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Barbed suture versus preperitoneal ventral patch in medium-size ventral hernia repair: randomized clinical trial. 倒钩缝合与腹膜前腹侧补片在中等大小腹疝修补中的应用:随机临床试验。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-10-30 DOI: 10.1093/bjsopen/zraf099
Asmatullah Katawazai, Göran Wallin, Gabriel Sandblom

Background: This study aimed to compare preperitoneal ventral mesh patch with barbed suture in ventral hernia repair, evaluating recurrence rates and complications, and to assess the safety of preperitoneal patch placement.

Methods: In this randomized clinical trial, adult patients undergoing ventral hernia repair at Karlskoga Hospital between 2020 and 2023 were randomized 1 : 1 to either a ventral mesh patch repair group or a non-absorbable barbed suture repair group, blinded to patients and outcome assessors. The primary outcome was recurrence detected at clinical examination and CT verification 1 year after surgery. Pain (measured on a visual analogue scale and using the Ventral Hernia Pain Questionnaire), nausea, and surgical site events (including wound infection, haematoma and seroma) were assessed 4 h, 1 week, 1 month, and 4 years after operation.

Results: Of 256 eligible patients, 209 were screened, and 205 were randomized to ventral mesh patch repair (103) or barbed suture repair (102). The hernia recurrence rate at 1 year was lower in the ventral patch repair group (1.9 versus 5.9%), although this was not statistically significant (P = 0.14). The surgical site infection rate at 1 month was significantly lower in the ventral patch group (0.9 versus 6.9%; P = 0.02). At 1 month, the ventral patch repair group had higher 'pain right now' scores on the Ventral Hernia Pain Questionnaire (P = 0.02), although this difference had disappeared by 1 year.

Conclusion: Preperitoneal ventral hernia patch repair is a safe and effective technique with a recurrence rate not statistically significant from that after barbed suture repair. Although postoperative pain scores at 1 month were higher after ventral patch repair, this difference had disappeared by 1 year.

背景:本研究旨在比较腹膜前腹膜补片与倒钩缝合在腹膜前疝修补中的应用,评估复发率和并发症,并评估腹膜前补片放置的安全性。方法:在这项随机临床试验中,2020年至2023年在Karlskoga医院接受腹侧疝修补术的成年患者被随机分为腹侧补片修补组和不可吸收的有刺缝线修补组,对患者和结果评估者进行盲法。主要预后指标为术后1年临床检查及CT检查发现复发。术后4小时、1周、1个月和4年评估疼痛(以视觉模拟量表和腹疝疼痛问卷测量)、恶心和手术部位事件(包括伤口感染、血肿和血肿)。结果:在256例符合条件的患者中,筛选了209例,其中205例随机分为腹侧补片修复(103例)或倒钩缝合修复(102例)。腹侧补片修补组1年疝复发率较低(1.9 vs 5.9%),但差异无统计学意义(P = 0.14)。腹侧贴片组1个月手术部位感染率明显低于对照组(0.9% vs . 6.9%; P = 0.02)。1个月时,腹侧补片修复组在腹侧疝疼痛问卷上的“即刻疼痛”得分较高(P = 0.02),尽管这种差异在1年后消失。结论:腹膜前腹疝补片修补术安全有效,复发率与倒钩缝合修补术比较无统计学差异。虽然腹侧补片修复术后1个月的疼痛评分较高,但这种差异在1年后消失。
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引用次数: 0
Laparoscopic versus open liver resection in patients aged at least 80 years: retrospective propensity score-matched cohort study. 80岁以上患者的腹腔镜与开放式肝切除术:回顾性倾向评分匹配队列研究。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-10-30 DOI: 10.1093/bjsopen/zraf102
Concepción Gómez-Gavara, Zenichi Morise, Victor López-López, Christoph Kuemmerli, Daniel Esono, Kazuharu Igarashi, Kohei Mishima, Akishige Kanazawa, Shogo Tanaka, Shoji Kubo, Satoshi Nemoto, Goro Honda, Kazuteru Monden, Masaki Ueno, Yasuhito Iwao, Naoto Gotohda, Masashi Kudo, Hiroyuki Nitta, Satoshi Amano, Rafael Díaz-Nieto, Alex Gordon-Weeks, Serena Langella, Alessandro Ferrero, Yuichiro Otsuka, Hironori Kaneko, Riccardo Boetto, Umberto Cillo, Daniel D'Souza, Pablo E Serrano, Giammauro Berardi, Marco Angrisani, Giuseppe Maria Ettorre, Parissa Tabrizian, Allen Yu, Brian K P Goh, Takuya Minagawa, Osamu Itano, Daisuke Asano, Minoru Tanabe, Marcello Di Martino, Elena Martín-Pérez, Simone Famularo, Elisa Paoluzzi Tomada, Guido Torzilli, Jaime Arthur Pirola Krüger, Paulo Herman, Mario Giuffrida, Ramon Charco, Mikel Gastaca, Waclaw Holowko, Stephanie Truant, Kit-Man Ho, Kai-Chi Cheng, Rafael José Maurette, Laura-Ann Blatt, Tatiana Belda, Yuta Abe, Shuichiro Uemura, Go Wakabayashi

Background: Laparoscopic liver resection has been associated with less morbidity than, and similar global outcomes to, open liver resection. There is no robust evidence that these outcomes lead to similar clinical outcomes in patients aged over 80 years. The aim of this study was to analyse the short-term outcomes between open and laparoscopic liver resection in patients over 80 years old.

