Pub Date : 2024-07-18DOI: 10.1097/sp9.0000000000000026
Minh T. Nguyen, Thuan C Dang, Song T. B. Nguyen, C. N. Pham, Duong D. Le, D. Pham, Tri H. Nguyen, Dung D. T. Phan, Phu D. V. Nguyen, Phuc T. Nguyen, Vung P. Doan, Son D. Nguyen, Vu A. Pham
Compared to conventional colon cancer surgery, laparoscopic complete mesocolic excision (CME) increases the likelihood of lymph node dissection. However, this surgery is not yet considered a safe strategy. The authors study this topic to evaluate the safety and feasibility of this surgery. A prospective cohort study was performed on patients undergoing laparoscopic CME surgery at the Hue University of Medicine and Pharmacy Hospital and Hue Central Hospital. Demographic data, surgical features, and postoperative complications. Evaluate different clinicopathological factors determining the number and distribution of lymph nodes; and the rate of lymph node metastasis by tumor location and lymph node groups. Three-year overall survival and disease-free survival follow-up after surgery. The results of laparoscopic CME colectomy surgery are safe, with a reliable maximum number of harvested nodes.
{"title":"Laparoscopic complete mesocolic excision in colon cancer: a prospective cohort study","authors":"Minh T. Nguyen, Thuan C Dang, Song T. B. Nguyen, C. N. Pham, Duong D. Le, D. Pham, Tri H. Nguyen, Dung D. T. Phan, Phu D. V. Nguyen, Phuc T. Nguyen, Vung P. Doan, Son D. Nguyen, Vu A. Pham","doi":"10.1097/sp9.0000000000000026","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000026","url":null,"abstract":"\u0000 \u0000 Compared to conventional colon cancer surgery, laparoscopic complete mesocolic excision (CME) increases the likelihood of lymph node dissection. However, this surgery is not yet considered a safe strategy. The authors study this topic to evaluate the safety and feasibility of this surgery.\u0000 \u0000 \u0000 \u0000 A prospective cohort study was performed on patients undergoing laparoscopic CME surgery at the Hue University of Medicine and Pharmacy Hospital and Hue Central Hospital.\u0000 \u0000 \u0000 \u0000 Demographic data, surgical features, and postoperative complications. Evaluate different clinicopathological factors determining the number and distribution of lymph nodes; and the rate of lymph node metastasis by tumor location and lymph node groups. Three-year overall survival and disease-free survival follow-up after surgery.\u0000 \u0000 \u0000 \u0000 The results of laparoscopic CME colectomy surgery are safe, with a reliable maximum number of harvested nodes.\u0000","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":1.1,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141826037","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 : 2024-04-15DOI: 10.1097/sp9.0000000000000024
Giorgio Gandaglia, F. Pellegrino, B. de Meulder, Ayman Hijazy, Thomas Abbott, A. Golozar, R. Nicoletti, Juan Gomez-Rivas, C. Steinbeisser, Susan Evans-Axelsson, A. Briganti, J. N’Dow
Metastatic prostate cancer (PCa) constitutes ~5% of all new PCa diagnoses in Western countries. For most cases, primary consideration should be given to systemic therapies as the first-line approach based on evidence from randomized controlled trials (RCTs). Despite the importance of RCTs as the pinnacle of evidence in modern medicine, concerns have been raised about their applicability to real-life scenarios. These trials often feature participants who are younger with better performance statuses and prognoses compared to their real-world counterparts. The PIONEER project falls under the Innovative Medicine Initiative’s (IMI) “Big Data for Better Outcomes” initiative, aimed at revolutionizing PCa care in Europe. The central focus lies in improving cancer-related outcomes, enhancing health system efficiency, and elevating the quality of health and social care. This study endeavours to evaluate the generalizability of RCT findings concerning newly diagnosed metastatic PCa. A systematic review of the literature will be conducted to compile patient characteristics from RCTs addressing this subject within the past decade. To create a real-world benchmark, patients with recently diagnosed metastatic PCa from a network of population-based databases will serve as a comparison group. The objective is to assess the applicability of RCT results in two ways. First, a comparison will be made between the characteristics of patients with newly diagnosed metastatic PCa enroled in RCTs and those with the same condition included in our databases which might represent the real-world setting. Second, an evaluation will be undertaken to determine the proportion of real-world patients with newly diagnosed metastatic PCa who meet the criteria for RCT enrolment. This study will rely on extensive observational data, primarily sourced from population-based registries, electronic health records, and insurance claims data. The study cohort is established upon routinely gathered healthcare data, meticulously mapped to the Observational Medical Outcomes Partnership Common Data Model.
