BJS Open最新文献

{"title":"Risk factors and development of machine learning diagnostic models for lateral lymph node metastasis in rectal cancer: multicentre study.","authors":"Shunsuke Kasai, Akio Shiomi, Hideyuki Shimizu, Monami Aoba, Yusuke Kinugasa, Takuya Miura, Kay Uehara, Jun Watanabe, Kazushige Kawai, Yoichi Ajioka","doi":"10.1093/bjsopen/zrae073","DOIUrl":"10.1093/bjsopen/zrae073","url":null,"abstract":"<p><strong>Background: </strong>The diagnostic criteria for lateral lymph node metastasis in rectal cancer have not been established. This research aimed to investigate the risk factors for lateral lymph node metastasis and develop machine learning models combining these risk factors to improve the diagnostic performance of standard imaging.</p><p><strong>Method: </strong>This multicentre prospective study included patients who underwent lateral lymph node dissection without preoperative treatment for rectal cancer between 2017 and 2019 in 15 Japanese institutions. First, preoperative clinicopathological factors and magnetic resonance imaging findings were evaluated using multivariable analyses for their correlation with lateral lymph node metastasis. Next, machine learning diagnostic models for lateral lymph node metastasis were developed combining these risk factors. The models were tested in a training set and in an internal validation cohort and their diagnostic performance was tested using receiver operating characteristic curve analyses.</p><p><strong>Results: </strong>Of 212 rectal cancers, 122 patients were selected, including 232 lateral pelvic sides, 30 sides of which had pathological lateral lymph node metastasis. Multivariable analysis revealed that poorly differentiated/mucinous adenocarcinoma, extramural vascular invasion, tumour deposit and a short-axis diameter of lateral lymph node ≥ 6.0 mm were independent risk factors for lateral lymph node metastasis. Patients were randomly divided into a training cohort (139 sides) and a test cohort (93 sides) and machine learning models were computed on the basis of a combination of significant features (including: histological type, extramural vascular invasion, tumour deposit, short- and long-axis diameter of lateral lymph node, body mass index, serum carcinoembryonic antigen level, cT, cN, cM, irregular border and mixed signal intensity). The top three models with the highest sensitivity in the training cohort were as follows: support vector machine (sensitivity, 1.000; specificity, 0.773), light gradient boosting machine (sensitivity, 0.950; specificity, 0.918) and ensemble learning (sensitivity, 0.950; specificity, 0.917). The diagnostic performances of these models in the test cohort were as follows: support vector machine (sensitivity, 0.750; specificity, 0.667), light gradient boosting machine (sensitivity, 0.500; specificity, 0.852) and ensemble learning (sensitivity, 0.667; specificity, 0.864).</p><p><strong>Conclusion: </strong>Machine learning models combining multiple risk factors can contribute to improving diagnostic performance of lateral lymph node metastasis.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11252850/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141625880","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}

