Michael F Bath, Katharina Kohler, Laura Hobbs, Isla Kuhn, William M Nabulyato, Arthur Kwizera, Laura E Walker, Tom Wilkins, Daniel Stubbs, Sara Halimah, Rowan Burnstein, Angelos G Kolias, Peter Hutchinson, John Clarkson, Tom Bashford
{"title":"The Impact of Trauma System Implementation on Patient Quality of Life and Economic Burden: A Systematic Review Study Protocol.","authors":"Michael F Bath, Katharina Kohler, Laura Hobbs, Isla Kuhn, William M Nabulyato, Arthur Kwizera, Laura E Walker, Tom Wilkins, Daniel Stubbs, Sara Halimah, Rowan Burnstein, Angelos G Kolias, Peter Hutchinson, John Clarkson, Tom Bashford","doi":"10.29337/ijsp.187","DOIUrl":"10.29337/ijsp.187","url":null,"abstract":"<p><strong>Background: </strong>Trauma accounts for 10% of global mortality, with increasing rates disproportionally affecting low- and middle-income countries. In an attempt to improve clinical outcomes after injury, trauma systems have been implemented in multiple countries over recent years. However, whilst many studies have subsequently demonstrated improvements in overall mortality outcomes, less is known about the impact trauma systems have on morbidity, quality of life, and economic burden. This systematic review seeks to assess the existing evidence base for trauma systems with these outcome measures.</p><p><strong>Methods: </strong>This review will include any study that assesses the impact implementation of a trauma system has on patient morbidity, quality of life, or economic burden. Any comparator study, including cohort, case-control, and randomised controlled studies, will be included, both retrospective or prospective in nature. Studies conducted from any region in the world and involving any age of patient will be included. We will collect data on any morbidity outcomes, health-related quality of life measures, or health economic assessments reported. We predict a high heterogeneity in these outcomes used and will therefore keep inclusion criteria broad.</p><p><strong>Discussion: </strong>Previous reviews have shown the significant improvements that can be achieved in mortality outcomes with the implementation of an organised trauma system, however the wider impact they can have on morbidity outcomes, quality of life measures, and the economic burden of trauma, is less well described. This systematic review will present all available data on these outcomes, helping to better characterise both the societal and economic impact of trauma system implementation.</p><p><strong>Highlights: </strong>Trauma systems are known to improve mortality rates, however less in known on the impact they have on morbidity outcomes, quality of life, and economic burdenWe aim to perform a systematic review to identify any comparator study that assesses the impact implementation of a trauma system on these outcomesUnderstanding the impact trauma systems can have on wider parameters, such as economic and quality of life outcomes, is crucial to allow governments globally to appropriately allocate often limited healthcare resources.<b>PROSPERO registration number:</b> CRD42022348529.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"27 1","pages":"84-89"},"PeriodicalIF":1.1,"publicationDate":"2023-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9983497/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9777581","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Joshua Muhumuza, Selamo Fabrice Molen, William Mauricio, Jorge Soria La O, Jethro Atumanyire, Nyenke Bassara Godefroy, Musa Abbas Waziri, Stephen Mbae Kithinji, Kiyaka Magugu Sonye, Mugisho Munyerenkana Leocadie, Franck Katembo Sikakulya, ByaMungu Pahari Kagenderezo, Musafiri Simba Lionel, Mumin Farah, Herman Lule
{"title":"Effect of Chewing Gum on Duration of Postoperative Ileus Following Laparotomy for Gastroduodenal Perforations: Protocol for a Randomized Controlled Trial.","authors":"Joshua Muhumuza, Selamo Fabrice Molen, William Mauricio, Jorge Soria La O, Jethro Atumanyire, Nyenke Bassara Godefroy, Musa Abbas Waziri, Stephen Mbae Kithinji, Kiyaka Magugu Sonye, Mugisho Munyerenkana Leocadie, Franck Katembo Sikakulya, ByaMungu Pahari Kagenderezo, Musafiri Simba Lionel, Mumin Farah, Herman Lule","doi":"10.29337/ijsp.188","DOIUrl":"10.29337/ijsp.188","url":null,"abstract":"<p><strong>Background: </strong>Prolonged post-operative ileus is associated with increased risk of other complications, length of hospital stays and health care related costs. Chewing gum has been shown to reduce duration of ileus in many elective surgeries, but there is a paucity of randomised controlled trials (RCTs) on its effect on duration of ileus among patients undergoing emergency surgery, specifically patients with peritonitis. The aim of this study is to determine the effect of chewing gum on duration of postoperative ileus following laparotomy for gastroduodenal perforations.