{"title":"Research protocol for an observational health data analysis to assess the applicability of randomized controlled trials focusing on newly diagnosed metastatic prostate cancer using real-world data: PIONEER IMI’s “big data for better outcomes” program","authors":"Giorgio Gandaglia, F. Pellegrino, B. de Meulder, Ayman Hijazy, Thomas Abbott, A. Golozar, R. Nicoletti, Juan Gomez-Rivas, C. Steinbeisser, Susan Evans-Axelsson, A. Briganti, J. N’Dow","doi":"10.1097/sp9.0000000000000024","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000024","url":null,"abstract":"\u0000 \u0000 Metastatic prostate cancer (PCa) constitutes ~5% of all new PCa diagnoses in Western countries. For most cases, primary consideration should be given to systemic therapies as the first-line approach based on evidence from randomized controlled trials (RCTs). Despite the importance of RCTs as the pinnacle of evidence in modern medicine, concerns have been raised about their applicability to real-life scenarios. These trials often feature participants who are younger with better performance statuses and prognoses compared to their real-world counterparts. The PIONEER project falls under the Innovative Medicine Initiative’s (IMI) “Big Data for Better Outcomes” initiative, aimed at revolutionizing PCa care in Europe. The central focus lies in improving cancer-related outcomes, enhancing health system efficiency, and elevating the quality of health and social care. This study endeavours to evaluate the generalizability of RCT findings concerning newly diagnosed metastatic PCa.\u0000 \u0000 \u0000 \u0000 A systematic review of the literature will be conducted to compile patient characteristics from RCTs addressing this subject within the past decade. To create a real-world benchmark, patients with recently diagnosed metastatic PCa from a network of population-based databases will serve as a comparison group. The objective is to assess the applicability of RCT results in two ways. First, a comparison will be made between the characteristics of patients with newly diagnosed metastatic PCa enroled in RCTs and those with the same condition included in our databases which might represent the real-world setting. Second, an evaluation will be undertaken to determine the proportion of real-world patients with newly diagnosed metastatic PCa who meet the criteria for RCT enrolment. This study will rely on extensive observational data, primarily sourced from population-based registries, electronic health records, and insurance claims data. The study cohort is established upon routinely gathered healthcare data, meticulously mapped to the Observational Medical Outcomes Partnership Common Data Model.\u0000","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140699025","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 : 2024-04-02DOI: 10.1097/sp9.0000000000000023
L. M. Van den Dop, J. Molina-Villar, E. Mäkäräinen, Jared Torkington, Dirk Weyhe, Igor Koncar, J. F. Lange
Incisional hernia (IH) after abdominal surgery is a frequent surgical complication. Risk factors associated with IH are midline incisions, patients with an abdominal aneurysm of the aorta, and high BMI. Preventive measures include the use of the small-bites suture technique and/or placing a prophylactic mesh for reinforcement of the midline closure. Although recommended for high-risk patients, many surgeons are still reluctant to place a prophylactic mesh due to related complications. To counter these concerns, new synthetic resorbable meshes are being developed, such as the Deternia Self-Gripping Resorbable Mesh (“investigational device”). However, the effectiveness of this mesh in IH prevention has not been proved. The Mesh Augmented Reinforcement of Abdominal Wall Suture Line (MARS) study is a European, multicentre, prospective, single-arm study. A total of 120 patients scheduled for elective midline laparotomy, and for that reason at risk of developing IH, will be recruited in ~12 sites after informed consent. The sample size was estimated based on greater than 80% power, two-sided alpha of 0.05, an expected 12 month IH rate of 8% and a predefined performance goal of 18% (10% clinical margin). Midline incisions will be closed by the small bites closure technique with a minimum 4:1 suture-to-wound length ratio and reinforced by mesh placement in the retrorectus position. The primary outcome will be IH occurrence at 12-month postoperatively, evaluated both clinically and by ultrasound. Secondary outcomes will include mesh-related and postoperative complications, surgical characteristics, IH incidence at 2 and 3 years after surgery, and quality of life. Currently, no conclusive evidence is available for synthetic resorbable meshes in a prophylactic setting to prevent IH. The MARS study will be the first prospective cohort study to investigate resorbable synthetic meshes and small bites closure to reduce IH incidence.