{"title":"Margin clearance greater than 1 mm in nodal-positive pancreatic adenocarcinoma patients: multicentre retrospective analysis.","authors":"Reea P Ahola, Eline S Zwart, Benediktas Kurlinkus, Asif Halimi, Bengi S Yilmaz, Giulio Belfiori, Keith Roberts, Rupaly Pande, Hasan A Al-Saffar, Patrick Maisonneuve, Güralp O Ceyhan, Johanna Laukkarinen","doi":"10.1093/bjsopen/zrae076","DOIUrl":"10.1093/bjsopen/zrae076","url":null,"abstract":"<p><strong>Background: </strong>The introduction of the 1 mm cut-off for resection margin according to the Leeds Pathology Protocol has transformed the concept of surgical radicality. Its impact on nodal-positive resected pancreatic ductal adenocarcinoma patients is unclear. The aim of this study was to analyse the effect of margin clearance on survival among resected, nodal-positive pancreatic ductal adenocarcinoma patients whose specimens were analysed according to the Leeds Pathology Protocol.</p><p><strong>Methods: </strong>Data were collected retrospectively from multicentre clinical databases. Resected patients with nodal involvement were included. Overall survival and disease-free survival were analysed according to minimum reported margin clearances of 0, 0.5, 1, and 2 mm. The results are reported separately for patients who had not undergone venous resection and for patients for whom data were available regarding the superior mesenteric vein-facing margin or the vein specimen. The eighth edition of TNM classification by the AJCC was used.</p><p><strong>Results: </strong>The study comprised 290 stage IIB patients and 215 stage III patients without venous resection. The superior mesenteric vein margin analysis comprised 127 stage IIB patients and 198 stage III patients. The different resection margin distances were not associated with overall survival and disease-free survival among patients without venous resection (P > 0.050). Receiving adjuvant therapy was associated with longer overall survival among stage IIB patients (P = 0.034) and stage III patients (P = 0.003) and with longer disease-free survival among stage III patients (P < 0.001).</p><p><strong>Conclusions: </strong>In this study, a margin clearance greater than 1 mm showed no clear effect on overall survival in pancreatic ductal adenocarcinoma patients with nodal involvement, whereas adjuvant therapy was confirmed to be essential to ensure longer overall survival.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11282436/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141787195","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}

{"title":"Survival outcomes after breast cancer surgery among older women with early invasive breast cancer in England: population-based cohort study.","authors":"Katie Miller, Melissa Ruth Gannon, Jibby Medina, Karen Clements, David Dodwell, Kieran Horgan, Min Hae Park, David Alan Cromwell","doi":"10.1093/bjsopen/zrae062","DOIUrl":"10.1093/bjsopen/zrae062","url":null,"abstract":"<p><strong>Background: </strong>This study assessed the influence of age, co-morbidity and frailty on 5-year survival outcomes after breast conservation surgery (BCS) with radiotherapy (RT) versus mastectomy (with or without RT) in women with early invasive breast cancer.</p><p><strong>Methods: </strong>Women aged over 50 years with early invasive breast cancer diagnosed in England (2014-2019) who had breast surgery were identified from Cancer Registry data. Survival estimates were calculated from a flexible parametric survival model. A competing risk approach was used for breast cancer-specific survival (BCSS). Standardized survival probabilities and cumulative incidence functions for breast cancer death were calculated for each treatment by age.</p><p><strong>Results: </strong>Among 101 654 women, 72.2% received BCS + RT and 27.8% received mastectomy. Age, co-morbidity and frailty were associated with overall survival (OS), but only age and co-morbidity were associated with BCSS. Survival probabilities for OS were greater for BCS + RT (90.3%) versus mastectomy (87.0%), and the difference between treatments varied by age (50 years: 1.9% versus 80 years: 6.5%). Cumulative incidence functions for breast cancer death were higher after mastectomy (5.1%) versus BCS + RT (3.9%), but there was little change in the difference by age (50 years: 0.9% versus 80 years: 1.2%). The results highlight the change in baseline mortality risk by age for OS compared to the stable baseline for BCSS.</p><p><strong>Conclusion: </strong>For OS, the difference in survival probabilities for BCS + RT and mastectomy increased slightly with age. The difference in cumulative incidence functions for breast cancer death by surgery type was small regardless of age. Evidence on real-world survival outcomes among older populations with breast cancer is informative for treatment decision-making.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11229699/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141558021","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}

