International Journal of Surgery Protocols最新文献

{"title":"A systematic scoping review protocol to summarise and appraise the use of artificial intelligence in the analysis of digital videos of invasive general surgical procedures","authors":"Anni King, George Fowler, Rhiannon C. Macefield, Fang-Fang Quek, Hamish Walker, Charlie Thomas, Sheraz Markar, Jane M. Blazeby, Natalie S. Blencowe","doi":"10.1097/sp9.0000000000000012","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000012","url":null,"abstract":"Background: Intraoperative video recordings are a valuable addition to operative written documentation. However, the review of these videos often requires surgical expertise and takes considerable time. While a large amount of work has been undertaken to understand the role of artificial intelligence (AI) in healthcare more generally, the application of these techniques to automate the analysis of surgical videos is currently unclear. In this systematic scoping review, we sought to give a contemporary overview of the use of AI research in the analysis of digital videos of invasive general surgical procedures. We will describe and summarise the study characteristics, purpose of the applications and stage of development, to ascertain how these techniques might be applied in future research and to identify gaps in current knowledge (e.g. uncertainties about the study methods). Methods: Systematic searches will be conducted in OVID Medline and Embase, using terms related to ‘artificial intelligence’, ‘surgery’ and ‘video’ to identify all potentially relevant studies published since 1st January 2012. All primary studies where AI has been applied to the analysis of videos (recorded by conventional digital cameras or laparoscopic or robotic-assisted technology) of general surgical procedures will be included. Data extraction will include study characteristics, governance, details of video datasets and AI models, measures of accuracy, validation and any reported limitations. Ethics and dissemination: No ethical approval is required as primary data will not be collected. The results will be disseminated at relevant conferences, on social media and published in a peer-reviewed journal.","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"54 ","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135928637","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":"Research protocol to identify progression and death amongst patients with metastatic hormone-sensitive prostate cancer treated with available treatments: PIONEER IMI’s “big data for better outcomes” program","authors":"Juan Gomez Rivas, Rossella Nicoletti, Laura Ibáñez, Carl Steinbeisser, Bertrand de Meulder, Asieh Golozar, Susan Evans Axelsson, Robert Snijder, Anders Bjartell, Philip Cornford, Mieke Van Hemelrijck, Katharina Beyer, Peter-Paul Willemse, Teemu Murtola, Monique J. Roobol, Jesús Moreno-Sierra, Riccardo Campi, Mauro Gacci, Nicolas Mottet, Axel Merseburger, James Ndow","doi":"10.1097/sp9.0000000000000009","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000009","url":null,"abstract":"Androgen deprivation therapy-based with or without first-generation anti-androgens, was the standard of care for patients with metastatic hormone-sensitive prostate cancer (mHSPC) for decades. However, the development of docetaxel chemotherapy and new androgen receptor-targeted agents, abiraterone acetate and prednisolone, apalutamide , enzalutamide and darolutamide (in combination with docetaxel chemotherapy) has proven that combination of treatments is more effective. Recently, intensification therapy, so-called “triplets”, have emerged in the armamentarium of mHSPC treatment. Metastatic disease is a clinical state that remains poorly understood. The optimal diagnostic and management of patients with mHSPC are changing thanks to the development of new imaging techniques and therapies. The primary objective of this study is to develop and validate a predictive model for the occurrence of symptomatic progression, initiation of new treatments and death amongst patients with mHSPC treated with one of the approved treatment plans, on characteristics present at admission.","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"71 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135888925","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":"Randomized trial of intravenous versus bidirectional chemotherapy after cytoreductive surgery for malignant peritoneal mesothelioma","authors":"Paul H. Sugarbaker","doi":"10.1097/sp9.0000000000000010","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000010","url":null,"abstract":"Background: Malignant peritoneal mesothelioma (MPM) is a rare disease that progresses within the peritoneal cavity and only disseminates to systemic sites in the terminal months of the disease. For this malignancy, there are several regimens of chemotherapy that have been accepted as standard, principally intraperitoneal chemotherapy (IPC) and intravenous chemotherapy (IVC); however, there is no standardized method of treatment. Selected patients with MPM who are amenable to cytoreductive surgery (CRS) and are fit for surgery typically undergo resection with hyperthermic intraperitoneal chemotherapy (HIPEC). Though individual toxicity and efficacy studies of IPC plus IVC (bidirectional) and IVC chemotherapy for MPM have been conducted, a prospective randomized clinical trial has not been performed for this disease. Materials and methods: The study objective is to compare the efficacy and toxicity of normothermic bidirectional (IPC/IVC) chemotherapy versus IVC after CRS and HIPEC for epithelial MPM. The patient population are those individuals undergoing CRS for MPM. Exclusion criteria include previous therapy form mesothelioma. The study design is a randomized, nonblinded, phase II clinical trial comparing multicycle IVC with cisplatin (CDDP) and pemetrexed (PMTX) versus multicycle bidirectional chemotherapy with IVC CDDP and IPC PMTX after optimal CRS and HIPEC with CDDP and doxorubicin. The primary endpoint is 2-year disease-free survival. The secondary endpoint is 30-day post-treatment morbidity. The primary objective is to compare the 2-year rates of disease-free survival in the two treatment arms. The secondary objective is to compare the toxicity of each treatment. Dissemination: The prospective randomized trial provides not only a standardized approach to treatment