Pub Date : 2024-02-23DOI: 10.1101/2024.02.21.24303165
Miriam Svensson, Par-Ola Bendahl, Sara Alkner, Emma Hansson, Lisa Ryden, Looket Dihge
Background: Postmastectomy radiotherapy (PMRT) impairs the outcome of immediate breast reconstruction (IBR) in patients with breast cancer, and the sentinel lymph node (SLN) status is crucial in evaluating the need for PMRT. This study aimed to develop models to preoperatively predict the risk for SLN metastasis indicating the need for PMRT. Methods: Women diagnosed with clinically node-negative (cN0) T1-T2 breast cancer from January 2014 to December 2017 were identified within the Swedish National Quality Register for Breast Cancer. Nomograms for nodal prediction based on preoperatively accessible patient and tumor characteristics were developed using adaptive LASSO logistic regression. The prediction of ≥1 and >2 SLN macrometastases (macro-SLNMs) adheres to the current guidelines on use of PMRT and reflects the exclusion criteria in ongoing clinical trials aiming to de-escalate locoregional radiotherapy in patients with 1-2 macro-SLNMs, respectively. Predictive performance was evaluated using area under the receiver operating characteristic curve (AUC) and calibration plots. Results: Overall, 18 185 women were grouped into training (n =13 656) and validation (n = 4529) cohorts. The well-calibrated nomograms predicting ≥1 and >2 macro-SLNMs displayed AUCs of 0.708 and 0.740, respectively, upon validation. By using the nomogram for ≥1 macro-SLNMs, the risk could be updated from the pre-test population prevalence 13% to the post-test range 2%-75%. Conclusion: Nomograms based on routine patient and tumor characteristics could be used for prediction of SLN status that would indicate PMRT need and assist the decision-making on IBR for patients with cN0 breast cancer.
{"title":"Development and Validation of Prediction Models for Sentinel Lymph Node Status Indicating Postmastectomy Radiotherapy in Breast Cancer: a Population-Based Study of 18 185 Women","authors":"Miriam Svensson, Par-Ola Bendahl, Sara Alkner, Emma Hansson, Lisa Ryden, Looket Dihge","doi":"10.1101/2024.02.21.24303165","DOIUrl":"https://doi.org/10.1101/2024.02.21.24303165","url":null,"abstract":"Background: Postmastectomy radiotherapy (PMRT) impairs the outcome of immediate breast reconstruction (IBR) in patients with breast cancer, and the sentinel lymph node (SLN) status is crucial in evaluating the need for PMRT. This study aimed to develop models to preoperatively predict the risk for SLN metastasis indicating the need for PMRT.\u0000Methods: Women diagnosed with clinically node-negative (cN0) T1-T2 breast cancer from January 2014 to December 2017 were identified within the Swedish National Quality Register for Breast Cancer. Nomograms for nodal prediction based on preoperatively accessible patient and tumor characteristics were developed using adaptive LASSO logistic regression. The prediction of ≥1 and >2 SLN macrometastases (macro-SLNMs) adheres to the current guidelines on use of PMRT and reflects the exclusion criteria in ongoing clinical trials aiming to de-escalate locoregional radiotherapy in patients with 1-2 macro-SLNMs, respectively. Predictive performance was evaluated using area under the receiver operating characteristic curve (AUC) and calibration plots. Results: Overall, 18 185 women were grouped into training (n =13 656) and validation (n = 4529) cohorts. The well-calibrated nomograms predicting ≥1 and >2 macro-SLNMs displayed AUCs of 0.708 and 0.740, respectively, upon validation. By using the nomogram for ≥1 macro-SLNMs, the risk could be updated from the pre-test population prevalence 13% to the post-test range 2%-75%. Conclusion: Nomograms based on routine patient and tumor characteristics could be used for prediction of SLN status that would indicate PMRT need and assist the decision-making on IBR for patients with cN0 breast cancer.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139954976","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-21DOI: 10.1101/2024.02.19.24302952
Ryan M McCormack, Arjun S Chandran, Samden D Lhatoo, Sandipan Pati, Zhouxuan Li, Katherine Harris, Giridhar Kalamangalam, Stephen Thompson, Nitin Tandon
Objective: Periventricular Nodular Heterotopia (PVNH) is the most common neuronal heterotopia, frequently resulting in pharmacoresistant epilepsy. PVNH has a deep location which renders localization of seizure onsets and traditional surgical therapy challenging and of limited success. Here we characterize variables that predict good epilepsy outcomes following surgical intervention using SEEG informed MRgLITT. Methods: A prospectively compiled surgical epilepsy database from a single high-volume epilepsy referral center was used to identify patients who underwent SEEG evaluation for PVNH and characterize the intervention on outcomes. Results: Thirty-nine patients underwent SEEG informed MRgLITT. Associated imaging abnormalities mesial temporal sclerosis (MTS) or polymicrogyria (PMG) were treated based on SEEG. SEEG guided MRgLITT of the seizure onset zone (SoZ) in PVNH and associated epileptic tissue was carried out. PVNH and PMG were densely sampled mean 16.5(SD=2)/209.4(SD=36.9) SEEG probes/recording contacts. A single trajectory was used in 18, two in 13, and three or more in eight patients. Volumetric analyses revealed a high percentage of PVNH SoZ ablation (96.6%, SD=5.3%) in unilateral and bilateral (92.9%, SD=7.2%) cases. Mean follow-up duration was 31.4 months (SD=20.9). Seizure freedom was excellent overall: unilateral PVNH without other imaging abnormalities 80%; PVNH with MTS or PMG 63%; Bilateral PVNH 50%. SoZ ablation percentage significantly impacted surgical outcomes (p<0.001). Interpretation: PVNH plays a central role in seizure genesis. MRgLITT represents a transformative technological advance in PVNH associated epilepsy with seizure control outcomes consistent with those seen in focal lesional epilepsies. In localized unilateral cases and otherwise normal imaging, performing PVNH ablation without invasive recordings may be reasonable.
