Pub Date : 2024-08-29DOI: 10.1101/2024.08.28.24312718
Kim Christin Honselmann, Jonathan Marschner, Anna Staufenbiel, Julia Bertram, Steffen Deichmann, Carsten Engelke, Martha Kirstein, Jens Marquardt, Marko Damm, Fanny Borowitzka, Veit Phillip, Ilaria Pergolini, Felix Harder, Rickmer Braren, Timo Gemoll, Susanne Roth, Sebastian Krug, Christoph W. Michalski, Robert Jaster, Tobias Keck, Ulrich Friedrich Wellner, the GERPACYST Study Group
Background Cystic lesions of the pancreas have continued to present a clinical challenge for the past decades now. The increasing rate of detection, the lack of high-quality data on the natural biology of pancreatic cysts and the resulting difficulty to predict malignant transformation in different types of pancreatic cysts make patients with these diseases hard to manage. The German Pancreas Club Cyst Registry (GERPACYST) (DRKS00025927) establishes a platform to discover the natural entity specific biology of pancreatic cysts, in a multicenter manner that should allow to assess risk models for malignancy.
{"title":"GERPACYST- The Trial Protocol Of The Prospective, Multicenter, Interdisciplinary German Pancreas Club Cyst Registry","authors":"Kim Christin Honselmann, Jonathan Marschner, Anna Staufenbiel, Julia Bertram, Steffen Deichmann, Carsten Engelke, Martha Kirstein, Jens Marquardt, Marko Damm, Fanny Borowitzka, Veit Phillip, Ilaria Pergolini, Felix Harder, Rickmer Braren, Timo Gemoll, Susanne Roth, Sebastian Krug, Christoph W. Michalski, Robert Jaster, Tobias Keck, Ulrich Friedrich Wellner, the GERPACYST Study Group","doi":"10.1101/2024.08.28.24312718","DOIUrl":"https://doi.org/10.1101/2024.08.28.24312718","url":null,"abstract":"<strong>Background</strong> Cystic lesions of the pancreas have continued to present a clinical challenge for the past decades now. The increasing rate of detection, the lack of high-quality data on the natural biology of pancreatic cysts and the resulting difficulty to predict malignant transformation in different types of pancreatic cysts make patients with these diseases hard to manage. The German Pancreas Club Cyst Registry (GERPACYST) (DRKS00025927) establishes a platform to discover the natural entity specific biology of pancreatic cysts, in a multicenter manner that should allow to assess risk models for malignancy.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142204033","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 : 2024-08-22DOI: 10.1101/2024.08.22.24312415
Alejandro Velandia-Sánchez, Camilo A. Polanía-Sandoval, José V. Álvarez-Martínez, Santiago Uribe-Ramírez, Juliana Tello-Pirateque, Carlos J. Pérez-Rivera, Juan P. Ávila-Madrigal, Danna L Cruz-Reyes, Paulo A. Cabrera-Rivera, Camilo E. Pérez-Cualtan, Edgar C Barrera, Yury F. Bustos-Martínez, Sebastián Gómez-Galán, Juan C Briceño, Michel MPJ Reijnen, Jaime Camacho-Mackenzie, Carlos O Mendivil, Juan G. Barrera-Carvajal
Introduction: Vascular surgery has been directed towards endovascular approaches; however, not all patients qualify for these procedures. Open vascular surgery remains crucial, demanding a steep learning curve. Exposure to these procedures has declined, resulting in a need for more standardization in acquiring open vascular surgery skills and potentially contributing to poorer outcomes. Simulation offers a solution, yet the evidence for structured programs in open vascular surgery is limited. This study aims to compare the efficacy of technical skill acquisition between a structured, progressive simulation-based training program and traditional experience-based training in open vascular surgery. Methods: A randomized, single-blinded, triple-arm educational clinical trial will be conducted. A control and intervention sequences of three groups with different exposure levels to the simulation program are proposed. Group 1: open abdominal aortic repair, Group 2: vascular anastomosis and open abdominal aortic repair, and Group 3: specific surgical skills, vascular anastomosis, and open abdominal aortic repair. 3D-printed models from AngioCT will be used for the open abdominal aortic repair simulation. Surgical residents of general, vascular, or cardiothoracic surgery programs will be included. Sample size calculation resulted in 45 participants, 15 per group. Simple blinding will involve external evaluators. Randomization will occur as simple randomization. Discussion: We expect that the structured and progressive simulation-based training program would enhance technical surgical skills. Based on the progression through different modules within the program, we aim to determine a significant difference in the acquisition of technical surgical skills. We hypothesize that 3D-printed patient-specific models can enhance participants' vascular surgery training and provide optimal simulated scenarios while prioritizing patient safety. We hope this initiative will impact the formation of future vascular surgeons, shape future training programs, and ensure comprehensive preparation for open vascular surgery. Trial registration: This study protocol was registered in clinicaltrials.gov with the NCT-ID: NCT06452901.