{"title":"Comparison of two bundles for reducing surgical site infection in colorectal surgery: multicentre cohort study.","authors":"Miriam Flores-Yelamos, Aina Gomila-Grange, Josep M Badia, Alexander Almendral, Ana Vázquez, David Parés, Marta Pascual, Enric Limón, Miquel Pujol, Montserrat Juvany","doi":"10.1093/bjsopen/zrae080","DOIUrl":"10.1093/bjsopen/zrae080","url":null,"abstract":"<p><strong>Background: </strong>There is controversy regarding the maximum number of elements that can be included in a surgical site infection prevention bundle. In addition, it is unclear whether a bundle of this type can be implemented at a multicentre level.</p><p><strong>Methods: </strong>A pragmatic, multicentre cohort study was designed to analyse surgical site infection rates in elective colorectal surgery after the sequential implementation of two preventive bundle protocols. Secondary outcomes were to determine compliance with individual measures and to establish their effectiveness, duration of stay, microbiology and 30-day mortality rate.</p><p><strong>Results: </strong>A total of 32 205 patients were included. A 50% reduction in surgical site infection was achieved after the implementation of two sequential sets of bundles: from 18.16% in the Baseline group to 10.03% with Bundle-1 and 8.19% with Bundle-2. Bundle-2 reduced superficial-surgical site infection (OR 0.74 (95% c.i. 0.58 to 0.95); P = 0.018) and deep-surgical site infection (OR 0.66 (95% c.i. 0.46 to 0.93); P = 0.018) but not organ/space-surgical site infection (OR 0.88 (95% c.i. 0.74 to 1.06); P = 0.172). Compliance increased after the addition of four measures to Bundle-2. In the multivariable analysis, for organ/space-surgical site infection, laparoscopy, oral antibiotic prophylaxis and mechanical bowel preparation were protective factors in colonic procedures, while no protective factors were found in rectal surgery. Duration of stay fell significantly over time, from 7 in the Baseline group to 6 and 5 days for Bundle-1 and Bundle-2 respectively (P < 0.001). The mortality rate fell from 1.4% in the Baseline group to 0.59% and 0.6% for Bundle-1 and Bundle-2 respectively (P < 0.001). There was an increase in Gram-positive bacteria and yeast isolation, and reduction in Gram-negative bacteria and anaerobes in organ/space-surgical site infection.</p><p><strong>Conclusions: </strong>The addition of measures to create a final 10-measure protocol had a cumulative protective effect on reducing surgical site infection. However, organ/space-surgical site infection did not benefit from the addition. No protective measures were found for organ/space-surgical site infection in rectal surgery. Compliance with preventive measures increased from Bundle-1 to Bundle-2.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11303006/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141896712","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}

{"title":"Japanese living donor liver transplantation criteria for hepatocellular carcinoma: nationwide cohort study.","authors":"Masahiro Ohira, Gaku Aoki, Yasushi Orihashi, Kenichi Yoshimura, Takeo Toshima, Etsuro Hatano, Susumu Eguchi, Taizo Hibi, Kiyoshi Hasegawa, Yuzo Umeda, Takuya Hashimoto, Yasushi Hasegawa, Shuji Nobori, Yasuhiro Ogura, Hiroyuki Nitta, Hiroto Egawa, Hidetoshi Eguchi, Yasutsugu Takada, Yoshihide Ueda, Mureo Kasahara, Shigeyuki Kawachi, Yuji Soejima, Katsutoshi Tokushige, Hiroaki Nagano, Hironori Haga, Takumi Fukumoto, Satoshi Mochida, Koji Umeshita, Hideki Ohdan","doi":"10.1093/bjsopen/zrae079","DOIUrl":"10.1093/bjsopen/zrae079","url":null,"abstract":"<p><strong>Background: </strong>Validating the expanded criteria for living donor liver transplantation for hepatocellular carcinoma using national data is highly significant. The aim of this study was to evaluate the validity of the new Japanese criteria for living donor liver transplantation for hepatocellular carcinoma patients and identify factors associated with a poor prognosis using the Japanese national data set.</p><p><strong>Methods: </strong>The study population comprised patients who underwent living donor liver transplantation for hepatocellular carcinoma at 37 centres in Japan between 2010 and 2018. In a nationwide survey, the overall survival and recurrence-free survival rates were evaluated based on the new Japanese criteria for applying the 5-5-500 rule when extending the indication beyond the Milan criteria. Prognostic factors within the Japanese criteria were determined using the Cox proportional hazards model.</p><p><strong>Results: </strong>Patients within (485 patients) and beyond (31 patients) the Japanese criteria exhibited 5-year overall survival rates of 81% and 58% and 5-year recurrence-free survival rates of 77% and 48% respectively. Patients who met the Milan criteria, but not the 5-5-500 rule, had poorer outcomes. Multivariate analysis for 474 patients identified a neutrophil-to-lymphocyte ratio greater than or equal to 5 and a history of hepatectomy as independent risk factors.</p><p><strong>Conclusion: </strong>This nationwide survey confirms the validity of the Japanese criteria. The poor prognostic factors within the Japanese criteria include a neutrophil-to-lymphocyte ratio greater than or equal to 5 and previous hepatectomy.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11295212/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141874141","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}

