Setthasorn Zhi Yang Ooi, Rosaline de Koning, Abdullah Egiz, David Ulrich Dalle, Moussa Denou, Marvin Richie Dongmo Tsopmene, Mehdi Khan, Régis Takoukam, Jay Kotecha, Dawin Sichimba, Yao Christian Hugues Dokponou, Ulrick Sidney Kanmounye, Nourou Dine Adeniran Bankole
{"title":"Management and Outcomes of Low-Grade Gliomas in Africa: A Scoping Review Protocol.","authors":"Setthasorn Zhi Yang Ooi, Rosaline de Koning, Abdullah Egiz, David Ulrich Dalle, Moussa Denou, Marvin Richie Dongmo Tsopmene, Mehdi Khan, Régis Takoukam, Jay Kotecha, Dawin Sichimba, Yao Christian Hugues Dokponou, Ulrick Sidney Kanmounye, Nourou Dine Adeniran Bankole","doi":"10.29337/ijsp.171","DOIUrl":"10.29337/ijsp.171","url":null,"abstract":"<p><strong>Background: </strong>Over the last decade, many advancements have been made in the management of low-grade gliomas (LGGs). Overall survival outcomes are correlated with factors such as postoperative residual volumes and specific tumor biomolecular profiles such as IDH mutation status. It is unclear whether these advancements have benefited LGG patients in Africa. This scoping review protocol outlines how the authors will evaluate the epidemiology, presentations, management and outcomes of LGGs in Africa.</p><p><strong>Methods: </strong>MEDLINE, Embase and African Journals Online will be searched from database inception to date in order to identify the relevant studies. Patients of all ages with histologically and/or radiologically confirmed LGGs that were managed in an African country will be included. Surgical and chemoradiation management of LGG tumours will be considered. Original research, reviews, commentaries, editorials and case reports will be included.</p><p><strong>Results: </strong>Primary outcomes of the review will include LGG management, morbidity and mortality. Secondary outcomes include epidemiology and recurrence of LGGs.</p><p><strong>Discussion: </strong>This scoping review will be the first to evaluate the current landscape of LGG management and outcomes in Africa, highlighting pertinent themes that may be used to guide further research as well as health system strengthening efforts by policymakers and stakeholders.</p><p><strong>Scoping review registration: </strong>The protocol has been registered on the Open Science Framework (OSF; registration link: <i>https://doi.org/10.17605/OSF.IO/E732G</i>).</p><p><strong>Highlights: </strong>LGGs account for 17% to 22% of total brain tumours and have a median survival time between 5.6 and 13.3 years.Despite many recent advancements in the management of LGGs, there is a paucity in the data within the African landscape.This scoping review will be the first to evaluate the current landscape of LGG management and outcomes in Africa, highlighting pertinent themes that may be used to guide further research and policymaking efforts.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"26 1","pages":"1-6"},"PeriodicalIF":1.1,"publicationDate":"2022-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8815446/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39642251","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}
Christin Hoffmann, Sina Hossaini, Sian Cousins, Natalie Blencowe, Angus G K McNair, Jane M Blazeby, Kerry N L Avery, Shelley Potter, Rhiannon Macefield
{"title":"Reporting Modifications in Surgical Innovation: A Systematic Scoping Review Protocol.","authors":"Christin Hoffmann, Sina Hossaini, Sian Cousins, Natalie Blencowe, Angus G K McNair, Jane M Blazeby, Kerry N L Avery, Shelley Potter, Rhiannon Macefield","doi":"10.29337/ijsp.167","DOIUrl":"10.29337/ijsp.167","url":null,"abstract":"<p><strong>Introduction: </strong>Innovation in surgery drives improvements to patient care. New surgical procedures and devices typically undergo a series of modifications as they are developed and refined during their introduction into clinical practice. These changes should ideally be reported and shared between surgeon-innovators to promote efficient, safe and transparent innovation. Currently, agreement on how modifications should be defined, conceptualised and classified, so they can be reported and shared efficiently and transparently, is lacking. The aim of this review is to examine and summarise existing literature on definitions, perceptions and classifications of modifications to surgical procedures/devices, including views on how to measure and report them. The findings will inform future work to standardise reporting and sharing of modifications in surgical innovation.