{"title":"Exploratory trial of urethral submucosa injection therapy of deflux for stress urinary incontinence after radical prostatectomy.","authors":"Atsuko Fujihara, Takumi Shiraishi, Masatsugu Miyashita, Yuta Inoue, Yumiko Saito, Hideto Taga, Yasuyuki Naitoh, Yayoi Iwami, Go Horiguchi, Toshiko Ito-Ihara, Osamu Ukimura","doi":"10.1097/SP9.0000000000000031","DOIUrl":"10.1097/SP9.0000000000000031","url":null,"abstract":"<p><strong>Background: </strong>After robot-assisted laparoscopic radical prostatectomy (RARP) for localized prostate cancer, post-operative stress urinary incontinence (SUI) impacts patient quality-of-life (QOL). A simple and less invasive treatment for SUI in these patients is urgently needed. Deflux is a viscous gel that consists of a mixture of sodium hyaluronate and dextranomer beads. It is administered by transurethral approach for the treatment of vesicoureteral reflux. In this study, we aim to establish a minimally invasive treatment for post-prostatectomy SUI through transurethral Deflux injection.</p><p><strong>Methods: </strong>We will perform a single-center, exploratory clinical trial to evaluate the safety and efficacy of transurethral injection of Deflux for SUI after RARP. Inclusion criteria are patients with SUI, a urine leakage volume between 15 and 500 g in a 24-h pad test, and those who use more than two pads per day. Five patients are scheduled to be enrolled in this pilot study. Deflux is injected endoscopically at the 3 o'clock and 9 o'clock positions in the submucosa until coaptation of submucosal bulking is achieved from both intraurethral sides. The primary endpoint is safety following Deflux injection. The secondary endpoint is efficacy on both SUI volume and patients' QOL.</p><p><strong>Discussion: </strong>The importance of this clinical trial is to propose a new minimally invasive treatment option for male SUI patients after RARP.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"28 4","pages":"1-6"},"PeriodicalIF":1.1,"publicationDate":"2024-10-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12124383/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144200294","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}
Yonghua Hu, Qinglin Wei, Yang Yu, Haiyuan Li, Hao Chen
{"title":"Risk and pattern analysis of distant metastases in colon cancer: protocol for a systematic review and meta-analysis.","authors":"Yonghua Hu, Qinglin Wei, Yang Yu, Haiyuan Li, Hao Chen","doi":"10.1097/SP9.0000000000000029","DOIUrl":"https://doi.org/10.1097/SP9.0000000000000029","url":null,"abstract":"<p><strong>Background: </strong>Understanding the metastatic risks and patterns of colon cancer is crucial for patient evaluation and decision-making. However, high-quality evidence on colon cancer metastases is lacking. This study aims to conduct a systematic review and meta-analysis to determine the risk of site-specific metastasis and provide a complete profiling of distant metastasis in colon cancer.</p><p><strong>Methods: </strong>This review will include studies reporting the proportion of different-site metastases among colon cancer patients. Clinical trials, follow-up studies, and cross-sectional surveys with English publications are eligible for inclusion. We will search Medline, Embase, Web of Science, and the Cochrane Library from inception to June 2023. Two reviewers will independently screen the title/abstract and full texts of identified records according to the eligibility criteria. Data from eligible studies will be extracted and used for meta-analysis. Meta-analyses will be conducted to estimate the overall proportion of site-specific metastasis. During meta-analyses, two proportions will be analyzed, i.e., the incidence of metastasis and component proportion. We will select the appropriate tools to assess the risk of biases based on the study design of included studies.</p><p><strong>Results: </strong>This study is still in preparation for launch. Once all analyses are complete, the results will be submitted for publication in a peer-reviewed journal.</p><p><strong>Conclusion: </strong>This review will provide a clear and systematic metastatic pattern of colon cancer and evidence-based recommendations for the management of distant metastasis.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"28 4","pages":"1-5"},"PeriodicalIF":1.1,"publicationDate":"2024-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12052224/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144003360","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}
Julian Süsstrunk, Johannes Baur, Rosita Sortino, Jörg Filser, Kim Herzog, Daniel C Steinemann, Beat P Müller, Fiorenzo V Angehrn