{"title":"Frailty using the Clinical Frailty Scale to predict short- and long-term adverse outcomes following emergency laparotomy: meta-analysis.","authors":"Brittany Park, Zena Alani, Edrick Sulistio, Ahmed W H Barazanchi, Jonathan Koea, Alain Vandal, Andrew G Hill, Andrew D MacCormick","doi":"10.1093/bjsopen/zrae078","DOIUrl":"10.1093/bjsopen/zrae078","url":null,"abstract":"<p><strong>Background: </strong>Emergency laparotomy has high morbidity and mortality rates. Frailty assessment remains underutilized in this setting, in part due to time constraints and feasibility. The Clinical Frailty Scale has been identified as the most appropriate tool for frailty assessment in emergency laparotomy patients and is recommended for all older patients undergoing emergency laparotomy. The prognostic impact of measured frailty using the Clinical Frailty Scale on short- and long-term mortality and morbidity rates remains to be determined.</p><p><strong>Methods: </strong>Observational cohort studies were identified by systematically searching Medline, Embase, Scopus and CENTRAL databases up to February 2024, comparing outcomes following emergency laparotomy for frail and non-frail participants defined according to the Clinical Frailty Scale. The primary outcomes were short- and long-term mortality rates. A random-effects model was created with pooling of effect estimates and a separate narrative synthesis was created. Risk of bias was assessed.</p><p><strong>Results: </strong>Twelve articles comprising 5704 patients were included. Frailty prevalence was 25% in all patients and 32% in older adults (age ≥55 years). Older patients with frailty had a significantly greater risk of postoperative death (30-day mortality rate OR 3.84, 95% c.i. 2.90 to 5.09, 1-year mortality rate OR 3.03, 95% c.i. 2.17 to 4.23). Meta-regression revealed that variations in cut-off values to define frailty did not significantly affect the association with frailty and 30-day mortality rate. Frailty was associated with higher rates of major complications (OR 1.93, 95% c.i. 1.27 to 2.93) and discharge to an increased level of care.</p><p><strong>Conclusion: </strong>Frailty is significantly correlated with short- and long-term mortality rates following emergency laparotomy, as well as an adverse morbidity rate and functional outcomes. Identifying frailty using the Clinical Frailty Scale may aid in patient-centred decision-making and implementation of tailored care strategies for these 'high-risk' patients, with the aim of reducing adverse outcomes following emergency laparotomy.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11336663/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016307","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}

{"title":"Magnetic versus conventional stent in ureteral stenting: meta-analysis.","authors":"Zhunan Xu, Hang Zhou, Qihua Wang, Congzhe Ren, Yang Pan, Shangren Wang, Li Liu, Xiaoqiang Liu","doi":"10.1093/bjsopen/zrae086","DOIUrl":"10.1093/bjsopen/zrae086","url":null,"abstract":"","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11287378/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141791812","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}

{"title":"BJS and BJS Open correspondence to move to the BJS Academy.","authors":"Ville Sallinen, Desmond C Winter, Jonothan J Earnshaw","doi":"10.1093/bjsopen/zrae077","DOIUrl":"10.1093/bjsopen/zrae077","url":null,"abstract":"","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11218766/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141490796","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}