{"title":"Laser Ablation of Periventricular Nodular Heterotopia for Medically Refractory Epilepsy","authors":"Ryan M McCormack, Arjun S Chandran, Samden D Lhatoo, Sandipan Pati, Zhouxuan Li, Katherine Harris, Giridhar Kalamangalam, Stephen Thompson, Nitin Tandon","doi":"10.1101/2024.02.19.24302952","DOIUrl":"https://doi.org/10.1101/2024.02.19.24302952","url":null,"abstract":"Objective: Periventricular Nodular Heterotopia (PVNH) is the most common neuronal heterotopia, frequently resulting in pharmacoresistant epilepsy. PVNH has a deep location which renders localization of seizure onsets and traditional surgical therapy challenging and of limited success. Here we characterize variables that predict good epilepsy outcomes following surgical intervention using SEEG informed MRgLITT. Methods: A prospectively compiled surgical epilepsy database from a single high-volume epilepsy referral center was used to identify patients who underwent SEEG evaluation for PVNH and characterize the intervention on outcomes. Results: Thirty-nine patients underwent SEEG informed MRgLITT. Associated imaging abnormalities mesial temporal sclerosis (MTS) or polymicrogyria (PMG) were treated based on SEEG. SEEG guided MRgLITT of the seizure onset zone (SoZ) in PVNH and associated epileptic tissue was carried out. PVNH and PMG were densely sampled mean 16.5(SD=2)/209.4(SD=36.9) SEEG probes/recording contacts. A single trajectory was used in 18, two in 13, and three or more in eight patients. Volumetric analyses revealed a high percentage of PVNH SoZ ablation (96.6%, SD=5.3%) in unilateral and bilateral (92.9%, SD=7.2%) cases. Mean follow-up duration was 31.4 months (SD=20.9). Seizure freedom was excellent overall: unilateral PVNH without other imaging abnormalities 80%; PVNH with MTS or PMG 63%; Bilateral PVNH 50%. SoZ ablation percentage significantly impacted surgical outcomes (p<0.001). Interpretation: PVNH plays a central role in seizure genesis. MRgLITT represents a transformative technological advance in PVNH associated epilepsy with seizure control outcomes consistent with those seen in focal lesional epilepsies. In localized unilateral cases and otherwise normal imaging, performing PVNH ablation without invasive recordings may be reasonable.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139924571","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-19DOI: 10.1101/2024.02.17.24302660
Victor M Kyaruzi, Berjo Takoutsing, Astel Dongmo, Michael Nana Yaw Yankey, Yvanah Owoundi Mbozoo, Nathan Ezie Kengo, Samuel Fodop, Mingo Naomi Younwi, Evert Foyenka, Tcheutchoua Kathy Foka, Yab Parfait Motah, Opara Oluwamayowa, Roland Nchufor, Yannick Onana, Ngaroua, Atangana Ernestine Renee Bikono, Ignatius Esene
Introduction: Chronic subdural hematoma (cSDH) is a common neurosurgical condition characterised by the accumulation of blood between the dura mater and the arachnoid membrane. It has a significant prevalence and high mortality. Over the years, the management of cSDH has been extensively studied in high-income countries. On the other hand, Africa, which is faced with a significant neurosurgical care deficit, lacks aggregate data on the management strategies and outcomes on cSDH on this continent. This protocol aims to guide the scoping review of published studies investigating the characteristics, management strategies, and outcomes of cSDH in Africa. Methods and Analysis: The scoping review protocol for the proposed study is in accordance with the Arksey and O Malleys framework. The objectives, eligibility criteria and search strategy were developed based on the Population, Intervention, Comparator, Outcome framework. A comprehensive search will be conducted in electronic databases, including MEDLine, African Index Medicus, PubMed, Embase, African Journals Online, and Scopus to identify relevant studies. Only peer-reviewed publications with primary data reporting on the management of cSDH in the African human population will be included. Extracted data from included articles will be presented as descriptive statistics, pooled statistics, and a narrative description where deemed necessary. Ethics and dissemination: Given the non-direct involvement of human individuals, ethical approval will not be necessary. Dissemination strategies will include publication in a peer-reviewed journal, oral and poster presentations at conferences and promotion over social media.