{"title":"PROgressive struCturEd Simulation-based Surgical training program (PROCESS) - Open Vascular Surgery: Study protocol for triple-arm, randomized, simple-blinded educational clinical trial.","authors":"Alejandro Velandia-Sánchez, Camilo A. Polanía-Sandoval, José V. Álvarez-Martínez, Santiago Uribe-Ramírez, Juliana Tello-Pirateque, Carlos J. Pérez-Rivera, Juan P. Ávila-Madrigal, Danna L Cruz-Reyes, Paulo A. Cabrera-Rivera, Camilo E. Pérez-Cualtan, Edgar C Barrera, Yury F. Bustos-Martínez, Sebastián Gómez-Galán, Juan C Briceño, Michel MPJ Reijnen, Jaime Camacho-Mackenzie, Carlos O Mendivil, Juan G. Barrera-Carvajal","doi":"10.1101/2024.08.22.24312415","DOIUrl":"https://doi.org/10.1101/2024.08.22.24312415","url":null,"abstract":"Introduction: Vascular surgery has been directed towards endovascular approaches; however, not all patients qualify for these procedures. Open vascular surgery remains crucial, demanding a steep learning curve. Exposure to these procedures has declined, resulting in a need for more standardization in acquiring open vascular surgery skills and potentially contributing to poorer outcomes. Simulation offers a solution, yet the evidence for structured programs in open vascular surgery is limited. This study aims to compare the efficacy of technical skill acquisition between a structured, progressive simulation-based training program and traditional experience-based training in open vascular surgery.\u0000Methods: A randomized, single-blinded, triple-arm educational clinical trial will be conducted. A control and intervention sequences of three groups with different exposure levels to the simulation program are proposed. Group 1: open abdominal aortic repair, Group 2: vascular anastomosis and open abdominal aortic repair, and Group 3: specific surgical skills, vascular anastomosis, and open abdominal aortic repair. 3D-printed models from AngioCT will be used for the open abdominal aortic repair simulation. Surgical residents of general, vascular, or cardiothoracic surgery programs will be included. Sample size calculation resulted in 45 participants, 15 per group. Simple blinding will involve external evaluators. Randomization will occur as simple randomization.\u0000Discussion: We expect that the structured and progressive simulation-based training program would enhance technical surgical skills. Based on the progression through different modules within the program, we aim to determine a significant difference in the acquisition of technical surgical skills. We hypothesize that 3D-printed patient-specific models can enhance participants' vascular surgery training and provide optimal simulated scenarios while prioritizing patient safety. We hope this initiative will impact the formation of future vascular surgeons, shape future training programs, and ensure comprehensive preparation for open vascular surgery.\u0000Trial registration: This study protocol was registered in clinicaltrials.gov with the NCT-ID: NCT06452901.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"36 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142204034","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 : 2024-08-20DOI: 10.1101/2024.08.19.24312047
Daniel J Stubbs, Benjamin M Davies, Ellie Edlmann, Akbar Ansari, Thomas H Bashford, Philip Braude, Diedrik Bulters, Sophie Camp, Georgina Carr, Jonathan P Coles, David DeMonteverde-Robb, Jugdeep Dhesi, Judith Dinsmore, Nicholas R Evans, Emily Foster, Elaine Fox, Ian Froom, Conor S Gillespie, Natalie Gray, Kirsty Grieve, Peter Hartley, Fiona Lecky, Angelos Kolias, J Jeeves, Alexis Joannides, Thais Minett, Iain Moppett, Mike H Nathanson, Virginia Newcombe, Joanne G Outtrim, Nicola Owen, Lisa Peterman, Shvaita Ralhan, David Shipway, Rohit Sinha, William Thomas, Peter J Whitfield, Sally R Wilson, Ardalan Zolnourian, Mary Dixon-Woods, David K Menon, Peter J Hutchinson, Improving care in elderly neurosurgery initiative (ICENI) working group
Introduction A cSDH is an encapsulated collection of fluid and blood degradation products in the subdural space. It is increasingly common, affecting older people and those living with frailty. Currently, no guidance exists to define optimal care from onset of symptoms through to recovery. This paper presents the first consensus-built recommendations for best practice in the care of cSDH, co-designed to support each stage of the patient pathway. Methods Guideline development was led by a multidisciplinary Steering Committee with representation from diverse clinical groups, professional associations, patients, and carers. Literature searching to identify relevant evidence was guided by core clinical questions formulated through facilitated discussion with specially convened working groups. A modified Delphi exercise was undertaken to build consensus on draft statements for inclusion in the guideline using survey methodology and an in-person meeting. The proposed guideline was subsequently endorsed by the Society for British Neurological Surgeons, Neuroanaesthesia and Critical Care Society, Association of Anaesthetists, British Association of Neuroscience Nurses, British Geriatric Society, and Centre for Perioperative Care. Results We identified that high quality evidence was generally lacking in the literature, although randomised controlled trial (RCT) data were available to inform specific recommendations on aspects of surgical technique and use of corticosteroids. The final guideline represents the outcome of synthesising the available evidence as well as consensus-built expert opinion and patient involvement. The guideline comprises 67 recommendations across 8 major themes, covering: presentation and diagnosis, neurosurgical triage and shared decision-making, non-operative management, perioperative management (including of anticoagulation), timing of surgery, intraoperative care, postoperative care, rehabilitation and recovery. Conclusions We present the first multidisciplinary guideline for the care of patients with cSDH. The recommendations reflect a paradigm shift in the care of cSDH, recognising and formalising the need for multidisciplinary and collaborative clinical management and communication and decision-making with patients delivered effectively across secondary and tertiary care.
