任务。本研究调查了该课程对学员自我效能感和教学动力的影响:在参加课程之前,学员匿名填写了一份包含 50 个问题的课前问卷,问卷中使用了标准化的问题来收集学员的个人履历、教学经验以及衡量教学动力和自我效能的有效工具(PRE)。课程结束后,学员们直接使用 25 个问题的课后问卷(POST1)对课程进行评估。课程结束至少 12 个月后,学员们会收到一份邮寄的后续问卷(POST2)。这份包含 44 个问题的问卷旨在收集学员的履历数据,回顾学员自培训以来所使用的教学方法,并重新评估他们的教学动机和自我效能:结果:2016 年 6 月至 2019 年 10 月期间,德国六所医学院共举办了 20 期 TTT 课程。共收集了 241 名学员的数据。课程结束后,邮寄了 182 份 POST2 调查问卷,其中 61 份被收回(回收率为 39%)。调查结果显示,教师的自我效能感(p=0.0025)、识别调节(p=0.0000)和职业动机(p=0.0044)均有明显提高。与此相反,内省式调节却有明显下降(p=0.0048)。在将学员与从文献中选取的参考样本进行比较时,内在动机(p=0.0000)和非内在动机(p=0.0025)出现了显著差异:课程参与者在参加课程之前就已经表现出强烈的内在动机和自我效能感。结业后,他们根据自身能力满足具体教学要求的信心有所增强。值得注意的是,所发现的动机维度和引入调节的变化指向了动机来源的转变,表明学员在教学活动中采用了更加自我调节的方法。要确定这种变化在多大程度上归因于课程的参与,还需要进一步的研究。
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引用次数: 0
A note from the Editor-in-Chief. 主编的说明
IF 1.3 Q2 SURGERY Pub Date : 2024-03-18 eCollection Date: 2024-03-01 DOI: 10.1515/iss-2024-0011
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引用次数: 0
What's new in surgery - essentials 2023: the ISS young surgeon issue. 外科新动向--2023 年要点:ISS 年轻外科医生问题。
IF 1.3 Q2 SURGERY Pub Date : 2024-03-07 eCollection Date: 2023-12-01 DOI: 10.1515/iss-2024-0009
Juliane Kröplin
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引用次数: 0
Imaging in reconstructive microsurgery - current standards and latest trends. 整形显微外科成像--当前标准和最新趋势。
IF 1.3 Q2 SURGERY Pub Date : 2024-02-22 eCollection Date: 2023-12-01 DOI: 10.1515/iss-2023-0040
Beate Blank, Aijia Cai

In microsurgery, many different imaging techniques are available in both flap and lymphatic surgery that all come with their own advantages and disadvantages. In flap surgery, CT angiography is considered as the gold standard. Among others, Doppler ultrasound, color Doppler ultrasound, ICG, and smartphone-based thermal cameras are valuable imaging techniques. In lymphatic surgery, photoacoustic imaging, laser tomography, contrast-enhanced magnetic resonance imaging, and high frequency ultrasound stand available to surgeons next to the current standard of lymphoscintigraphy. It is crucial to know the advantages and disadvantages to various techniques and highly adviced to microsurgeons be capable of using a variety of them.