Methods: A retrospective analysis was undertaken. The study population comprised patients aged ≥ 80 years who underwent laparoscopic or open liver resection between January 2014 and December 2019, and who presented with resectable malignant tumours. The primary outcome was postoperative morbidity, according to Dindo-Clavien grading. Cox regression models were used to compute hazard ratios and 95% confidence intervals. Propensity score matching (1 : 1) was performed to balance the two groups according to independent prognostic factors for morbidity.

Results: A total of 988 patients were analysed from 34 centres (16 from Asia, 14 from Europe and 4 from America): 487 in the open group and 501 in the laparoscopic group. Independent risk factors associated with severe morbidity were the open approach (hazard ratio 1.59, 95% confidence interval 1.19 to 2.11; P < 0.001), Charlson Co-morbidity Index score > 7 (HR 1.69, 1.26 to 2.27; P < 0.001), more than one resected tumour (hazard ratio 1.55, 1.13 to 2.11; P = 0.006), major hepatectomy (hazard ratio 1.86, 1.22 to 2.83; P = 0.003), and Iwate score ≥ 7 (hazard ratio 1.43, 1.02 to 2.01; P = 0.03). Before propensity score matching, severe morbidity, length of intensive care unit stay, 90-day mortality, length of hospital stay, and readmission were better in the laparoscopic group (P < 0.050). These observations were confirmed after propensity score matching.

Conclusion: The laparoscopic approach is a safe procedure for elderly patients, with better morbidity and mortality outcomes than the open approach, and should be considered as a default option.

背景:腹腔镜肝切除术的发病率比开放肝切除术低,总体结果与开放肝切除术相似。没有强有力的证据表明这些结果会导致80岁以上患者的类似临床结果。本研究的目的是分析80岁以上患者开放和腹腔镜肝切除术的短期结果。方法:进行回顾性分析。研究人群包括年龄≥80岁的患者,他们在2014年1月至2019年12月期间接受了腹腔镜或开放肝切除术,并且出现了可切除的恶性肿瘤。根据Dindo-Clavien分级,主要结局是术后发病率。Cox回归模型用于计算风险比和95%置信区间。根据发病率的独立预后因素进行倾向评分匹配(1:1)以平衡两组。结果:共分析了来自34个中心的988例患者(亚洲16例,欧洲14例,美洲4例):开放组487例,腹腔镜组501例。与严重发病率相关的独立危险因素有:开放入路(风险比1.59,95%可信区间1.19 ~ 2.11,P < 0.001)、Charlson共发病指数评分bbbb7(风险比1.69,1.26 ~ 2.27,P < 0.001)、多个肿瘤切除(风险比1.55,1.13 ~ 2.11,P = 0.006)、肝切除术(风险比1.86,1.22 ~ 2.83,P = 0.003)、Iwate评分≥7(风险比1.43,1.02 ~ 2.01,P = 0.03)。倾向评分匹配前,腹腔镜组重症发病率、重症监护室住院时间、90天死亡率、住院时间、再入院率均优于腹腔镜组(P < 0.050)。这些观察结果在倾向评分匹配后得到证实。结论:腹腔镜入路对老年患者是一种安全的手术方式,其发病率和死亡率均优于开放入路,应作为一种默认选择。
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引用次数: 0
Safe and transparent introduction and evaluation of targeted axillary dissection in patients with node-positive breast cancer undergoing primary surgery: international consensus process. 安全透明地介绍和评价淋巴结阳性乳腺癌原发性手术患者的靶向腋窝清扫:国际共识过程。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-10-30 DOI: 10.1093/bjsopen/zraf121
Shelley Potter, Ruth Mullan, Henry Cain, Edward R St John, Peter Barry, Yazan Massanat, James Harvey, Katherine Fairhurst, Adrienne Morgan, Margaret Perkins, Gregory Bruce Mann, Jocelyn Lippey, Katherine Cowan, Natalie Blencowe, Stuart A McIntosh

Background: Axillary node clearance is the current standard of care in patients with node-positive breast cancer undergoing primary surgery, despite a lack of evidence to demonstrate survival benefit and high rates of life-changing morbidity. Targeted axillary dissection (TAD) may be a safe alternative to axillary node clearance, but there is no agreement how primary TAD should be performed. TADPOLE-TOGETHER aimed to use international consensus methods to agree the key components of primary TAD to promote standardized introduction and evaluation of the technique within the TADPOLE trial.

Methods: A scoping review and key stakeholder interviews were used to generate a longlist of possible procedure steps for inclusion in the Delphi questionnaire. Two rounds of an international online survey were then used to agree the mandatory, optional, and prohibited steps of TAD, together with any standardization and training required. The final approach to primary TAD was agreed at an online consensus meeting.

Results: Thirteen potential steps of a TAD procedure were identified from the literature and expert interviews, together with information regarding standardization and training. Some 244 surgeons with global representation participated in the Round 1 survey, of whom 161 (66.0%) participated in Round 2. Seven mandatory steps of primary TAD, including localization and removal of the involved node, combined with a sentinel node biopsy, were agreed upon and ratified by 42 surgeons from the UK, Europe, and Asia who attended the consensus meeting.

Conclusion: Robust international consensus methods have been used to agree how primary TAD should be performed, promoting safe and transparent introduction and evaluation of the technique.