{"title":"Clinical practice guidelines for the care of patients with a chronic subdural haematoma: multidisciplinary recommendations from presentation to recovery","authors":"Daniel J Stubbs, Benjamin M Davies, Ellie Edlmann, Akbar Ansari, Thomas H Bashford, Philip Braude, Diedrik Bulters, Sophie Camp, Georgina Carr, Jonathan P Coles, David DeMonteverde-Robb, Jugdeep Dhesi, Judith Dinsmore, Nicholas R Evans, Emily Foster, Elaine Fox, Ian Froom, Conor S Gillespie, Natalie Gray, Kirsty Grieve, Peter Hartley, Fiona Lecky, Angelos Kolias, J Jeeves, Alexis Joannides, Thais Minett, Iain Moppett, Mike H Nathanson, Virginia Newcombe, Joanne G Outtrim, Nicola Owen, Lisa Peterman, Shvaita Ralhan, David Shipway, Rohit Sinha, William Thomas, Peter J Whitfield, Sally R Wilson, Ardalan Zolnourian, Mary Dixon-Woods, David K Menon, Peter J Hutchinson, Improving care in elderly neurosurgery initiative (ICENI) working group","doi":"10.1101/2024.08.19.24312047","DOIUrl":"https://doi.org/10.1101/2024.08.19.24312047","url":null,"abstract":"Introduction\u0000A cSDH is an encapsulated collection of fluid and blood degradation products in the subdural space. It is increasingly common, affecting older people and those living with frailty. Currently, no guidance exists to define optimal care from onset of symptoms through to recovery. This paper presents the first consensus-built recommendations for best practice in the care of cSDH, co-designed to support each stage of the patient pathway. Methods\u0000Guideline development was led by a multidisciplinary Steering Committee with representation from diverse clinical groups, professional associations, patients, and carers. Literature searching to identify relevant evidence was guided by core clinical questions formulated through facilitated discussion with specially convened working groups. A modified Delphi exercise was undertaken to build consensus on draft statements for inclusion in the guideline using survey methodology and an in-person meeting. The proposed guideline was subsequently endorsed by the Society for British Neurological Surgeons, Neuroanaesthesia and Critical Care Society, Association of Anaesthetists, British Association of Neuroscience Nurses, British Geriatric Society, and Centre for Perioperative Care. Results\u0000We identified that high quality evidence was generally lacking in the literature, although randomised controlled trial (RCT) data were available to inform specific recommendations on aspects of surgical technique and use of corticosteroids. The final guideline represents the outcome of synthesising the available evidence as well as consensus-built expert opinion and patient involvement. The guideline comprises 67 recommendations across 8 major themes, covering: presentation and diagnosis, neurosurgical triage and shared decision-making, non-operative management, perioperative management (including of anticoagulation), timing of surgery, intraoperative care, postoperative care, rehabilitation and recovery. Conclusions\u0000We present the first multidisciplinary guideline for the care of patients with cSDH. The recommendations reflect a paradigm shift in the care of cSDH, recognising and formalising the need for multidisciplinary and collaborative clinical management and communication and decision-making with patients delivered effectively across secondary and tertiary care.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"36 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142204051","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 : 2024-08-19DOI: 10.1101/2024.08.19.24312209
Julie Croft, Emily Farrow, Alexandra Coxon-Meggy, Katie Gordon, Neil Corrigan, Hannah Mather, Deborah Stocken, Megan Dale, Huey Yi Chong, Judith White, Laura Knight, Alun Meggy, Christina Lloydwin, Betty Tan, Ashley Douglas, Ralph Powell, Julie Hepburn, David Jayne, Jared Torkington, Andrea Warwick, Kheng-Seong Ng, Kate Wilson, Charles Knowles, Aaron Quyn, Julie Cornish
Introduction As a result of improving survival rates, the adverse consequences of rectal cancer surgery are becoming increasingly recognised. Low Anterior Resection Syndrome (LARS) is one such consequence and describes a constellation of bowel symptoms after rectal cancer surgery which includes urgency, faecal incontinence, stool clustering and incomplete evacuation. LARS has a significant adverse impact on Quality-of-Life (QoL) and symptoms are present in up to 75% of patients in the first year after surgery. Despite this, little is known about the natural history and there is poor evidence to support current treatment options. Methods and Analysis The objectives of POLARiS are to explore the natural history of LARS and to evaluate the clinical and cost-effectiveness of trans-anal irrigation (TAI) or sacral neural modulation (SNM) compared to optimised conservative management (OCM) for people with major LARS. All patients who have had an anterior resection in the last 10 years who meet the eligibility criteria will be invited to participate in the cohort. Patients identified as having a major LARS score (LARS score ≥30) and who meet the eligibility criteria will be invited to take part in the randomised controlled trial (RCT). Cohort and RCT participants will be followed up for a 24-month period, and will complete a series of questionnaires measuring LARS symptoms and quality-of-life, as well as clinical review for those in the RCT. A process evaluation, qualitative sub-study and economic evaluation will also be conducted. The primary outcome measure of the POLARiS cohort and RCT is the LARS score at 24 months. Analyses of the RCT will be conducted on an intention-to-treat basis. Comparative effectiveness analyses for each endpoint will consist of two pairwise treatment comparisons: TAI vs OCM and SNM vs OCM. Ethics and Dissemination Ethical approval has been granted by Wales REC 4 (reference: 23/WA/0171) in the UK and Sydney Local Health District HREC (reference: 2023/ETH00749) in Australia. The results of this trial will be disseminated to participants upon request and published on completion of the trial in a peer-reviewed journal and at international conferences Trial Registration Number ISRCTN12834598 Registered 04/08/2023 ACTRN12623001166662 Registered 10/11/2023
