medRxiv - Surgery最新文献

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Evaluation of the Efficacy and Safety of FFX Facet Cages Compared to Pedicle Screw Fixation in Patients with Lumbar Spinal Stenosis: A Long-Term Study 评估腰椎管狭窄症患者使用 FFX 椎板面固定架与椎弓根螺钉固定的有效性和安全性:一项长期研究
medRxiv - Surgery Pub Date : 2023-12-19 DOI: 10.1101/2023.12.18.23300167
Omar Houari, Arnaud Douanla, Mehdi Ben Ammar, Mustapha Benmekhbi, Jihad Mortada, Gabriel Lungu, Cristian Magheru, Jimmy Voirin, Pablo Ariel Lebedinsky, Mariano Musacchio, Federico Bolognini, Robin Srour
{"title":"Evaluation of the Efficacy and Safety of FFX Facet Cages Compared to Pedicle Screw Fixation in Patients with Lumbar Spinal Stenosis: A Long-Term Study","authors":"Omar Houari, Arnaud Douanla, Mehdi Ben Ammar, Mustapha Benmekhbi, Jihad Mortada, Gabriel Lungu, Cristian Magheru, Jimmy Voirin, Pablo Ariel Lebedinsky, Mariano Musacchio, Federico Bolognini, Robin Srour","doi":"10.1101/2023.12.18.23300167","DOIUrl":"https://doi.org/10.1101/2023.12.18.23300167","url":null,"abstract":"Objective: The study evaluated the long-term safety and efficacy of the FFX facet cage versus pedicle screw (PS) fixation in patients with lumbar spinal stenosis (LSS).\u0000Methods: A hybrid retrospective/prospective study design was used. Following a medical records review, subjects meeting the inclusion/exclusion criteria were consented and enrolled in the prospective arm of the study. CT-scans and dynamic X-rays were performed to assess fusion rates, range of motion and translation. Adverse events during the 2-year post-index procedure were also analyzed. Pre-operative and 2+ year Visual Analogue Scale (VAS) back and leg scores and Oswestry Disability Index (ODI) were also obtained. Results: A total of 112 subjects were enrolled with 56 patients included in the PS and FFX groups. Mean age was 63.1±11.2 and 67.1±10.9 years and the mean number of levels operated was 1.8±0.8 and 2.3±1.0 respectively for the PS and FFX groups. There was no difference between the two groups for the primary composite fusion endpoint assessed (respectively 60.0% vs. 70.9%, p=0.120). There was also no difference in postoperative complications or adverse events during the 2-year follow-up period. A higher percentage of patients in the PS group (10.7%) required reoperation compared to the FFX group (3.6%). While both groups experienced significant improvements in VAS and ODI scores versus pre-operative assessment, there was no difference between the two groups. Conclusion: The present study documents the long-term safety and efficacy of the FFX device in patients with LSS with a reduction in reoperation rate when compared to PS fixation.","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":"138816638","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}
引用次数: 0
Evaluation of gastric electrophysiology, symptoms and quality of life after pancreaticoduodenectomy 评估胰十二指肠切除术后的胃电生理学、症状和生活质量
medRxiv - Surgery Pub Date : 2023-12-17 DOI: 10.1101/2023.12.14.23299984
Tim Hsu-Han Wang, Chris Varghese, Stefan Calder, Armen Gharibans, Gabriel Schamberg, Adam Bartlett, Sanket Srinivasa, Greg O’Grady
{"title":"Evaluation of gastric electrophysiology, symptoms and quality of life after pancreaticoduodenectomy","authors":"Tim Hsu-Han Wang, Chris Varghese, Stefan Calder, Armen Gharibans, Gabriel Schamberg, Adam Bartlett, Sanket Srinivasa, Greg O’Grady","doi":"10.1101/2023.12.14.23299984","DOIUrl":"https://doi.org/10.1101/2023.12.14.23299984","url":null,"abstract":"<strong>Background</strong> Pancreaticoduodenectomy (PD) is an operation performed for several indications, including pancreatic and biliary malignancies. Delayed gastric emptying (DGE) is a common post-operative complication and the underlying pathophysiology remains poorly understood. This study aimed to evaluate the gastric electrophysiology, symptoms and quality of life following PD, using the novel non-invasive Gastric Alimetry System.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138816745","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}