背景:腋窝淋巴结清扫是目前接受原发性手术的淋巴结阳性乳腺癌患者的标准护理,尽管缺乏证据证明生存获益和改变生活的高发病率。靶向腋窝清扫(TAD)可能是一种安全的替代腋窝淋巴结清扫,但如何进行原发性TAD尚未达成一致。TADPOLE- together旨在使用国际共识方法来商定主要TAD的关键组成部分,以促进蝌蚪试验中该技术的标准化引入和评估。方法:使用范围审查和关键利益相关者访谈来生成一长串可能的程序步骤,以纳入德尔菲问卷。然后通过两轮国际在线调查来确定TAD的强制性、可选性和禁止性步骤,以及所需的标准化和培训。在一次在线共识会议上商定了主要贸易援助的最终办法。结果:从文献和专家访谈中确定了TAD程序的13个潜在步骤,以及有关标准化和培训的信息。约244名具有全球代表性的外科医生参加了第一轮调查,其中161名(66.0%)参加了第二轮调查。来自英国、欧洲和亚洲的42位外科医生同意并批准了原发性TAD的七个强制性步骤,包括定位和切除受病灶淋巴结,并进行前哨淋巴结活检。结论:强有力的国际共识方法已被用于同意如何进行初级TAD,促进安全透明地引入和评估该技术。
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引用次数: 0
Hiatal hernia after open versus minimally invasive transthoracic oesophagectomy for cancer. 开放性与微创经胸食管癌切除术后食道裂孔疝的比较。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf095
Luca Giulini, Irina Avramovska, Melissa Kemeter, Lisa Bernhardt, Lucas Thumfart, Felix J Hüttner, Patrick Heger, Wolfgang Hitzl, Markus K Diener, Attila Dubecz

Background: Hiatal hernia (HH) after oesophagectomy is a potentially life-threatening complication, more commonly observed after minimally invasive procedures. The aim of the study was to compare the incidence of HH after open versus minimally invasive oesophagectomy (MIO) for cancer, to identify risk factors for its onset, and analyse the technical differences between the approaches.

Methods: This was a retrospective study of patients who underwent transthoracic oesophagectomy for cancer over a 15-year period. Open and minimally invasive procedures were compared according to demographics, and operative and perioperative parameters. MIO included both laparoscopic and robotic operations. Risk factors for HH after oesophagectomy were analysed by calculating odds ratios of uni- and multivariable generalized linear models.

Results: A total of 898 patients operated on between 2008 and 2023 were included in the study. HH was observed in 1 of 490 patients (0.2%) in the open group and in 21 of 408 patients (5.2%) in the minimally invasive group (P < 0.001). At multivariable analysis, patients with an ASA score of II and III within the MIO group had a significantly lower risk of HH compared with ASA I subjects (P = 0.002 and P < 0.001, respectively). Omentectomy was performed in all open procedures but in none of the MIO.

Conclusion: The rate of HH was significantly lower in patients who underwent open oesophagectomy. Omentectomy may prevent postoesophagectomy HH as it was the only additional technical difference between the groups. Multicentric randomized clinical trials are needed to assess whether omentectomy during MIO may reduce the occurrence of paraconduit HH.