</p><p><strong>Materials and methods: </strong>A systematic scoping review will be conducted adhering to PRISMA-ScR guidelines. Included articles will focus on review articles and opinion pieces relevant to modifications to new surgical procedures or devices introduced to clinical practice. Methods to identify relevant literature will include systematic searches in MEDLINE (Ovid version), targeted internet searches (Google Scholar) and snowball searches. A two-stage screening process (titles/abstracts/keywords and full-texts) will use specified exclusion/inclusion criteria to identify eligible articles. Data on how modifications are i) defined, ii) perceived, and iii) classified, and iv) views on how modifications should be measured and reported, will be extracted verbatim. Inductive thematic analysis will be applied to extracted data where appropriate. Results will be presented as a narrative summary including descriptive characteristics of included articles. Findings will inform a preliminary conceptual framework to facilitate the systematic reporting and sharing of modifications to novel procedures and devices.</p><p><strong>Highlights: </strong>This work will generate an in-depth understanding of how modifications are currently defined, perceived and classified, and views on how they may be reported, in the context of surgical innovation.Rigorous and comprehensive search methods will be applied to identify a wide range of diverse data sources for inclusion in the review.A summary of existing relevant literature on modifications is a necessary step to inform development of a framework for transparent, real-time reporting and sharing of modifications in future studies of innovative invasive procedures/devices.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"25 1","pages":"250-256"},"PeriodicalIF":1.1,"publicationDate":"2021-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8588892/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9156630","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}
Abeeshna Ashok, K U Dhanesh Kumar, Mundayat Gopalakrishnan
{"title":"Outcome of Chair Aerobics & Pranayama on Anxiety and Exercise Tolerance in Coronary Artery Bypass Grafting Patients: Study Protocol of a Randomized Clinical Trial.","authors":"Abeeshna Ashok, K U Dhanesh Kumar, Mundayat Gopalakrishnan","doi":"10.29337/ijsp.166","DOIUrl":"https://doi.org/10.29337/ijsp.166","url":null,"abstract":"<p><strong>Objectives: </strong>The current Indian scenario follows the western cardiac rehabilitation protocol; hence the primary aim of the study is to develop a cardiac rehabilitation phase 1 protocol for the Indian scenario. The protocol will be used in the study as standard rehabilitation protocol for the intervention groups. The literature suggests the use of Pranayama and chair aerobics to improve the anxiety in CABG patients. This study also aims to provide the answer for the effect of Pranayama and chair aerobics on anxiety and exercise tolerance in CABG patients. And also try to find out which among the two intervention is superior among one another.</p><p><strong>Methods: </strong>The cardiac rehabilitation protocol will be validated by experts in the field and applied in the patients and the results will be analysed. Then the protocol will be used as the standard rehabilitation protocol in both the groups. 100 patients will be randomised and allocated into 2 groups. Group 1 will receive Nadi Sodhana Chair aerobics for 15 minutes along with phase I cardiac rehabilitation. The group 2 will receive Chair aerobics for 15 minutes along with phase I cardiac rehabilitation. The outcome measures will be taken before the surgery and on the post-operative day 7. The primary outcome measures are Hospital anxiety and depression scale (HADS) and Heart rate and the secondary outcome measure is 6-minute walk test. The intention to treat analysis will be done after the data collection.</p><p><strong>Results: </strong>The data will be analysed using unpaired t test, p value <0.05 will be considered significant.</p><p><strong>Conclusion: </strong>The result will give a new insight into the field of cardiac surgery, where the effect of pranayama and chair aerobics on anxiety and functional outcome will be proved.</p><p><strong>Ctri registration: </strong>This trial is prospectively registered in CTRI, the registration number of the trial is <b>CTRI/2021/09/037008</b>.</p><p><strong>Highlights: </strong><b>What is already known about this subject?