在显微外科中,皮瓣和淋巴手术都有许多不同的成像技术,这些技术各有利弊。在皮瓣手术中,CT 血管造影被认为是金标准。此外,多普勒超声、彩色多普勒超声、ICG 和基于智能手机的热像仪也是很有价值的成像技术。在淋巴手术中,光声成像、激光断层扫描、造影剂增强磁共振成像和高频超声都是外科医生可以使用的成像技术,仅次于目前的淋巴管造影标准。了解各种技术的优缺点至关重要,我们强烈建议显微外科医生能够使用各种技术。
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引用次数: 0
An update on liver surgery – a new terminology and modern techniques 肝脏手术的最新进展--新术语和现代技术
IF 1.3 Q2 SURGERY Pub Date : 2024-01-04 DOI: 10.1515/iss-2023-0032
V. Tripke, Nils Sommer
Abstract Liver surgery is the cornerstone of the curative treatment of malignant liver tumors. However, the liver anatomy is very complex, and liver surgery is still associated with relevant morbidity despite many technical advances. The Brisbane nomenclature is used worldwide to classify liver resection. However, this nomenclature has several limitations as multiple terms are used for the same type of resection. Non-anatomical resections, multiple resections, and combined bilio-vascular resections were not mentioned. Therefore, new terminologies have been proposed for the precise and simple classification of liver resection. Furthermore, in recent years, many technical innovations have been introduced in liver surgery, such as 3D imaging systems and indocyanine green fluorescence, for better preoperative and intraoperative identification of tumor localization and critical vascular structures. Minimally invasive techniques are used more frequently in liver surgery. Potential benefits include less intraoperative blood loss, less pain, and a shorter hospital stay. The implementation of robotic systems also has an impact on liver surgery, and the number of cases reported in the literature is constantly increasing. The potential benefits of robotic liver resection over laparoscopic liver resection will be the subject of future studies.
摘要 肝脏手术是治愈肝脏恶性肿瘤的基石。然而,肝脏的解剖结构非常复杂,尽管技术上取得了许多进步,肝脏手术仍然与相关的发病率有关。全世界都采用布里斯班命名法对肝切除术进行分类。然而,这种命名法存在一些局限性,因为同一类型的切除术使用了多个术语。非解剖性切除术、多重切除术和双侧血管联合切除术均未提及。因此,人们提出了新的术语,以便对肝切除术进行精确而简单的分类。此外,近年来,肝脏外科引入了许多创新技术,如三维成像系统和吲哚青绿荧光技术,以便在术前和术中更好地识别肿瘤定位和重要的血管结构。微创技术在肝脏手术中的应用越来越频繁。其潜在优势包括术中失血少、疼痛轻、住院时间短。机器人系统的应用也对肝脏手术产生了影响,文献报道的病例数量也在不断增加。与腹腔镜肝脏切除术相比,机器人肝脏切除术的潜在优势将是未来研究的主题。
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引用次数: 0
Endovascular repair of the aortic arch 主动脉弓的血管内修复
IF 1.3 Q2 SURGERY Pub Date : 2023-12-18 DOI: 10.1515/iss-2023-0029
Florian Kursch, Panagiotis Doukas
Abstract Objectives The gold standard for the treatment of pathologies of the aortic arch remains the open surgical reconstruction of the affected segments. However, endovas-cular treatment options have emerged that eliminate the need for invasive open surgery. Several endograft devices – with fenestrations or branches for the supraaortic vessels – are currently available to address different pathologies and anatomical variations. Parallel-graft techniques and in situ fenestrations expand the treatment options for emergent cases. In this selective review of the literature of 2020 and 2021, we summarize the current chances and challenges of endovascular aortic repair. Content Reported mortality rates range from 0 to 13.2 %. Although technical success rates for fenestrated and branched devices are promising (98 %), stroke rates remain a relevant issue (10 and 3 % for BTEVAR and FTEVAR respectively). The reported technical success rate for in situ fenestrations is also encouraging (94 %) and the stroke rates acceptable (5 %). Parallel-graft techniques are associated with high early and late endoleak rates (early 76 %; late 31 %), but still hold a valuable place in the treatment of emergent cases or in bail-out situations. Summary and Outlook The endovascular repair of the aortic arch expands the range of patients with pathologies of the arch eligible for treatment to those unfit for open surgery offering a minimally invasive, yet technically challenging procedure. More data and meta-analyses are needed to define the benefits and drawbacks of this promising treatment option in an aging population with increasing co-morbidities.