背景:食道切除术后食道裂孔疝(HH)是一种潜在的危及生命的并发症,更常见于微创手术后。该研究的目的是比较开放式和微创食管癌切除术(MIO)后HH的发生率,确定其发病的危险因素,并分析两种入路之间的技术差异。方法:这是一项对15年期间接受经胸食道切除术的癌症患者的回顾性研究。根据人口统计学、手术和围手术期参数对开放和微创手术进行比较。MIO包括腹腔镜手术和机器人手术。通过计算单变量和多变量广义线性模型的优势比,分析食管切除术后HH的危险因素。结果:2008年至2023年共纳入898例手术患者。开放组490例患者中有1例(0.2%)出现HH,微创组408例患者中有21例(5.2%)出现HH (P < 0.001)。在多变量分析中,与ASA I组相比,MIO组中ASA评分为II和III的患者发生HH的风险显著降低(P分别= 0.002和P < 0.001)。所有开放手术均行网膜切除术,但没有一例MIO手术。结论:行开放式食管切除术患者HH发生率明显降低。网膜切除术可以预防食管切除术后HH,因为这是两组之间唯一的额外技术差异。需要多中心随机临床试验来评估MIO期间网膜切除术是否可以减少管道旁HH的发生。
{"title":"Hiatal hernia after open versus minimally invasive transthoracic oesophagectomy for cancer.","authors":"Luca Giulini, Irina Avramovska, Melissa Kemeter, Lisa Bernhardt, Lucas Thumfart, Felix J Hüttner, Patrick Heger, Wolfgang Hitzl, Markus K Diener, Attila Dubecz","doi":"10.1093/bjsopen/zraf095","DOIUrl":"10.1093/bjsopen/zraf095","url":null,"abstract":"<p><strong>Background: </strong>Hiatal hernia (HH) after oesophagectomy is a potentially life-threatening complication, more commonly observed after minimally invasive procedures. The aim of the study was to compare the incidence of HH after open versus minimally invasive oesophagectomy (MIO) for cancer, to identify risk factors for its onset, and analyse the technical differences between the approaches.</p><p><strong>Methods: </strong>This was a retrospective study of patients who underwent transthoracic oesophagectomy for cancer over a 15-year period. Open and minimally invasive procedures were compared according to demographics, and operative and perioperative parameters. MIO included both laparoscopic and robotic operations. Risk factors for HH after oesophagectomy were analysed by calculating odds ratios of uni- and multivariable generalized linear models.</p><p><strong>Results: </strong>A total of 898 patients operated on between 2008 and 2023 were included in the study. HH was observed in 1 of 490 patients (0.2%) in the open group and in 21 of 408 patients (5.2%) in the minimally invasive group (P < 0.001). At multivariable analysis, patients with an ASA score of II and III within the MIO group had a significantly lower risk of HH compared with ASA I subjects (P = 0.002 and P < 0.001, respectively). Omentectomy was performed in all open procedures but in none of the MIO.</p><p><strong>Conclusion: </strong>The rate of HH was significantly lower in patients who underwent open oesophagectomy. Omentectomy may prevent postoesophagectomy HH as it was the only additional technical difference between the groups. Multicentric randomized clinical trials are needed to assess whether omentectomy during MIO may reduce the occurrence of paraconduit HH.</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/PMC12461579/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112119","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
Implementation of guideline recommendations in coloanal anastomosis: results from the Tender Loving Care in Coloanal Anastomosis survey. 结肠肛管吻合术指南建议的实施:结肠肛管吻合术温情护理调查结果。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf106
Daniel Krstic, Moritz Sparn, Dimitrios Chatziisaak, Pascal Burri, Rene Warschkow, Bruno Schmied, Dieter Hahnloser, Lukas Marti, Walter Brunner, Stephan Bischofberger
{"title":"Implementation of guideline recommendations in coloanal anastomosis: results from the Tender Loving Care in Coloanal Anastomosis survey.","authors":"Daniel Krstic, Moritz Sparn, Dimitrios Chatziisaak, Pascal Burri, Rene Warschkow, Bruno Schmied, Dieter Hahnloser, Lukas Marti, Walter Brunner, Stephan Bischofberger","doi":"10.1093/bjsopen/zraf106","DOIUrl":"10.1093/bjsopen/zraf106","url":null,"abstract":"","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/PMC12452265/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145112057","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
Definition of failure to rescue in gastrointestinal and hepatobiliary cancer surgery: national cohort study. 胃肠和肝胆癌手术抢救失败的定义:国家队列研究。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf116
Cameron I Wells, William Xu, Chris Varghese, Sameer Bhat, Wal Baraza, Chris Harmston, Greg O'Grady, Ian P Bissett

Background: Failure to rescue (FTR) is the mortality rate among patients with complications, and is a quality indicator for surgical care. FTR has been inconsistently defined in the literature, with potential impacts on reported rates and hospital benchmarking. This study examined the impact of differences in the FTR definition on hospital rankings.

Methods: A retrospective population-based cohort study of patients undergoing gastrointestinal or hepatopancreatobiliary cancer resection from 2005 to 2020 was performed using linkage of the New Zealand Cancer Registry and National Minimum Dataset. FTR was defined as the mortality rate among patients with any of 19 postoperative complications. Five FTR definitions commonly used in the literature were adapted for comparison. Risk-adjusted rates were compared between hospitals using each definition, as well as for in-hospital and 90-day outcomes.

Results: In total, 31 199 patients were included from 20 hospitals, with 1517 90-day deaths (4.9%). The 90-day FTR rate with all 19 complications included was 10.4% (1517 of 14 646). The FTR definition affected hospital rankings, with the Bland-Altman 95% limits of agreement ranging between 4 and 11 position differences. There were 847 in-hospital deaths, and the in-hospital FTR rate was 5.8% (847 of 14 516). Hospital rankings were affected by the timing of outcome measurement; 95% limits of agreement ranged from 5 to 8 position differences compared with 90-day outcomes.

Conclusion: The definition and timing of FTR measurement affected hospital rankings. This may have important ramifications for FTR as a quality indicator when benchmarking institutional performance.

