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Artificial sphincter with a new silicone band for treating faecal incontinence: IDEAL 2b prospective multicentre trial. 人工括约肌与新型硅胶带治疗大便失禁:IDEAL 2b前瞻性多中心试验。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf112
Christopher Dawoud, José Manuel Devesa, Mathias Löhnert, Rosana Vicente, Sherif Akram Metwalli, Stefan Riss

Introduction: The management of faecal incontinence (FI) remains challenging and further treatment modalities are urgently needed. The aim of this study was to assess the efficacy of a novel artificial bowel sphincter (SimplyFI anal band), which is implanted around the anal sphincter complex to enhance continence.

Methods: An exploratory prospective multicentre study based on the IDEAL 2b framework was conducted in patients with FI unresponsive to conservative treatment. Participants underwent SimplyFI implantation, followed by assessments at 1 week and 1, 3, 6, and 12 months after implantation. Intraoperative and postoperative complications were recorded. Functional improvement and quality of life were measured using the St Mark's incontinence score (SMIS) and the Faecal Incontinence Quality of Life Scale (FIQLS).

Results: Eighteen patients were included in the study (17 women, 1 man). The median operating time was 27 (range 13-60) min, with a median hospital stay of 2 (range 1-5) days. One intraoperative complication occurred without affecting the outcome. One patient (5.6%) underwent band removal due to anal discomfort without signs of infection. Relative to baseline, significant improvements were seen at 12 months in median scores for both the SMIS (from 16.5 to 12.5; P = 0.013) and the FIQLS (from 2.0 to 2.6; P = 0.006). Anorectal manometry showed a significant increase in the anal resting pressure from preoperative values to 3 months after implantation (median 15.5 versus 19.0 mmHg, respectively; P = 0.037); however, the increase in anal resting pressure was no longer seen at the 12-month follow-up.

Conclusion: In this exploratory study of 18 patients, the SimplyFI anal band appears to be safe with short-term improvement in function. Future studies with longer follow-up periods are needed to better define the role of this new treatment modality. Registration number: NCT05708612 (http://www.clinicaltrials.gov).

导言:大便失禁(FI)的管理仍然具有挑战性,迫切需要进一步的治疗方式。本研究的目的是评估一种新型人工肠括约肌(SimplyFI肛门带)的疗效,该肛门括约肌周围植入肛门括约肌复合体以增强失禁。方法:基于IDEAL 2b框架对保守治疗无反应的FI患者进行探索性前瞻性多中心研究。参与者接受SimplyFI植入,随后在植入后1周、1、3、6和12个月进行评估。记录术中及术后并发症。使用St Mark失禁评分(SMIS)和粪便失禁生活质量量表(FIQLS)测量功能改善和生活质量。结果:18例患者纳入研究,其中女性17例,男性1例。手术时间中位数为27分钟(13-60分钟),住院时间中位数为2天(1-5天)。术中发生1例并发症,未影响预后。1例患者(5.6%)因肛门不适而无感染迹象而行束带摘除。相对于基线,在12个月时,SMIS(从16.5到12.5,P = 0.013)和FIQLS(从2.0到2.6,P = 0.006)的中位数得分均有显著改善。肛门直肠测压显示,从术前值到植入后3个月,肛门静息压显著增加(中位数分别为15.5和19.0 mmHg, P = 0.037);然而,在12个月的随访中,肛门静息压力不再增加。结论:在这项18例患者的探索性研究中,SimplyFI肛门带似乎是安全的,短期内功能得到改善。未来需要更长随访期的研究来更好地确定这种新的治疗方式的作用。注册号:NCT05708612 (http://www.clinicaltrials.gov)。
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引用次数: 0
Incidence, treatment, and survival of patients with appendiceal adenocarcinomas and low-grade appendiceal mucinous neoplasms: linked Swedish national registry study. 阑尾腺癌和低级别阑尾黏液性肿瘤患者的发病率、治疗和生存率:瑞典国家登记研究
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf109
Joel Johansson, Roland E Andersson, Per Loftås, Stefan Redéen

Background: Appendiceal adenocarcinomas and low-grade appendiceal mucinous neoplasms (LAMNs) are rare tumours. Much of the existing knowledge is derived from registry-based studies, particularly the Surveillance, Epidemiology, and End Results database in the USA.

Methods: This retrospective cohort study used data from the Swedish Cancer Registry, Swedish Cause of Death Registry, and the National Patient Registry to analyse demographic characteristics and outcomes of patients diagnosed with appendiceal adenocarcinoma or LAMN between 2005 and 2019. Kaplan-Meier survivor function, multivariate Cox regression analysis, standardized mortality ratio, and net survival were used to assess survival. Incidence was estimated by direct standardization from 2005 to 2019.

Results: In all, 1159 patients with appendiceal neoplasms were included, with a mean age at diagnosis of 63.3 years. The incidence of adenocarcinomas was stable, whereas the incidence of LAMNs increased from 2012 onwards. Patients with non-mucinous adenocarcinomas who underwent colonic resection had better survival outcomes than patients treated with appendicectomy alone. For mucinous adenocarcinomas, colonic resection did not improve survival outcomes compared with appendicectomy. Patients with non-mucinous adenocarcinoma, mucinous adenocarcinoma, or LAMN who underwent cytoreductive surgery and heated intraperitoneal chemotherapy (CRS-HIPEC) had favourable overall and net survival.

Conclusion: Colonic resection increased survival only for patients with non-mucinous adenocarcinomas. Since 2012, the incidence of LAMN has increased, most likely due to changes in diagnostic and coding practices, but the incidence of appendiceal adenocarcinomas has remained stable. The survival benefit of CRS-HIPEC is observed in a very specific patient population, emphasizing the importance of careful patient selection.