{"title":"ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in ventral hernia repair - a multi-center randomized controlled trial: the ALPINE study protocol.","authors":"Julian Süsstrunk, Johannes Baur, Rosita Sortino, Jörg Filser, Kim Herzog, Daniel C Steinemann, Beat P Müller, Fiorenzo V Angehrn","doi":"10.1097/SP9.0000000000000030","DOIUrl":"10.1097/SP9.0000000000000030","url":null,"abstract":"<p><strong>Introduction: </strong>Minimally invasive ventral hernia repair (MIVHR) is a frequently performed surgical procedure to address primary or incisional ventral hernias and is recommended by numerous societies. Various techniques are available for MIVHR, including the intraperitoneal onlay mesh (IPOM) procedure and the enhanced view totally extraperitoneal (eTEP) approach. While both techniques are increasingly applied, they continue to be subject of controversy in literature. Well-designed randomized controlled trials comparing both procedures are lacking. The objective of this study is to investigate whether eTEP is associated with a decreased level of postoperative pain compared to IPOM.</p><p><strong>Methods: </strong>This is a prospective, multi-center, randomized, and blinded controlled trial. Patients presenting with primary or incisional epigastric, umbilical, or infraumbilical hernia with a transverse diameter >1 cm and ≤4 cm, or multiple hernias with a cumulative transverse diameter ≤4 cm, will be randomly assigned to undergo either IPOM or eTEP procedures. All patients and assessors of the study outcomes are blinded to the treatment allocation. The trial will be conducted at the St. Clara Hospital Basel, at the University Hospital Basel (Switzerland) and at the Innklinikum Altötting (Germany). It remains open for additional sites to be included. The multi-center design is chosen to minimize environmental bias related to perioperative anesthesiology and nursing care and to enhance participant recruitment. The primary outcome of this study is to evaluate postoperative pain (numeric rating scale and Patient-Reported Outcome Measurement Information System Pain Intensity Short Form 3a) 24 hours after the surgical procedure. Secondary outcomes include the assessment of pain at different times, length of hospital stay, operative time, readmission rate, intraoperative, and postoperative adverse events.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"28 4","pages":"1-6"},"PeriodicalIF":1.1,"publicationDate":"2024-09-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12124376/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144200295","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}
Thomas J E Hubbard, Anna T Isaac, Alice Cui, Ramsey I Cutress, Rajiv Dave, Katy Ellis, Jo Fields, Suzanne Halliday, Jennifer Hu, Shelley Potter, Leena Chagla, Karina Cox, Christopher Holcombe
{"title":"The association of breast surgery ASPIRE: breast pain pathway rapid evaluation project - study protocol.","authors":"Thomas J E Hubbard, Anna T Isaac, Alice Cui, Ramsey I Cutress, Rajiv Dave, Katy Ellis, Jo Fields, Suzanne Halliday, Jennifer Hu, Shelley Potter, Leena Chagla, Karina Cox, Christopher Holcombe","doi":"10.1097/SP9.0000000000000021","DOIUrl":"10.1097/SP9.0000000000000021","url":null,"abstract":"<p><strong>Background: </strong>Breast pain accounts for 20-40% of new referrals to breast units in the UK and these patients have a very low risk of breast cancer. Patients have previously been assessed in resource-intensive, cancer-exclusion, one stop clinics, which are now failing to meet government targets due to excessive demand. UK Breast units are increasingly piloting Breast Pain-only Pathways (BPP) to assess these patients, and there is no consensus for the optimal pathway. The aim of this prospective multicentre study is to assess the safety and patient satisfaction of different BPPs to inform future BPP design and implementation.</p><p><strong>Methods: </strong>All UK breast units will be invited to join the ASPIRE study between January 2023 and December 2023. Units with a BPP are invited to submit their pathway for evaluation; and those without a BPP who see patients with breast pain-only in a one stop clinics setting are also invited to join the study to evaluate the traditional pathway model concurrently. Patient satisfaction assessments will be collected after their initial consultation and patient outcomes, including subsequent cancer diagnosis, will be followed up at 12 months to determine if they have cancer diagnosis after discharge to assess pathway safety.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"28 1","pages":"37-42"},"PeriodicalIF":0.9,"publicationDate":"2024-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10905496/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140022874","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}
Sue M Hartup, Jenna L Morgan, Vinton Wt Cheng, Peter A Barry, Ellen Copson, Ramsey I Cutress, Rajiv Dave, Beatrix Elsberger, Patricia Fairbrother, Brian Hogan, Kieran Horgan, Cliona C Kirwan, Stuart A McIntosh, Rachel L O'Connell, Neill Patani, Shelley Potter, Tim Rattay, Lisa Sheehan, Lynda Wyld, Baek Kim