背景:抢救失败(FTR)是并发症患者的死亡率,是外科护理质量的一个指标。文献中对FTR的定义不一致,对报告的发生率和医院基准有潜在影响。本研究考察了FTR定义差异对医院排名的影响。方法:利用新西兰癌症登记处和国家最小数据集的链接,对2005年至2020年接受胃肠道或肝胆管癌切除术的患者进行回顾性人群队列研究。FTR定义为19种术后并发症中任何一种患者的死亡率。本文采用文献中常用的五种FTR定义进行比较。我们比较了使用每种定义的医院之间的风险调整率,以及住院和90天的结果。结果:20家医院共纳入31 199例患者,90天死亡1517例(4.9%)。包括所有19种并发症的90天FTR率为10.4%(14646例中的1517例)。FTR的定义影响了医院的排名,Bland-Altman 95%的一致性限制范围在4到11个位置差异之间。院内死亡847例,院内FTR率为5.8%(14516例中有847例)。结果测量时间对医院排名有影响;与90天的结果相比,95%的协议限制在5到8个立场差异之间。结论:FTR测量的定义和时间影响医院排名。这可能会对FTR作为衡量机构绩效的质量指标产生重要影响。
{"title":"Definition of failure to rescue in gastrointestinal and hepatobiliary cancer surgery: national cohort study.","authors":"Cameron I Wells, William Xu, Chris Varghese, Sameer Bhat, Wal Baraza, Chris Harmston, Greg O'Grady, Ian P Bissett","doi":"10.1093/bjsopen/zraf116","DOIUrl":"10.1093/bjsopen/zraf116","url":null,"abstract":"<p><strong>Background: </strong>Failure to rescue (FTR) is the mortality rate among patients with complications, and is a quality indicator for surgical care. FTR has been inconsistently defined in the literature, with potential impacts on reported rates and hospital benchmarking. This study examined the impact of differences in the FTR definition on hospital rankings.</p><p><strong>Methods: </strong>A retrospective population-based cohort study of patients undergoing gastrointestinal or hepatopancreatobiliary cancer resection from 2005 to 2020 was performed using linkage of the New Zealand Cancer Registry and National Minimum Dataset. FTR was defined as the mortality rate among patients with any of 19 postoperative complications. Five FTR definitions commonly used in the literature were adapted for comparison. Risk-adjusted rates were compared between hospitals using each definition, as well as for in-hospital and 90-day outcomes.</p><p><strong>Results: </strong>In total, 31 199 patients were included from 20 hospitals, with 1517 90-day deaths (4.9%). The 90-day FTR rate with all 19 complications included was 10.4% (1517 of 14 646). The FTR definition affected hospital rankings, with the Bland-Altman 95% limits of agreement ranging between 4 and 11 position differences. There were 847 in-hospital deaths, and the in-hospital FTR rate was 5.8% (847 of 14 516). Hospital rankings were affected by the timing of outcome measurement; 95% limits of agreement ranged from 5 to 8 position differences compared with 90-day outcomes.</p><p><strong>Conclusion: </strong>The definition and timing of FTR measurement affected hospital rankings. This may have important ramifications for FTR as a quality indicator when benchmarking institutional performance.</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/PMC12481687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145198033","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
Single and double faecal immunochemical test strategies are effective in risk stratification for patients with symptoms of per rectal bleeding suggestive of colorectal cancer. 单次和双次粪便免疫化学测试策略对提示结直肠癌的直肠出血患者的风险分层是有效的。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf100
Fatima Shah, Frances Gunn, Malcolm G Dunlop, Farhat V N Din, Adam D Gerrard

Background: Faecal immunochemical test (FIT) results triage urgent suspicion of colorectal cancer (USoC) referrals to investigation. As FIT detects microscopic blood, its role in patients with per rectal bleeding (PRB) is controversial. Patients are encouraged to submit sample stools without evident bleeding. The positivity rate, colorectal cancer (CRC) detection accuracy, and benefits from repeated FITs in patients with rectal bleeding are unknown.

Methods: A prospective dataset of USoC referrals for CRC was interrogated for referral symptoms, FIT results, and colorectal investigation outcomes. These were linked to South-East Scotland Cancer Network data to ensure complete CRC outcome data. A FIT result of 10 µg Hb/g or more was considered positive. The primary outcome of interest was diagnostic performance of FIT in patients with PRB compared with symptoms excluding PRB, including sensitivity, specificity, and negative predictive value (NPV). Secondarily, the impact of double FITs in these cohorts was investigated.

Results: A total of 5686 patients completed a FIT and subsequent colorectal investigation, and 2130 (37.5%) of these had PRB as a referral symptom. FIT positivity was higher in patients with PRB compared with no PRB (34.7% versus 18.6%; P < 0.001). When two successive FITs were completed, the positivity rate rose to 43.5%. Significant bowel pathology (CRC, advanced adenoma, inflammatory bowel disease (IBD)) was more prevalent in patients with PRB. The majority of CRCs in the PRB group were located distally (PRB 94.1% versus no PRB 51.5%; P < 0.001). The sensitivity for CRC was significantly greater in those with PRB compared with no PRB (98.0% (95% confidence interval (c.i.) 95.1-99.2) versus 82.5% (95% c.i. 74.6-88.9)), with respective NPVs of 99.8% and 99.4%. Double FITs increased CRC sensitivity in the non-PRB group, removing the difference in sensitivity between the two groups observed with one test (PRB 100% (95% c.i. 92.3-100) versus no PRB 92.9% (95% c.i. 79.4-97.8)). The NPV for CRC in PRB when two FITs were complete was 100% (99.0-100).

Conclusion: Rectal bleeding makes up one-third of USoC referrals to secondary care. The FIT positivity rate is 34.7% and it has a high sensitivity for CRC. Patients with PRB with two negative FITs have a negligible CRC prevalence.