背景:阑尾腺癌和低级别阑尾粘液瘤(LAMNs)是罕见的肿瘤。许多现有的知识来源于基于登记的研究,特别是美国的监测、流行病学和最终结果数据库。方法:本回顾性队列研究使用瑞典癌症登记处、瑞典死因登记处和国家患者登记处的数据,分析2005年至2019年间诊断为阑尾腺癌或LAMN的患者的人口统计学特征和结局。使用Kaplan-Meier生存函数、多变量Cox回归分析、标准化死亡率和净生存来评估生存。2005年至2019年的发病率采用直接标准化估算。结果:共纳入1159例阑尾肿瘤患者,诊断时平均年龄63.3岁。腺癌的发病率保持稳定,而lamn的发病率从2012年开始上升。非黏液性腺癌患者行结肠切除术比单独行阑尾切除术有更好的生存结果。对于黏液性腺癌,与阑尾切除术相比,结肠切除术并没有改善生存结果。非黏液性腺癌、黏液性腺癌或LAMN患者接受细胞减缩手术和腹腔内加热化疗(CRS-HIPEC)后,总生存率和净生存率均较好。结论:结肠切除术仅能提高非黏液性腺癌患者的生存率。自2012年以来,LAMN的发病率有所增加,很可能是由于诊断和编码实践的变化,但阑尾腺癌的发病率保持稳定。CRS-HIPEC的生存获益是在一个非常特定的患者群体中观察到的,这强调了仔细选择患者的重要性。
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引用次数: 0
Breast satisfaction and health-related quality of life following total mastectomy, breast-conserving surgery, or immediate breast reconstruction in Japanese patients with breast cancer: multicentre cross-sectional controlled study (Reborn). 日本乳腺癌患者全乳切除术、保乳手术或立即乳房重建后乳房满意度和健康相关生活质量:多中心横断面对照研究(Reborn)
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf094
Hirohito Seki, Takako Komiya, Yoshihiro Sowa, Maho Kato, Yutaka Nishida, Hirotsugu Isaka, Jyunji Takano, Shigeru Imoto, Miho Saiga

Background: Surgical decision-making for breast cancer requires consideration of both treatment outcomes and health-related quality of life (HR-QoL). However, data on HR-QoL differences across surgical procedures remain limited. This study compared breast satisfaction and HR-QoL among Japanese patients with breast cancer undergoing mastectomy (MT), breast-conserving surgery (BCS), or immediate breast reconstruction (IBR).

Methods: A survey using the Japanese version of the BREAST-Q was conducted among patients with primary breast cancer who underwent surgery between August 2013 and July 2021.

Results: Of 648 patients, 577 were included in this study. The median time from surgery to questionnaire completion was 56 months. Satisfaction with breast scores was highest in patients undergoing BCS, followed by those undergoing IBR and MT. Psychosocial and sexual well-being were significantly better in patients undergoing BCS and IBR than in those undergoing MT, whereas physical well-being showed no significant differences among the three groups. In multiple regression analysis, surgical procedure was identified as the most influential factor for breast satisfaction, psychosocial well-being, and sexual well-being.

Conclusions: This multicentre Japanese study confirmed that the choice of surgical procedure is the most influential factor affecting postoperative HR-QoL, with both BCS and IBR offering advantages over MT. The findings highlight the importance of comprehensive preoperative counselling to ensure patients receive detailed information on potential HR-QoL differences.

背景:乳腺癌的手术决策需要考虑治疗结果和健康相关生活质量(HR-QoL)。然而,关于不同手术方式的HR-QoL差异的数据仍然有限。这项研究比较了日本乳腺癌患者接受乳房切除术(MT)、保乳手术(BCS)或立即乳房重建(IBR)的乳房满意度和HR-QoL。方法:使用日本版breast - q对2013年8月至2021年7月期间接受手术的原发性乳腺癌患者进行调查。结果:648例患者中,577例纳入本研究。从手术到完成问卷的中位时间为56个月。接受BCS的患者对乳房评分的满意度最高,其次是接受IBR和MT的患者。接受BCS和IBR的患者的社会心理和性幸福感显著优于接受MT的患者,而三组之间的身体幸福感无显著差异。在多元回归分析中,外科手术被确定为乳房满意度、社会心理健康和性健康的最重要影响因素。结论:这项日本多中心研究证实,手术方式的选择是影响术后HR-QoL的最重要因素,BCS和IBR均优于MT。研究结果强调了术前全面咨询的重要性,以确保患者获得潜在HR-QoL差异的详细信息。
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引用次数: 0
Novel scoring system to predict futile liver transplantation by multiterm outcomes to optimize recipient selection: retrospective cohort study. 通过多期预后预测无效肝移植以优化受体选择的新评分系统:回顾性队列研究。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf108
Xi Wang, Xiubi Yin, Shaohua Song, Di Jiang, Yuancheng Li, Zeliang Xu, Xingchao Liu, Zhu Li, Xiaofang Zhang, Chengcheng Zhang

Background: Improvements in medical standards have allowed critically ill patients to benefit from liver transplantation, but defining futility arbitrarily according to one single-stage outcome could deprive patients of the potential benefits of transplantation. This study aimed to redefine futile liver transplantation by multiterm outcomes and develop a novel scoring system to predict futile liver transplantation.

Methods: This retrospective study in China enrolled patients who had liver transplantation from 3 centres between January 2015 and April 2021. Independent risk factors were identified by logistic regression analysis and used to establish risk prediction models. Kaplan-Meier survival curves were calculated to explore the association between futile score and overall survival.

Results: Of 1408 patients undergoing liver transplantation, patients at persistent high risk for mortality in the short term (3 months), mid term (1 year), and long term (3 years) were defined as the truly futile liver transplantation group. Higher donor and recipient age, hepatorenal syndrome, intensive care unit stay, need for mechanical ventilator, ABO blood group incompatibility, prolonged cold ischaemia time, increased alanine aminotransferase levels, and decreased albumin levels were independent risk factors for futility, and were used to construct a futile scoring system. The scoring system had good predictive capability, with an area under the receiver operating characteristic curve of 0.921, better than that of a previously established scoring system. Survival analysis showed that the group with a high futile risk had decreased survival.