</b> The effect of Pranayama and chair aerobics on various components like pain, peak expiratory flow after CABG is proven in different studies. The phase 1 cardiac rehabilitation is practiced and adopted from western protocol.<b>What does this study add?</b> The study will give a new insight into the field of cardiac rehabilitation. Definite phase I cardiac rehabilitation protocol for Indian population is not exist in the literature. The Indian set up is using the western protocol, which is not suitable for the Indian population hence could not achieve the expected outcome on discharge. We believe that this study will provide a definite phase I cardiac rehabilitation protocol for the Indian population. This can be followed in the community. Also, this study aims to explore the unexplored area of anxiety after CABG. Where the effect of the Pranayama and chair aerobics will be identified. And also give idea about","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"238-243"},"PeriodicalIF":0.9,"publicationDate":"2021-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8533659/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39669139","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}
Elsaline Rijkse, Sarah Bouari, Hendrikus J A N Kimenai, Jeroen de Jonge, Ron W F de Bruin, Julia S Slagter, Martijn W F van den Hoogen, Jan N M IJzermans, Martin J Hoogduijn, Robert C Minnee
{"title":"Additional Normothermic Machine Perfusion Versus Hypothermic Machine Perfusion in Suboptimal Donor Kidney Transplantation: Protocol of a Randomized, Controlled, Open-Label Trial.","authors":"Elsaline Rijkse, Sarah Bouari, Hendrikus J A N Kimenai, Jeroen de Jonge, Ron W F de Bruin, Julia S Slagter, Martijn W F van den Hoogen, Jan N M IJzermans, Martin J Hoogduijn, Robert C Minnee","doi":"10.29337/ijsp.165","DOIUrl":"https://doi.org/10.29337/ijsp.165","url":null,"abstract":"<p><strong>Introduction: </strong>Ageing of the general population has led to an increase in the use of suboptimal kidneys from expanded criteria donation after brain death (ECD-DBD) and donation after circulatory death (DCD) donors. However, these kidneys have inferior graft outcomes and lower rates of immediate function. Normothermic machine perfusion (NMP) may improve outcomes of these suboptimal donor kidneys. Previous non-randomized studies have shown the safety of this technique and suggested its efficacy in improving the proportion of immediate functioning kidneys compared to static cold storage (SCS). However, its additional value to hypothermic machine perfusion (HMP), which has already been proved superior to SCS, has not yet been established.</p><p><strong>Methods and analysis: </strong>This single-center, open-label, randomized controlled trial aims to assess immediate kidney function after 120 minutes additional, end-ischemic NMP compared to HMP alone. Immediate kidney function is defined as no dialysis treatment in the first week after transplant. Eighty recipients on dialysis at the time of transplant who receive an ECD-DBD or DCD kidney graft are eligible for inclusion. In the NMP group, the donor kidney is taken of HMP upon arrival in the recipient hospital and thereafter put on NMP for 120 minutes at 37 degrees Celsius followed by transplantation. In the control group, donor kidneys stay on HMP until transplantation. The primary outcome is immediate kidney function.</p><p><strong>Ethics and dissemination: </strong>The protocol has been approved by the Medical Ethical Committee of Erasmus Medical Center (2020-0366). Results of this study will be submitted to peer-reviewed journals.</p><p><strong>Registration: </strong>registered in <i>clinicaltrials.gov</i> (NCT04882254).</p><p><strong>Highlights: </strong>This is the first RCT to compare additional NMP to HMP alone.Extensive sampling will offer in-depth analysis of kidney physiology during NMP.This RCT may help identify biomarkers to predict clinical outcomes during NMP.Biomarkers can help develop NMP as assessment tool for declined kidneys.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"227-237"},"PeriodicalIF":0.9,"publicationDate":"2021-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8499718/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39564833","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}
Jeremy Meyer, Constantinos Simillis, Heman Joshi, Athanasios Xanthis, James Ashcroft, Nicolas Buchs, Frédéric Ris, R Justin Davies