</p><p><strong>Methods: </strong>This will be a randomised controlled trial done in 3 hospitals. Fifty-two patients will be randomised to 2 groups. Group A will receive chewing gum in addition to routine care, whereas group B will receive routine care only. The duration of post-operative ileus in the two groups which is the primary outcome, will be compared using the independent samples t-test in SPSS version 22. The length of hospital stay, in-hospital morbidity and mortality will be the secondary outcomes. This trial has been approved by Kampala International University research and Ethics committee (Ref No. <b>KIU-2021-60</b>) and Uganda national council of science and technology (Ref No. <b>HS1665ES</b>). Retrospective registration with the research registry has also been done (UIN: researchregistry8565).</p><p><strong>Highlights: </strong>Prolonged post-operative ileus significantly contributes to adverse surgical outcomesChewing gum has been shown to reduce duration of ileus in many elective surgeriesThere is paucity of RCTs on role of chewing gum following surgery for peritonitis.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"27 1","pages":"9-17"},"PeriodicalIF":1.1,"publicationDate":"2023-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9912851/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10763444","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Maguatte Faye, Adja Coumba Diallo, Mamadou Ndiaye, Papa Mamadou Faye, Abdourahmane Ndong, Mamadou Cisse
{"title":"Epidemiology of Digestive Surgical Emergencies in a Sub-Saharan African Country: A Multicentre Pilot Study Protocol.","authors":"Maguatte Faye, Adja Coumba Diallo, Mamadou Ndiaye, Papa Mamadou Faye, Abdourahmane Ndong, Mamadou Cisse","doi":"10.29337/ijsp.186","DOIUrl":"https://doi.org/10.29337/ijsp.186","url":null,"abstract":"<p><strong>Introduction: </strong>Digestive surgical emergencies remains one of the main general surgery activities. Despite the associated mortality rate in low income countries, epidemiologic data about this subject is rare and multicenter studies are even more. We aimed to study an epidemiology of digestive surgical emergencies in Senegal by multicenter protocol.</p><p><strong>Methods and analysis: </strong>it will a prospective multicenter pilot study from May to July 2022. The patients were from General surgery departments of these teaching hospital in Senegal: Dakar Principal Hospital, Aristide le Dantec Hospital, Dalal Jamm hospital and Saint-Louis Regional Hospital. The Schwartz formula was used. We used a proportion of abdominal surgical emergency of 20%. We had a sample size of 246 patients.</p><p><strong>Ethics and dissemination: </strong>this research protocol will be submitted to Ethics committee of four hospital that included. The results of this study can help to get better the management of our digestives emergencies and at the same time improve mortality rate.</p><p><strong>Highlights: </strong>Digestive surgical emergencies is a public health issueBecause of high mortality rate in poorest countries, epidemiological data in Senegal must be knownThese information can help to lower associated mortality.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"27 1","pages":"18-22"},"PeriodicalIF":0.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9912850/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10643367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anna Serene Babu, R Rashmi, V Manju, Pramod Subash, Arjun Krishnadas, Manitha Nair, Subramania Iyer
{"title":"NANOTEX BONE Graft along with Fibula Flap in the Reconstruction of Segmental Mandibular Defect: Protocol for Pilot Clinical Trial.","authors":"Anna Serene Babu, R Rashmi, V Manju, Pramod Subash, Arjun Krishnadas, Manitha Nair, Subramania Iyer","doi":"10.29337/ijsp.185","DOIUrl":"https://doi.org/10.29337/ijsp.185","url":null,"abstract":"<p><strong>Introduction and objectives: </strong>Mandible reconstruction with vascularized fibula flap is the standard treatment for segmental mandibulectomy in patients with tumor or trauma. But the height of the fibula graft is insufficient for dental implant placement and prosthetic rehabilitation to replace the missing teeth, which in turn will compromise the functional efficiency and aesthetics of the patient. Although the bone height can be augmented through onlay grafting with iliac crest, it is associated with limitations like donor site morbidity and fast resorbability. This suggests the need for a synthetic biomaterial for vertical bone augmentation in implant dentistry.We have developed a biomimetic, porous, mechanically stable, and biodegradable nanocomposite named \"NANOTEX BONE Graft\" and its bone regeneration potential was evaluated in pre-clinical animal models. In this clinical trial, the safety as well as the efficacy of NANOTEX to augment new bone over fibula and further its ability to integrate with dental implants will be studied. The study has received the approval of the Ethics Committee of Amrita Institute of Medical Sciences and Central Drugs Standard Control Organization (CDSCO), India.