Conclusion: This study has redefined futile liver transplantation and established a novel futile scoring system. This can be used to optimize the allocation of medical resources, especially with regard to recipient selection for liver transplantation, and increase survival prediction for selected patients.

背景:医疗标准的提高使危重患者可以从肝移植中获益,但武断地根据一个单阶段结果来定义无效可能会剥夺患者移植的潜在益处。本研究旨在通过多期预后来重新定义无效肝移植,并开发一种新的评分系统来预测无效肝移植。方法:这项在中国进行的回顾性研究纳入了2015年1月至2021年4月期间来自3个中心的肝移植患者。通过logistic回归分析确定独立危险因素,建立风险预测模型。计算Kaplan-Meier生存曲线,探讨无效评分与总生存率之间的关系。结果:1408例肝移植患者中,短期(3个月)、中期(1年)和长期(3年)持续存在高死亡率的患者被定义为真正无效肝移植组。供体和受体年龄较高、肝肾综合征、重症监护病房住院时间、机械呼吸机使用需求、ABO血型不合、冷缺血时间延长、丙氨酸转氨酶水平升高、白蛋白水平降低是无效的独立危险因素,并用于构建无效评分系统。该评分系统具有较好的预测能力,受试者工作特征曲线下面积为0.921,优于已有评分系统。生存分析显示,无效风险高的组生存率降低。结论:本研究重新定义了无效肝移植的概念,建立了新的无效肝移植评分体系。这可用于优化医疗资源的分配,特别是在肝移植受体选择方面,并提高所选患者的生存预测。
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引用次数: 0
Oncological impact of unexpected horizontal tumour spread in oesophagogastric junction cancer. 食管癌中肿瘤水平扩散的影响。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf119
Qingjiang Hu, Manabu Ohashi, Motonari Ri, Rie Makuuchi, Tomoyuki Irino, Masaru Hayami, Takeshi Sano, Souya Nunobe

Background: Unexpected horizontal tumour spread towards the proximal and distal margins complicates the assessment of surgical margins in oesophagogastric junction (OGJ) cancer. Its impact on oncological outcomes remains unclear.

Methods: This study retrospectively analysed patients with OGJ adenocarcinoma undergoing proximal or total gastrectomy. Unexpected horizontal tumour spread was measured as the discrepancy between gross and pathological margins proximally (ΔPM) and distally (ΔDM). Clinicopathological features, recurrence-free survival (RFS), and overall survival (OS) were evaluated based on ΔPM and ΔDM.

Results: Based on cut-off values identified by time-dependent receiver operating characteristic curve analysis (ΔPM, 8 mm; ΔDM, 3 mm) in 197 patients, patients were classified into four groups: short; long ΔPM; long ΔDM; and both long ΔPM and ΔDM (both-long). RFS was best in the short group and worst in the both-long group. The long ΔPM and long ΔDM groups had intermediate and comparable RFS. Subsequently, patients were categorized into two groups: a short group and a long group, which included patients in the long ΔPM, long ΔDM, and both-long groups. The type of infiltrative growth and postoperative recurrence were significantly associated with the long group. Moreover, the long group had significantly worse RFS and OS than the short group. Multivariate Cox regression analyses identified the long group as an independent risk factor for both RFS and OS. Patients in the long group with clinical lymph node metastasis or tumours located in the proximal 2-cm segment of the OGJ, predominantly in the proximal rather than distal 2-cm segment of the OGJ, or equal involvement in both areas had markedly worse survival outcomes.

Conclusion: Unexpected horizontal tumour spread, represented by ΔPM and ΔDM, is a strong predictor of poor survival and recurrence in OGJ cancer. Intraoperative assessment of ΔPM and ΔDM using frozen section analysis may be useful in guiding additional resections, particularly when combined with other predictive factors.