{"title":"Management and outcomes of Chronic Subdural Hematoma in Africa: a protocol for a scoping review","authors":"Victor M Kyaruzi, Berjo Takoutsing, Astel Dongmo, Michael Nana Yaw Yankey, Yvanah Owoundi Mbozoo, Nathan Ezie Kengo, Samuel Fodop, Mingo Naomi Younwi, Evert Foyenka, Tcheutchoua Kathy Foka, Yab Parfait Motah, Opara Oluwamayowa, Roland Nchufor, Yannick Onana, Ngaroua, Atangana Ernestine Renee Bikono, Ignatius Esene","doi":"10.1101/2024.02.17.24302660","DOIUrl":"https://doi.org/10.1101/2024.02.17.24302660","url":null,"abstract":"Introduction: Chronic subdural hematoma (cSDH) is a common neurosurgical condition characterised by the accumulation of blood between the dura mater and the arachnoid membrane. It has a significant prevalence and high mortality. Over the years, the management of cSDH has been extensively studied in high-income countries. On the other hand, Africa, which is faced with a significant neurosurgical care deficit, lacks aggregate data on the management strategies and outcomes on cSDH on this continent. This protocol aims to guide the scoping review of published studies investigating the characteristics, management strategies, and outcomes of cSDH in Africa. Methods and Analysis: The scoping review protocol for the proposed study is in accordance with the Arksey and O Malleys framework. The objectives, eligibility criteria and search strategy were developed based on the Population, Intervention, Comparator, Outcome framework. A comprehensive search will be conducted in electronic databases, including MEDLine, African Index Medicus, PubMed, Embase, African Journals Online, and Scopus to identify relevant studies. Only peer-reviewed publications with primary data reporting on the management of cSDH in the African human population will be included. Extracted data from included articles will be presented as descriptive statistics, pooled statistics, and a narrative description where deemed necessary. Ethics and dissemination: Given the non-direct involvement of human individuals, ethical approval will not be necessary. Dissemination strategies will include publication in a peer-reviewed journal, oral and poster presentations at conferences and promotion over social media.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139924570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-18DOI: 10.1101/2024.02.16.24302807
Fabio Botelho, Said Ashkar, Shreenik Kundu, TJ Mathews, Elena Guadagno, Jason Harley, Dan D Poenaru
Purpose: Pediatric trauma is a leading cause of death and disability among children. While trauma education can improve these outcomes, it remains expensive and available only to a few providers worldwide. Innovative educational technologies like virtual reality (VR) can be key to democratizing trauma education. This study, therefore, evaluates the face and content validity of a VR platform designed to enhance pediatric trauma skills. Specifically, we seek to determine whether the platform effectively presents an injured child and comprehensively covers the essential tasks to successfully treat them within a trauma team. Methods: Physicians were invited to test a VR platform simulating a child with blunt head and truncal trauma. After the simulation, they filled out surveys assessing the face and content validity of the scenario, including their opinions on the realism, interaction, ease of use, and the educational content of the platform. Additionally, they completed a cybersickness questionnaire. Demographic data were also collected, including age, gender, country of medical education, and previous experience with VR. A descriptive analysis was performed. Results: Eleven physicians graduated from eight different countries tested the VR platform. Most (87%) found it valuable, and 81% preferred using it over high-fidelity mannequins for training purposes. The platform received more favorable evaluations for non-technical skills training (median: 5, IQR: 5.0 to 5.0) than for technical skills (median: 4, IQR: 3.0 to 5.0). Regarding cybersickness, 73% of the participants reported experiencing any or minimal discomfort during the simulation, and none needed to stop the test due to discomfort. Conclusion: Our initial validation of a VR platform designed for pediatric trauma education was positive. Participants endorsed VR and its potential to enhance performance, particularly in non-technical skills. Encouraged by these results, we will proceed with feasibility and implementation studies, comparing VR to high-fidelity mannequins.