</p><p><strong>Methods: </strong>We have designed a prospective, single-center, non-randomized pilot clinical study. Patients with benign tumor or trauma indicated for mandibular reconstruction followed by implant rehabilitation will be included in the study. Eligible patients will be enrolled after obtaining informed consent. The study will be initiated and followed up as per defined timelines.</p><p><strong>Highlights: </strong>Resection of benign mandibular tumours necessitates surgical removal of jaw bone and adjacent affected areas.The segmental mandibulectomy leaves the patient with functional impairments and aesthetic defects which in turn affect the quality of life.The standard treatment of reconstruction with vascularized fibula flap has challenge in achieving sufficient vertical bone height for implant placement and prosthetic rehabilitation.Alternate surgical techniques cause donor site morbidity and surgical complications.There is need for a synthetic biomaterial to be grafted over fibula for vertical bone augmentation.NANOTEX BONE Graft, a nanofibrous composite scaffold that mimics native bone, promote cell infiltration, neo-angiogenesis and new bone formation.Preclinical studies of NANOTEX in animal models showed bone tissue regeneration, better biodegradation in critical sized defects and efficient integration with dental implants.This clinical study propose to evaluate the safety and efficacy of NANOTEX bone graft augmented over fibula in bone regeneration and Titanium dental implant integration.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"27 1","pages":"90-96"},"PeriodicalIF":0.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9912909/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10763445","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Giovanni E Cacciamani, Michael Eppler, Aref S Sayegh, Tamir Sholklapper, Muneeb Mohideen, Gus Miranda, Mitch Goldenberg, Rene J Sotelo, Mihir M Desai, Inderbir S Gill
{"title":"Recommendations for Intraoperative Adverse Events Data Collection in Clinical Studies and Study Protocols. An ICARUS Global Surgical Collaboration Study.","authors":"Giovanni E Cacciamani, Michael Eppler, Aref S Sayegh, Tamir Sholklapper, Muneeb Mohideen, Gus Miranda, Mitch Goldenberg, Rene J Sotelo, Mihir M Desai, Inderbir S Gill","doi":"10.29337/ijsp.183","DOIUrl":"https://doi.org/10.29337/ijsp.183","url":null,"abstract":"<p><strong>Introduction: </strong>Intraoperative adverse events (iAEs) occur and have the potential to impact the postoperative course. However, iAEs are underreported and are not routinely collected in the contemporary surgical literature. There is no widely utilized system for the collection of essential aspects of iAEs, and there is no established database for the standardization and dissemination of this data that likely have implications for outcomes and patient safety. The Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) Global Surgical Collaboration initiated a global effort to address these shortcomings, and the establishment of an adverse event data collection system is an essential step. In this study, we present the core-set variables for collecting iAEs that were based on the globally validated ICARUS criteria for surgical/interventional and anesthesiologic intraoperative adverse event collection and reporting.</p><p><strong>Material and methods: </strong>This article includes three tools to capture the essential aspects of iAEs. The core-set variables were developed from the globally validated ICARUS criteria for reporting iAEs (item 1). Next, the summary table was developed to guide researchers in summarizing the accumulated iAE data in item 1 (item 2). Finally, this article includes examples of the method and results sections to include in a manuscript reporting iAE data (item 3). Then, 5 scenarios demonstrating best practices for completing items 1-3 were presented both in prose and in a video produced by the ICARUS collaboration.</p><p><strong>Dissemination: </strong>This article provides the surgical community with the tools for collecting essential iAE data. The ICARUS collaboration has already published the 13 criteria for reporting surgical adverse events, but this article is unique and essential as it actually provides the tools for iAE collection. The study team plans to collect feedback for future directions of adverse event collection and reporting.