背景:意想不到的水平肿瘤向近端和远端边缘扩散使食管胃交界癌(OGJ)手术边缘的评估复杂化。其对肿瘤预后的影响尚不清楚。方法:回顾性分析行近端或全胃切除术的OGJ腺癌患者。意想不到的水平肿瘤扩散被测量为近端(ΔPM)和远端(ΔDM)大体和病理边缘之间的差异。基于ΔPM和ΔDM评估临床病理特征、无复发生存期(RFS)和总生存期(OS)。结果:197例患者根据时间依赖性受试者工作特征曲线分析确定的截断值(ΔPM, 8 mm; ΔDM, 3 mm)将患者分为4组:短组;长Δ点;长ΔDM;并且都长ΔPM和ΔDM(都长)。短组的RFS最好,双长组的RFS最差。长ΔPM和长ΔDM组的RFS为中等和可比。随后,将患者分为两组:短组和长组,其中包括长ΔPM组、长ΔDM组和两长组的患者。浸润生长类型及术后复发率与长组有显著相关性。此外,长时间组的RFS和OS明显低于短时间组。多变量Cox回归分析发现,长组是RFS和OS的独立危险因素。长组患者临床淋巴结转移或肿瘤位于OGJ近2 cm节段,主要位于OGJ近2 cm节段而不是远2 cm节段,或在两个区域均受损伤,其生存结果明显较差。结论:意想不到的水平肿瘤扩散,以ΔPM和ΔDM为代表,是OGJ癌不良生存和复发的有力预测因子。术中使用冷冻切片分析评估ΔPM和ΔDM可能有助于指导其他手术,特别是当结合其他预测因素时。
{"title":"Oncological impact of unexpected horizontal tumour spread in oesophagogastric junction cancer.","authors":"Qingjiang Hu, Manabu Ohashi, Motonari Ri, Rie Makuuchi, Tomoyuki Irino, Masaru Hayami, Takeshi Sano, Souya Nunobe","doi":"10.1093/bjsopen/zraf119","DOIUrl":"10.1093/bjsopen/zraf119","url":null,"abstract":"<p><strong>Background: </strong>Unexpected horizontal tumour spread towards the proximal and distal margins complicates the assessment of surgical margins in oesophagogastric junction (OGJ) cancer. Its impact on oncological outcomes remains unclear.</p><p><strong>Methods: </strong>This study retrospectively analysed patients with OGJ adenocarcinoma undergoing proximal or total gastrectomy. Unexpected horizontal tumour spread was measured as the discrepancy between gross and pathological margins proximally (ΔPM) and distally (ΔDM). Clinicopathological features, recurrence-free survival (RFS), and overall survival (OS) were evaluated based on ΔPM and ΔDM.</p><p><strong>Results: </strong>Based on cut-off values identified by time-dependent receiver operating characteristic curve analysis (ΔPM, 8 mm; ΔDM, 3 mm) in 197 patients, patients were classified into four groups: short; long ΔPM; long ΔDM; and both long ΔPM and ΔDM (both-long). RFS was best in the short group and worst in the both-long group. The long ΔPM and long ΔDM groups had intermediate and comparable RFS. Subsequently, patients were categorized into two groups: a short group and a long group, which included patients in the long ΔPM, long ΔDM, and both-long groups. The type of infiltrative growth and postoperative recurrence were significantly associated with the long group. Moreover, the long group had significantly worse RFS and OS than the short group. Multivariate Cox regression analyses identified the long group as an independent risk factor for both RFS and OS. Patients in the long group with clinical lymph node metastasis or tumours located in the proximal 2-cm segment of the OGJ, predominantly in the proximal rather than distal 2-cm segment of the OGJ, or equal involvement in both areas had markedly worse survival outcomes.</p><p><strong>Conclusion: </strong>Unexpected horizontal tumour spread, represented by ΔPM and ΔDM, is a strong predictor of poor survival and recurrence in OGJ cancer. Intraoperative assessment of ΔPM and ΔDM using frozen section analysis may be useful in guiding additional resections, particularly when combined with other predictive factors.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12502906/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145243675","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Anastomotic leakage after ileoanal pouch surgery: risk factors and salvage rate. 回肠袋术后吻合口漏:危险因素及抢救率。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf110
Tycho B Moojen, Malaika S Vlug, Eva Visser, Maud A Reijntjes, Johan F M Lange, Gabriele Bislenghi, Michele Carvello, Janindra Warusavitarne, Roel Hompes, Laurents P S Stassen, Omar D Faiz, Antonino Spinelli, André D'Hoore, Willem A Bemelman

Background: Chronic anastomotic leakage (AL) is the most common cause of pouch failure after restorative proctocolectomy with ileal pouch-anal anastomosis for ulcerative colitis. This study investigated factors associated with AL and successful salvage of leaking anastomoses after ileoanal pouch surgery.

Method: This multicentre retrospective cohort study included patients aged ≥ 18 years with ulcerative colitis or unclassified inflammatory bowel disease who underwent ileoanal pouch surgery between 2016 and 2021 in six European centres, with a > 12-month follow-up. The primary outcome was AL rate. Secondary outcomes included factors associated with AL occurrence, timing of AL diagnosis (early (< 21 days) versus late), AL management, AL salvage rate, and stoma-free survival.

Results: Overall, 411 patients were included, of whom 13.6% (56) had a diagnosed AL. The rate of AL was significantly higher in low-volume (less than ten procedures annually) centres (28.0% versus 12.7%; P = 0.031). Of the 56 ALs, 44 were diagnosed as early leaks and 12 were diagnosed as late leaks. A three-stage approach was associated with late diagnosis and treatment. AL was managed using various techniques, including diverting ileostomy, antibiotics, and drainage. The overall AL salvage rate was 85.4%, but increased to 92% when diagnosed and treated early (compared with 60% when diagnosed and treated late; P = 0.010). Successful AL salvage was associated with long-term stoma-free status (P = 0.002). The median follow-up was 3.8 years (range 1.0-8.1 years). The long-term stoma-free rate was 95.5% in patients with AL diagnosed and treated early, but only 41.7% when diagnosed and treated late (P < 0.001).

Conclusion: Early diagnosis and treatment of AL diminishes the negative effect of AL after ileoanal pouch surgery. Proactive anastomotic assessment enable early diagnosis and management, especially in patients undergoing a three-stage approach.

背景:慢性吻合口漏(AL)是溃疡性结肠炎恢复性直结肠切除术回肠袋-肛门吻合术后眼袋失败最常见的原因。本研究探讨了回肠袋术后AL及吻合口漏成功抢救的相关因素。方法:这项多中心回顾性队列研究纳入了6个欧洲中心的年龄≥18岁的溃疡性结肠炎或未分类炎症性肠病患者,这些患者在2016年至2021年期间接受了回肠袋手术,随访12个月。主要观察指标为AL率。次要结局包括与AL发生、AL诊断时间(早期(< 21天)与晚期)、AL管理、AL挽回率和无气孔生存相关的因素。结果:总共纳入411例患者,其中13.6%(56例)诊断为AL。AL的发生率在小容量(每年少于10例)中心显着更高(28.0%对12.7%;P = 0.031)。在56例ALs中,44例诊断为早期泄漏,12例诊断为晚期泄漏。三阶段方法与晚期诊断和治疗相关。AL的治疗采用多种技术,包括回肠造口转移、抗生素和引流。早期诊断和治疗的AL整体挽救率为85.4%,而晚期诊断和治疗的AL整体挽救率为60%,P = 0.010。AL修复成功与长期无造口状态相关(P = 0.002)。中位随访时间为3.8年(1.0-8.1年)。早期诊断和治疗的AL患者远期无瘘率为95.5%,晚期诊断和治疗的AL患者远期无瘘率仅为41.7% (P < 0.001)。结论:早期诊断和治疗AL可减少回肛门袋术后AL的负面影响。主动吻合口评估有助于早期诊断和治疗,特别是在接受三阶段方法的患者中。
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引用次数: 0
Postoperative complications in Hartmann's procedure versus intersphincteric abdominoperineal excision in rectal cancer: randomized clinical trial (HAPIrect). Hartmann手术与直肠括约肌间腹会阴切除术的术后并发症:随机临床试验(HAPIrect)
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf093
Maziar Nikberg, Viktor Åkerlund, Torbjörn Swartling, Pamela Buchwald, Kenneth Smedh

Background: In patients with rectal cancer, when it is not possible to restore bowel continuity with an anastomosis, the optimal surgical method is still a matter of debate. The aim of this trial was to determine 30-day postoperative surgical complication rates after Hartmann's procedure (HP) versus intersphincteric abdominoperineal excision (iAPE) in patients with rectal cancer who were not suitable for restorative surgery.

