Pub Date : 2024-01-26eCollection Date: 2024-03-01DOI: 10.1097/SP9.0000000000000018
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
Background: 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.
Methods: 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.
Discussion: 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.
{"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":null,"pages":null},"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}
Pub Date : 2024-01-22DOI: 10.1097/sp9.0000000000000017
P. Sugarbaker, Tom Deng
Peritoneal metastases from gastrointestinal or gynecologic malignancy are a prominent part of the natural history of these diseases. Peritoneal metastases, if not effectively treated, will result in a decreased survival and cause an impaired quality of life. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a treatment specifically designed to combat peritoneal metastases. A group of patients who, from a theoretical perspective, may benefit from HIPEC are those patients with a positive peritoneal cytology. In order to identify these patients at the time of a surgical intervention, a same day cytology is to be performed. The result of this test is to be available at or before the completion of the cancer resection. If the cytology is positive, the patient immediately becomes a candidate for HIPEC. The HIPEC will be of maximal value if a complete cytoreduction, as judged by the surgeon, has been possible. This phase 1 trial is to demonstrate that the Surgical Oncology Service, the Department of Pathology, the Pharmacy and the Operating Room personnel can co-ordinate a phase 1 protocol to successfully complete the same day cytology with an efficient delivery of HIPEC. A standardized plan for consent, cytology collection, preparation of the specimen, reading of the specimen, reporting the results in a timely manner facilitates the administration of HIPEC in peritoneal cytology positive patients. Successful completion of these requirements is a positive result for this study and allows for future protocols to be generated. Successful completion of the same day cytology phase 1 protocol will allow the efficacy, safety, and efficiency of this plan of patient management to be evaluated.
{"title":"Phase 1 trial of same day cytology to guide the use of HIPEC","authors":"P. Sugarbaker, Tom Deng","doi":"10.1097/sp9.0000000000000017","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000017","url":null,"abstract":"\u0000 \u0000 Peritoneal metastases from gastrointestinal or gynecologic malignancy are a prominent part of the natural history of these diseases. Peritoneal metastases, if not effectively treated, will result in a decreased survival and cause an impaired quality of life. Hyperthermic intraperitoneal chemotherapy (HIPEC) is a treatment specifically designed to combat peritoneal metastases. A group of patients who, from a theoretical perspective, may benefit from HIPEC are those patients with a positive peritoneal cytology. In order to identify these patients at the time of a surgical intervention, a same day cytology is to be performed.\u0000 \u0000 \u0000 \u0000 The result of this test is to be available at or before the completion of the cancer resection. If the cytology is positive, the patient immediately becomes a candidate for HIPEC. The HIPEC will be of maximal value if a complete cytoreduction, as judged by the surgeon, has been possible. This phase 1 trial is to demonstrate that the Surgical Oncology Service, the Department of Pathology, the Pharmacy and the Operating Room personnel can co-ordinate a phase 1 protocol to successfully complete the same day cytology with an efficient delivery of HIPEC. A standardized plan for consent, cytology collection, preparation of the specimen, reading of the specimen, reporting the results in a timely manner facilitates the administration of HIPEC in peritoneal cytology positive patients.\u0000 \u0000 \u0000 \u0000 Successful completion of these requirements is a positive result for this study and allows for future protocols to be generated. Successful completion of the same day cytology phase 1 protocol will allow the efficacy, safety, and efficiency of this plan of patient management to be evaluated.\u0000","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-01-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139606227","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}
Pub Date : 2023-12-22eCollection Date: 2024-03-01DOI: 10.1097/SP9.0000000000000016
Lekaashree Rambabu, Brandon G Smith, Stasa Tumpa, Katharina Kohler, Angelos G Kolias, Peter J Hutchinson, Tom Bashford
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.
{"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":null,"pages":null},"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}
Pub Date : 2023-12-18DOI: 10.1097/sp9.0000000000000015
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
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.
在肝硬化等慢性肝病患者中，肝切除术后大量腹水是导致住院时间延长和预后恶化的原因。最近，有报道称托伐普坦对难治性腹水有疗效；但目前还没有关于托伐普坦对肝切除术后难治性腹水的疗效或安全性的报道。本研究旨在评估肝切除术后难治性腹水患者早期服用托伐普坦的疗效。 这是一项开放标签、单臂 I/II 期研究。研究对象包括计划进行肝肿瘤肝切除术的患者。肝切除术后出现难治性腹水（术后第1天引流量≥5毫升/体重1千克/天）的患者将接受托伐普坦治疗。主要终点包括肝切除术后体重相对于术前基线的最大变化。次要终点包括引流量、腹围、尿量、术后并发症发生率（心力衰竭和呼吸衰竭）、术后因腹水导致体重增加至术前体重所需的天数、术后胸腔积液改善情况的变化、白蛋白或新鲜冰冻血浆输注总量、利尿剂的种类和用量以及术后住院天数。 这项试验将评估托伐普坦预防肝切除术后难治性腹水的有效性和安全性。由于目前还没有报告证明托伐普坦预防性治疗肝切除术后难治性腹水的疗效，作者希望这些研究结果能促成未来的 III 期试验，并为选择术后难治性腹水的治疗方法提供有价值的参考。
{"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":null,"pages":null},"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}
Pub Date : 2023-11-17DOI: 10.1097/sp9.0000000000000011
Frank W. de Jongh, Laurens Kooiman, Elijah E. Sanches, S. Pouwels, Koen J A O Ingels, K. Wehrens, Liang T. Tan
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.
{"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":null,"pages":null},"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}
Pub Date : 2023-10-31DOI: 10.1097/sp9.0000000000000012
Anni King, George Fowler, Rhiannon C. Macefield, Fang-Fang Quek, Hamish Walker, Charlie Thomas, Sheraz Markar, Jane M. Blazeby, Natalie S. Blencowe
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.
{"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":null,"pages":null},"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}
Pub Date : 2023-10-18DOI: 10.1097/sp9.0000000000000009
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
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.
{"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":null,"pages":null},"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}
Pub Date : 2023-09-27DOI: 10.1097/sp9.0000000000000010
Paul H. Sugarbaker
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.
{"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":null,"pages":null},"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}
Pub Date : 2023-09-18DOI: 10.1097/sp9.0000000000000008
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
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.
{"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":null,"pages":null},"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}
Pub Date : 2023-09-18DOI: 10.1097/sp9.0000000000000007
Renee M. Maina, Caroline A. Rader, Jeevan Kypa, Hilary M. Jasmin, Constantine Asahngwa, Clarisse S. Muenyi, Denis A. Foretia
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.
{"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":null,"pages":null},"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}
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