导言：随着生存率的提高，人们越来越认识到直肠癌手术的不良后果。低位前切除综合症（LARS）就是这样一种后果，它描述了直肠癌手术后的一系列肠道症状，包括便急、大便失禁、大便成团和排便不完全。LARS 对患者的生活质量（QoL）有很大的负面影响，多达 75% 的患者在术后第一年会出现 LARS 症状。尽管如此，人们对其自然病史却知之甚少，而且支持当前治疗方案的证据也不充分。方法和分析POLARiS的目的是探索LARS的自然病史，并评估经肛门灌注（TAI）或骶神经调节（SNM）与优化保守治疗（OCM）相比，对重大LARS患者的临床和成本效益。所有在过去 10 年中接受过前部切除术且符合资格标准的患者都将被邀请参加该群组。被确定为重度 LARS（LARS 评分≥30 分）且符合资格标准的患者将被邀请参加随机对照试验 (RCT)。将对队列研究和随机对照试验的参与者进行为期 24 个月的随访，并完成一系列测量 LARS 症状和生活质量的问卷调查，以及对随机对照试验参与者的临床审查。此外，还将进行过程评估、定性子研究和经济评估。POLARiS 队列和 RCT 的主要结果指标是 24 个月时的 LARS 评分。RCT 分析将在意向治疗的基础上进行。每个终点的疗效比较分析将包括两个成对治疗比较：TAI vs OCM 和 SNM vs OCM。伦理与传播英国威尔士 REC 4（参考文献：23/WA/0171）和澳大利亚悉尼地方卫生区 HREC（参考文献：2023/ETH00749）已批准了该试验。本试验的结果将应要求向参与者公布，并在试验结束后在同行评审期刊和国际会议上发表。
{"title":"Pathway of Low Anterior Resection Syndrome (LARS) Relief After Surgery (POLARiS) Trial Protocol. A prospective, international, open-label, multi-arm, phase 3 randomised superiority trial within a cohort to explore the natural history of LARS and compare the trans-anal irrigation and sacral neuromodulation to optimised conservative management for people with major LARS.","authors":"Julie Croft, Emily Farrow, Alexandra Coxon-Meggy, Katie Gordon, Neil Corrigan, Hannah Mather, Deborah Stocken, Megan Dale, Huey Yi Chong, Judith White, Laura Knight, Alun Meggy, Christina Lloydwin, Betty Tan, Ashley Douglas, Ralph Powell, Julie Hepburn, David Jayne, Jared Torkington, Andrea Warwick, Kheng-Seong Ng, Kate Wilson, Charles Knowles, Aaron Quyn, Julie Cornish","doi":"10.1101/2024.08.19.24312209","DOIUrl":"https://doi.org/10.1101/2024.08.19.24312209","url":null,"abstract":"Introduction\u0000As a result of improving survival rates, the adverse consequences of rectal cancer surgery are becoming increasingly recognised. Low Anterior Resection Syndrome (LARS) is one such consequence and describes a constellation of bowel symptoms after rectal cancer surgery which includes urgency, faecal incontinence, stool clustering and incomplete evacuation. LARS has a significant adverse impact on Quality-of-Life (QoL) and symptoms are present in up to 75% of patients in the first year after surgery. Despite this, little is known about the natural history and there is poor evidence to support current treatment options. Methods and Analysis\u0000The objectives of POLARiS are to explore the natural history of LARS and to evaluate the clinical and cost-effectiveness of trans-anal irrigation (TAI) or sacral neural modulation (SNM) compared to optimised conservative management (OCM) for people with major LARS. All patients who have had an anterior resection in the last 10 years who meet the eligibility criteria will be invited to participate in the cohort. Patients identified as having a major LARS score (LARS score ≥30) and who meet the eligibility criteria will be invited to take part in the randomised controlled trial (RCT). Cohort and RCT participants will be followed up for a 24-month period, and will complete a series of questionnaires measuring LARS symptoms and quality-of-life, as well as clinical review for those in the RCT. A process evaluation, qualitative sub-study and economic evaluation will also be conducted. The primary outcome measure of the POLARiS cohort and RCT is the LARS score at 24 months. Analyses of the RCT will be conducted on an intention-to-treat basis. Comparative effectiveness analyses for each endpoint will consist of two pairwise treatment comparisons: TAI vs OCM and SNM vs OCM. Ethics and Dissemination\u0000Ethical approval has been granted by Wales REC 4 (reference: 23/WA/0171) in the UK and Sydney Local Health District HREC (reference: 2023/ETH00749) in Australia. The results of this trial will be disseminated to participants upon request and published on completion of the trial in a peer-reviewed journal and at international conferences Trial Registration Number ISRCTN12834598 Registered 04/08/2023\u0000ACTRN12623001166662\u0000Registered 10/11/2023","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"45 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142204049","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 : 2024-08-14DOI: 10.1101/2024.08.13.24311878
Emily L Isch, Aviana Duca, Theodore Habarth-Morales, D Mitchell Self, Edward J Caterson
Introduction: The objective of this article is to assess and describe the incidence of postoperative hemorrhage following cleft palate surgery (palatoplasty), specifically focusing on need for return to the operating room for management of post-operative hemorrhage. Methods: The TriNetX federated database was used to identify patients with a diagnosis of cleft lip and/or palate undergoing primary cleft palate repair over a twenty-year period from 2003 until2023. Primary endpoints assessed include post operative hemorrhage resulting in blood transfusion and/or return to the operating room; Kaplan-Meier analysis was used for statistical analysis. Results: A total of 13,161 patients with cleft lip or palate over the last 20 years underwent operative intervention (palatoplasty). Of those patients, ninety-seven patients were found to have diagnosis of post-operative bleeding (confidence interval 1.196 +/-0.606). One hundred and seventy-five patients experienced post operative hemorrhage requiring transfusion of blood product (CI 1.491 +/-0.952). Seventy patients required return to the operating room for post-operative bleeding in the immediate post operative period. Conclusions: Historic reporting of post-operative bleeding suggests a moderate rate of post-operative hemorrhage rate following palatoplasty, occasionally necessitating transfusion and return to operating room following index palatoplasty. Our retrospective review of a national database demonstrates a lesser incidence of post-operative hemorrhage than previously noted.
