International Journal of Surgery Protocols最新文献

{"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}

{"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}

{"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}

{"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}

{"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,&nbsp;K U Dhanesh Kumar,&nbsp;Mundayat Gopalakrishnan","doi":"10.29337/ijsp.166","DOIUrl":"https://doi.org/10.29337/ijsp.166","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objectives: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The data will be analysed using unpaired t test, p value &lt;0.05 will be considered significant.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Ctri registration: &lt;/strong&gt;This trial is prospectively registered in CTRI, the registration number of the trial is &lt;b&gt;CTRI/2021/09/037008&lt;/b&gt;.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Highlights: &lt;/strong&gt;&lt;b&gt;What is already known about this subject?&lt;/b&gt; 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.&lt;b&gt;What does this study add?&lt;/b&gt; 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}

{"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,&nbsp;Sarah Bouari,&nbsp;Hendrikus J A N Kimenai,&nbsp;Jeroen de Jonge,&nbsp;Ron W F de Bruin,&nbsp;Julia S Slagter,&nbsp;Martijn W F van den Hoogen,&nbsp;Jan N M IJzermans,&nbsp;Martin J Hoogduijn,&nbsp;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}

{"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,&nbsp;Constantinos Simillis,&nbsp;Heman Joshi,&nbsp;Athanasios Xanthis,&nbsp;James Ashcroft,&nbsp;Nicolas Buchs,&nbsp;Frédéric Ris,&nbsp;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,&nbsp;Sarada Dakua,&nbsp;Julien Abinahed,&nbsp;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}

{"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,&nbsp;Pietro Achilli,&nbsp;Giacomo Calini,&nbsp;Andrea Costanzi,&nbsp;Michela Monteleone,&nbsp;Isacco Montroni,&nbsp;Dario Maggioni,&nbsp;Eugenio Cocozza,&nbsp;Stefano Megna,&nbsp;Mauro Totis,&nbsp;Nicolo' Tamini,&nbsp;Antonio Ziccarelli,&nbsp;Gaetano Filippone,&nbsp;Giovanni Ferrari,&nbsp;Jacopo Crippa,&nbsp;Antonino Spinelli,&nbsp;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^st, 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}

{"title":"Single-Incision Versus Conventional Laparoscopic Appendectomy: A Multi-Center Randomized Controlled Trial (SCAR trial).","authors":"Sung Il Kang,&nbsp;In Teak Woo,&nbsp;Sung Uk Bae,&nbsp;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}