{"title":"Does the Choice of Extraction Site During Minimally Invasive Colorectal Surgery Change the Incidence of Incisional Hernia? Protocol for a Systematic Review and Network Meta-Analysis.","authors":"Jeremy Meyer, Constantinos Simillis, Heman Joshi, Athanasios Xanthis, James Ashcroft, Nicolas Buchs, Frédéric Ris, R Justin Davies","doi":"10.29337/ijsp.164","DOIUrl":"https://doi.org/10.29337/ijsp.164","url":null,"abstract":"<p><strong>Background: </strong>Various sites are used for specimen extraction in oncological minimally invasive colorectal surgery. The objective is to determine if the choice of extraction site modulates the incidence of incisional hernia (IH).</p><p><strong>Methods/design: </strong>A systematic review will be performed in accordance to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. MEDLINE, Embase and CENTRAL will be searched to look for original studies reporting the incidence of IH after minimally invasive colorectal surgery. Studies will be excluded from the analysis if: 1) they do not report original data, 2) the outcome of interest (incidence of incisional hernia) is not clearly reported and does not allow to extrapolate and/or calculate the required data for network meta-analysis, 3) they include pediatric patients, 4) they include a patients' population with a conversion rate to laparotomy >10%, 5) they do not compare at least two different extraction sites for the operative specimen, 6) they report patients who underwent pure (and not hybrid) natural orifice transluminal endoscopic surgery (NOTES). Network meta-analysis will be performed to determine the incidence of IH per extraction site.</p><p><strong>Discussion: </strong>By determining which specimen extraction site leads to reduced rate of IH, this systematic review and network meta-analysis will help colorectal surgeons to choose their extraction site and reduce the morbidity and costs associated with IH.</p><p><strong>Registration: </strong>The systematic review and meta-analysis protocol is registered in the International Prospective Register of Ongoing Systematic Reviews (PROSPERO) with number CRD42021272226.</p><p><strong>Highlights: </strong>Various sites are used for specimen extraction in oncological minimally invasive colorectal surgery, and the choice of the site may probably modulate the incidence of incisional hernia.The present protocol aims to design a systematic review which will identify original studies comparing two extraction sites during minimally invasive colorectal surgery in terms of incidence of incisional hernia.Network meta-analysis will be performed to determine the incidence of IH per extraction site.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"216-219"},"PeriodicalIF":0.9,"publicationDate":"2021-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8462477/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39516918","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":"Feasibility and Efficacy of Fusion Imaging Systems for Immediate Post Ablation Assessment of Liver Neoplasms: Protocol for a Rapid Systematic Review.","authors":"Pragati Rai, Sarada Dakua, Julien Abinahed, Shidin Balakrishnan","doi":"10.29337/ijsp.162","DOIUrl":"https://doi.org/10.29337/ijsp.162","url":null,"abstract":"<p><strong>Introduction: </strong>Percutaneous thermal ablation is widely adopted as a curative treatment approach for unresectable liver neoplasms. Accurate immediate assessment of therapeutic response post-ablation is critical to achieve favourable outcomes. The conventional technique of side-by-side comparison of pre- and post-ablation scans is challenging and hence there is a need for improved methods, which will accurately evaluate the immediate post-therapeutic response.</p><p><strong>Objectives and significance: </strong>This review summarizes the findings of studies investigating the feasibility and efficacy of the fusion imaging systems in the immediate post-operative assessment of the therapeutic response to thermal ablation in liver neoplasms. The findings could potentially empower the clinicians with updated knowledge of the state-of-the-art in the assessment of treatment response for unresectable liver neoplasms.</p><p><strong>Methods and analysis: </strong>A rapid review will be performed on publicly available major electronic databases to identify articles reporting the feasibility and efficacy of the fusion imaging systems in the immediate assessment of the therapeutic response to thermal ablation in liver neoplasms. The risk of bias and quality of articles will be assessed using the Cochrane risk of bias tool 2.0 and Newcastle Ottawa tool.