</p><p><strong>Highlights: </strong>This article represents a novel, fully-encompassing system for the data collection of intraoperative adverse events.The presented core-set variables for reporting intraoperative adverse events are not based solely on our opinion, but rather are synthesized from the globally validated ICARUS criteria for reporting intraoperative adverse events.Together, the included text, figures, and ICARUS collaboration-produced video should equip any surgeon, anesthesiologist, or nurse with the tools to properly collect intraoperative adverse event data.Future directions include translation of this article to allow for the widest possible adoption of this important collection system.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"27 1","pages":"23-83"},"PeriodicalIF":0.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9912855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10763888","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jane Yao, Ngo Valery Ngo, Odette D Kibu, Constantine Asahngwa, Hilary M Jasmin, Ronald M Gobina, Denis A Foretia
{"title":"Availability and Use of Essential Opioid Analgesics in Sub-Saharan Africa: A Scoping Review Protocol.","authors":"Jane Yao, Ngo Valery Ngo, Odette D Kibu, Constantine Asahngwa, Hilary M Jasmin, Ronald M Gobina, Denis A Foretia","doi":"10.29337/ijsp.184","DOIUrl":"https://doi.org/10.29337/ijsp.184","url":null,"abstract":"<p><strong>Introduction: </strong>The treatment of acute, peri-operative, and chronic pain by healthcare practitioners and health systems requires appropriate access to and availability of essential opioid medications. While opioids are often oversupplied and overprescribed in high-income countries, there are significant inequities as many low- and middle-income countries (LMICs) experience severe shortages. In fact, while the richest 10% in the world reside in countries receiving almost 90% of all available opioids, 50% of the poorest in the world reside in countries receiving just 1% of all available opioids.Understanding the social, economic, cultural, and regulatory barriers to access essential opioid analgesics in LMICs is critical in delineating and prioritizing appropriate interventions. We aim to conduct a scoping review on the availability and usage of essential opioid analgesics in LMICs, specifically in sub-Saharan Africa, to identify barriers, themes, and knowledge gaps.</p><p><strong>Materials and methods: </strong>We will utilize the framework for conducting scoping reviews by Arksey and O'Malley. We will perform the search for articles in 3 electronic databases (i.e., SCOPUS, PubMed, Embase) and relevant gray literature. Only articles in English will be included. There will be no restriction on the publication period. All articles will directly involve either the availability and/or the use of essential opioid analgesics. Studies will be restricted to focus on sub-Saharan Africa. We will use a tailored extraction frame to extract relevant information from published articles that meet our inclusion criteria. We will analyze the data using both descriptive statistics and thematic analysis on the main study questions.</p><p><strong>Ethics and dissemination: </strong>Since we will not be collecting primary data, formal ethical approval is not required.Our study findings will be disseminated through abstracts, conference presentations, and peer-reviewed publications.</p><p><strong>Highlights: </strong>50 percent of the poorest in the world reside in countries receiving just 1 percent of all available opioidsThere is a paucity of data analyzing the inequitable distribution of essential opioid analgesics worldwideOur scoping review will identify barriers, themes, and knowledge gaps on the availability and use of essential opioids in SSAIt will identify areas for further research and potential policy initiatives.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"27 1","pages":"1-8"},"PeriodicalIF":0.9,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9896994/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10738245","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Development of Surgical Error Reduction System (SERS) for Laparoscopic Appendectomy by using Observational Human Reliability Analysis (OCHRA) model and to analyse its impact on patient outcomes.","authors":"Girivasan Muthukumarasamy, Samer Zino, Benjie Tang, Pradeep Patil","doi":"10.29337/ijsp.181","DOIUrl":"https://doi.org/10.29337/ijsp.181","url":null,"abstract":"<p><p>This project is to develop a surgical error reduction system (SERS) for laparoscopic appendectomy by using observational Human Reliability Analysis (OCHRA) model and to analyse it impact on patient's outcome.