背景:粪便免疫化学试验(FIT)结果分类紧急怀疑大肠癌(USoC)转介调查。由于FIT检测显微血液,它在直肠出血(PRB)患者中的作用是有争议的。鼓励患者提交无明显出血的粪便样本。直肠出血患者的阳性率、结直肠癌(CRC)检测的准确性以及反复FITs的益处尚不清楚。方法:对USoC转诊CRC患者的前瞻性数据集进行询问,以了解转诊症状、FIT结果和结直肠调查结果。这些数据与东南苏格兰癌症网络数据相关联,以确保完整的CRC结果数据。FIT结果大于等于10µg Hb/g被认为是阳性。研究的主要结局是将FIT在PRB患者中的诊断表现与非PRB患者的症状进行比较,包括敏感性、特异性和阴性预测值(NPV)。其次,研究了双fit对这些队列的影响。结果:共有5686例患者完成了FIT和随后的结肠直肠调查,其中2130例(37.5%)患者有PRB作为转诊症状。有PRB的患者FIT阳性率高于无PRB的患者(34.7%比18.6%,P < 0.001)。当连续两次完成fit时,阳性率上升至43.5%。显著的肠道病理(结直肠癌、晚期腺瘤、炎症性肠病(IBD))在PRB患者中更为普遍。PRB组的大多数crc位于远端(PRB组94.1%,无PRB组51.5%,P < 0.001)。与没有PRB的患者相比,有PRB的患者对CRC的敏感性明显更高(98.0%(95%可信区间(c.i.))。95.1-99.2) vs 82.5% (95% c.i. 74.6-88.9), npv分别为99.8%和99.4%。双fit增加了非PRB组的CRC敏感性,消除了两组之间的敏感性差异(PRB 100% (95% c.i. 92.3-100)与无PRB 92.9% (95% c.i. 79.4-97.8))。两次fit完成后,PRB中CRC的NPV为100%(99.0-100)。结论:直肠出血占三分之一的USoC转介到二级护理。FIT阳性率为34.7%,对结直肠癌有较高的敏感性。伴有两次fit阴性的PRB患者的CRC患病率可以忽略不计。
{"title":"Single and double faecal immunochemical test strategies are effective in risk stratification for patients with symptoms of per rectal bleeding suggestive of colorectal cancer.","authors":"Fatima Shah, Frances Gunn, Malcolm G Dunlop, Farhat V N Din, Adam D Gerrard","doi":"10.1093/bjsopen/zraf100","DOIUrl":"10.1093/bjsopen/zraf100","url":null,"abstract":"<p><strong>Background: </strong>Faecal immunochemical test (FIT) results triage urgent suspicion of colorectal cancer (USoC) referrals to investigation. As FIT detects microscopic blood, its role in patients with per rectal bleeding (PRB) is controversial. Patients are encouraged to submit sample stools without evident bleeding. The positivity rate, colorectal cancer (CRC) detection accuracy, and benefits from repeated FITs in patients with rectal bleeding are unknown.</p><p><strong>Methods: </strong>A prospective dataset of USoC referrals for CRC was interrogated for referral symptoms, FIT results, and colorectal investigation outcomes. These were linked to South-East Scotland Cancer Network data to ensure complete CRC outcome data. A FIT result of 10 µg Hb/g or more was considered positive. The primary outcome of interest was diagnostic performance of FIT in patients with PRB compared with symptoms excluding PRB, including sensitivity, specificity, and negative predictive value (NPV). Secondarily, the impact of double FITs in these cohorts was investigated.</p><p><strong>Results: </strong>A total of 5686 patients completed a FIT and subsequent colorectal investigation, and 2130 (37.5%) of these had PRB as a referral symptom. FIT positivity was higher in patients with PRB compared with no PRB (34.7% versus 18.6%; P < 0.001). When two successive FITs were completed, the positivity rate rose to 43.5%. Significant bowel pathology (CRC, advanced adenoma, inflammatory bowel disease (IBD)) was more prevalent in patients with PRB. The majority of CRCs in the PRB group were located distally (PRB 94.1% versus no PRB 51.5%; P < 0.001). The sensitivity for CRC was significantly greater in those with PRB compared with no PRB (98.0% (95% confidence interval (c.i.) 95.1-99.2) versus 82.5% (95% c.i. 74.6-88.9)), with respective NPVs of 99.8% and 99.4%. Double FITs increased CRC sensitivity in the non-PRB group, removing the difference in sensitivity between the two groups observed with one test (PRB 100% (95% c.i. 92.3-100) versus no PRB 92.9% (95% c.i. 79.4-97.8)). The NPV for CRC in PRB when two FITs were complete was 100% (99.0-100).</p><p><strong>Conclusion: </strong>Rectal bleeding makes up one-third of USoC referrals to secondary care. The FIT positivity rate is 34.7% and it has a high sensitivity for CRC. Patients with PRB with two negative FITs have a negligible CRC prevalence.</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/PMC12507080/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249542","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
Evaluating normothermic artery bypass and visceral-anastomosis-first strategy in thoracoabdominal aortic aneurysm repair: propensity-weighted analysis. 胸腹主动脉瘤修复中正常动脉旁路和脏器吻合术优先策略的评价:倾向加权分析。
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf114
Shuai Zhang, Hongwei Guo, Cuntao Yu, Xiaogang Sun, Jing Sun, Xiangyang Qian

Objective: To assess the effectiveness and safety of a normothermic artery bypass and visceral-anastomosis-first (NABV) strategy for thoracoabdominal aortic aneurysm repair.

Methods: From July 2017 to September 2024, a retrospective analysis was conducted on early postoperative complications in two groups of patients undergoing thoracoabdominal aortic aneurysm repair. The analysis compared patients treated with a new strategy with those treated with deep hypothermic circulatory arrest, clarifying the protective effects of the new strategy on visceral organs, particularly the spinal cord.

Results: A total of 182 patients were included in the study; 73 in the NABV group and 109 in the DHCA group. After inverse probability of treatment weighting, the NABV group had lower incidences of spinal cord deficit, pulmonary complications, and gastrointestinal insufficiency, a shorter duration of mechanical ventilation, and a shorter hospital stay. Body mass index ≥ 24.0 (odds ratio 3.099, 95% confidence interval (c.i.) 1.051 to 9.142; P = 0.004) and coronary artery disease (odds ratio 4.848, 95% c.i. 1.169 to 20.102; P = 0.030) were independent risk factors for spinal cord deficit in the entire cohort, in contrast to the NABV strategy (odds ratio 0.283, 95% c.i. 0.039 to 0.806; P = 0.025), which was a protective factor. The multivariable Cox regression analyses identified smoking history (hazard ratio 2.61, 95% c.i. 1.12 to 6.05; P = 0.026) as an independent risk factor for overall survival.