引用次数: 0
Assessment of symptoms, quality of life and remnant gastric activity following gastric bypass using Gastric Alimetry® 使用 Gastric Alimetry® 评估胃旁路术后的症状、生活质量和残胃活性
medRxiv - Surgery Pub Date : 2023-12-15 DOI: 10.1101/2023.12.14.23299974
Tim Hsu-Han Wang, Chris Varghese, Stefan Calder, Armen Gharibans, Nicholas Evennett, Grant Beban, Gabriel Schamberg, Greg O’Grady
{"title":"Assessment of symptoms, quality of life and remnant gastric activity following gastric bypass using Gastric Alimetry®","authors":"Tim Hsu-Han Wang, Chris Varghese, Stefan Calder, Armen Gharibans, Nicholas Evennett, Grant Beban, Gabriel Schamberg, Greg O’Grady","doi":"10.1101/2023.12.14.23299974","DOIUrl":"https://doi.org/10.1101/2023.12.14.23299974","url":null,"abstract":"<strong>Background</strong> While most gastric bypass patients recover well, some experience long-term complications, including nausea, pain, stricture, and dumping. This study aimed to evaluate symptoms and quality of life (QoL) together with remnant stomach function using the novel Gastric Alimetry® system.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138717083","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}
引用次数: 0
Effect of rural trauma team development on outcomes of motorcycle related injuries: A protocol for a multi-center cluster randomized controlled clinical trial (The MOTOR trial) 农村创伤团队的发展对摩托车相关伤害后果的影响:多中心群组随机对照临床试验方案(MOTOR 试验)
medRxiv - Surgery Pub Date : 2023-12-09 DOI: 10.1101/2023.12.07.23299662
Herman Lule, Micheal A. Mugerwa, Robinson SSebuufu, Patrick Kyamanywa, Till Bärnighausen, Jussi P. Posti, Michael Lowery Wilson
{"title":"Effect of rural trauma team development on outcomes of motorcycle related injuries: A protocol for a multi-center cluster randomized controlled clinical trial (The MOTOR trial)","authors":"Herman Lule, Micheal A. Mugerwa, Robinson SSebuufu, Patrick Kyamanywa, Till Bärnighausen, Jussi P. Posti, Michael Lowery Wilson","doi":"10.1101/2023.12.07.23299662","DOIUrl":"https://doi.org/10.1101/2023.12.07.23299662","url":null,"abstract":"<strong>Background</strong> Injury is a global health concern whose mortality disproportionately impact low-income countries. Compelling evidence from high-income countries show that rural trauma team development courses (RTTDC) increase clinicians’ knowledge. There is a dearth of evidence from controlled clinical trials to demonstrate the effect of RTTDC on process and patient outcomes. We document a protocol for a multi-center cluster randomized controlled clinical trial which aims to examine the impact of RTTDC on process and patient outcomes of motorcycle-related injuries.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138572133","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}
引用次数: 0
Length of hospital stay and associated factors among adult surgical patients admitted to a surgical ward in Amhara Regional State Comprehensive Specialized Hospitals, Ethiopia 埃塞俄比亚阿姆哈拉地区州立综合专科医院外科病房收治的成人外科病人的住院时间及相关因素
medRxiv - Surgery Pub Date : 2023-12-09 DOI: 10.1101/2023.12.07.23299680
Habtamu Hurisa Dadi, Netsanet Habte, Yenework Mulu, Yabibal Asfaw