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"26 1","pages":"81-87"},"PeriodicalIF":0.9,"publicationDate":"2022-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9503951/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"33497357","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Clinical Effectiveness of Various Surgical Reconstruction Modalities for Acute ACJ Separation: Protocol for a Systematic Review and Meta-Analysis","authors":"A. Hartland, S. Nayar, K. H. Teoh, M. Rashid","doi":"10.29337/ijsp.172","DOIUrl":"https://doi.org/10.29337/ijsp.172","url":null,"abstract":"Introduction: Acute acromioclavicular joint separation is a common injury to the shoulder. Various surgical reconstruction methods exist when operative management is required, but the optimal procedure is not known. The aim of this systematic review and meta-analysis is to review the literature to assess the clinical effectiveness of various surgical reconstruction modalities used for acute ACJ separation. Methods: The study protocol was designed and registered prospectively on PROSPERO (International prospective register for systematic reviews). Literature search will include MEDLINE, EMBASE, PsycINFO, and The Cochrane Library electronic databases. Randomised controlled trials (RCTs) evaluating surgical procedures for acute acromioclavicular joint (ACJ) separation will be included. Our primary outcome is any functional patient-reported outcome measure related to the shoulder. Secondary outcomes may include radiological measurements, objective measurements of strength testing, range of motion, other patient-reported outcome measures not specific to the shoulder such as the Visual-Analog Scale (VAS) for pain, timelines for return to sport or work, and rate of complications. Risk of bias will be assessed within each study using The Cochrane Risk of Bias Tool 2.0 and the Jadad score. Inconsistency and bias across included studies will be assessed statistically. Comparable outcome data will be pooled and analysed quantitatively or qualitatively as appropriate. Ethics and dissemination: This study did not require ethical clearance. We plan to publish this systematic review and meta-analysis in a peer-reviewed journal and present the results at various national and international conferences. Highlights There is currently variation in surgical synthetic ligament reconstruction techniques for acute acromioclavicular separation, with no clear consensus established. This systematic review evaluates the clinical effectiveness of various surgical reconstruction modalities used for acute ACJ separation. Our primary outcome is any functional patient-reported outcome measure related to the shoulder.","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"26 1","pages":"22 - 26"},"PeriodicalIF":0.9,"publicationDate":"2022-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48986609","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}
Omer Al-Yahri, R. Al‐Zoubi, Azza Alam Elhuda, Amina Ahmad, M. Al Dhaheri, S. Abdelaziem, M. Alwani, A. Al-Qudimat, Ahmad Zarour
{"title":"Diagnostic Inflammation Biomarkers for Prediction of 30-Day Mortality Rate in Acute Cholangitis","authors":"Omer Al-Yahri, R. Al‐Zoubi, Azza Alam Elhuda, Amina Ahmad, M. Al Dhaheri, S. Abdelaziem, M. Alwani, A. Al-Qudimat, Ahmad Zarour","doi":"10.29337/ijsp.170","DOIUrl":"https://doi.org/10.29337/ijsp.170","url":null,"abstract":"Background: Acute cholangitis (AC) is an acute inflammation and infection of the biliary tract, a potentially life-threatening infection, which is usually associated with biliary tree obstruction and impairment of bile flow from the liver to the duodenum. AC is classified by severity from mild, moderate to severe infection (grade I to III, respectively). Methods: This study recruited a retrospective cohort from Jan 2015 to July 2018. Overall, 294 patients of age ≥ 18 years with AC were enrolled. The study was conducted according to the World Medical Association Declaration of Helsinki. Demographic and laboratory data were collected for analysis. T-Bilirubin and other laboratory results were collected and analyzed using independent T-test and ANOVA for continuous values and multivariate COX regression for survival analysis for identifying independent factors for early mortality. The cut-off threshold of T-bilirubin was determined by calculating the area under the receiver operating characteristic (ROC) curve. Results: There were 213 male and 81 female patients and mean age ± SD of patients was 49.57 ± 16.1 and 56.12 ± 20.18 respectively. 