Conclusion: The treatment of thoracoabdominal aortic aneurysm through open surgery is still an important method and remains difficult. The NABV strategy, as a safe and reproducible technique, minimizes the risk of complications associated with spinal cord injury when implemented at experienced medical centres. To better evaluate the clinical outcomes of this surgical approach, long-term follow-up and further prospective cohort studies are necessary.

目的:评价正常动脉旁路及脏器吻合术(NABV)在胸腹主动脉瘤修复中的有效性和安全性。方法:回顾性分析2017年7月至2024年9月两组胸腹主动脉瘤修复术患者术后早期并发症。该分析比较了接受新策略治疗的患者与接受深度低温循环停止治疗的患者,阐明了新策略对内脏器官,特别是脊髓的保护作用。结果:共纳入182例患者;NABV组73例,DHCA组109例。经治疗加权逆概率计算,NABV组脊髓缺损、肺部并发症、胃肠功能不全发生率较低,机械通气时间较短,住院时间较短。体重指数≥24.0(优势比3.099,95%可信区间(ci .))1.051 ~ 9.142;P = 0.004)和冠状动脉疾病(优势比4.848,95% ci . 1.169 ~ 20.102, P = 0.030)是整个队列脊髓缺损的独立危险因素,而NABV策略(优势比0.283,95% ci . 0.039 ~ 0.806, P = 0.025)是一个保护因素。多变量Cox回归分析确定吸烟史(危险比2.61,95% ci 1.12 ~ 6.05; P = 0.026)是总生存的独立危险因素。结论:开放性手术治疗胸腹主动脉瘤仍是一种重要的治疗方法,但仍是治疗的难点。NABV战略作为一种安全和可重复的技术,在经验丰富的医疗中心实施时,可最大限度地减少与脊髓损伤相关的并发症风险。为了更好地评价该手术入路的临床效果,有必要进行长期随访和进一步的前瞻性队列研究。
{"title":"Evaluating normothermic artery bypass and visceral-anastomosis-first strategy in thoracoabdominal aortic aneurysm repair: propensity-weighted analysis.","authors":"Shuai Zhang, Hongwei Guo, Cuntao Yu, Xiaogang Sun, Jing Sun, Xiangyang Qian","doi":"10.1093/bjsopen/zraf114","DOIUrl":"10.1093/bjsopen/zraf114","url":null,"abstract":"<p><strong>Objective: </strong>To assess the effectiveness and safety of a normothermic artery bypass and visceral-anastomosis-first (NABV) strategy for thoracoabdominal aortic aneurysm repair.</p><p><strong>Methods: </strong>From July 2017 to September 2024, a retrospective analysis was conducted on early postoperative complications in two groups of patients undergoing thoracoabdominal aortic aneurysm repair. The analysis compared patients treated with a new strategy with those treated with deep hypothermic circulatory arrest, clarifying the protective effects of the new strategy on visceral organs, particularly the spinal cord.</p><p><strong>Results: </strong>A total of 182 patients were included in the study; 73 in the NABV group and 109 in the DHCA group. After inverse probability of treatment weighting, the NABV group had lower incidences of spinal cord deficit, pulmonary complications, and gastrointestinal insufficiency, a shorter duration of mechanical ventilation, and a shorter hospital stay. Body mass index ≥ 24.0 (odds ratio 3.099, 95% confidence interval (c.i.) 1.051 to 9.142; P = 0.004) and coronary artery disease (odds ratio 4.848, 95% c.i. 1.169 to 20.102; P = 0.030) were independent risk factors for spinal cord deficit in the entire cohort, in contrast to the NABV strategy (odds ratio 0.283, 95% c.i. 0.039 to 0.806; P = 0.025), which was a protective factor. The multivariable Cox regression analyses identified smoking history (hazard ratio 2.61, 95% c.i. 1.12 to 6.05; P = 0.026) as an independent risk factor for overall survival.</p><p><strong>Conclusion: </strong>The treatment of thoracoabdominal aortic aneurysm through open surgery is still an important method and remains difficult. The NABV strategy, as a safe and reproducible technique, minimizes the risk of complications associated with spinal cord injury when implemented at experienced medical centres. To better evaluate the clinical outcomes of this surgical approach, long-term follow-up and further prospective cohort studies are necessary.</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/PMC12492478/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145211564","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
Clinical impact of double-faecal immunochemical testing following implementation into standard triage and investigation of primary care referrals in patients with lower gastrointestinal symptoms. 双粪免疫化学检测在标准分诊和调查下消化道症状患者的初级保健转诊后的临床影响
IF 4.5 3区 医学 Q1 SURGERY Pub Date : 2025-09-08 DOI: 10.1093/bjsopen/zraf098
Adam D Gerrard, Yasuko Maeda, Colin Noble, Frances Gunn, Lorna Porteous, Rebecca Cheesbrough, Alastair Thomson, Malcolm G Dunlop, Farhat V N Din

Background: Faecal immunochemical testing has rapidly been established as the first-line triage for patients with symptoms suspicious for colorectal cancer. However, the reported low compliance of test returns issued from primary care is concerning. This article reports the real-world impact of implementation of a double-faecal immunochemical testing pathway for symptomatic referrals into routine clinical practice.