{"title":"Virtual Reality for Pediatric Trauma Education - A Face and Content Validation Study","authors":"Fabio Botelho, Said Ashkar, Shreenik Kundu, TJ Mathews, Elena Guadagno, Jason Harley, Dan D Poenaru","doi":"10.1101/2024.02.16.24302807","DOIUrl":"https://doi.org/10.1101/2024.02.16.24302807","url":null,"abstract":"Purpose: Pediatric trauma is a leading cause of death and disability among children. While trauma education can improve these outcomes, it remains expensive and available only to a few providers worldwide. Innovative educational technologies like virtual reality (VR) can be key to democratizing trauma education. This study, therefore, evaluates the face and content validity of a VR platform designed to enhance pediatric trauma skills. Specifically, we seek to determine whether the platform effectively presents an injured child and comprehensively covers the essential tasks to successfully treat them within a trauma team.\u0000Methods: Physicians were invited to test a VR platform simulating a child with blunt head and truncal trauma. After the simulation, they filled out surveys assessing the face and content validity of the scenario, including their opinions on the realism, interaction, ease of use, and the educational content of the platform. Additionally, they completed a cybersickness questionnaire. Demographic data were also collected, including age, gender, country of medical education, and previous experience with VR. A descriptive analysis was performed.\u0000Results: Eleven physicians graduated from eight different countries tested the VR platform. Most (87%) found it valuable, and 81% preferred using it over high-fidelity mannequins for training purposes. The platform received more favorable evaluations for non-technical skills training (median: 5, IQR: 5.0 to 5.0) than for technical skills (median: 4, IQR: 3.0 to 5.0). Regarding cybersickness, 73% of the participants reported experiencing any or minimal discomfort during the simulation, and none needed to stop the test due to discomfort.\u0000Conclusion: Our initial validation of a VR platform designed for pediatric trauma education was positive. Participants endorsed VR and its potential to enhance performance, particularly in non-technical skills. Encouraged by these results, we will proceed with feasibility and implementation studies, comparing VR to high-fidelity mannequins.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139903731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-13DOI: 10.1101/2024.02.13.24302744
Elisabeth A Kappos, Yvonne Haas, Alexandra Schulz, Florian Peters, Shakuntala Savanthrapadian, Julia Stoffel, Maria Katapodi, Rosine Mucklow, Benedict Kaiser, Alexander Haumer, Stephanie Etter, Marco Cattaneo, Daniel Staub, Karin Ribi, Jane Shaw, Tristan M Handschin, Steffen Eisenhardt, Giuseppe Visconti, Gianluca Franceschini, Lorenzo Scardina, Benedetto Longo, Marcus Vetter, Khalil Zaman, Jan A Plock, Mario Scaglioni, Eduardo G Gonzalez, Sergio D Quildrian, Gunther Felmerer, Babak J Mehrara, Jaume Masia, Gemma Pons, Daniel F Kalbermatten, Justin M Sacks, Martin Halle, Maximillian V Muntean, Erin M Taylor, Maria Mani, Florian J Jung, Pietro G di Summa, Efterpi Demiri, Dimitris Dionyssiou, Anne K Groth, Norbert Heine, Joshua Vorstenborsch, Kathryn V Isaac, Shan S Qiu, Patricia E Engels, Axelle Serre, Anna-Lena Eberhardt, Sonja Ebner, Matthias Schwenkglenks, Yvette Stoel, Cornelia Leo, Raymund E Horch, Phillip Blondeel, Bjoern Behr, Ulrich Kneser, Lukas Prantl, Daniel T Boll, Cristina Granziera, Lars G Hemkens, Nicole Lindenblatt, Martin Haug, Dirk J Schaefer, Christoph Hirche, Andrea L Pusic, Katrin Seidenstuecker, Yves Harder, Walter P Weber
Introduction: Up to one fifth of breast cancer survivors will develop chronic breast cancer-related lymphedema (BCRL). To date complex physical decongestion therapy (CDT) is the gold standard of treatment. However, it is mainly symptomatic and often ineffective in preventing BCRL progression. Lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) are microsurgical techniques that aim to restore lymphatic drainage. This international randomized trial aims to evaluate advantages of microsurgical interventions plus CDT vs CDT alone for BCRL treatment. Methods and analysis: The effectiveness of LVA and/or VLNT in combination with CDT, which may be combined with liposuction, versus CDT alone will be evaluated in routine practice across the globe. BCRL patients will be randomly allocated to either surgical or conservative therapy. The primary endpoint of this trial is the patient-reported quality of life (QoL) outcome lymphedema-specific QoL, which will be assessed 15 months after randomization. Secondary endpoints are further patient reported outcomes (PROs), arm volume measurements, economic evaluations, and imaging at different timepoints. A long-term follow-up will be conducted up to 10 years after randomization. A total of 280 patients will be recruited in over 20 sites worldwide. Ethics and dissemination: This study will be conducted in compliance with the Declaration of Helsinki and the ICH-GCP E6 guideline. Ethical approval has been obtained by the lead Ethics Committee Ethikkommission Nordwest- und Zentralschweiz (2023-00733, 22.05.2023). Ethical approval from local authorities will be sought for all participating sites. Regardless of outcomes, the findings will be published in a peer-reviewed medical journal. Metadata detailing the dataset type, size and content will be made available, along with the full study protocol and case report forms, in public repositories in compliance with the FAIR principles. Trial registration: The trial is registered at https://clinicaltrials.gov (ID: NCT05890677) and on the Swiss National Clinical Trials Portal (SNCTP, BASEC project-ID: 2023-00733) at https://kofam.ch/de. The date of first registration was 23.05.2023. Strengths and limitations of this study: -This is a pragmatic, randomized, international, multicentre, superiority trial, which has the potential to impact the clinical practice of therapy for patients with chronic BCRL. -The pragmatic design will reflect clinical practice, thereby directly providing applicable results. -A comprehensive long-term follow-up will be conducted, extending up to 10 years, to assess and analyze long-term outcomes. -Patient advocates were intensely involved throughout the trial design. -To date, no multicentric RCT has compared microsurgical techniques (LVA and VLNT) possibly combined with liposuction with CDT alone, thereby limiting access of the patients to available treatment options. -The assessment of treatment quality (both conservative and surg