摘要 目的 治疗主动脉弓病变的金标准仍然是对受影响的节段进行开放手术重建。不过,现在已经出现了无需进行侵入性开放手术的腔内治疗方案。目前有几种带有主动脉上血管开口或分支的内移植装置,可用于不同的病理和解剖变异。并行移植技术和原位瘘管技术为急诊病例提供了更多的治疗选择。在这篇对 2020 年和 2021 年文献的选择性回顾中,我们总结了目前血管内主动脉修复的机遇和挑战。报告内容 死亡率从 0% 到 13.2% 不等。尽管有孔和分支装置的技术成功率很高(98%),但中风率仍是一个相关问题(BTEVAR 和 FTEVAR 的中风率分别为 10% 和 3%)。据报道,原位穿刺的技术成功率也令人鼓舞(94%),中风率也在可接受范围内(5%)。平行移植物技术的早期和晚期内漏率较高(早期 76%;晚期 31%),但在治疗急诊病例或救治情况下仍具有重要价值。总结与展望 主动脉弓血管内修复术扩大了主动脉弓病变患者的治疗范围,为不适合开放手术的患者提供了一种微创但具有技术挑战性的手术。需要更多的数据和荟萃分析来确定在合并疾病日益增多的老龄化人群中这一前景广阔的治疗方案的利弊。
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引用次数: 0
Virtual planning for mandible resection and reconstruction. 下颌骨切除和重建的虚拟规划。
IF 1.3 Q2 SURGERY Pub Date : 2023-12-06 eCollection Date: 2023-09-01 DOI: 10.1515/iss-2021-0045
Florian Andreas Probst, Paris Liokatis, Gerson Mast, Michael Ehrenfeld

In mandibular reconstruction, computer-assisted procedures, including virtual surgical planning (VSP) and additive manufacturing (AM), have become an integral part of routine clinical practice. Especially complex cases with extensive defects after ablative tumor surgery benefit from a computer-assisted approach. Various CAD/CAM-manufactured tools such as surgical guides (guides for osteotomy, resection and predrilling) support the transition from virtual planning to surgery. Patient-specific implants (PSIs) are of particular value as they facilitate both osteosynthesis and the positioning of bone elements. Computer-based approaches may be associated with higher accuracy, efficiency, and superior patient outcomes. However, certain limitations should be considered, such as additional costs or restricted availability. In the future, automation of the planning process and augmented reality techniques, as well as MRI as a non-ionizing imaging modality, have the potential to further improve the digital workflow.

在下颌骨重建方面,包括虚拟手术规划(VSP)和增材制造(AM)在内的计算机辅助程序已成为常规临床实践中不可或缺的一部分。尤其是在肿瘤消融手术后出现大面积缺损的复杂病例中,计算机辅助方法更能发挥作用。各种由 CAD/CAM 制造的工具,如手术导板(用于截骨、切除和预钻孔的导板),为从虚拟规划到手术的过渡提供了支持。患者专用植入体(PSI)具有特殊价值,因为它们既能促进骨合成,又能确定骨元素的位置。基于计算机的方法可能具有更高的准确性、效率和更好的患者疗效。但也应考虑到某些限制因素,如额外成本或可用性限制。未来,规划过程的自动化和增强现实技术,以及作为非电离成像模式的核磁共振成像,都有可能进一步改善数字化工作流程。
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引用次数: 0
Anticoagulation management in elderly patients with proximal femur fractures – overview of current concepts 股骨近端骨折老年患者的抗凝治疗--当前概念概述
IF 1.3 Q2 SURGERY Pub Date : 2023-12-05 DOI: 10.1515/iss-2023-0030
Yasmin Youssef, Anna K. I. M. Dietrich, Annika Hättich
Abstract Objectives Proximal femur fractures (PFF) are common injuries in elderly patients and can have considerable effects on their quality of life, morbidity, and mortality. Due to pre-existing comorbidities, the prevalence of anticoagulated patients is increasing. The right timing for surgery and perioperative anticoagulation treatment remains controversial. Content This overview aims to summarize current practices in the pre- and postoperative anticoagulation management and the recommended time to surgery in elderly patients with PFF. Summary and Outlook Time to surgery for anticoagulated patients is often prolonged due to worries about serious perioperative bleeding and higher transfusion demands. But the delay of surgical PFF treatment increases the risk for perioperative complications like pulmonary embolism, pneumonia, deep vein thrombosis and urinary tract infections. Early surgery can be achieved with a consistent and interdisciplinary perioperative anticoagulation management. Antiplatelets do not have to be discontinued and surgery should be performed early without delay. For patients taking vitamin K antagonists (VKA) an INR less than 1.5 is recommended prior to surgery, which can be achieved by pausing VKA intake or by administering vitamin K, prothrombin complex concentrate (PCC) or fresh frozen plasma (FFP). For the treatment with direct oral anticoagulants (DOAC) a plasma drug level of under 50 pg/mL is considered safe for surgery. If the plasma level can not be determined, a gap of 24 h between the last DOAC dose and surgery is recommended. The systemic administration of tranexamic acid can reduce overall blood loss and transfusion rates in anticoagulated patients with PFF. Surgical treatment of PFF should be performed within 24 h, as delayed surgery increases the risk for perioperative complications. This also applies to anticoagulated patients, when clinically appropriate. International and interdisciplinary guidelines are necessary to ensure early and appropriate treatment of anticoagulated elderly patients with PFF.