{"title":"The MARECA (national study of management of breast cancer locoregional recurrence and oncological outcomes) study: protocol for a prospective, multicentre cohort study.","authors":"Sue M Hartup, Jenna L Morgan, Vinton Wt Cheng, Peter A Barry, Ellen Copson, Ramsey I Cutress, Rajiv Dave, Beatrix Elsberger, Patricia Fairbrother, Brian Hogan, Kieran Horgan, Cliona C Kirwan, Stuart A McIntosh, Rachel L O'Connell, Neill Patani, Shelley Potter, Tim Rattay, Lisa Sheehan, Lynda Wyld, Baek Kim","doi":"10.1097/SP9.0000000000000018","DOIUrl":"10.1097/SP9.0000000000000018","url":null,"abstract":"<p><strong>Background: </strong>Despite a UK 5-year breast cancer survival rate of 86.6%, patients may develop breast cancer recurrence within the same breast after breast conserving surgery, as well as in the remaining skin or chest wall after mastectomy or in the ipsilateral lymph glands. These recurrences, collectively termed locoregional recurrence (LRR), occur in around 8% of patients within 10 years of their original diagnosis. Currently, there is a lack of robust information on the presentation and prevalence of LRR with no UK-specific clinical guidelines available for the optimal management of this patient group. Additionally, there is a need to identify patterns of LRR presentation and their progression, which will enable prognostic factors to be determined. This will subsequently enable the tailoring of treatment and improve patient outcome.</p><p><strong>Methods: </strong>The MARECA study is a prospective, multicentre cohort study recruiting patients diagnosed with breast cancer LRR +/- associated distant metastases. Over 50 UK breast units are participating in the study with the aim of recruiting at least 500 patients over a recruitment period of 24 months. The data collected will detail the tumour pathology, imaging results, surgical treatment, radiotherapy and systemic therapy of the primary and recurrent breast cancer. Study follow-up will be for up to 5 years following LRR diagnosis to determine subsequent oncological outcomes and evaluate potential prognostic factors.</p><p><strong>Discussion: </strong>This study will address the current knowledge gap and identify subgroups of patients who have less successful treatment outcomes. The results will determine the current management of LRR and the prognosis of patients diagnosed with breast cancer LRR +/- distant metastases in the UK, with the aim of establishing best practice and informing future national guidelines. The results will direct future research and inform the design of additional interventional trials and translational studies.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"28 1","pages":"20-26"},"PeriodicalIF":0.9,"publicationDate":"2024-01-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10905491/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140022875","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}
Lekaashree Rambabu, Brandon G Smith, Stasa Tumpa, Katharina Kohler, Angelos G Kolias, Peter J Hutchinson, Tom Bashford
{"title":"Artificial intelligence-enabled ophthalmoscopy for papilledema: a systematic review protocol.","authors":"Lekaashree Rambabu, Brandon G Smith, Stasa Tumpa, Katharina Kohler, Angelos G Kolias, Peter J Hutchinson, Tom Bashford","doi":"10.1097/SP9.0000000000000016","DOIUrl":"10.1097/SP9.0000000000000016","url":null,"abstract":"<p><p>Papilledema is a pathology delineated by the swelling of the optic disc secondary to raised intracranial pressure (ICP). Diagnosis by ophthalmoscopy can be useful in the timely stratification of further investigations, such as magnetic resonance imaging or computed tomography to rule out pathologies associated with raised ICP. In resource-limited settings, in particular, access to trained specialists or radiological imaging may not always be readily available, and accurate fundoscopy-based identification of papilledema could be a useful tool for triage and escalation to tertiary care centres. Artificial intelligence (AI) has seen a rise in neuro-ophthalmology research in recent years, but there are many barriers to the translation of AI to clinical practice. The objective of this systematic review is to garner and present a comprehensive overview of the existing evidence on the application of AI in ophthalmoscopy for papilledema, and to provide a valuable perspective on this emerging field that sits at the intersection of clinical medicine and computer science, highlighting possible avenues for future research in this domain.</p>","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"28 1","pages":"27-30"},"PeriodicalIF":0.9,"publicationDate":"2023-12-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10905490/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140022873","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}
Yosuke Namba, Tsuyoshi Kobayashi, S. Kuroda, Masakazu Hashimoto, Daisuke Takei, S. Fukuhara, Ko Oshita, Keiso Matsubara, Naruhiko Honmyo, R. Nakano, Hiroshi Sakai, H. Tahara, M. Ohira, K. Ide, Hideki Ohdan