but also a path forward to optimize the survival of patients with MPM. In addition, any increase or decrease in the adverse events associated with PMTX administered as IPC will be demonstrated. Because MPM is a rare disease a multi-institutional implementation of the protocol is required.","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"60 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135580067","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":"Framework for a living systematic review and meta-analysis for the surgical treatment of bladder cancer: introducing EVIglance to urology","authors":"Victoria L.S. Wieland, Daniel Uysal, Pascal Probst, Maurizio Grilli, Caelán M. Haney, Marie A. Sidoti Abate, Luisa Egen, Manuel Neuberger, Giovanni E. Cacciamani, Maximilian C. Kriegmair, Maurice S. Michel, Karl-Friedrich Kowalewski","doi":"10.1097/sp9.0000000000000008","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000008","url":null,"abstract":"Background: Knowledge of current and ongoing studies is critical for identifying research gaps and enabling evidence-based decisions for individualized treatment. However, the increasing number of scientific publications poses challenges for healthcare providers and patients in all medical fields to stay updated with the latest evidence. To overcome these barriers, we aim to develop a living systematic review and open-access online evidence map of surgical therapy for bladder cancer (BC), including meta-analyses. Methods: Following the guidelines provided in the Cochrane Handbook for Systematic Reviews of Interventions and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Statement, a systematic literature search on uro-oncological therapy in BC will be performed across various literature databases. Within the scope of a meta-analysis and living systematic review, relevant randomized controlled trials will be identified. Data extraction and quantitative analysis will be conducted, along with a critical appraisal of the quality and risk of bias of each study. The available research evidence will be entered into an open-access framework (www.evidencemap.surgery) and will also be accessible via the EVIglance app. Regular semi-automatic updates will enable the implementation of a real-living review concept and facilitate resource-efficient screening. Discussion: A regularly updated evidence map provides professionals and patients with an open-access knowledge base on the current state of research, allowing for decision-making based on recent evidence. It will help identify an oversupply of evidence, thus avoiding redundant work. Furthermore, by identifying research gaps, new hypotheses can be formulated more precisely, enabling planning, determination of sample size, and definition of endpoints for future trials.","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"226 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135208304","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 chemotherapy-associated pneumoperitoneum in cancer patients: a scoping review protocol","authors":"Renee M. Maina, Caroline A. Rader, Jeevan Kypa, Hilary M. Jasmin, Constantine Asahngwa, Clarisse S. Muenyi, Denis A. Foretia","doi":"10.1097/sp9.0000000000000007","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000007","url":null,"abstract":"Introduction: Pneumoperitoneum – free air within the peritoneal cavity – is often the result of bowel perforation, though other causes include residual postprocedural or postoperative air and barotrauma. In non-cancer patients, operative intervention is often required. Cancer patients, on the other hand, present a unique set of challenges as they usually have elevated risk of pneumoperitoneum from local radiation therapy, frequent endoscopic procedures, and tumor invasion. Factors such as malnutrition, neutropenia, chemotherapy, and steroid use make emergent surgery tenuous in cancer patients. There is a paucity of published literature on the management of pneumoperitoneum in patients actively undergoing chemotherapy. The main objective of this scoping review is to assess the presentation, management, and subsequent outcomes of this unique patient population. Materials and Methods: The authors will utilize the framework for performing scoping reviews as outlined by Arksey and O’Malley. They will perform the search for articles in three electronic databases (i.e. SCOPUS, PubMed, Embase) and relevant gray literature. Only articles available in English and published between 1999 and 2022 will be included. Inclusion criteria will be a known diagnosis of cancer, chemotherapy within 6 months of presentation, and imaging confirmation of pneumoperitoneum. Exclusion criteria will be cancer diagnosis at the time of presentation, perforation secondary to cancer itself, and chemotherapy greater than 6 months prior to presentation. A tailored extraction frame to extract relevant information from published articles that meet our inclusion criteria. The data using both descriptive statistics and thematic analysis of the main study questions. Ethics and Dissemination: Since the authors will not be collecting primary data, formal ethical approval is not required. They study findings will be disseminated through abstracts, conference presentations, and peer-reviewed publications.","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"15 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135208305","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":"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}

{"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}

{"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":"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":1.1,"publicationDate":"2023-02-01","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":"Epidemiology of Digestive Surgical Emergencies in a Sub-Saharan African Country: A Multicentre Pilot Study Protocol.","authors":"Maguatte Faye,&nbsp;Adja Coumba Diallo,&nbsp;Mamadou Ndiaye,&nbsp;Papa Mamadou Faye,&nbsp;Abdourahmane Ndong,&nbsp;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}

{"title":"NANOTEX BONE Graft along with Fibula Flap in the Reconstruction of Segmental Mandibular Defect: Protocol for Pilot Clinical Trial.","authors":"Anna Serene Babu,&nbsp;R Rashmi,&nbsp;V Manju,&nbsp;Pramod Subash,&nbsp;Arjun Krishnadas,&nbsp;Manitha Nair,&nbsp;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}