腹部手术后的切口疝（IH）是一种常见的手术并发症。与切口疝相关的风险因素包括中线切口、腹主动脉瘤患者和高体重指数。预防措施包括使用小口缝合技术和/或放置预防性网片以加固中线闭合。尽管建议对高风险患者使用预防性网片，但由于相关并发症的存在，许多外科医生仍不愿意放置预防性网片。为了消除这些顾虑，目前正在开发新的合成可吸收网片，如 Deternia 自抓取可吸收网片（"在研设备"）。然而，这种网片在预防 IH 方面的有效性尚未得到证实。 腹壁缝合线网片增强加固（MARS）研究是一项欧洲多中心、前瞻性、单臂研究。在征得知情同意后，将在约 12 个研究地点招募 120 名计划进行选择性中线开腹手术的患者，这些患者因此有患 IH 的风险。样本量是根据大于 80% 的功率、0.05 的双侧α值、8% 的预期 12 个月 IH 率和 18% 的预定绩效目标（10% 的临床边缘）估算的。中线切口将采用小口缝合技术缝合，缝合线与伤口长度比至少为 4:1，并在后直肌位置放置网片进行加固。主要结果是术后 12 个月的 IH 发生率，通过临床和超声波进行评估。次要结果包括网片相关并发症和术后并发症、手术特点、术后 2 年和 3 年的 IH 发生率以及生活质量。 目前，还没有确凿的证据表明合成可吸收网片可以预防 IH。MARS 研究将是第一项研究可吸收合成网片和小切口闭合以降低 IH 发生率的前瞻性队列研究。
{"title":"Prophylactic slowly resorbable mesh in midline laparotomy to limit incisional hernia incidence: the prospective ‘Mesh Augmented Reinforcement of Abdominal Wall Suture Line (MARS)’ cohort study protocol","authors":"L. M. Van den Dop, J. Molina-Villar, E. Mäkäräinen, Jared Torkington, Dirk Weyhe, Igor Koncar, J. F. Lange","doi":"10.1097/sp9.0000000000000023","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000023","url":null,"abstract":"\u0000 \u0000 Incisional hernia (IH) after abdominal surgery is a frequent surgical complication. Risk factors associated with IH are midline incisions, patients with an abdominal aneurysm of the aorta, and high BMI. Preventive measures include the use of the small-bites suture technique and/or placing a prophylactic mesh for reinforcement of the midline closure. Although recommended for high-risk patients, many surgeons are still reluctant to place a prophylactic mesh due to related complications. To counter these concerns, new synthetic resorbable meshes are being developed, such as the Deternia Self-Gripping Resorbable Mesh (“investigational device”). However, the effectiveness of this mesh in IH prevention has not been proved.\u0000 \u0000 \u0000 \u0000 The Mesh Augmented Reinforcement of Abdominal Wall Suture Line (MARS) study is a European, multicentre, prospective, single-arm study. A total of 120 patients scheduled for elective midline laparotomy, and for that reason at risk of developing IH, will be recruited in ~12 sites after informed consent. The sample size was estimated based on greater than 80% power, two-sided alpha of 0.05, an expected 12 month IH rate of 8% and a predefined performance goal of 18% (10% clinical margin). Midline incisions will be closed by the small bites closure technique with a minimum 4:1 suture-to-wound length ratio and reinforced by mesh placement in the retrorectus position. The primary outcome will be IH occurrence at 12-month postoperatively, evaluated both clinically and by ultrasound. Secondary outcomes will include mesh-related and postoperative complications, surgical characteristics, IH incidence at 2 and 3 years after surgery, and quality of life.