{"title":"Length of hospital stay and associated factors among adult surgical patients admitted to a surgical ward in Amhara Regional State Comprehensive Specialized Hospitals, Ethiopia","authors":"Habtamu Hurisa Dadi, Netsanet Habte, Yenework Mulu, Yabibal Asfaw","doi":"10.1101/2023.12.07.23299680","DOIUrl":"https://doi.org/10.1101/2023.12.07.23299680","url":null,"abstract":"<strong>Introduction</strong> Hospitals across the country are experiencing a rise in the length of hospital stays, ranging from 2% to 14%. As a result, patients who remain hospitalized for a prolonged period are three times more likely to suffer in-hospital deaths. Therefore, identifying contributing factors for prolonged hospital stays enhances the ability to improve services and the quality of patient care. However, there is limited documented evidence in Ethiopia as well as in the study area about factors associated with prolonged hospital stays among surgical inpatients.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138572061","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}
引用次数: 0
The Role of Early Brain Injury assessment in a-SAH in predicting Structural Brain Abnormalities in Cognitive Impairments a-SAH 早期脑损伤评估在预测认知障碍的脑结构异常中的作用
medRxiv - Surgery Pub Date : 2023-12-07 DOI: 10.1101/2023.12.05.23299565
Mingdong Wang, Qian-Hui Fu, Andrew Ni, Yun-Peng Yuan, Chun-Hui Li, Zhan Xiang WANG, Hong Wang
{"title":"The Role of Early Brain Injury assessment in a-SAH in predicting Structural Brain Abnormalities in Cognitive Impairments","authors":"Mingdong Wang, Qian-Hui Fu, Andrew Ni, Yun-Peng Yuan, Chun-Hui Li, Zhan Xiang WANG, Hong Wang","doi":"10.1101/2023.12.05.23299565","DOIUrl":"https://doi.org/10.1101/2023.12.05.23299565","url":null,"abstract":"Background Early brain edema and/or Hematoma after aneurysmal subarachnoid hemorrhage (a-SAH) is an important impact determinant of clinical cognition outcomes. However, due to the lack of early assessment of the impact on cognitive structural systems, Therefore, there is a need to develop early predictive and/or decision-making models, termed the a-SAH Early Brain Edema/Hematoma Compression Neural (Structural Brain) Networks Score System (SEBE-HCNNSS). Methods 202 consecutive patients with spontaneous a-SAH and initial CT/ magnetic resonance imaging (MRI) scans (24 h of ictus) and follow-up 2 months. Clinically relevant factors and a variety of traditional different scale ratings were defined using Linear regression analysis (Univariate, multivariate). The risk factors with highest values for area under the curve (AUC) were included in the multivariate analysis and least absolute shrinkage and selection operator (LASSO) analysis or Cox regression analysis.\u0000Results A total of 177 patients were enrolled in this study, 43 patients had a high SEBE-HCNNSS classification (grade 3 to 5). After a mean follow-up of 2month, 121 individuals (68.36%) with a-SAH and 3 control subjects had incident CI. The CT inter-observer reliability of the SEBE-HCNNSS scale was high, with a Kappa value of 1. ROC analysis showed that the SEBE-HCNNSS scale (OR 3.322, 95% CI 2.312-7.237, p = 0.00025) was determined to be an independent predictor of edema, CI and unfavorable prognosis. These results were replicated in validation cohort.\u0000Conclusions SEBE-HCNNSS scale is fairly easy to perform and this study indicates that is good predictor value for CI and clinical outcomes after SAH. we suggest that it is practically useful prognostic instrument for the risk evaluation after a-SAH.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138555904","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}
引用次数: 0
Systematic Review Protocol of aetiology of mechanical bowel obstruction in Low-and-middle income countries: Has anything changed in the last two decades? 中低收入国家机械性肠梗阻病因的系统综述方案:过去二十年有什么变化吗?