Methods: This multicentre randomized controlled trial (HAPIrect) was performed in Sweden and Finland between 2014 and 2021. Eligible patients with adenocarcinoma of the rectum located ≥ 5 cm from the anal verge and deemed unsuitable for anterior resection with anastomosis were randomized (1:1) intraoperatively to either HP or iAPE. The primary outcome was 30-day postoperative surgical complications. Secondary outcomes were major surgical complications (Clavien-Dindo grade ≥ IIIa), perineopelvic complications, and overall complications. Logistic regression in the intention-to-treat population was the primary method used to compare the surgical approaches.

Results: Of 194 eligible patients, 163 were randomized (80 patients to HP and 83 to iAPE). The study was closed before achieving the target accrual. The main reasons for not receiving an anastomosis were advanced age, co-morbidity, or poor anal sphincter function. Mean operating time in the HP and iAPE groups was 291 and 373 minutes, respectively. In the HP and iAPE groups, the surgical complication rate was 39% and 43%, respectively (odds ratio (OR) for HP 0.83; 95% confidence interval (c.i.) 0.44 to 1.54; P = 0.549) and the rate of major surgical complications was 14% and 11%, respectively (P = 0.573). Perineopelvic complications occurred in 21% and 30% of patients in the HP and iAPE groups, respectively (OR for HP 0.63; 95% c.i. 0.31 to 1.28; P = 0.197). The overall complication rate (including both medical and surgical complications) was 45% and 49% in the HP and iAPE groups, respectively (P = 0.574). In multivariable analysis adjusted for sex, preoperative radiotherapy, and surgical procedure, there was no statistically significant difference in surgical complications between the two groups.

Conclusion: Although the trial was underpowered and did not reach accrual, in randomized patients, both HP and iAPE are practicable surgical options for patients unsuitable for anastomosis.

Registration number: NCT01995396 (http://www.clinicaltrials.gov).

背景:在直肠癌患者中,当无法通过吻合恢复肠的连续性时,最佳的手术方法仍然是一个有争议的问题。本试验的目的是确定在不适合恢复性手术的直肠癌患者中,Hartmann手术(HP)和括约肌间腹会阴切除术(iAPE)后30天的手术并发症发生率。方法:这项多中心随机对照试验(HAPIrect)于2014年至2021年在瑞典和芬兰进行。符合条件的直肠腺癌患者位于距肛门边缘≥5cm,认为不适合前切吻合术,术中随机(1:1)选择HP或iAPE。主要结局是术后30天的手术并发症。次要结局为主要手术并发症(Clavien-Dindo分级≥IIIa)、盆腔周围并发症和总并发症。意向治疗人群的逻辑回归是比较手术入路的主要方法。结果:194例符合条件的患者中,163例随机化(80例HP组,83例iAPE组)。该研究在达到目标收益之前就结束了。不接受吻合术的主要原因是高龄、合并症或肛门括约肌功能差。HP组和iAPE组的平均手术时间分别为291分钟和373分钟。HP组和iAPE组手术并发症发生率分别为39%和43% (HP组的优势比(OR)为0.83;95%置信区间(ci .)0.44 ~ 1.54;P = 0.549),主要手术并发症发生率分别为14%和11% (P = 0.573)。HP组和iAPE组患者盆腔周围并发症发生率分别为21%和30% (HP OR 0.63; 95% ci 0.31 ~ 1.28; P = 0.197)。HP组和iAPE组的总并发症发生率(包括内科和外科并发症)分别为45%和49% (P = 0.574)。在校正性别、术前放疗和手术方式的多变量分析中,两组手术并发症无统计学差异。结论:虽然该试验功率不足且未达到累积效果,但在随机患者中,HP和iAPE对于不适合吻合的患者都是可行的手术选择。注册号:NCT01995396 (http://www.clinicaltrials.gov)。
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引用次数: 0
Management and risk factors for colonic volvulus: retrospective national cohort study. 结肠扭转的管理和危险因素:回顾性国家队列研究。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf113
Suvi Rasilainen, Mohamud Aden, Antti J Kivelä, Sakari Pakarinen, Jukka Rintala, Susanna Niemeläinen, Ilona Helavirta, Salla Moilanen, Anne Mattila, Tarja Pinta, Kapo Saukkonen, Pälvi Vento, Niko Turkka, Pasi Pengermä, Jenny Häggblom, Tom Scheinin

Background: This study evaluated the outcomes of colonic volvulus management in a national cohort, and identified risk factors for morbidity and mortality.

Methods: This was a multicentre national retrospective study of patients presenting with colonic volvulus between 2010 and 2019. Main outcome measures were 30-day and 1-year mortality. Multivariable regression and Kaplan-Meier analyses were used to study predictors of mortality and survival.