\u0000 \u0000 \u0000 \u0000 Currently, no conclusive evidence is available for synthetic resorbable meshes in a prophylactic setting to prevent IH. The MARS study will be the first prospective cohort study to investigate resorbable synthetic meshes and small bites closure to reduce IH incidence.\u0000","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-04-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140751287","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 : 2024-03-06DOI: 10.1097/sp9.0000000000000022
Krishnapriya V N, V. Ramanarayanan, M. V, Chandrashekar Janakiram, P. Subash, S. Iyer
Oral cancer is the sixth most prevalent cancer type worldwide. Patients are placed in a crippling predicament due to the functional and psychosocial difficulties brought on by the illness and its treatments. Both surgeons and maxillofacial prosthodontists may encounter challenges with reconstruction and therapy following cancer treatment. Over 20 years, the fibula has remained the mainstay of reconstructions for head and neck cancer. Maxillary and mandibular jaws with fibula reconstructions can use fixed or removable prosthetic rehabilitation solutions. The proposed scoping review aims to ascertain the volume and nature of evidence concerning the difficulties and corrective measures in the prosthetic rehabilitation of fibula-reconstructed head and neck cancer cases. The findings will aid in improving the prosthetic treatment care for the affected population. The Joanna Briggs Institute (JBI) scoping review protocol will be followed in developing and reporting the scoping review methodology. Methods to identify the relevant literature will involve the systematic search of databases like PubMed, Scopus, Google Scholar, Cochrane Library, and gray literature sources for pertinent articles on the subject. Only papers published in English literature will be considered for the review, and the data collection period is limited to the past 20 years. The screening process will utilize defined inclusion/exclusion criteria for Title/Abstract and Full-text screening by two independent reviewers in covidence, and a third reviewer will resolve any conflicts. The data extracted will include specific details about the participants, concept, population, study methods, challenges encountered during prosthetic rehabilitation, and their management. Inductive thematic analysis and descriptive statistics will be applied where appropriate. The narrative synthesis of the evidence will be accomplished through data extraction in a tabular format, and the results will be presented as a narrative summary.