{"title":"Post-Operative Bleeding After Facial Cleft Repair: A Retrospective Review of TriNetX Database","authors":"Emily L Isch, Aviana Duca, Theodore Habarth-Morales, D Mitchell Self, Edward J Caterson","doi":"10.1101/2024.08.13.24311878","DOIUrl":"https://doi.org/10.1101/2024.08.13.24311878","url":null,"abstract":"Introduction: The objective of this article is to assess and describe the incidence of postoperative hemorrhage following cleft palate surgery (palatoplasty), specifically focusing on need for return to the operating room for management of post-operative hemorrhage. Methods: The TriNetX federated database was used to identify patients with a diagnosis of cleft lip and/or palate undergoing primary cleft palate repair over a twenty-year period from 2003 until2023. Primary endpoints assessed include post operative hemorrhage resulting in blood transfusion and/or return to the operating room; Kaplan-Meier analysis was used for statistical analysis. Results: A total of 13,161 patients with cleft lip or palate over the last 20 years underwent operative intervention (palatoplasty). Of those patients, ninety-seven patients were found to have diagnosis of post-operative bleeding (confidence interval 1.196 +/-0.606). One hundred and seventy-five patients experienced post operative hemorrhage requiring transfusion of blood product (CI 1.491 +/-0.952). Seventy patients required return to the operating room for post-operative bleeding in the immediate post operative period. Conclusions: Historic reporting of post-operative bleeding suggests a moderate rate of post-operative hemorrhage rate following palatoplasty, occasionally necessitating transfusion and return to operating room following index palatoplasty. Our retrospective review of a national database demonstrates a lesser incidence of post-operative hemorrhage than previously noted.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"8 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142204048","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 : 2024-08-13DOI: 10.1101/2024.08.12.24311874
Marcella Moura Ceratti, Carolina Carvalho Jansen Sorbello, Marcelo Fiorelli Alexandrino da Silva, Marcelo Passos Teivelis, Nelson Wolosker
Background: Upper limb vascular trauma (ULVT) is a prevalent injury associated with significant morbidity and mortality. Despite its clinical importance, epidemiological studies on ULVT are scarce, particularly in developing countries where the incidence may be heightened by factors such as traffic accidents and violence. Objective: To analyze the epidemiology of ULVT across Brazil, a developing country, evaluating incidence rates, demographic characteristics, mortality rates, days of hospitalization, and related healthcare costs. Methods: A cross-sectional, retrospective analysis using data from the Brazilian public health system (SUS) over a sixteen-year period (2008-2023). The automated data extraction utilized Python-based tools to gather information on vascular trauma procedures identified by ICD-10 codes. Statistical analyses were performed to assess variations in incidence, mortality, and treatment costs across Brazilian regions. Results: A total of 25,573 cases of ULVT were recorded, representing approximately 0.02% of the studied population. The majority of cases occurred in males (79.8%) with a mean age of 34.71 years, with a peak incidence in the 20-24 age group. The region in Brazil with the highest incidence of ULVT was the North (16.6 cases per 100,000 inhabitants) and the region with the lowest was the Southeast (10.7 cases per 100,000 inhabitants). The average hospital stay was 4.39 days and 92,8% of patients did not need to be admitted to an intensive care unit (ICU). Of the patients admitted to the ICU, the average length of stay was 4.52 days. Overall lethality (deaths per cases of ULVT) was 2.37%, with higher lethality observed in bilateral ULVT cases (3.81%). Conclusions: ULVT is more prevalent in Brazil than in developed countries, even when adjusted for population size. However, mortality rates and hospitalization durations do not appear to differ significantly from those in developed countries.