Methods: All eligible referrals between November 2021 and October 2022 were sent two faecal immunochemical tests via the faecal immunochemical testing interface office. Colorectal investigations were instigated if either test result was ≥10 µg haemoglobin per g. Referrals with double-negative results were reviewed by consultants who decided whether symptoms merited further investigation. Cancer registry follow-up data were cross-checked, and a further electronic registry allowed capture of re-referrals.

Results: Some 5425 patients were triaged using double-faecal immunochemical testing, with 5116 (94.3%) completing at least 1 and 4607 (84.9%) both faecal immunochemical tests. The positivity of one test was 20.8%, rising to 27.8% where both tests were completed. The number of referred patients undergoing colorectal investigation fell from 90% before faecal immunochemical testing-directed pathways to 56.6% owing to a reduction in investigating patients with double-negative results. The double-faecal immunochemical testing pathway had a sensitivity of 94.3% for the detection of colorectal cancer, with 37.5% of cancers with a negative first test being detected by the second. Only 3.3% of patients triaged through the double-faecal immunochemical testing pathway were re-referred.

Conclusion: The double-faecal immunochemical testing pathway demonstrated high test return rates, a reduction in unnecessary investigations, and colorectal cancer detection rates similar to preimplementation rates.

背景:粪便免疫化学检测已迅速成为疑似大肠癌患者的一线分诊方法。然而,据报道,来自初级保健的检测报告的低符合性令人担忧。这篇文章报道了实施双重粪便免疫化学检测途径对症状转诊到常规临床实践的实际影响。方法:在2021年11月至2022年10月期间,所有符合条件的转诊患者通过粪便免疫化学检测界面办公室进行两次粪便免疫化学检测。如果其中任何一项检测结果≥10µg血红蛋白/ g,则启动结直肠调查。咨询师对双阴性结果的转诊患者进行审查,以决定症状是否值得进一步调查。癌症登记处的随访数据被交叉核对,进一步的电子登记处允许捕获再转诊。结果:5425例患者接受了双重粪便免疫化学检查,其中5116例(94.3%)完成了至少一项粪便免疫化学检查,4607例(84.9%)完成了两项粪便免疫化学检查。一项检测的阳性率为20.8%,两项检测均完成时,阳性率上升至27.8%。由于调查双阴性结果患者的减少,接受结肠直肠检查的转诊患者数量从粪便免疫化学检测指导途径前的90%下降到56.6%。双粪免疫化学检测途径对结直肠癌的检测灵敏度为94.3%,第一次检测阴性的癌症有37.5%被第二次检测出。通过双粪免疫化学检测途径分类的患者中只有3.3%再次转诊。结论:双粪免疫化学检测途径具有较高的检测回收率,减少了不必要的检查,结直肠癌的检出率与实施前相似。
{"title":"Clinical impact of double-faecal immunochemical testing following implementation into standard triage and investigation of primary care referrals in patients with lower gastrointestinal symptoms.","authors":"Adam D Gerrard, Yasuko Maeda, Colin Noble, Frances Gunn, Lorna Porteous, Rebecca Cheesbrough, Alastair Thomson, Malcolm G Dunlop, Farhat V N Din","doi":"10.1093/bjsopen/zraf098","DOIUrl":"10.1093/bjsopen/zraf098","url":null,"abstract":"<p><strong>Background: </strong>Faecal immunochemical testing has rapidly been established as the first-line triage for patients with symptoms suspicious for colorectal cancer. However, the reported low compliance of test returns issued from primary care is concerning. This article reports the real-world impact of implementation of a double-faecal immunochemical testing pathway for symptomatic referrals into routine clinical practice.</p><p><strong>Methods: </strong>All eligible referrals between November 2021 and October 2022 were sent two faecal immunochemical tests via the faecal immunochemical testing interface office. Colorectal investigations were instigated if either test result was ≥10 µg haemoglobin per g. Referrals with double-negative results were reviewed by consultants who decided whether symptoms merited further investigation. Cancer registry follow-up data were cross-checked, and a further electronic registry allowed capture of re-referrals.</p><p><strong>Results: </strong>Some 5425 patients were triaged using double-faecal immunochemical testing, with 5116 (94.3%) completing at least 1 and 4607 (84.9%) both faecal immunochemical tests. The positivity of one test was 20.8%, rising to 27.8% where both tests were completed. The number of referred patients undergoing colorectal investigation fell from 90% before faecal immunochemical testing-directed pathways to 56.6% owing to a reduction in investigating patients with double-negative results. The double-faecal immunochemical testing pathway had a sensitivity of 94.3% for the detection of colorectal cancer, with 37.5% of cancers with a negative first test being detected by the second. Only 3.3% of patients triaged through the double-faecal immunochemical testing pathway were re-referred.</p><p><strong>Conclusion: </strong>The double-faecal immunochemical testing pathway demonstrated high test return rates, a reduction in unnecessary investigations, and colorectal cancer detection rates similar to preimplementation rates.</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/PMC12507089/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145249540","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
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)。
{"title":"Artificial sphincter with a new silicone band for treating faecal incontinence: IDEAL 2b prospective multicentre trial.","authors":"Christopher Dawoud, José Manuel Devesa, Mathias Löhnert, Rosana Vicente, Sherif Akram Metwalli, Stefan Riss","doi":"10.1093/bjsopen/zraf112","DOIUrl":"10.1093/bjsopen/zraf112","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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).</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/PMC12541383/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145343078","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
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