{"title":"Association of resilience and psychological flexibility with surgeons' mental wellbeing.","authors":"Maddy Greville-Harris, Catherine Withers, Agata Wezyk, Kevin Thomas, Helen Bolderston, Amy Kane, Sine McDougall, Kevin J Turner","doi":"10.1093/bjsopen/zrae060","DOIUrl":"10.1093/bjsopen/zrae060","url":null,"abstract":"<p><strong>Background: </strong>Existing research highlights the link between certain personality traits and mental health in surgeons. However, little research has explored the important role of psychological skills and qualities in potentially explaining this link. A cross-sectional survey of UK-based surgeons was used to examine whether two such skills (psychological flexibility and resilience) helped to explain why certain personality traits might be linked to mental health in surgeons.</p><p><strong>Method: </strong>An online survey comprising measures of personality (neuroticism, extraversion and conscientiousness), psychological skills/qualities (psychological flexibility and resilience) and mental health (depression, anxiety, stress and burnout) was sent to surgeons practising in the UK. Mediation analyses were used to examine the potential mediating role of psychological flexibility and resilience in explaining the relationship between personality factors and mental health.</p><p><strong>Results: </strong>A total of 348 surgeons completed the survey. In all 12 mediation models, psychological flexibility and/or resilience played a significant role in explaining the relationship between personality traits (neuroticism, extraversion and conscientiousness) and mental health (depression, anxiety and burnout).</p><p><strong>Conclusion: </strong>Findings suggest that it is not only a surgeon's personality that is associated with their mental health, but the extent to which a surgeon demonstrates specific psychological qualities and skills (psychological flexibility and resilience). This has important implications for improving surgeons' mental wellbeing, because psychological flexibility and resilience are malleable, and can be successfully targeted with interventions in a way that personality traits cannot.</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11264141/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141747419","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}

{"title":"Prophylactic negative pressure wound therapy (NPWT) in laparotomy wounds (PROPEL-2): protocol for a randomized clinical trial.","authors":"Matthew G Davey, Noel E Donlon, Stewart R Walsh, Claire L Donohoe","doi":"10.1093/bjsopen/zrae081","DOIUrl":"10.1093/bjsopen/zrae081","url":null,"abstract":"<p><strong>Background: </strong>A proportion of patients undergoing midline laparotomy will develop surgical site infections after surgery. These complications place considerable financial burden on healthcare economies and have negative implications for patient health and quality of life. The prophylactic application of negative pressure wound therapy devices has been mooted as a pragmatic strategy to reduce surgical site infections. Nevertheless, further availability of multicentre randomized clinical trial data evaluating the prophylactic use of negative pressure wound therapy following midline laparotomy is warranted to definitely provide consensus in relation to these closure methods, while also deciphering potential differences among subgroups. The aim of this study is to determine whether prophylactic negative pressure wound therapy reduces postoperative wound complications in patients undergoing midline laparotomy.</p><p><strong>Methods: </strong>PROPEL-2 is a multicentre prospective randomized clinical trial designed to compare standard surgical dressings (control arm) with negative pressure wound therapy dressings (Prevena™ and PICO™ being the most commonly utilized). Patient recruitment will include adult patients aged 18 years or over, who are indicated to undergo emergency or elective laparotomy. To achieve 90% power at the 5% significance level, 1006 patients will be required in each arm, which when allowing for losses to follow-up, 10% will be added to each arm, leaving the total projected sample size to be 2013 patients, who will be recruited across a 36-month enrolment period.</p><p><strong>Conclusion: </strong>The PROPEL-2 trial will be the largest independent multicentre randomized clinical trial designed to assess the role of prophylactic negative pressure wound therapy in patients indicated to undergo midline laparotomy. The comparison of standard treatment to two commercially available negative pressure wound therapy devices will help provide consensus on the routine management of laparotomy wounds. Enrolment to PROPEL-2 began in June 2023. Registration number: NCT05977816 (http://www.clinicaltrials.gov).</p>","PeriodicalId":9028,"journal":{"name":"BJS Open","volume":null,"pages":null},"PeriodicalIF":3.5,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11342967/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142043858","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}