{"title":"Nationwide Epidemiological Analysis of Surgically Treated Upper Limb Vascular Trauma Over 16 Years in Brazil","authors":"Marcella Moura Ceratti, Carolina Carvalho Jansen Sorbello, Marcelo Fiorelli Alexandrino da Silva, Marcelo Passos Teivelis, Nelson Wolosker","doi":"10.1101/2024.08.12.24311874","DOIUrl":"https://doi.org/10.1101/2024.08.12.24311874","url":null,"abstract":"Background: Upper limb vascular trauma (ULVT) is a prevalent injury associated with significant morbidity and mortality. Despite its clinical importance, epidemiological studies on ULVT are scarce, particularly in developing countries where the incidence may be heightened by factors such as traffic accidents and violence.\u0000Objective: To analyze the epidemiology of ULVT across Brazil, a developing country, evaluating incidence rates, demographic characteristics, mortality rates, days of hospitalization, and related healthcare costs.\u0000Methods: A cross-sectional, retrospective analysis using data from the Brazilian public health system (SUS) over a sixteen-year period (2008-2023). The automated data extraction utilized Python-based tools to gather information on vascular trauma procedures identified by ICD-10 codes. Statistical analyses were performed to assess variations in incidence, mortality, and treatment costs across Brazilian regions.\u0000Results: A total of 25,573 cases of ULVT were recorded, representing approximately 0.02% of the studied population. The majority of cases occurred in males (79.8%) with a mean age of 34.71 years, with a peak incidence in the 20-24 age group. The region in Brazil with the highest incidence of ULVT was the North (16.6 cases per 100,000 inhabitants) and the region with the lowest was the Southeast (10.7 cases per 100,000 inhabitants). The average hospital stay was 4.39 days and 92,8% of patients did not need to be admitted to an intensive care unit (ICU). Of the patients admitted to the ICU, the average length of stay was 4.52 days. Overall lethality (deaths per cases of ULVT) was 2.37%, with higher lethality observed in bilateral ULVT cases (3.81%). Conclusions: ULVT is more prevalent in Brazil than in developed countries, even when adjusted for population size. However, mortality rates and hospitalization durations do not appear to differ significantly from those in developed countries.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"59 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142204050","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 : 2024-08-12DOI: 10.1101/2024.08.11.24311831
Kristian Als Nielsen, Karsten Kaiser, Per Helligsø, Michael Festersen Nielsen, Alexandros Valorenzos
Background: Healthcare expenditure is increasing at a rate that surpasses the growth of the gross domestic product in most Western nations, emphasizing the need for precise hospital accounting practices. In resource-constrained environments, accurately estimating the costs of hospital services, such as robotic ventral hernia repair, is essential for achieving efficiency and transparency. Despite the existence of several studies reporting on the cost of robotic ventral hernia repair, there is a lack of systematic mapping of current knowledge on the methodological designs used in studies reporting on the costs and resource use. Methods: This study protocol outlines the methodology for a scoping review aimed at systematically mapping the existing literature on costing methodologies in robotic ventral hernia repair. The scoping review will follow the framework outlined by Arksey and O'Malley and adhere to the PRISMA-ScR guidelines. A systematic search will be conducted in Embase, Medline and Cochrane Library. Studies will be included if they involve patients undergoing robotic ventral hernia repair and report on cost/costing methodologies. The review will extract data on study characteristics, intervention specifics, and detailed costing methodologies. Two independent reviewers will conduct the data extraction, with discrepancies resolved through discussion or by a third reviewer. Discussion: The review will identify significant variations in costing methodologies, including differences in perspectives (hospital vs. societal), time horizons, and cost components. It aims to highlight gaps and inconsistencies in the current literature, providing a foundation for future research to standardize costing methodologies and improve the accuracy of economic evaluations in robotic surgery. By systematically mapping the existing literature, this scoping review will provide valuable insights into the current state of costing methodologies in robotic ventral hernia repair. It will serve as a foundational reference for researchers, policymakers, and healthcare providers, offering recommendations to enhance the economic evaluation of robotic surgical technologies.
{"title":"Study Protocol: A Scoping Review on Costing Methodologies in Robotic Ventral Hernia Repair","authors":"Kristian Als Nielsen, Karsten Kaiser, Per Helligsø, Michael Festersen Nielsen, Alexandros Valorenzos","doi":"10.1101/2024.08.11.24311831","DOIUrl":"https://doi.org/10.1101/2024.08.11.24311831","url":null,"abstract":"Background: Healthcare expenditure is increasing at a rate that surpasses the growth of the gross domestic product in most Western nations, emphasizing the need for precise hospital accounting practices. In resource-constrained environments, accurately estimating the costs of hospital services, such as robotic ventral hernia repair, is essential for achieving efficiency and transparency. Despite the existence of several studies reporting on the cost of robotic ventral hernia repair, there is a lack of systematic mapping of current knowledge on the methodological designs used in studies reporting on the costs and resource use.\u0000Methods: This study protocol outlines the methodology for a scoping review aimed at systematically mapping the existing literature on costing methodologies in robotic ventral hernia repair. The scoping review will follow the framework outlined by Arksey and O'Malley and adhere to the PRISMA-ScR guidelines. A systematic search will be conducted in Embase, Medline and Cochrane Library. Studies will be included if they involve patients undergoing robotic ventral hernia repair and report on cost/costing methodologies. The review will extract data on study characteristics, intervention specifics, and detailed costing methodologies. Two independent reviewers will conduct the data extraction, with discrepancies resolved through discussion or by a third reviewer.\u0000Discussion: The review will identify significant variations in costing methodologies, including differences in perspectives (hospital vs. societal), time horizons, and cost components. It aims to highlight gaps and inconsistencies in the current literature, providing a foundation for future research to standardize costing methodologies and improve the accuracy of economic evaluations in robotic surgery. By systematically mapping the existing literature, this scoping review will provide valuable insights into the current state of costing methodologies in robotic ventral hernia repair. It will serve as a foundational reference for researchers, policymakers, and healthcare providers, offering recommendations to enhance the economic evaluation of robotic surgical technologies.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"38 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141946250","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}
Background In the research field of artificial intelligence (AI) in surgery, there are many open questions that must be clarified. Well-designed randomized controlled trials (RCTs) are required to explore the positive clinical impacts by comparing the use and non-use of AI-based intraoperative image navigation. Therefore, herein, we propose the ImNavi trial, a multicenter RCT, to compare the use and non-use of an AI-based intraoperative image navigation system in laparoscopic surgery.<br>Methods The ImNavi trial is a Japanese multicenter RCT involving 1:1 randomization between the use and non-use of an AI-based intraoperative image navigation system in laparoscopic colorectal surgery. The participating institutions will include three high-volume centers with sufficient laparoscopic colorectal surgery caseloads (>100 cases/year), including one national cancer center and two university hospitals in Japan. Written informed consent will be obtained from all patients. Patients aged between 18 and 80 years scheduled to undergo laparoscopic left-sided colorectal resection will be included in the study. The primary outcome is the time required for each target organ, including the ureter and autonomic nerves, to be recognized by the surgeon after its initial appearance on the monitor. Secondary outcomes include intraoperative target organ injuries, intraoperative complications, operation time, blood loss, duration of postoperative hospital stay, postoperative complications within 30 days, postoperative male sexual dysfunction 1 month after surgery, surgeon′s confidence in recognizing each target organ, and the postoperative fatigue of the primary surgeon.<br>Discussion The impact of AI-based surgical applications on clinical outcomes beyond numerical expression will be explored from a variety of viewpoints while evaluating quantitative items, including intraoperative complications and operation time, as secondary endpoints. We expect that the findings of this RCT will contribute to advancing research in the domain of AI in surgery.