medRxiv - Surgery Pub Date : 2023-12-06 DOI: 10.1101/2023.12.05.23299503
Yakubu Kevin Kwarshak, Mohammed Nakodi Yisa, Oghenegare Asheaba Kigbu, Daniel Akut John, Karen Chineme Ubabuike, Nankam David Jimwan, Peter Mkurtar Yawe
{"title":"Systematic Review Protocol of aetiology of mechanical bowel obstruction in Low-and-middle income countries: Has anything changed in the last two decades?","authors":"Yakubu Kevin Kwarshak, Mohammed Nakodi Yisa, Oghenegare Asheaba Kigbu, Daniel Akut John, Karen Chineme Ubabuike, Nankam David Jimwan, Peter Mkurtar Yawe","doi":"10.1101/2023.12.05.23299503","DOIUrl":"https://doi.org/10.1101/2023.12.05.23299503","url":null,"abstract":"Background: Despite various causes of mechanical obstruction, there appears to be a great deal of variation depending on geographical location and age. Geographically, postoperative adhesions and hernia have been documented as the most common aetiology of mechanical bowel obstruction in high-income and low-and-middle-income countries, respectively. Whether there has been a change in this trend in low- and middle-income countries is a matter of speculation in the surgical community. Therefore, to fill this knowledge gap, this study aims to systematically review the existing literature on the aetiology of mechanical bowel obstruction with a focus on understanding the most common cause of mechanical bowel obstruction in low- and middle-income countries in both paediatric and adult populations to guide surgical practice.\u0000Methodology and Analysis: This protocol was designed and written according to the guidelines of the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol 2015 (PRISMA-P 2015) statement. However, the results of the systematic review will be reported in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. We will consider studies published in English and French between 2002 and 2022 that reported on the aetiology of mechanical bowel obstruction in any age group in low- and middle-income countries. We will conduct a literature search using Ovid MEDLINE, Ovid Embase, CINAHL on EBSCO and Web of Science databases employing relevant subject headings, keywords and synonyms, which will be combined using Boolean operators to refine the search results. A hand search of references of retrieved literature will be conducted. The retrieved articles will be imported into Zotero for de-duplication. The resulting set of titles and abstracts will be uploaded to Rayyan (an AI-assisted online systematic review tool), where they will be double-checked to identify articles eligible for inclusion. Two independent reviewers will screen articles to be included and disagreement will be resolved by discussion or by a third reviewer as a tie-breaker. Also, data extraction will be done by one reviewer and confirmed by another. Critical appraisal to assess the quality of the included studies will be carried out by two independent reviewers using the Joanna Briggs Institute (JBI) tools. We anticipate that the eligible studies will be quite heterogeneous in terms of their design, outcomes of interest, populations and comorbidities. Therefore, results may be synthesised descriptively without meta-analysis using charts, graphs and tables. Where possible, we will conduct a sub-analysis using conceptual frameworks based on age, WHO regions and continents.\u0000Ethics and Dissemination: No ethical approval will be sought because the required data is already in the public domain. Findings will be published in peer-reviewed journals.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138547390","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}
引用次数: 0
The influence of sidedness in unilateral cleft lip and palate on mid facial growth at 5 years of age 单侧唇腭裂对5岁儿童面部中部发育的影响
medRxiv - Surgery Pub Date : 2023-12-05 DOI: 10.1101/2023.12.05.23299328
Matthew John Fell, David Chong, Paras Parmar, Ting-Li Su, Lars Enocson, Bruce Richard
{"title":"The influence of sidedness in unilateral cleft lip and palate on mid facial growth at 5 years of age","authors":"Matthew John Fell, David Chong, Paras Parmar, Ting-Li Su, Lars Enocson, Bruce Richard","doi":"10.1101/2023.12.05.23299328","DOIUrl":"https://doi.org/10.1101/2023.12.05.23299328","url":null,"abstract":"Objective: To determine whether facial growth at five years is different for children with a right versus left sided cleft lip and palate. Design: Retrospective cohort study Setting: Nine UK cleft centres Patients: Patients born between 2000-2014 with a complete unilateral cleft lip and palate (UCLP) Main outcomes measure: 5-Year-Olds Index scores Results: 378 children were included. 122 (32%) had a right sided UCLP and 256 (68%) had a left sided UCLP. 5-Year-Olds index scores ranged from 1 (good) to 5 (poor). There was a higher proportion of patients getting good scores (1 and 2) in left UCLP (43%) compared to right UCLP (37%) but there was weak evidence for a difference (Adjusted summary odds ratio 1.27, 95% CI 0.87 to 1.87; P=0.22). Conclusions:\u0000Whilst maxillary growth may be different for left versus right sided UCLP, definitive analysis requires older growth indices and arch forms.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138493433","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}