{"title":"Protocol to evaluate the efficacy and safety of tolvaptan in patients with refractory ascites after liver resection: an open-label, single-arm phase I/II study","authors":"Yosuke Namba, Tsuyoshi Kobayashi, S. Kuroda, Masakazu Hashimoto, Daisuke Takei, S. Fukuhara, Ko Oshita, Keiso Matsubara, Naruhiko Honmyo, R. Nakano, Hiroshi Sakai, H. Tahara, M. Ohira, K. Ide, Hideki Ohdan","doi":"10.1097/sp9.0000000000000015","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000015","url":null,"abstract":"In patients with chronic liver diseases such as cirrhosis, massive ascites after hepatic resection is the cause of prolonged hospitalization and worsening prognosis. Recently, the efficacy of tolvaptan in refractory ascites has been reported; however, there are no reports on the efficacy or safety of tolvaptan for refractory ascites after hepatic resection. This study aims to evaluate the efficacy of early administration of tolvaptan in patients with refractory ascites after hepatic resection. This is an open-label, single-arm phase I/II study. This study subject will comprise patients scheduled for hepatic resection of a liver tumor. Patients with refractory ascites after hepatic resection (drainage volume on postoperative day 1 ≥5 ml/body weight 1 kg/day) will be treated with tolvaptan. The primary endpoint will include the maximum change in body weight after hepatic resection relative to the preoperative baseline. The secondary endpoints will include drainage volume, abdominal circumference, urine output, postoperative complication rate (heart failure and respiratory failure), number of days required for postoperative weight gain because of ascites to decrease to preoperative weight, change in improvement of postoperative pleural effusion, total amount of albumin or fresh frozen plasma transfusion, type and amount of diuretics used, and postoperative hospitalization days. This trial will evaluate the efficacy and safety of tolvaptan prophylaxis for refractory ascites after hepatic resection. As there are no reports demonstrating the efficacy of tolvaptan prophylaxis for refractory ascites after hepatic resection, the authors expect that these findings will lead to future phase III trials and provide valuable indications for the selection of treatments for refractory postoperative ascites.","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"103 2","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-12-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139174461","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}
Frank W. de Jongh, Laurens Kooiman, Elijah E. Sanches, S. Pouwels, Koen J A O Ingels, K. Wehrens, Liang T. Tan
{"title":"A new minimally invasive, nonexcisional, surgical browlift technique with minimal scarring: a protocol for a prospective observational study","authors":"Frank W. de Jongh, Laurens Kooiman, Elijah E. Sanches, S. Pouwels, Koen J A O Ingels, K. Wehrens, Liang T. Tan","doi":"10.1097/sp9.0000000000000011","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000011","url":null,"abstract":"The aim of this study is to prospectively evaluate the new minimal invasive (MINE) browlift technique with possibly superior results and minimal visible scarring. A prospective observational study will be performed on all available data from patients who will undergo a browlift procedure in the HMC from 1 June 2021 till 31 May 2024. Our goal is to include at least 50 patients. Inclusion criteria are: patients with medical (i.e. brow ptosis and facial paralysis) or cosmetic indication, patients with sufficient understanding of the Dutch or English language and willingness to participate in extra study specific follow-up moments and filling in of questionnaires. Exclusion criteria are: less than 18 years of age and patients with previous brow or eyelid surgery. Patients will be photographed preoperatively and postoperatively using the VECTRA camera. Scarring after procedure; functionality of eyebrow movement; amount of correction in brow ptosis, measured in VECTRA; longevity of procedure in months; aesthetic result as assessed by questionnaires and adverse effects of procedure will be measured. The database management software ʻCastorʼ will be used to store and collect the data from the questionnaire. The Medical Research Ethics Committee found this study not eligible to be submitted to the Dutch Medical Research Involving Human Subjects Acts (WMO). Written consent will be obtained from all patients.","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":"26 5","pages":""},"PeriodicalIF":0.9,"publicationDate":"2023-11-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139262554","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}
Anni King, George Fowler, Rhiannon C. Macefield, Fang-Fang Quek, Hamish Walker, Charlie Thomas, Sheraz Markar, Jane M. Blazeby, Natalie S. Blencowe
{"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}
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
{"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}