{"title":"The LYMPH Trial - Comparing Microsurgical with Conservative Treatment of Chronic Breast Cancer Associated Lymphedema: Study Protocol of a Pragmatic Randomized International Multicentre Superiority Trial","authors":"Elisabeth A Kappos, Yvonne Haas, Alexandra Schulz, Florian Peters, Shakuntala Savanthrapadian, Julia Stoffel, Maria Katapodi, Rosine Mucklow, Benedict Kaiser, Alexander Haumer, Stephanie Etter, Marco Cattaneo, Daniel Staub, Karin Ribi, Jane Shaw, Tristan M Handschin, Steffen Eisenhardt, Giuseppe Visconti, Gianluca Franceschini, Lorenzo Scardina, Benedetto Longo, Marcus Vetter, Khalil Zaman, Jan A Plock, Mario Scaglioni, Eduardo G Gonzalez, Sergio D Quildrian, Gunther Felmerer, Babak J Mehrara, Jaume Masia, Gemma Pons, Daniel F Kalbermatten, Justin M Sacks, Martin Halle, Maximillian V Muntean, Erin M Taylor, Maria Mani, Florian J Jung, Pietro G di Summa, Efterpi Demiri, Dimitris Dionyssiou, Anne K Groth, Norbert Heine, Joshua Vorstenborsch, Kathryn V Isaac, Shan S Qiu, Patricia E Engels, Axelle Serre, Anna-Lena Eberhardt, Sonja Ebner, Matthias Schwenkglenks, Yvette Stoel, Cornelia Leo, Raymund E Horch, Phillip Blondeel, Bjoern Behr, Ulrich Kneser, Lukas Prantl, Daniel T Boll, Cristina Granziera, Lars G Hemkens, Nicole Lindenblatt, Martin Haug, Dirk J Schaefer, Christoph Hirche, Andrea L Pusic, Katrin Seidenstuecker, Yves Harder, Walter P Weber","doi":"10.1101/2024.02.13.24302744","DOIUrl":"https://doi.org/10.1101/2024.02.13.24302744","url":null,"abstract":"Introduction: Up to one fifth of breast cancer survivors will develop chronic breast cancer-related lymphedema (BCRL). To date complex physical decongestion therapy (CDT) is the gold standard of treatment. However, it is mainly symptomatic and often ineffective in preventing BCRL progression. Lymphovenous anastomosis (LVA) and vascularized lymph node transfer (VLNT) are microsurgical techniques that aim to restore lymphatic drainage. This international randomized trial aims to evaluate advantages of microsurgical interventions plus CDT vs CDT alone for BCRL treatment. Methods and analysis: The effectiveness of LVA and/or VLNT in combination with CDT, which may be combined with liposuction, versus CDT alone will be evaluated in routine practice across the globe. BCRL patients will be randomly allocated to either surgical or conservative therapy. The primary endpoint of this trial is the patient-reported quality of life (QoL) outcome lymphedema-specific QoL, which will be assessed 15 months after randomization. Secondary endpoints are further patient reported outcomes (PROs), arm volume measurements, economic evaluations, and imaging at different timepoints. A long-term follow-up will be conducted up to 10 years after randomization. A total of 280 patients will be recruited in over 20 sites worldwide. Ethics and dissemination: This study will be conducted in compliance with the Declaration of Helsinki and the ICH-GCP E6 guideline. Ethical approval has been obtained by the lead Ethics Committee Ethikkommission Nordwest- und Zentralschweiz (2023-00733, 22.05.2023). Ethical approval from local authorities will be sought for all participating sites. Regardless of outcomes, the findings will be published in a peer-reviewed medical journal. Metadata detailing the dataset type, size and content will be made available, along with the full study protocol and case report forms, in public repositories in compliance with the FAIR principles. Trial registration: The trial is registered at https://clinicaltrials.gov (ID: NCT05890677) and on the Swiss National Clinical Trials Portal (SNCTP, BASEC project-ID: 2023-00733) at https://kofam.ch/de. The date of first registration was 23.05.2023. Strengths and limitations of this study:\u0000-This is a pragmatic, randomized, international, multicentre, superiority trial, which has the potential to impact the clinical practice of therapy for patients with chronic BCRL.\u0000-The pragmatic design will reflect clinical practice, thereby directly providing applicable results.\u0000-A comprehensive long-term follow-up will be conducted, extending up to 10 years, to assess and analyze long-term outcomes. -Patient advocates were intensely involved throughout the trial design.\u0000-To date, no multicentric RCT has compared microsurgical techniques (LVA and VLNT) possibly combined with liposuction with CDT alone, thereby limiting access of the patients to available treatment options.\u0000-The assessment of treatment quality (both conservative and surg","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139771119","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-08DOI: 10.1101/2024.02.07.24302455
Sergey Yuryevich Boldyrev, Valentina Nikolaevna Suslova, Mariya Vladimirovna Dontsova, Kirill Olegovich Barbukhatti, Vladimir Alekseevich Porkhanov
Background The question of choosing surgical tactics in patients with acute aortic dissection type A unresolved to now. In patients with massive destruction of the aortic root the «gold standard» is the Bentall procedure. Aortic valve reimplantation is an attractive alternative, especially in patients with preserved aortic valve leaflets anatomy.