摘要:目的股骨近端骨折(PFF)是老年患者常见的损伤,对患者的生活质量、发病率和死亡率都有相当大的影响。由于先前存在的合并症,抗凝患者的患病率正在增加。手术和围手术期抗凝治疗的正确时机仍然存在争议。本综述旨在总结目前老年PFF患者术前和术后抗凝治疗的实践以及推荐的手术时间。摘要与展望抗凝患者的手术时间往往延长,因为担心严重的围手术期出血和较高的输血需求。但手术治疗PFF的延迟增加了围手术期并发症的风险,如肺栓塞、肺炎、深静脉血栓形成和尿路感染。早期手术可以通过一致和跨学科的围手术期抗凝管理来实现。抗血小板不必停药,手术应尽早进行,不得延误。对于服用维生素K拮抗剂(VKA)的患者,在手术前建议INR小于1.5,可通过暂停VKA摄入或给予维生素K、凝血酶原复合物浓缩物(PCC)或新鲜冷冻血浆(FFP)来实现。对于直接口服抗凝剂(DOAC)治疗,血浆药物水平低于50 pg/mL被认为是安全的手术。如果不能确定血浆水平,建议在最后一次DOAC剂量和手术之间间隔24 h。全身性给药氨甲环酸可以减少抗凝PFF患者的总失血量和输血率。PFF的手术治疗应在24 h内进行,因为延迟手术会增加围手术期并发症的风险。当临床需要时,这也适用于抗凝患者。国际和跨学科的指南是必要的,以确保早期和适当的治疗抗凝性PFF老年患者。
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引用次数: 0
Multivisceral resection of advanced colon and rectal cancer: a prospective multicenter observational study with propensity score analysis of the morbidity, mortality, and survival. 晚期结肠癌和直肠癌多脏器切除:一项前瞻性多中心观察性研究,对发病率、死亡率和生存率进行倾向评分分析。
IF 1.3 Q2 SURGERY Pub Date : 2023-11-27 eCollection Date: 2023-06-01 DOI: 10.1515/iss-2023-0027
Michael Arndt, Hans Lippert, Roland S Croner, Frank Meyer, Ronny Otto, Karsten Ridwelski
<p><strong>Objectives: </strong>In the surgical treatment of colorectal carcinoma (CRC), 1 in 10 patients has a peritumorous adhesion or tumor infiltration in the adjacent tissue or organs. Accordingly, multivisceral resection (MVR) must be performed in these patients. This prospective multicenter observational study aimed to analyze the possible differences between non-multivisceral resection (nMVR) and MVR in terms of early postoperative and long-term oncological treatment outcomes. We also aimed to determine the factors influencing overall survival.</p><p><strong>Methods: </strong>The data of 25,321 patients from 364 hospitals who had undergone surgery for CRC (the Union for International Cancer Control stages I-III) during a defined period were evaluated. MVR was defined as (partial) resection of the tumor-bearing organ along with resection of the adherent and adjacent organs or tissues. In addition to the patients' personal, diagnosis (tumor findings), and therapy data, demographic data were also recorded and the early postoperative outcome was determined. Furthermore, the long-term survival of each patient was investigated, and a "matched-pair" analysis was performed.