{"title":"Challenges during implant-assisted prosthetic rehabilitation in fibula reconstructed jaws and its management: a scoping review protocol","authors":"Krishnapriya V N, V. Ramanarayanan, M. V, Chandrashekar Janakiram, P. Subash, S. Iyer","doi":"10.1097/sp9.0000000000000022","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000022","url":null,"abstract":"\u0000 \u0000 Oral cancer is the sixth most prevalent cancer type worldwide. Patients are placed in a crippling predicament due to the functional and psychosocial difficulties brought on by the illness and its treatments. Both surgeons and maxillofacial prosthodontists may encounter challenges with reconstruction and therapy following cancer treatment. Over 20 years, the fibula has remained the mainstay of reconstructions for head and neck cancer. Maxillary and mandibular jaws with fibula reconstructions can use fixed or removable prosthetic rehabilitation solutions. The proposed scoping review aims to ascertain the volume and nature of evidence concerning the difficulties and corrective measures in the prosthetic rehabilitation of fibula-reconstructed head and neck cancer cases. The findings will aid in improving the prosthetic treatment care for the affected population.\u0000 \u0000 \u0000 \u0000 The Joanna Briggs Institute (JBI) scoping review protocol will be followed in developing and reporting the scoping review methodology. Methods to identify the relevant literature will involve the systematic search of databases like PubMed, Scopus, Google Scholar, Cochrane Library, and gray literature sources for pertinent articles on the subject. Only papers published in English literature will be considered for the review, and the data collection period is limited to the past 20 years. The screening process will utilize defined inclusion/exclusion criteria for Title/Abstract and Full-text screening by two independent reviewers in covidence, and a third reviewer will resolve any conflicts. The data extracted will include specific details about the participants, concept, population, study methods, challenges encountered during prosthetic rehabilitation, and their management. Inductive thematic analysis and descriptive statistics will be applied where appropriate. The narrative synthesis of the evidence will be accomplished through data extraction in a tabular format, and the results will be presented as a narrative summary.\u0000","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-03-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140262990","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 : 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":null,"pages":null},"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 : 2024-02-12DOI: 10.1097/sp9.0000000000000019
Xiaofang Tang, Lixi Long, Xiaoyun Wang, Yiwu Zhou
Previous studies have reached mixed conclusions regarding the timing of endoscopic approaches for managing individuals with acute upper gastrointestinal bleeding (AUGIB). Therefore, the authors performed a protocol for systematic review and meta-analysis to assess the efficacy of various timing endoscopic approaches in managing individuals with AUGIB. The authors will search multiple databases, including PubMed, Embase, Web of Science, China National Knowledge Infrastructure, VIP Database, Wanfang Database, WHO International Clinical Trials Registry Platform, and Chinese Clinical Trial Register. The search will cover the entire duration, starting from the establishment of these databases until July 2023. The selection criteria will focus on randomized controlled trials that assess the efficacy of endoscopy with varying timing in managing patients with AUGIB. The primary outcomes will include primary hemostasis and inpatient death. The secondary outcomes will include recurrent bleeding, need for surgical intervention, admission to the ICU, blood transfusion needs, and duration of hospitalization. Two reviewers will select the studies, extract data, and assess the risk of bias. A Bayesian approach will be used to conduct a network meta-analysis. The results of this systematic review and meta-analysis will be published in peer-reviewed journals. This network meta-analysis provides comprehensive evidence of different timing endoscopic approaches for managing individuals with AUGIB.