背景 对急性主动脉夹层 A 型患者选择手术策略的问题至今悬而未决。对于主动脉根部严重破坏的患者，"金标准 "是 Bentall 手术。主动脉瓣再植术是一种很有吸引力的选择，尤其是对于主动脉瓣叶解剖结构保留的患者。
{"title":"MODIFIED AORTIC VALVE REIMPLANTATION IN PATIENTS WITH ACUTE AORTIC DISSECTION TYPE A","authors":"Sergey Yuryevich Boldyrev, Valentina Nikolaevna Suslova, Mariya Vladimirovna Dontsova, Kirill Olegovich Barbukhatti, Vladimir Alekseevich Porkhanov","doi":"10.1101/2024.02.07.24302455","DOIUrl":"https://doi.org/10.1101/2024.02.07.24302455","url":null,"abstract":"<strong>Background</strong> The question of choosing surgical tactics in patients with acute aortic dissection type A unresolved to now. In patients with massive destruction of the aortic root the «gold standard» is the Bentall procedure. Aortic valve reimplantation is an attractive alternative, especially in patients with preserved aortic valve leaflets anatomy.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139771555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-06DOI: 10.1101/2024.02.04.24302290
Siddhesh Zadey, Emily R. Smith, Catherine A. Staton, Tamara N. Fitzgerald, Joao Ricardo Nickenig Vissoci
Introduction Building on past frameworks, our aim was to systematically analyze the healthcare access and quality (HAQ) index for surgically treatable conditions, its progress over time, and the gap compared to non-surgical HAQ across 204 countries and territories from 1990 to 2019.
导言 在过去框架的基础上，我们的目标是系统分析 1990 年至 2019 年期间 204 个国家和地区的可手术治疗疾病的医疗服务获得和质量（HAQ）指数、随时间推移的进展情况以及与非手术 HAQ 相比的差距。
{"title":"Indexing Healthcare Access and Quality for Surgically Amenable Conditions: A Global Analysis of 204 Countries and Territories from 1990 to 2019","authors":"Siddhesh Zadey, Emily R. Smith, Catherine A. Staton, Tamara N. Fitzgerald, Joao Ricardo Nickenig Vissoci","doi":"10.1101/2024.02.04.24302290","DOIUrl":"https://doi.org/10.1101/2024.02.04.24302290","url":null,"abstract":"<strong>Introduction</strong> Building on past frameworks, our aim was to systematically analyze the healthcare access and quality (HAQ) index for surgically treatable conditions, its progress over time, and the gap compared to non-surgical HAQ across 204 countries and territories from 1990 to 2019.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139771001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-25DOI: 10.1101/2024.01.23.24301707
Rohan Khandelwal, Pooja Sharma, Dev Desai, Sambit Mohanty
Introduction: - Intraductal papilloma, although benign, has a high upgradation rate to malignant breast cancer. Surgical excision is necessary, but the rate of complications is high. Ultrasound-guided vacuum-assisted excision (US-VAE) is a new technique derived from the VABB biopsy method that can give better cosmetic results as well as fewer surgical complications. Objectives:- Understanding the utility of US-VAE in the diagnosis and treatment of intraductal papillomas of the breast. Methodology:- With permission from the Ethics Board and consent of the patients, 47 patients were recruited to undergo the US-VAE procedure. USG was used to stage the tumor with Mammography and CNB as needed and patients with single duct or adjacent duct lesions were included while the rest, including patients with malignant changes, were excluded. The Bard VABB biopsy machine and the 7G probe were used by highly trained breast surgeons to perform the procedure. Results:- Of the 47 patients included, 32 patients under local anesthesia were operated while others were under general anesthesia according to the preference of the patient and the level of apprehension. The patients received oral paracetamol as the only painkiller for 5 days. Only 3 patients required prolonged analgesics. 7 patients had prolonged bruising (lasting more than one week), which was the most common complication. All patients (100%) were happy with the cosmetic result after the procedure. Conclusions- The advantages of VABB-guided surgery are faster recovery, scarless procedure, and the ability to perform the surgery under local anesthesia, making it an OPD and daycare procedure. Key words:- Intraductal Papilloma; US-VAE; Excision; Surgery; VABB; Upgradation; Cosmesis