</p><p><strong>Ethics and dissemination: </strong>Being a review, we do not anticipate the need for any approval from the Institutional Review Board. The outcomes of this study will be published in a peer-reviewed journal.</p><p><strong>Highlights: </strong>Evaluation of the therapeutic response in liver neoplasms immediately post-ablation is critical to achieve favourable patient outcomes. We will examine the feasibility and technical efficacy of different fusion imaging systems in assessing the immediate treatment response post-ablation. The findings are expected to guide the clinicians with updated knowledge on the state-of-the-art when assessing the immediate treatment response for unresectable liver neoplasms.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"209-215"},"PeriodicalIF":0.9,"publicationDate":"2021-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8447974/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39490606","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}
Matteo Origi, Pietro Achilli, Giacomo Calini, Andrea Costanzi, Michela Monteleone, Isacco Montroni, Dario Maggioni, Eugenio Cocozza, Stefano Megna, Mauro Totis, Nicolo' Tamini, Antonio Ziccarelli, Gaetano Filippone, Giovanni Ferrari, Jacopo Crippa, Antonino Spinelli, Giulio M Mari
{"title":"The Diverticular Disease Registry (DDR Trial) by the Advanced International Mini-Invasive Surgery Academy Clinical Research Network: Protocol for a Multicenter, Prospective Observational Study.","authors":"Matteo Origi, Pietro Achilli, Giacomo Calini, Andrea Costanzi, Michela Monteleone, Isacco Montroni, Dario Maggioni, Eugenio Cocozza, Stefano Megna, Mauro Totis, Nicolo' Tamini, Antonio Ziccarelli, Gaetano Filippone, Giovanni Ferrari, Jacopo Crippa, Antonino Spinelli, Giulio M Mari","doi":"10.29337/ijsp.157","DOIUrl":"https://doi.org/10.29337/ijsp.157","url":null,"abstract":"<p><p>Diverticular disease is an increasingly common issue, with a variety of clinical presentations and treatment options. However, very few prospective cohort studies explore outcomes between the different presentations and treatments. The Diverticular Disease Registry (DDR Trial) is a multicenter, prospective, observational cohort study on behalf of the Advanced International Mini-Invasive Surgery (AIMS) academy clinical research network. The DDR Trial aims to investigate the short-term postoperative and long-term quality of life outcomes in patients undergoing surgery or medical treatments for diverticular disease. DDR Trial is open to participation by all tertiary-care hospitals. DDR Trial has been registered at ClinicalTrials.gov (NCT04907383). Data collection will be recorded on Research Electronic Data Capture (REDCap) starting on June 1<sup>st</sup>, 2021 and will end after 5 years of recruitment. All adult patients with imaging-proven colonic diverticular disease (i.e., symptomatic colonic diverticulosis including diverticular bleeding, diverticulitis, and Symptomatic Uncomplicated Diverticular Disease) will be included. The primary outcome of DDR Trial is quality of life assessment at 12-month according to the Gastrointestinal Quality of Life Index (GIQLI). The secondary outcome is 30-day postoperative outcomes according to the Clavien-Dindo classification. DDR Trial will significantly advance in identifying the optimal care for patients with diverticular disease by exploring outcomes of different presentations and treatments.</p><p><strong>Highlights: </strong>Diverticular disease (i.e., diverticulitis, bleeding) has different treatments.This is a clinical protocol for the Diverticular Disease Registry (DDR Trial).DDR Trial is a multicenter, prospective, observational cohort study open to participation.DDR Trial will study short-term postoperative and long-term quality of life outcomes.Medical treatments, interventional radiology and surgery will be explored.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"194-200"},"PeriodicalIF":0.9,"publicationDate":"2021-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8415185/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39431775","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}
Sung Il Kang, In Teak Woo, Sung Uk Bae, Chun-Seok Yang
