Pub Date : 2023-12-19DOI: 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
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). Methods: 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.
研究目的该研究评估了腰椎管狭窄症（LSS）患者使用 FFX 椎面骨架与椎弓根螺钉（PS）固定的长期安全性和有效性：方法：采用回顾性/前瞻性混合研究设计。经过病历审查，符合纳入/排除标准的受试者被同意并纳入前瞻性研究部分。研究人员通过 CT 扫描和动态 X 光片评估融合率、活动范围和平移。此外，还对指标术后两年内的不良事件进行了分析。此外，还获得了术前和术后两年多的视觉模拟量表（VAS）背部和腿部评分以及奥斯韦特里残疾指数（ODI）。结果：共有 112 名受试者参加，其中 PS 组和 FFX 组共有 56 名患者。PS 组和 FFX 组的平均年龄分别为（63.1±11.2）岁和（67.1±10.9）岁，平均手术层数分别为（1.8±0.8）层和（2.3±1.0）层。两组的主要复合融合终点评估结果无差异（分别为60.0% vs. 70.9%，P=0.120）。在两年的随访期间，术后并发症或不良事件也没有差异。PS 组需要再次手术的患者比例（10.7%）高于 FFX 组（3.6%）。与术前评估相比，两组患者的 VAS 和 ODI 评分均有明显改善，但两组之间并无差异。结论：本研究证实了 FFX 装置在 LSS 患者中的长期安全性和有效性，与 PS 固定相比，FFX 装置降低了再手术率。
{"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":"33 1","pages":""},"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}
Pub Date : 2023-12-17DOI: 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
Background 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.
{"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":"27 1","pages":""},"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}
Pub Date : 2023-12-15DOI: 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
Background 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.
{"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":"1 1","pages":""},"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}
Pub Date : 2023-12-09DOI: 10.1101/2023.12.07.23299662
Herman Lule, Micheal A. Mugerwa, Robinson SSebuufu, Patrick Kyamanywa, Till Bärnighausen, Jussi P. Posti, Michael Lowery Wilson
Background 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.
{"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":"18 1","pages":""},"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}
Introduction 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.
{"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":"28 1","pages":""},"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}
Pub Date : 2023-12-07DOI: 10.1101/2023.12.05.23299565
Mingdong Wang, Qian-Hui Fu, Andrew Ni, Yun-Peng Yuan, Chun-Hui Li, Zhan Xiang WANG, Hong Wang
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. Results 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. Conclusions 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.
{"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":"65 1","pages":""},"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}
Pub Date : 2023-12-06DOI: 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
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. Methodology 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. Ethics 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.
背景：尽管机械性肠梗阻的病因多种多样，但似乎因地理位置和年龄的不同而存在很大差异。从地域上看，在高收入国家和中低收入国家，术后粘连和疝气分别是机械性肠梗阻最常见的病因。中低收入国家的这一趋势是否发生了变化是外科界的一个猜测。因此，为了填补这一知识空白，本研究旨在系统地回顾有关机械性肠梗阻病因的现有文献，重点了解中低收入国家儿科和成人中最常见的机械性肠梗阻病因，以指导外科实践：本研究是根据《2015 年系统综述和元分析首选报告项目协议》（PRISMA-P 2015）的指导原则设计和编写的。但是，系统性综述的结果将根据系统性综述和 Meta 分析首选报告项目 (PRISMA) 声明进行报告。我们将考虑 2002 年至 2022 年间以英语和法语发表的、报道中低收入国家任何年龄组机械性肠梗阻病因的研究。我们将使用 Ovid MEDLINE、Ovid Embase、EBSCO 上的 CINAHL 和 Web of Science 数据库进行文献检索，使用相关主题词、关键词和同义词，并使用布尔运算符进行组合，以完善检索结果。将对检索到的文献的参考文献进行人工检索。检索到的文章将导入 Zotero 进行去重。由此产生的一系列标题和摘要将上传到 Rayyan（人工智能辅助在线系统综述工具），并在那里进行双重检查，以确定符合纳入条件的文章。两名独立审稿人将对拟纳入的文章进行筛选，出现分歧时将通过讨论解决，或由第三名审稿人作为决胜者。此外，数据提取将由一位审稿人完成，并由另一位审稿人确认。两位独立审稿人将使用乔安娜-布里格斯研究所（JBI）的工具对纳入研究的质量进行严格评估。我们预计，符合条件的研究在设计、相关结果、人群和并发症等方面将存在很大差异。因此，我们可能会使用图表、图形和表格对结果进行描述性综合，而不会进行荟萃分析。在可能的情况下，我们将使用基于年龄、世界卫生组织地区和大洲的概念框架进行子分析：由于所需的数据已经公开，因此不需要伦理批准。研究结果将在同行评审期刊上发表。
{"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":"19 1","pages":""},"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}
Pub Date : 2023-12-05DOI: 10.1101/2023.12.05.23299328
Matthew John Fell, David Chong, Paras Parmar, Ting-Li Su, Lars Enocson, Bruce Richard
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: Whilst maxillary growth may be different for left versus right sided UCLP, definitive analysis requires older growth indices and arch forms.
目的:探讨左、右唇腭裂患儿5岁时面部发育的差异。设计:回顾性队列研究设置:9个英国唇腭裂中心患者:2000-2014年间出生的完全性单侧唇腭裂(UCLP)患者主要结局测量:5岁儿童指数评分结果:纳入378名儿童。122例(32%)为右侧UCLP, 256例(68%)为左侧UCLP。5岁儿童的指数得分从1(好)到5(差)不等。左侧UCLP获得良好评分(1分和2分)的患者比例(43%)高于右侧UCLP(37%)，但证据不足(调整后的总优势比1.27,95% CI 0.87至1.87;P = 0.22)。结论:虽然左侧和右侧UCLP的上颌生长可能不同，但明确的分析需要更早的生长指数和弓形。
{"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":" 38","pages":""},"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}
Pub Date : 2023-12-05DOI: 10.1101/2023.12.05.23299347
Moatasem Azzam
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.
{"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":" 42","pages":""},"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}
Pub Date : 2023-12-05DOI: 10.1101/2023.12.01.23297348
Fabian Kockelmann, Daniel Goehler, Sarah Barbay, Mehdi Ouaissi, Juergen Zieren, Urs Giger-Pabst
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). Study 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). Results: 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. Conclusions: 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.
{"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":" 37","pages":""},"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}
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