{"title":"Management of Intraductal Papilloma Using Vacuum Assisted Breast Surgery (VABB/VAE):- A Single Institute Study","authors":"Rohan Khandelwal, Pooja Sharma, Dev Desai, Sambit Mohanty","doi":"10.1101/2024.01.23.24301707","DOIUrl":"https://doi.org/10.1101/2024.01.23.24301707","url":null,"abstract":"Introduction: - Intraductal papilloma, although benign, has a high upgradation rate to malignant breast cancer. Surgical excision is necessary, but the rate of complications is high. Ultrasound-guided vacuum-assisted excision (US-VAE) is a new technique derived from the VABB biopsy method that can give better cosmetic results as well as fewer surgical complications. Objectives:- Understanding the utility of US-VAE in the diagnosis and treatment of intraductal papillomas of the breast. Methodology:- With permission from the Ethics Board and consent of the patients, 47 patients were recruited to undergo the US-VAE procedure. USG was used to stage the tumor with Mammography and CNB as needed and patients with single duct or adjacent duct lesions were included while the rest, including patients with malignant changes, were excluded. The Bard VABB biopsy machine and the 7G probe were used by highly trained breast surgeons to perform the procedure. Results:- Of the 47 patients included, 32 patients under local anesthesia were operated while others were under general anesthesia according to the preference of the patient and the level of apprehension. The patients received oral paracetamol as the only painkiller for 5 days. Only 3 patients required prolonged analgesics. 7 patients had prolonged bruising (lasting more than one week), which was the most common complication. All patients (100%) were happy with the cosmetic result after the procedure. Conclusions-\u0000The advantages of VABB-guided surgery are faster recovery, scarless procedure, and the ability to perform the surgery under local anesthesia, making it an OPD and daycare procedure. Key words:- Intraductal Papilloma; US-VAE; Excision; Surgery; VABB; Upgradation; Cosmesis","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139583414","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-01-10DOI: 10.1101/2024.01.09.23297913
Mathias Aagaard Christensen, Arnór Sigurdsson, Alexander Bonde, Simon Rasmussen, Sisse R Ostrowski, Mads Nielsen, Martin Sillesen
Introduction Postoperative complications affect up to 15% of surgical patients constituting a major part of the overall disease burden in a modern healthcare system. While several surgical risk calculators have been developed, none have so far been shown to decrease the associated mortality and morbidity. Combining deep neural networks and genomics with the already established clinical predictors may hold promise for improvement. Methods The UK Biobank was utilized to build linear and deep learning models for the prediction of surgery relevant outcomes. An initial GWAS for the relevant outcomes was initially conducted to select the Single Nucleotide Polymorphisms for inclusion in the models. Model performance was assessed with Receiver Operator Characteristics of the Area Under the Curve and optimum precision and recall. Feature importance was assessed with SHapley Additive exPlanations. Results Models were generated for atrial fibrillation, venous thromboembolism and pneumonia as genetics only, clinical features only and a combined model. For venous thromboembolism, the ROC-AUCs were 59.6% [59.0%-59.7%], 63.4% [63.2%-63.4%] and 66.1% [65.7%-66.1%] for the linear models and 60.0% [57.8%-61.8%], 63.2% [61.2%-65.0%] and 65.4% [63.6%-67.2%] for the deep learning SNP, clinical and combined models, respectively. For atrial fibrillation, the ROC-AUCs were 60.9% [60.6%-61.0%], 78.7% [78.7%-78.7%] and 80.1% [80.0%-80.1%] for the linear models and 59.9% [.6%-61.3%], 78.8% [77.8%-79.8%] and 79.4% [78.8%-80.5%] for the deep learning SNP, clinical and combined models, respectively. For pneumonia, the ROC-AUCs were 57.3% [56.5%-57.4%], 69.2% [69.1%-69.2%] and 70.5% [70.2%-70.6%] for the linear models and 55.5% [54.1%-56.9%], 69.7% [.5%-70.8%] and 69.9% [68.7%-71.0%] for the deep learning SNP, clinical and combined models, respectively. Conclusion In this report we presented linear and deep learning predictive models for surgery relevant outcomes. Overall, predictability were similar between linear and deep learning models and inclusion of genetics seemed to improve accuracy.