{"title":"Exploring the impact of an artificial intelligence-based intraoperative image navigation system in laparoscopic surgery on clinical outcomes: A protocol for a multicenter randomized controlled trial","authors":"Daichi Kitaguchi, Nozomu Fuse, Masashi Wakabayashi, Norihito Kosugi, Yuto Ishikawa, Kazuyuki Hayashi, Hiro Hasegawa, Nobuyoshi Takeshita, Masaaki Ito","doi":"10.1101/2024.08.05.24310603","DOIUrl":"https://doi.org/10.1101/2024.08.05.24310603","url":null,"abstract":"<strong>Background</strong> In the research field of artificial intelligence (AI) in surgery, there are many open questions that must be clarified. Well-designed randomized controlled trials (RCTs) are required to explore the positive clinical impacts by comparing the use and non-use of AI-based intraoperative image navigation. Therefore, herein, we propose the ImNavi trial, a multicenter RCT, to compare the use and non-use of an AI-based intraoperative image navigation system in laparoscopic surgery.<br><strong>Methods</strong> The ImNavi trial is a Japanese multicenter RCT involving 1:1 randomization between the use and non-use of an AI-based intraoperative image navigation system in laparoscopic colorectal surgery. The participating institutions will include three high-volume centers with sufficient laparoscopic colorectal surgery caseloads (>100 cases/year), including one national cancer center and two university hospitals in Japan. Written informed consent will be obtained from all patients. Patients aged between 18 and 80 years scheduled to undergo laparoscopic left-sided colorectal resection will be included in the study. The primary outcome is the time required for each target organ, including the ureter and autonomic nerves, to be recognized by the surgeon after its initial appearance on the monitor. Secondary outcomes include intraoperative target organ injuries, intraoperative complications, operation time, blood loss, duration of postoperative hospital stay, postoperative complications within 30 days, postoperative male sexual dysfunction 1 month after surgery, surgeon′s confidence in recognizing each target organ, and the postoperative fatigue of the primary surgeon.<br><strong>Discussion</strong> The impact of AI-based surgical applications on clinical outcomes beyond numerical expression will be explored from a variety of viewpoints while evaluating quantitative items, including intraoperative complications and operation time, as secondary endpoints. We expect that the findings of this RCT will contribute to advancing research in the domain of AI in surgery.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"171 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141946249","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}
Background and Objective: Neurosurgical research is a rapidly evolving field, with numerous studies continuously published. As the body of research grows, upholding high-quality standards becomes increasingly essential. Open science practices offer tools to ensure quality and transparency. However, the prevalence of these practices remains unclear. This study investigated the extent to which neurosurgical publications have implemented open science practices. Methods: Five open science practices (preprint, equator guidelines, published peer review comments, preregistration, and open accessibility to data and methods) were measured from five top-ranked neurosurgical journals (Neurosurgery, Journal of Neurosurgery, World Neurosurgery, Neurosurgical Review, and Acta Neurochirurgica), according to Google Scholar. One hundred fifty articles were randomly sampled from January 1, 2022, to December 31, 2023. Two reviewers analyzed these articles for their utilization of open science practices. A third reviewer settled disagreements. Results: One journal required (20%) and three journals (60%) recommended utilizing EQUATOR guidelines. Three journals (60%) allowed preprints, and all five journals (100%) recommended or required preregistration of clinical trials, but only two (40%) recommended preregistration for systematic reviews (Figure 1). All five journals (100%) recommended or required methods to be publicly available, but none (0%) published peer-review comments. Neurosurgical Review utilized the most open science practices, with a mean utilization of 1.4 open science practices per publication versus 0.9 across the other four journals (p < 0.001). Moreover, Neurosurgical Review significantly utilized more open science practices versus Journal of Neurosurgery (p < .05) and World Neurosurgery (p < .05). Both randomized controlled trials (p < .001) and systematic reviews (p < .001) significantly utilized more open science practices compared to observational studies. Conclusions: Despite advocacy from neurosurgical journals, the adoption of open science practices still needs improvement. Implementing incentives and clearer requirements may prove beneficial. Promoting these practices is crucial to enhancing transparency and research quality in neurosurgery. Keywords: Neurosurgical journals, open science practices, research quality, research transparency, research reproducibility
{"title":"Investigation of Research Quality and Transparency in Neurosurgery Through the Utilization of Open Science Practices","authors":"Zahin Alam, Kush Desai, Anirudh Maddali, Vijay Sivan, Rohit PremKumar, Geoffrey O'Malley, NItesh Patel","doi":"10.1101/2024.08.03.24311452","DOIUrl":"https://doi.org/10.1101/2024.08.03.24311452","url":null,"abstract":"Background and Objective: Neurosurgical research is a rapidly evolving field, with numerous studies continuously published. As the body of research grows, upholding high-quality standards becomes increasingly essential. Open science practices offer tools to ensure quality and transparency. However, the prevalence of these practices remains unclear. This study investigated the extent to which neurosurgical publications have implemented open science practices. Methods: Five open science practices (preprint, equator guidelines, published peer review comments, preregistration, and