</p><p><strong>Results: </strong>From 2008 to 2015, the MVR rates were 9.9 % (n=1,551) for colon cancer (colon CA) and 10.6 % (n=1,027) for rectal cancer (rectal CA). CRC was more common in men (colon CA: 53.4 %; rectal CA: 62.0 %) than in women; all MVR groups had high proportions of women (53.6 % vs. 55.2 %; pairs of values in previously mentioned order). Resection of another organ frequently occurred (75.6 % vs. 63.7 %). The MVR group had a high prevalence of intraoperative (5.8 %; 12.1 %) and postoperative surgical complications (30.8 % vs. 36.4 %; each p<0.001). Wound infections (colon CA: 7.1 %) and anastomotic insufficiencies (rectal CA: 8.3 %) frequently occurred after MVR. The morbidity rates of the MVR groups were also determined (43.7 % vs. 47.2 %). The hospital mortality rates were 4.9 % in the colon CA-related MVR group and 3.8 % in the rectal CA-related MVR group and were significantly increased compared with those of the nMVR group (both p<0.001). Results of the matched-pair analysis showed that the morbidity rates in both MVR groups (colon CA: 42.9 % vs. 34.3 %; rectal CA: 46.3 % vs. 37.2 %; each p<0.001) were significantly increased. The hospital lethality rate tended to increase in the colon CA-related MVR group (4.8 % vs. 3.7 %; p=0.084), while it significantly increased in the rectal CA-related MVR group (3.4 % vs. 3.0 %; p=0.005). Moreover, the 5-year (yr) overall survival rates were 53.9 % (nMVR: 69.5 %; p<0.001) in the colon CA group and 56.8 % (nMVR: 69.4 %; p<0.001) in the rectal CA group. Comparison of individual T stages (MVR vs. nMVR) showed no significant differences in the survival outcomes (p<0.05); however, according to the matched-pair analysis, a significant difference was observed in the survival outcomes of those with pT4 colon CA (40.6 % vs.
目的:在结直肠癌(CRC)的手术治疗中,每10例患者中就有1例存在瘤周粘连或肿瘤浸润邻近组织或器官。因此,这些患者必须进行多脏器切除(MVR)。本前瞻性多中心观察性研究旨在分析非多脏器切除(nMVR)和MVR在术后早期和长期肿瘤治疗结果方面可能存在的差异。我们还旨在确定影响总生存率的因素。方法:对来自364家医院的25321例CRC手术患者(国际癌症控制联盟I-III期)的数据进行评估。MVR的定义是(部分)切除荷瘤器官,同时切除附着和邻近的器官或组织。除了患者的个人、诊断(肿瘤发现)和治疗数据外,还记录了人口统计学数据,并确定了术后早期结局。此外,对每位患者的长期生存进行了调查,并进行了“配对”分析。结果:2008 - 2015年,结肠癌(结肠CA)的MVR率为9.9 % (n= 1551),直肠癌(直肠CA)的MVR率为10.6 % (n= 1027)。结直肠癌在男性中更为常见(结肠CA: 53.4% %;直肠CA: 62.0 %)高于女性;所有MVR组的女性比例都很高(53.6 % vs. 55.2% %;按前面提到的顺序排列的值对)。另一器官的切除经常发生(75.6% % vs. 63.7 %)。MVR组术中发生率高(5.8% %;12.1 %)和术后手术并发症(30.8 % vs 36.4 %;每个p0.05)。两种肿瘤类型的共同危险因素为高龄(>79 yr)、pT分期、性别和发病率(各危险比>1;结论:MVR可以通过R0切除进行治疗,并有足够的长期生存。对于结肠或直肠CA, MVR往往与5年总生存率降低相关(基于MPA结果,仅pT4结肠CA显著),并且两种肿瘤实体的发病率均显著增加。在总体数据中,配对分析表明,MVR与医院死亡率的显著增加相关(仅对直肠CA有显著性)。
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引用次数: 0
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Innovative Surgical Sciences
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