引用次数: 0
Comprehensive Evaluation and Analysis of Multi-Rod Constructs in Adult Spinal Deformity 成人脊柱畸形多棒结构的综合评价与分析
medRxiv - Surgery Pub Date : 2023-12-05 DOI: 10.1101/2023.12.05.23299347
Moatasem Azzam
{"title":"Comprehensive Evaluation and Analysis of Multi-Rod Constructs in Adult Spinal Deformity","authors":"Moatasem Azzam","doi":"10.1101/2023.12.05.23299347","DOIUrl":"https://doi.org/10.1101/2023.12.05.23299347","url":null,"abstract":"Adult spinal deformity (ASD) is a complex condition characterized by abnormal alignment and curvature of the spine, often leading to pain, functional limitations, and decreased quality of life. Surgical intervention is frequently required to correct these deformities and restore spinal alignment. Multi-rod constructs have emerged as a valuable technique in the surgical management of ASD. This approach involves the utilization of multiple rods in the spinal fusion procedure, offering enhanced stability and correction of deformities. The primary objective of this review is to explore the benefits and outcomes associated with multi-rod use in adult spinal deformity. The study highlights key findings from several studies that demonstrate the advantages of multi-rod constructs over single-rod constructs. These advantages include improved three-dimensional correction, increased fusion rates, and enhanced stability. Considerations are also discussed, such as surgical complexity, surgeon expertise, and potential complications associated with multi-rod use.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138494033","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}
引用次数: 0
Chemical/technical risk analysis of a new multidirectional nebulizer (MDN) and its clinical implementation for the safe administration of Pressurized Intraperitoneal Aerosol Chemotherapy (MDN-PIPAC) 一种新型多向喷雾器(MDN)的化学/技术风险分析及其在加压腹腔喷雾化疗(MDN- pipac)中的临床应用
medRxiv - Surgery Pub Date : 2023-12-05 DOI: 10.1101/2023.12.01.23297348
Fabian Kockelmann, Daniel Goehler, Sarah Barbay, Mehdi Ouaissi, Juergen Zieren, Urs Giger-Pabst
{"title":"Chemical/technical risk analysis of a new multidirectional nebulizer (MDN) and its clinical implementation for the safe administration of Pressurized Intraperitoneal Aerosol Chemotherapy (MDN-PIPAC)","authors":"Fabian Kockelmann, Daniel Goehler, Sarah Barbay, Mehdi Ouaissi, Juergen Zieren, Urs Giger-Pabst","doi":"10.1101/2023.12.01.23297348","DOIUrl":"https://doi.org/10.1101/2023.12.01.23297348","url":null,"abstract":"Background/Aim: To test the chemoresistance of a multi-directional nebulizer (MDN) and to establish and implement a perioperative clinical safety concept for its clinical use to deliver pressurised intraperitoneal aerosol chemotherapy (MDN-PIPAC).\u0000Study design: Ex-vivo nebulization of cytostatic drugs with the MDN device to assess chemoresistance/toxicological risks. Establishment of a perioperative safety concept for the clinical administration of MDN-PIPAC by ex- and in-vivo porcine simulation studies. Consecutive unicentric case series of 30 MDN-PIPACs in patients with peritoneal surface malignancies (PSM). Endpoints were intraoperative adverse events and perioperative complications (Clavien-Dindo).\u0000Results: Toxicological studies/risk assessment confirm the safety of administering PIPAC with the MDN. The horizontal nozzles must protrude at least 7 mm beyond the most distal end of the trocar tip and lateral tilting should be prevented by fixation of the device in a single-arm holder. A total of 21 patients (male/female ratio: 2:1) with a mean age of 62 (range: 38-86) years underwent 30 consecutive MDN-PIPACs for peritoneal surface malignancies of different origin. ECOG 0 and 1 were seen in five and 16 patients, respectively. Thirteen, seven and one patient underwent one, two and three MDN-PIPACs, respectively. Two patients received only one cycle of MDN-PIPAC because they were considered candidates for cytoreductive surgery and heated intraperitoneal chemotherapy. There were no intraoperative technical/medical problems observed. Four patients suffered from postoperative grade I complications.\u0000Conclusions: Compounds leached during chemotherapy nebulization with the MDN are toxicologically safe. MDN-PIPAC administration is safe and the postoperative course comparable to that of the conventional PIPAC nebulizer.","PeriodicalId":501051,"journal":{"name":"medRxiv - Surgery","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"138493434","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}
引用次数: 0
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