Pub Date : 2024-10-21DOI: 10.1097/SP9.0000000000000029
Yonghua Hu, Qinglin Wei, Yang Yu, Haiyuan Li, Hao Chen
Background: 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.
Methods: 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.
Results: 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.
Conclusion: This review will provide a clear and systematic metastatic pattern of colon cancer and evidence-based recommendations for the management of distant metastasis.
背景:了解结肠癌的转移风险和模式对患者评估和决策至关重要。然而,关于结肠癌转移的高质量证据缺乏。本研究旨在进行系统回顾和荟萃分析,以确定部位特异性转移的风险,并提供结肠癌远端转移的完整概况。方法:本综述将包括报道结肠癌患者中不同部位转移比例的研究。临床试验、随访研究和英文出版物的横断面调查符合纳入条件。我们将搜索Medline, Embase, Web of Science和Cochrane Library从成立到2023年6月。两名审稿人将根据资格标准独立筛选已确定记录的标题/摘要和全文。从符合条件的研究中提取数据并用于荟萃分析。将进行荟萃分析以估计部位特异性转移的总体比例。在meta分析中,将分析两个比例,即转移发生率和成分比例。我们将根据纳入研究的研究设计选择合适的工具来评估偏倚风险。结果:本研究仍处于准备启动阶段。一旦所有的分析完成,结果将提交到同行评议的期刊上发表。结论:本综述将提供一个清晰、系统的结肠癌转移模式,并为远处转移的治疗提供循证建议。
{"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}
Pub Date : 2024-09-28eCollection Date: 2024-10-21DOI: 10.1097/SP9.0000000000000030
Julian Süsstrunk, Johannes Baur, Rosita Sortino, Jörg Filser, Kim Herzog, Daniel C Steinemann, Beat P Müller, Fiorenzo V Angehrn
Introduction: 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.
Methods: 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.
{"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}
Pub Date : 2024-02-15eCollection Date: 2024-03-01DOI: 10.1097/SP9.0000000000000021
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
Background: 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.
Methods: 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.
{"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}
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":"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}
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":"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}
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":"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}
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":"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}
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":"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}
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":"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}
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":"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}