{"title":"Endoscopy for acute upper gastrointestinal bleeding: a protocol for systematic review and network meta-analysis of randomized controlled trials","authors":"Xiaofang Tang, Lixi Long, Xiaoyun Wang, Yiwu Zhou","doi":"10.1097/sp9.0000000000000019","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000019","url":null,"abstract":"\u0000 \u0000 Previous studies have reached mixed conclusions regarding the timing of endoscopic approaches for managing individuals with acute upper gastrointestinal bleeding (AUGIB). Therefore, the authors performed a protocol for systematic review and meta-analysis to assess the efficacy of various timing endoscopic approaches in managing individuals with AUGIB.\u0000 \u0000 \u0000 \u0000 The authors will search multiple databases, including PubMed, Embase, Web of Science, China National Knowledge Infrastructure, VIP Database, Wanfang Database, WHO International Clinical Trials Registry Platform, and Chinese Clinical Trial Register. The search will cover the entire duration, starting from the establishment of these databases until July 2023. The selection criteria will focus on randomized controlled trials that assess the efficacy of endoscopy with varying timing in managing patients with AUGIB. The primary outcomes will include primary hemostasis and inpatient death. The secondary outcomes will include recurrent bleeding, need for surgical intervention, admission to the ICU, blood transfusion needs, and duration of hospitalization. Two reviewers will select the studies, extract data, and assess the risk of bias. A Bayesian approach will be used to conduct a network meta-analysis.\u0000 \u0000 \u0000 \u0000 The results of this systematic review and meta-analysis will be published in peer-reviewed journals.\u0000 \u0000 \u0000 \u0000 This network meta-analysis provides comprehensive evidence of different timing endoscopic approaches for managing individuals with AUGIB.\u0000","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139783711","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 : 2024-02-12DOI: 10.1097/sp9.0000000000000020
Kang Zou, Jingwen Chen, Jin Guo, Wanqiang Wei, Mingyu Liao, Qixin Cai, Yiquan Xiong
Hepatitis B virus (HBV) infection is a significant public health issue worldwide, with a hepatitis B surface antigen (HBsAg) seroprevalence of 3.5%. Maternal HBV infection during pregnancy, a common comorbidity, is associated with an increase in the risk of adverse obstetric and perinatal outcomes. However, the relationship between maternal HBV infection and postpartum hemorrhage (PPH), a leading contributor to maternal morbidity and mortality, is currently uncertain. The aim of this study is to comprehensively clarify the potential impact of maternal HBV on PPH risk. The authors initially searched five English databases and three Chinese databases from their inception to 26th June 2023. Two reviewers will independently conduct study selection, data extraction, and quality assessment. Cohort and case–control studies investigating the effect of maternal HBV infection on PPH will be included, with study quality assessed using the Newcastle–Ottawa Scale (NOS). Meta-analyses will be performed using a fixed-effects model for I 2≤50% or a random-effects model otherwise. Several categories of subgroup analyses (e.g. sample size more than 1000 vs. less than 1000) and sensitivity analyses (e.g. omit NOS scores less than 7) will be conducted, and publication bias will be assessed through funnel plots, Begg’s and Egger’s tests using STATA 18.0. This systematic review and meta-analysis do not require ethics approval and the results will be published in peer-reviewed journals. The findings of this systematic review will provide evidence on the impact of maternal HBV infection on PPH, which will contribute to better prevention and management of PPH in clinical practice and a better understanding of the disease burden of HBV infection. CRD42023442626