Results: Of the 559 patients presenting with sigmoid volvulus, 381 underwent surgery and 178 received conservative treatment. The 30-day mortality rates were 11.0% and 19.0%, respectively. Emergency surgery (P = 0.030), nursing home residence (P = 0.040), increased co-morbidity (P = 0.017), and male sex (P = 0.029) predicted postoperative 30-day mortality. Primary endoscopic detorsion followed by elective surgery during a subsequent hospital admission resulted in best survival. Of the 342 patients presenting with caecal volvulus, 340 underwent surgery. The 30-day mortality rate was 6.4%. Increased co-morbidity (P = 0.008), nursing home residence (P = 0.002), and necrotic caecum (P = 0.007) predicted 30-day mortality. At 1 year, the mortality rate among patients with sigmoid volvulus was 19.9% after surgery and 43.2% after conservative treatment. Emergency surgery (P = 0.023), nursing home residence (P = 0.009), and increased co-morbidity (P < 0.001) were associated with 1-year postoperative mortality. In patients with caecal volvulus the 1-year mortality rate was 13.1%. Increased co-morbidity (P < 0.001) and nursing home residence (P < 0.001) were predictive. Anastomotic leakage in patients with sigmoid volvulus was associated with an American Society of Anesthesiologists fitness grade of III (P = 0.032) and total colectomy (P = 0.012).

Conclusion: Surgery should be recommended for colonic volvulus where co-morbidity, patient preference, and functional status allows. Surgically unfit patients have poorer outcomes. Elective sigmoidectomy after endoscopic detorsion is preferred as it carries the lowest mortality risk. Necrotic bowel, dependency, and co-morbidities predict death for both sigmoid and caecal volvulus.

背景:本研究评估了国家队列中结肠扭转治疗的结果,并确定了发病率和死亡率的危险因素。方法:这是一项针对2010年至2019年结肠扭转患者的多中心全国性回顾性研究。主要结局指标为30天和1年死亡率。采用多变量回归和Kaplan-Meier分析来研究死亡率和生存率的预测因素。结果:559例乙状结肠扭转患者中,381例接受手术治疗,178例接受保守治疗。30天死亡率分别为11.0%和19.0%。急诊手术(P = 0.030)、养老院居住(P = 0.040)、合并发病率增加(P = 0.017)和男性(P = 0.029)预测术后30天死亡率。在随后的住院期间,原发性内窥镜扭曲和择期手术导致了最佳的生存率。在342例出现盲肠扭转的患者中,340例接受了手术。30天死亡率为6.4%。共发病(P = 0.008)、养老院居住(P = 0.002)和盲肠坏死(P = 0.007)的增加预测了30天死亡率。乙状结肠扭转患者术后1年死亡率为19.9%,保守治疗后为43.2%。急诊手术(P = 0.023)、养老院居住(P = 0.009)和合并症增加(P < 0.001)与术后1年死亡率相关。盲肠扭转患者1年死亡率为13.1%。增加的合并症(P < 0.001)和养老院居住(P < 0.001)是预测因素。乙状窦扭转患者吻合口漏与美国麻醉学会健康等级III (P = 0.032)和全结肠切除术(P = 0.012)相关。结论:在合并症、患者偏好和功能状况允许的情况下,结肠扭转应推荐手术治疗。不适合手术的患者预后较差。内镜下乙状结肠扭转后择期乙状结肠切除术是首选,因为其死亡率最低。肠坏死、依赖性和合并症预示乙状结肠扭转和盲肠扭转的死亡。
{"title":"Management and risk factors for colonic volvulus: retrospective national cohort study.","authors":"Suvi Rasilainen, Mohamud Aden, Antti J Kivelä, Sakari Pakarinen, Jukka Rintala, Susanna Niemeläinen, Ilona Helavirta, Salla Moilanen, Anne Mattila, Tarja Pinta, Kapo Saukkonen, Pälvi Vento, Niko Turkka, Pasi Pengermä, Jenny Häggblom, Tom Scheinin","doi":"10.1093/bjsopen/zraf113","DOIUrl":"10.1093/bjsopen/zraf113","url":null,"abstract":"<p><strong>Background: </strong>This study evaluated the outcomes of colonic volvulus management in a national cohort, and identified risk factors for morbidity and mortality.</p><p><strong>Methods: </strong>This was a multicentre national retrospective study of patients presenting with colonic volvulus between 2010 and 2019. Main outcome measures were 30-day and 1-year mortality. Multivariable regression and Kaplan-Meier analyses were used to study predictors of mortality and survival.</p><p><strong>Results: </strong>Of the 559 patients presenting with sigmoid volvulus, 381 underwent surgery and 178 received conservative treatment. The 30-day mortality rates were 11.0% and 19.0%, respectively. Emergency surgery (P = 0.030), nursing home residence (P = 0.040), increased co-morbidity (P = 0.017), and male sex (P = 0.029) predicted postoperative 30-day mortality. Primary endoscopic detorsion followed by elective surgery during a subsequent hospital admission resulted in best survival. Of the 342 patients presenting with caecal volvulus, 340 underwent surgery. The 30-day mortality rate was 6.4%. Increased co-morbidity (P = 0.008), nursing home residence (P = 0.002), and necrotic caecum (P = 0.007) predicted 30-day mortality. At 1 year, the mortality rate among patients with sigmoid volvulus was 19.9% after surgery and 43.2% after conservative treatment. Emergency surgery (P = 0.023), nursing home residence (P = 0.009), and increased co-morbidity (P < 0.001) were associated with 1-year postoperative mortality. In patients with caecal volvulus the 1-year mortality rate was 13.1%. Increased co-morbidity (P < 0.001) and nursing home residence (P < 0.001) were predictive. Anastomotic leakage in patients with sigmoid volvulus was associated with an American Society of Anesthesiologists fitness grade of III (P = 0.032) and total colectomy (P = 0.012).</p><p><strong>Conclusion: </strong>Surgery should be recommended for colonic volvulus where co-morbidity, patient preference, and functional status allows. Surgically unfit patients have poorer outcomes. Elective sigmoidectomy after endoscopic detorsion is preferred as it carries the lowest mortality risk. Necrotic bowel, dependency, and co-morbidities predict death for both sigmoid and caecal volvulus.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12461565/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136264","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Risk factors and clinical consequences of interval cancers arising within faecal immunochemical testing-based colorectal cancer screening programme. 以粪便免疫化学测试为基础的结直肠癌筛检计划中发生间隔期癌症的危险因素和临床后果。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf096
Adam D Gerrard, Roberta Garau, Yasuko Maeda, Alastair Thomson, Evropi Theodoratou, Malcolm G Dunlop, Farhat V N Din

Background: Colorectal cancer (CRC) screening programmes aim to detect early, asymptomatic cancers and improve survival. This study aimed to establish the proportion of interval cancers, and the consequences with regard to stage, clinical outcome, and overall survival. Risk factors associated with interval CRCs were investigated.