open accessibility to data and methods) were measured from five top-ranked neurosurgical journals (Neurosurgery, Journal of Neurosurgery, World Neurosurgery, Neurosurgical Review, and Acta Neurochirurgica), according to Google Scholar. One hundred fifty articles were randomly sampled from January 1, 2022, to December 31, 2023. Two reviewers analyzed these articles for their utilization of open science practices. A third reviewer settled disagreements. Results: One journal required (20%) and three journals (60%) recommended utilizing EQUATOR guidelines. Three journals (60%) allowed preprints, and all five journals (100%) recommended or required preregistration of clinical trials, but only two (40%) recommended preregistration for systematic reviews (Figure 1). All five journals (100%) recommended or required methods to be publicly available, but none (0%) published peer-review comments. Neurosurgical Review utilized the most open science practices, with a mean utilization of 1.4 open science practices per publication versus 0.9 across the other four journals (p < 0.001). Moreover, Neurosurgical Review significantly utilized more open science practices versus Journal of Neurosurgery (p < .05) and World Neurosurgery (p < .05). Both randomized controlled trials (p < .001) and systematic reviews (p < .001) significantly utilized more open science practices compared to observational studies. Conclusions: Despite advocacy from neurosurgical journals, the adoption of open science practices still needs improvement. Implementing incentives and clearer requirements may prove beneficial. Promoting these practices is crucial to enhancing transparency and research quality in neurosurgery. Keywords: Neurosurgical journals, open science practices, research quality, research transparency, research reproducibility","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"31 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141946248","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 : 2024-07-26DOI: 10.1101/2024.07.25.24311019
Abdullah Khalid, Hamdan Mallick, Muhammad Yasir Khan, Shiraz Hashmi, Syed Shahabuddin
Introduction: Hypoxemia is a well-known postoperative complication following open heart surgery. There is minimal literature and a lack of consensus on postoperative hypoxemia as a complication following open heart surgery and its relation to adverse outcomes, risk factors, and population characteristics. This is especially more apparent in lower middle-income countries where there is a double burden of disease. We aimed to determine the predictive and risk factors for postoperative hypoxemia due to the high incidence of associated complications that include increased morbidity, mortality, and length of hospital stay. Methods: This study was a retrospective analysis, evaluating first-time open-heart surgery patients over a period of one year from January to December 2020. Data was collected prospectively through the section of cardiothoracic surgery computerized database, using standardized data collection strategies and definitions. Results: The overall prevalence of hypoxemia was estimated to be 73 (11.8%). Morbidity and Mortality were significantly higher in the hypoxemic group. Male gender, diabetes, hypertension, low EF%, CBP time, increased preoperative PaCO2, were found to be independent risk factors for the development of hypoxemia. Conclusion: From the results of this study, it could be concluded that the magnitude of hypoxemia is substantial after on-pump open heart surgery. High-risk and independent factors identified from this study were cumulatively grouped and preventive use of BiPAP was found to be a possible option to prevent hypoxemia This study highlights the importance of one of the underestimated post-op morbid factors with cost, quality, and outcome implications.
{"title":"The Silent Threat: Unveiling the Mystery of Post Op Hypoxemia after Open Heart Surgery","authors":"Abdullah Khalid, Hamdan Mallick, Muhammad Yasir Khan, Shiraz Hashmi, Syed Shahabuddin","doi":"10.1101/2024.07.25.24311019","DOIUrl":"https://doi.org/10.1101/2024.07.25.24311019","url":null,"abstract":"Introduction:\u0000Hypoxemia is a well-known postoperative complication following open heart surgery. There is minimal literature and a lack of consensus on postoperative hypoxemia as a complication following open heart surgery and its relation to adverse outcomes, risk factors, and population characteristics. This is especially more apparent in lower middle-income countries where there is a double burden of disease. We aimed to determine the predictive and risk factors for postoperative hypoxemia due to the high incidence of associated complications that include increased morbidity, mortality, and length of hospital stay.\u0000Methods:\u0000This study was a retrospective analysis, evaluating first-time open-heart surgery patients over a period of one year from January to December 2020. Data was collected prospectively through the section of cardiothoracic surgery computerized database, using standardized data collection strategies and definitions. Results:\u0000The overall prevalence of hypoxemia was estimated to be 73 (11.8%). Morbidity and Mortality were significantly higher in the hypoxemic group. Male gender, diabetes, hypertension, low EF%, CBP time, increased preoperative PaCO2, were found to be independent risk factors for the development of hypoxemia. Conclusion:\u0000From the results of this study, it could be concluded that the magnitude of hypoxemia is substantial after on-pump open heart surgery. High-risk and independent factors identified from this study were cumulatively grouped and preventive use of BiPAP was found to be a possible option to prevent hypoxemia This study highlights the importance of one of the underestimated post-op morbid factors with cost, quality, and outcome implications.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":"52 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141773851","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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