31.9% patients were found older than 60 years of age and 35% patients were found between 30–45 years of age. T-bilirubin and length of hospital stay (LOS) were found statistically significant (P < 0.05) in relation to mortality in AC patients. The area under ROC curve for T-bilirubin level (P = 0.017, OR = 1.010) was 0.717 (95% CI, 6.25–168.9) and this is consistent with the Cut-off point for more than or equal to 38.6 µmol/L (2.26 mg/dL). Conclusions: In this study, T-bilirubin level is found to be significantly related to short-term mortality in AC. Further studies are still needed with larger cohorts to shed more light on these findings. Highlights: Herein, we report a retrospective observational study aiming to evaluate biomarkers contributing to mortality in AC and to determine the cut-off diagnostic levels that could be easily used in emergency setting. Overall, 294 patients of age ≥ 18 years with AC were enrolled. The study was conducted according to the World Medical Association Declaration of Helsinki and approved by Institutional Review Board (IRB) with approval: MRC-01-20-823 at Hamad Medical Corporation (HMC). Demographic and laboratory data were collected for analysis. Total-Bilirubin and other laboratory results were collected and analyzed using independent T-test and ANOVA for continuous values and multivariate COX regression for survival analysis for identifying independent factors for early mortality. The cut-off threshold of T-bilirubin was determined by calculating the area under the receiver operating characteristic (ROC) curve. There were 213 male and 81 female patients and mean age ± SD of patients was 49.57 ± 16.1 and 56.12 ± 20.18 respectively. 31.9% patients were found older than 60 years of age and 35% patients were found between 30-45 years of age. T-bilirubin and length of hospital stay","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"26 1","pages":"14 - 21"},"PeriodicalIF":0.9,"publicationDate":"2022-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41643735","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}
R. Jootun, Pedja Cuk, M. Ellebæk, P. V. Andersen, S. Salomon, G. Baatrup, I. Al-Najami, J. Khan
{"title":"Robotic vs. TaTME Rectal Surgery (ROTA STUDY) Matched Cohort Trial for Mid to Low Rectal Cancer Surgery Evaluation Trial in the Hands of an Experienced Surgeon","authors":"R. Jootun, Pedja Cuk, M. Ellebæk, P. V. Andersen, S. Salomon, G. Baatrup, I. Al-Najami, J. Khan","doi":"10.29337/ijsp.163","DOIUrl":"https://doi.org/10.29337/ijsp.163","url":null,"abstract":"Background: Recent novel surgical techniques for resection of low rectal cancer have been introduced and these approaches have the potential to overcome anatomical limitations like obesity, narrow male pelvis and bulky and low tumours. Two of these procedures are robotic low anterior resection (RLAR) and transanal total mesorectal excision (TaTME). Both approaches have distinct advantages and limitations. There has been no head to head trial comparing RLAR and TaTME for patients with mid to low rectal cancer undergoing surgery by experienced surgeons. Previous studies looking at the oncological outcomes of either TaTME or robotic TME included many centres where the surgeons were on a learning curve and hence the true oncological outcomes and clinical benefits can not be measured accurately. Method: The inclusion criteria include experienced surgeons defined as minimum of 60 prior procedures with RLAR or TaTME. Successful oncological and clinical outcomes are defined as circumferential resection margin (CRM) ≥1 mm with limited postoperative morbidity (absence of Clavien-Dindo grade III–IV complications within 30 days after surgery). Local and distal recurrence rates with DFS over 3 years will be measured as primary outcome. Data will be collected prospectively and entered in a dedicated database. Discussion: The primary objective of this study is to conduct a multicentre prospective trial to investigate clinical outcomes, in particular disease free survival (DFS) in patients undergoing RLAR and TaTME. The additional goal is to investigate other efficacy measures, complications rates, health economic aspects and patient reported health related quality of life. This paper describes an important trial conducted in expert centres to establish the needed knowledge for a detailed comparison of outcomes for TaTME versus RLAR. This trial is the first comparative study, comparing TaTME and RLAR, seeking to establish foothold for tailor-made surgical treatment of low rectal cancer patients. Trial registration: The trial is registered in clinicaltrials.gov September 2019. Clinicaltrials.gov id: NCT04200027.","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"26 1","pages":"7 - 13"},"PeriodicalIF":0.9,"publicationDate":"2022-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"48646071","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}