{"title":"Single-Incision Versus Conventional Laparoscopic Appendectomy: A Multi-Center Randomized Controlled Trial (SCAR trial).","authors":"Sung Il Kang, In Teak Woo, Sung Uk Bae, Chun-Seok Yang","doi":"10.29337/ijsp.159","DOIUrl":"https://doi.org/10.29337/ijsp.159","url":null,"abstract":"<p><strong>Introduction: </strong>Although single-incision laparoscopic appendectomy (SILA) was introduced decades ago, it is still considered a difficult technique to perform compared to conventional laparoscopic appendectomy (CLA). In addition, controversy about the benefits of SILA compared to CLA abound and no definite criteria for choosing SILA over CLA in patients with appendicitis currently exist. Therefore, we have planned a multi-center randomized controlled trial to compare SILA with CLA in terms of cosmetic satisfaction and pain reduction.</p><p><strong>Methods and analysis: </strong>Patients diagnosed with appendicitis at the participating centers will be recruited and allocated into either a CLA or an SILA groups using a 1:1 randomization. Patients in the CLA group will receive a conventional 3-port laparoscopic appendectomy and patients in the SILA group will receive a laparoscopic appendectomy using a single-incision at the umbilicus. The primary trial endpoint is cosmetic satisfaction assessed using the Patients and Observer Scar Assessment Scale (POSAS) administered 6 weeks post-surgery. Secondary trial endpoints include cosmetic satisfaction assessed via the Body Image Questionnaire, pain levels assessed via the Visual Analog Scale and International Pain Outcomes questionnaire, and the presence of postoperative complications. The target sample size of this superiority trial is 120 patients, as this will provide 80% power at the 2.5% level of significance to detect a 3-point difference in POSAS.</p><p><strong>Discussion: </strong>The results of this planned multi-center randomized controlled trial will provide substantive evidence to help surgeons choose when to use SILA over CLA in patients with appendicitis.</p><p><strong>Ethics and dissemination: </strong>This trial was approved by the institutional review board at Daegu joint on February 27, 2020 (No: 19-12-001-001) and registered with the clinical research information service (CRIS) (KCT0005048). The results of the study will be published and presented at appropriate conferences.</p><p><strong>Highlights: </strong>To investigate the clinical benefits comparing between single incision laparoscopic appendectomy and conventional laparoscopic appendectomyTo assess the pain and cosmetic satisfaction through quantitative scales, Patient-Reported Outcomes Measures (PROMs), International Pain Outcome (IPO) Questionnaire, the Patient and Observer Scar Assessment Scale (POSAS), and the Body Image Questionnaire (BIQ)To help surgeons choose when to use single incision laparoscopic appendectomy in patients with appendicitis.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"201-208"},"PeriodicalIF":0.9,"publicationDate":"2021-08-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8415183/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39431776","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":"The Effect of ω3 Fatty Acids Supplementation on Levels of PPARγ and UCP2 Genes Expression, Serum Level of UCP2 Protein, Metabolic Status, and Appetite in Elite male Athletes: Protocol for a Randomized Control Trial.","authors":"Sara Moradi, Mohamadreza Alivand, Yaser KhajeBishak, Mohamad AsghariJafarabadi, Maedeh Alipour, Amirhosien Faghfouri, Beitullah Alipour","doi":"10.29337/ijsp.161","DOIUrl":"https://doi.org/10.29337/ijsp.161","url":null,"abstract":"<p><p>Some genetic factors may influence body composition, such as PPARγ and UCP2. PPARγ plays an important role in body fat distribution. The objective of the present study is to determine the effects of omega3 fatty acids on the gene expression of PPARγ and UCP2, levels of blood lipid profile, fat mass, and fat-free mass, and appetite. Elite male athlete volunteers of up to 36 subjects were invited to participate in this RCT. Following a public announcement, volunteers were recruited from gyms, teams, and sports medicine boards in Tabriz, Iran. Gene's expression of PPARγ and UCP2, serum levels of blood lipid profile, fat mass, and fat-free mass was collected. Data collection time points include baseline in addition to 3 weeks follow up. The study was approved by the Ethics Committee of the Tabriz University Medical of Sciences (IR.TBZMED.REC.1398.782) in October 2019 and was registered with the Iranian Registry of Clinical Trials: 20190625044008N1 on December 19, 2019. Recruitment began in July and concluded in December 2019. As of August 19, 2019, we have screened 373 volunteers. 