乙型肝炎病毒（HBV）感染是全球重大的公共卫生问题，乙型肝炎表面抗原（HBsAg）血清阳性率为 3.5%。妊娠期母体感染 HBV 是一种常见的合并症，与不良产科和围产期结局风险的增加有关。然而，孕产妇 HBV 感染与产后出血（PPH）之间的关系目前尚不确定，而产后出血是导致孕产妇发病和死亡的主要因素。本研究旨在全面阐明孕产妇 HBV 对 PPH 风险的潜在影响。 作者初步检索了从开始到 2023 年 6 月 26 日的五个英文数据库和三个中文数据库。两名审稿人将独立进行研究选择、数据提取和质量评估。将纳入调查母体 HBV 感染对 PPH 影响的队列研究和病例对照研究，并使用纽卡斯尔-渥太华量表（NOS）评估研究质量。对于 I 2≤50% 的研究，将使用固定效应模型进行 Meta 分析，否则将使用随机效应模型进行 Meta 分析。将进行几类亚组分析（如样本量大于 1000 与小于 1000）和敏感性分析（如忽略 NOS 评分小于 7 分），并使用 STATA 18.0 通过漏斗图、Begg's 和 Egger's 检验评估发表偏倚。 本系统综述和荟萃分析不需要伦理审批，其结果将在同行评审期刊上发表。本系统综述的研究结果将为孕产妇 HBV 感染对 PPH 的影响提供证据，从而有助于在临床实践中更好地预防和管理 PPH，并更好地了解 HBV 感染的疾病负担。 CRD42023442626
{"title":"Hepatitis B virus infection during pregnancy and the risk of postpartum hemorrhage: a protocol for systematic review and meta-analysis","authors":"Kang Zou, Jingwen Chen, Jin Guo, Wanqiang Wei, Mingyu Liao, Qixin Cai, Yiquan Xiong","doi":"10.1097/sp9.0000000000000020","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000020","url":null,"abstract":"\u0000 \u0000 Hepatitis B virus (HBV) infection is a significant public health issue worldwide, with a hepatitis B surface antigen (HBsAg) seroprevalence of 3.5%. Maternal HBV infection during pregnancy, a common comorbidity, is associated with an increase in the risk of adverse obstetric and perinatal outcomes. However, the relationship between maternal HBV infection and postpartum hemorrhage (PPH), a leading contributor to maternal morbidity and mortality, is currently uncertain. The aim of this study is to comprehensively clarify the potential impact of maternal HBV on PPH risk.\u0000 \u0000 \u0000 \u0000 The authors initially searched five English databases and three Chinese databases from their inception to 26th June 2023. Two reviewers will independently conduct study selection, data extraction, and quality assessment. Cohort and case–control studies investigating the effect of maternal HBV infection on PPH will be included, with study quality assessed using the Newcastle–Ottawa Scale (NOS). Meta-analyses will be performed using a fixed-effects model for I\u0000 2≤50% or a random-effects model otherwise. Several categories of subgroup analyses (e.g. sample size more than 1000 vs. less than 1000) and sensitivity analyses (e.g. omit NOS scores less than 7) will be conducted, and publication bias will be assessed through funnel plots, Begg’s and Egger’s tests using STATA 18.0.\u0000 \u0000 \u0000 \u0000 This systematic review and meta-analysis do not require ethics approval and the results will be published in peer-reviewed journals. The findings of this systematic review will provide evidence on the impact of maternal HBV infection on PPH, which will contribute to better prevention and management of PPH in clinical practice and a better understanding of the disease burden of HBV infection.\u0000 \u0000 \u0000 \u0000 CRD42023442626\u0000","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139784281","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 : 2024-02-12DOI: 10.1097/sp9.0000000000000020
Kang Zou, Jingwen Chen, Jin Guo, Wanqiang Wei, Mingyu Liao, Qixin Cai, Yiquan Xiong
Hepatitis B virus (HBV) infection is a significant public health issue worldwide, with a hepatitis B surface antigen (HBsAg) seroprevalence of 3.5%. Maternal HBV infection during pregnancy, a common comorbidity, is associated with an increase in the risk of adverse obstetric and perinatal outcomes. However, the relationship between maternal HBV infection and postpartum hemorrhage (PPH), a leading contributor to maternal morbidity and mortality, is currently uncertain. The aim of this study is to comprehensively clarify the potential impact of maternal HBV on PPH risk. The authors initially searched five English databases and three Chinese databases from their inception to 26th June 2023. Two reviewers will independently conduct study selection, data extraction, and quality assessment. Cohort and case–control studies investigating the effect of maternal HBV infection on PPH will be included, with study quality assessed using the Newcastle–Ottawa Scale (NOS). Meta-analyses will be performed using a fixed-effects model for I 2≤50% or a random-effects