{"title":"An assessment of the value of deep neural networks in genetic risk prediction for surgically relevant outcomes","authors":"Mathias Aagaard Christensen, Arnór Sigurdsson, Alexander Bonde, Simon Rasmussen, Sisse R Ostrowski, Mads Nielsen, Martin Sillesen","doi":"10.1101/2024.01.09.23297913","DOIUrl":"https://doi.org/10.1101/2024.01.09.23297913","url":null,"abstract":"Introduction Postoperative complications affect up to 15% of surgical patients constituting a major part of the overall disease burden in a modern healthcare system. While several surgical risk calculators have been developed, none have so far been shown to decrease the associated mortality and morbidity. Combining deep neural networks and genomics with the already established clinical predictors may hold promise for improvement. Methods The UK Biobank was utilized to build linear and deep learning models for the prediction of surgery relevant outcomes. An initial GWAS for the relevant outcomes was initially conducted to select the Single Nucleotide Polymorphisms for inclusion in the models. Model performance was assessed with Receiver Operator Characteristics of the Area Under the Curve and optimum precision and recall. Feature importance was assessed with SHapley Additive exPlanations. Results Models were generated for atrial fibrillation, venous thromboembolism and pneumonia as genetics only, clinical features only and a combined model. For venous thromboembolism, the ROC-AUCs were 59.6% [59.0%-59.7%], 63.4% [63.2%-63.4%] and 66.1% [65.7%-66.1%] for the linear models and 60.0% [57.8%-61.8%], 63.2% [61.2%-65.0%] and 65.4% [63.6%-67.2%] for the deep learning SNP, clinical and combined models, respectively. For atrial fibrillation, the ROC-AUCs were 60.9% [60.6%-61.0%], 78.7% [78.7%-78.7%] and 80.1% [80.0%-80.1%] for the linear models and 59.9% [.6%-61.3%], 78.8% [77.8%-79.8%] and 79.4% [78.8%-80.5%] for the deep learning SNP, clinical and combined models, respectively. For pneumonia, the ROC-AUCs were 57.3% [56.5%-57.4%], 69.2% [69.1%-69.2%] and 70.5% [70.2%-70.6%] for the linear models and 55.5% [54.1%-56.9%], 69.7% [.5%-70.8%] and 69.9% [68.7%-71.0%] for the deep learning SNP, clinical and combined models, respectively. Conclusion In this report we presented linear and deep learning predictive models for surgery relevant outcomes. Overall, predictability were similar between linear and deep learning models and inclusion of genetics seemed to improve accuracy.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139413710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-12-19DOI: 10.1101/2023.12.19.23300215
Matthew Machin, Sarah Whittley, John Norrie, Laura Burgess, Beverley J. Hunt, Layla Bolton Saghdaoui, Joseph Shalhoub, Tamara Everington, Manjit Gohel, Mark Whiteley, Steven Rogers, Sarah Onida, Benedict Turner, Sandip Nandhra, Rebecca Lawton, Annya Stephens-Boal, Carolyn Singer, Joanne Dunbar, Alun Huw Davies, Daniel Carradice
Introduction Endovenous therapy is the first-choice management for symptomatic varicose veins in NICE guidelines, with 56-70,000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), and endothermal heat-induced thrombosis (EHIT), are known complications of endovenous therapy, occurring at a rate of up to 3.4%. In an attempt to reduce VTE, 73% of UK practitioners administer pharmacological thromboprophylaxis. However, no high-quality evidence to support this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE, however, further evidence is needed. The aims of this study are to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective. Methods and analysis A multi-centre, assessor-blind, randomised controlled trial (RCT). We aim to recruit 6660 participants undergoing superficial endovenous interventions under local anaesthesia. Forty sites across the UK, both NHS and private, will be included. Participants will be randomised to either intervention (a single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The ultrasound duplex scan will be conducted locally by blinded assessors. Participants will also be contacted remotely for follow-up at 7-days and 90-days post-procedure. The primary outcome is imaging confirmed lower limb DVT with or without symptoms, or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance (ANOVA), adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression.
{"title":"THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment: a multi-centre, assessor blind, randomised controlled trial (THRIVE trial)","authors":"Matthew Machin, Sarah Whittley, John Norrie, Laura Burgess, Beverley J. Hunt, Layla Bolton Saghdaoui, Joseph Shalhoub, Tamara Everington, Manjit Gohel, Mark Whiteley, Steven Rogers, Sarah Onida, Benedict Turner, Sandip Nandhra, Rebecca Lawton, Annya Stephens-Boal, Carolyn Singer, Joanne Dunbar, Alun Huw Davies, Daniel Carradice","doi":"10.1101/2023.12.19.23300215","DOIUrl":"https://doi.org/10.1101/2023.12.19.23300215","url":null,"abstract":"Introduction Endovenous therapy is the first-choice management for symptomatic varicose veins in NICE guidelines, with 56-70,000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), and endothermal heat-induced thrombosis (EHIT), are known complications of endovenous therapy, occurring at a rate of up to 3.4%. In an attempt to reduce VTE, 73% of UK practitioners administer pharmacological thromboprophylaxis. However, no high-quality evidence to support this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE, however, further evidence is needed. The aims of this study are to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective.\u0000Methods and analysis A multi-centre, assessor-blind, randomised controlled trial (RCT). We aim to recruit 6660 participants undergoing superficial endovenous interventions under local anaesthesia. Forty sites across the UK, both NHS and private, will be included. Participants will be randomised to either intervention (a single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The ultrasound duplex scan will be conducted locally by blinded assessors. Participants will also be contacted remotely for follow-up at 7-days and 90-days post-procedure. The primary outcome is imaging confirmed lower limb DVT with or without symptoms, or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance (ANOVA), adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138745779","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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