Methods: The Scottish Bowel Screening Programme uses faecal immunochemical testing at a threshold of 80 µg haemoglobin per g as a positive trigger for investigation. Screening was offered to all eligible individuals in one region, from November 2017 to October 2021. Cancer registries were cross-checked to ensure complete capture of all cancers including interval CRCs. The primary outcome was rate of interval CRCs among participants with follow-up of 24 months, and its relationship to faecal immunochemical testing results, clinical variables, stage, time to diagnosis, and survival. The secondary outcome was identification of risk factors associated with interval CRCs.

Results: The Scottish Bowel Screening Programme generated 316 583 tests during the study period. Participation was 71.0% of the eligible population (212 664 patients); it was greater among women (71.9 versus 70.0%; P < 0.001) and in higher socioeconomic areas (76.9 versus 58.6%; P < 0.001). In the screened population, 546 CRCs were diagnosed within 2 years of screening. Some 289 of these patients (52.9%) had positive bowel screening. There were 257 patients with interval CRCs, who waited a median of 13 (interquartile range 7-20) months for diagnosis. Of CRCs diagnosed, 24.9% had screening faecal immunochemical test results of < 10 µg haemoglobin per g. The interval CRC rate was greater in women, older patients, and among the least socioeconomically deprived. Interval CRCs were associated with worse 2-year all-cause mortality than screen-detected CRCs (23.0 versus 10.8%; P < 0.001). Importantly, 121 of the 257 interval CRCs (47.1%) had detectable faecal immunochemical test results at 10-79 µg haemoglobin per g.

Conclusion: Patients with interval CRCs and a detectable faecal immunochemical test result below the predetermined threshold appear to be significantly disadvantaged with respect to stage at presentation and survival. Almost half of interval CRCs diagnosed within 2 years had detectable haemoglobin on screening faecal immunochemical test and would be a target for lower positivity thresholds.

背景:结直肠癌(CRC)筛查计划旨在发现早期、无症状的癌症并提高生存率。本研究旨在确定间隔期癌症的比例,以及与分期、临床结局和总生存期有关的结果。研究了与间歇期crc相关的危险因素。方法:苏格兰肠道筛查计划使用粪便免疫化学测试,阈值为80µg血红蛋白/ g作为调查的阳性触发因素。从2017年11月到2021年10月,对一个地区的所有符合条件的个人进行了筛查。癌症登记处进行了交叉检查,以确保完全捕获包括间隔crc在内的所有癌症。主要结局是随访24个月的参与者间期crc的发生率,以及其与粪便免疫化学检测结果、临床变量、分期、诊断时间和生存率的关系。次要结局是确定与间歇期crc相关的危险因素。结果:苏格兰肠道筛查计划在研究期间进行了316583次测试。符合条件的人群中有71.0%(212 664例患者)参与了研究;女性(71.9%对70.0%,P < 0.001)和社会经济地位较高的地区(76.9对58.6%,P < 0.001)患病率更高。在接受筛查的人群中,546例在筛查后2年内被诊断出crc。其中289例(52.9%)患者的肠道筛查呈阳性。257例间歇期crc患者等待诊断的中位时间为13个月(四分位数间距7-20个月)。在诊断的CRC中,24.9%的筛查粪便免疫化学测试结果< 10µg血红蛋白/ g。间隔期CRC率在女性、老年患者和社会经济条件最低的患者中更高。间隔期crc的2年全因死亡率比筛查检测的crc更差(23.0% vs 10.8%; P < 0.001)。重要的是,257例间断性crc中有121例(47.1%)的粪便免疫化学检测结果为每g 10-79µg血红蛋白。结论:间断性crc患者的粪便免疫化学检测结果低于预定阈值,在发病和生存方面明显处于不利地位。在2年内诊断出的间隔期crc中,几乎有一半在筛查粪便免疫化学试验中可检测到血红蛋白,这将是较低阳性阈值的目标。
{"title":"Risk factors and clinical consequences of interval cancers arising within faecal immunochemical testing-based colorectal cancer screening programme.","authors":"Adam D Gerrard, Roberta Garau, Yasuko Maeda, Alastair Thomson, Evropi Theodoratou, Malcolm G Dunlop, Farhat V N Din","doi":"10.1093/bjsopen/zraf096","DOIUrl":"10.1093/bjsopen/zraf096","url":null,"abstract":"<p><strong>Background: </strong>Colorectal cancer (CRC) screening programmes aim to detect early, asymptomatic cancers and improve survival. This study aimed to establish the proportion of interval cancers, and the consequences with regard to stage, clinical outcome, and overall survival. Risk factors associated with interval CRCs were investigated.</p><p><strong>Methods: </strong>The Scottish Bowel Screening Programme uses faecal immunochemical testing at a threshold of 80 µg haemoglobin per g as a positive trigger for investigation. Screening was offered to all eligible individuals in one region, from November 2017 to October 2021. Cancer registries were cross-checked to ensure complete capture of all cancers including interval CRCs. The primary outcome was rate of interval CRCs among participants with follow-up of 24 months, and its relationship to faecal immunochemical testing results, clinical variables, stage, time to diagnosis, and survival. The secondary outcome was identification of risk factors associated with interval CRCs.</p><p><strong>Results: </strong>The Scottish Bowel Screening Programme generated 316 583 tests during the study period. Participation was 71.0% of the eligible population (212 664 patients); it was greater among women (71.9 versus 70.0%; P < 0.001) and in higher socioeconomic areas (76.9 versus 58.6%; P < 0.001). In the screened population, 546 CRCs were diagnosed within 2 years of screening. Some 289 of these patients (52.9%) had positive bowel screening. There were 257 patients with interval CRCs, who waited a median of 13 (interquartile range 7-20) months for diagnosis. Of CRCs diagnosed, 24.9% had screening faecal immunochemical test results of < 10 µg haemoglobin per g. The interval CRC rate was greater in women, older patients, and among the least socioeconomically deprived. Interval CRCs were associated with worse 2-year all-cause mortality than screen-detected CRCs (23.0 versus 10.8%; P < 0.001). Importantly, 121 of the 257 interval CRCs (47.1%) had detectable faecal immunochemical test results at 10-79 µg haemoglobin per g.</p><p><strong>Conclusion: </strong>Patients with interval CRCs and a detectable faecal immunochemical test result below the predetermined threshold appear to be significantly disadvantaged with respect to stage at presentation and survival. Almost half of interval CRCs diagnosed within 2 years had detectable haemoglobin on screening faecal immunochemical test and would be a target for lower positivity thresholds.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":"9 5","pages":""},"PeriodicalIF":4.5,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12507088/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249509","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Indocyanine green versus technetium-99m for sentinel lymph node biopsy in breast cancer: the FLUORO trial. 吲哚菁绿与锝-99m用于乳腺癌前哨淋巴结活检:FLUORO试验。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf104
Chu Luan Nguyen, Jianing Kwok, Michael Zhou, Neshanth Easwaralingam, Jue Li Seah, Belinda Chan, Susannah Graham, Farhad Azimi, Cindy Mak, Carlo Pulitano, Sanjay Warrier