36 were enrolled. Baseline measurements of participants were collected. After three-week of intervention, end study measurements of participants were collected. The results are expected to be released in 2021. Participants have a median age of 21.86 (±3.15). The finding of this study showed Results showed PPARγ mRNA levels, and UCP2 mRNA and protein levels increased in the omega3 group (p < 0.05), as did REE (p < 0.05). Also, differences in the sensation of hunger or satiety were significant (p < 0.05). This study could result in the effects of omega-3 fatty acids on PPARγ, and UCP2 expressions, blood lipid profiles and body composition. In addition, the results of this trial can be used as baseline information for conducting further clinical and sport nutrition studies.</p><p><strong>Trial registration: </strong>The trial was registered at the Iranian registry of the clinical trial website (<i>www.irct.ir</i>) as IRCT20190625044008N1 (<i>https://en.irct.ir/trial/43332</i>), registered at (19/12/2019).</p><p><strong>Highlights: </strong>Omega3 fatty acids as a ligand of metabolic-related genes, have a role in energy expenditure.Omega3 supplements effect on PPARγ and UCP2 mRNA expression as regulators of energy metabolismOmega3 supplements increased REE.Omega-3 supplementation could change the changes in body composition.For athletes, omega-3 simultaneously decreased fat mass and increased fat-mass.HDL-C increased after short-term supplementation with omega-3.Increased intake of omega-3, caused increased intake of energy and protein.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"184-193"},"PeriodicalIF":0.9,"publicationDate":"2021-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8378073/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39366711","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":"Surgical Approaches for Allergic Rhinitis: A Systematic Review Protocol.","authors":"Soumya Soumya, Gideon Adegboyega, Hassan Elhassan","doi":"10.29337/ijsp.160","DOIUrl":"https://doi.org/10.29337/ijsp.160","url":null,"abstract":"<p><strong>Background: </strong>Exposure to inhaled allergens in patients with allergic rhinitis results in IgE mediated hypersensitivity of nasal mucosa. The mainstay of management is allergen identification and avoidance, pharmacotherapy with antihistamines, corticosteroids and nasal douching and immunotherapy. Patients refractory to medical management can be offered surgical interventions aimed at providing symptom relief. The objective of this review is to evaluate the effectiveness of surgical intervention on functional and symptomatic outcomes in patients with allergic rhinitis that have failed medical management.</p><p><strong>Methods: </strong>Prospective and retrospective studies that assess the effectiveness of intranasal surgery to include inferior turbinate surgery, posterior nerve resection, vidian neurectomy, septoplasty and endoscopic sinus surgery (ESS) in patients that have failed medical treatment for proven allergic rhinitis. Medline, Web of Science and Embase will be searched for studies published in English from 1990. Two authors will independently screen the search results and assess the full text of potentially relevant studies. Studies that meet the inclusion criteria will be critically appraised and the data will be extracted and synthesised by two authors.</p><p><strong>Ethics and dissemination: </strong>Ethical approval was not required for this study as secondary data will be collected. The results will be disseminated through peer-reviewed medical journal.</p><p><strong>Systematic review registration: </strong>This protocol has been registered on the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42020223773).</p><p><strong>Highlights: </strong>Allergic rhinitis (AR) is a chronic immune-mediated inflammatory nasal condition with hallmark symptoms of sneezing, nasal obstruction, mucus discharge and anosmia in adverse cases.A plethora of interventions are at the hands of otolaryngologists in order to relieve symptoms of AR, however literature is yet to determine which method is best for patient outcome and quality of life.The primary objective of this study is to convey a systematic qualitative analysis of all the surgical interventions used in AR management.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":" ","pages":"178-183"},"PeriodicalIF":0.9,"publicationDate":"2021-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8362620/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"39344797","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}