Background: Standard sentinel lymph node (SLN) mapping for early breast cancer involves technetium-99m (99mTc) lymphoscintigraphy. Indocyanine green (ICG) fluorescence allows real-time visualization of lymphatics and nodes while avoiding radiation exposure and the inconvenience of 99mTc, but its inclusion in international guidelines is not widespread. This study compared efficacy and costs between ICG and 99mTc for axillary SLN lymphatic mapping.

Methods: Patients with early breast cancer and clinically negative axilla who underwent lymphatic mapping with ICG and 99mTc were enrolled in a prospective single-institution single-arm non-randomized trial (2021-2024). Data on the number of SLNs, including metastatic nodes, rate of failed mapping, costs, and the surgeon's reported ease of mapping with ICG compared with 99mTc were collected. Cost analysis used Medicare item numbers and microcosting.

Results: A total of 305 patients were enrolled, with 637 SLNs sampled. The SLN identification rate was 97.8% (95% confidence interval (c.i.) 96.3 to 98.7%) for ICG and 98.3% (95% c.i. 96.9 to 99%) for 99mTc. The mean(standard deviation (s.d.)) number of SLNs identified with ICG and 99mTc was 2.06 (1.99) and 2.07 (2.02), respectively (P = 0.871). Metastatic SLNs were identified in 70 of 305 patients (23.0%), with 83 metastatic SLNs in total. ICG identified 79 of 83 metastatic SLNs (95.2%; 95% c.i. 88.3 to 98.1%) and 99mTc identified 82 of 83 metastatic SLNs (98.8%; 95% c.i. 93.5 to 99.8%; P = 0.256). Mean(s.d.) surgeon-reported ease for using ICG and 99mTc, rated used a five-point Likert scale, was 1.67 (0.98) (95% c.i. 1.56 to 1.78) and 1.5 (0.59) (95% c.i. 1.43 to 1.57), respectively (P = 0.082). 99mTc cost an additional EUR841 (95% c.i. EUR766 to EUR917) per patient but ICG would require > 35 patients before breaking even with initial outlay equipment costs.

Conclusion: ICG fluorescence performed similarly to 99mTc lymphoscintigraphy and may be less costly over the long term.

背景:早期乳腺癌的标准前哨淋巴结(SLN)定位包括锝-99m (99mTc)淋巴显像。吲哚菁绿(ICG)荧光可以实时显示淋巴和淋巴结,同时避免辐射暴露和99mTc的不便,但其在国际指南中的纳入并不普遍。本研究比较了ICG和99mTc在腋窝SLN淋巴标测中的疗效和成本。方法:采用ICG和99mTc进行淋巴定位的早期乳腺癌临床阴性腋窝患者入组一项前瞻性单机构单臂非随机试验(2021-2024)。收集sln数量的数据,包括转移淋巴结、定位失败率、成本以及外科医生报告的ICG与99mTc相比易于定位的数据。成本分析使用医疗保险项目编号和微观成本。结果:共入组305例患者,共纳入637例sln。SLN的识别率为97.8%(95%置信区间(ci。ICG为96.3 ~ 98.7%),99mTc为98.3% (95% ci . 96.9 ~ 99%)。ICG和99mTc鉴定的sln的平均(标准差)分别为2.06个(1.99个)和2.07个(2.02个)(P = 0.871)。305例患者中有70例(23.0%)发现转移性sln,总共83例转移性sln。ICG鉴定83例转移性sln中的79例(95.2%;95% ci . 88.3 ~ 98.1%), 99mTc鉴定83例转移性sln中的82例(98.8%;95% ci . 93.5 ~ 99.8%; P = 0.256)。使用5点李克特量表评分的ICG和99mTc的平均(s.d)外科医生报告的易用性分别为1.67 (0.98)(95% ci . 1.56至1.78)和1.5 (0.59)(95% ci . 1.43至1.57)(P = 0.082)。9900万tc的成本为每位患者额外增加841欧元(95% c.i 766欧元至917欧元),但ICG需要35名患者才能达到收支平衡。结论:ICG荧光检测的效果与99mTc淋巴显像相似,从长期来看成本可能更低。
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