model otherwise. Several categories of subgroup analyses (e.g. sample size more than 1000 vs. less than 1000) and sensitivity analyses (e.g. omit NOS scores less than 7) will be conducted, and publication bias will be assessed through funnel plots, Begg’s and Egger’s tests using STATA 18.0. This systematic review and meta-analysis do not require ethics approval and the results will be published in peer-reviewed journals. The findings of this systematic review will provide evidence on the impact of maternal HBV infection on PPH, which will contribute to better prevention and management of PPH in clinical practice and a better understanding of the disease burden of HBV infection. CRD42023442626
乙型肝炎病毒（HBV）感染是全球重大的公共卫生问题，乙型肝炎表面抗原（HBsAg）血清阳性率为 3.5%。妊娠期母体感染 HBV 是一种常见的合并症，与不良产科和围产期结局风险的增加有关。然而，孕产妇 HBV 感染与产后出血（PPH）之间的关系目前尚不确定，而产后出血是导致孕产妇发病和死亡的主要因素。本研究旨在全面阐明孕产妇 HBV 对 PPH 风险的潜在影响。 作者初步检索了从开始到 2023 年 6 月 26 日的五个英文数据库和三个中文数据库。两名审稿人将独立进行研究选择、数据提取和质量评估。将纳入调查母体 HBV 感染对 PPH 影响的队列研究和病例对照研究，并使用纽卡斯尔-渥太华量表（NOS）评估研究质量。对于 I 2≤50% 的研究，将使用固定效应模型进行 Meta 分析，否则将使用随机效应模型进行 Meta 分析。将进行几类亚组分析（如样本量大于 1000 与小于 1000）和敏感性分析（如忽略 NOS 评分小于 7 分），并使用 STATA 18.0 通过漏斗图、Begg's 和 Egger's 检验评估发表偏倚。 本系统综述和荟萃分析不需要伦理审批，其结果将在同行评审期刊上发表。本系统综述的研究结果将为孕产妇 HBV 感染对 PPH 的影响提供证据，从而有助于在临床实践中更好地预防和管理 PPH，并更好地了解 HBV 感染的疾病负担。 CRD42023442626
{"title":"Hepatitis B virus infection during pregnancy and the risk of postpartum hemorrhage: a protocol for systematic review and meta-analysis","authors":"Kang Zou, Jingwen Chen, Jin Guo, Wanqiang Wei, Mingyu Liao, Qixin Cai, Yiquan Xiong","doi":"10.1097/sp9.0000000000000020","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000020","url":null,"abstract":"\u0000 \u0000 Hepatitis B virus (HBV) infection is a significant public health issue worldwide, with a hepatitis B surface antigen (HBsAg) seroprevalence of 3.5%. Maternal HBV infection during pregnancy, a common comorbidity, is associated with an increase in the risk of adverse obstetric and perinatal outcomes. However, the relationship between maternal HBV infection and postpartum hemorrhage (PPH), a leading contributor to maternal morbidity and mortality, is currently uncertain. The aim of this study is to comprehensively clarify the potential impact of maternal HBV on PPH risk.\u0000 \u0000 \u0000 \u0000 The authors initially searched five English databases and three Chinese databases from their inception to 26th June 2023. Two reviewers will independently conduct study selection, data extraction, and quality assessment. Cohort and case–control studies investigating the effect of maternal HBV infection on PPH will be included, with study quality assessed using the Newcastle–Ottawa Scale (NOS). Meta-analyses will be performed using a fixed-effects model for I\u0000 2≤50% or a random-effects model otherwise. Several categories of subgroup analyses (e.g. sample size more than 1000 vs. less than 1000) and sensitivity analyses (e.g. omit NOS scores less than 7) will be conducted, and publication bias will be assessed through funnel plots, Begg’s and Egger’s tests using STATA 18.0.\u0000 \u0000 \u0000 \u0000 This systematic review and meta-analysis do not require ethics approval and the results will be published in peer-reviewed journals. The findings of this systematic review will provide evidence on the impact of maternal HBV infection on PPH, which will contribute to better prevention and management of PPH in clinical practice and a better understanding of the disease burden of HBV infection.\u0000 \u0000 \u0000 \u0000 CRD42023442626\u0000","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139843809","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 : 2024-02-08DOI: 10.1097/sp9.0000000000000013
Herman Lule, M. Mugerwa, R. Ssebuufu, P. Kyamanywa, J. P. Posti, M. L. Wilson
Road traffic injuries and their resulting mortality disproportionately affect rural communities in low-middle-income countries (LMICs) due to limited human and infrastructural resources for postcrash care. Evidence from high-income countries show that trauma team development training could improve the efficiency, care, and outcome of injuries. A paucity of studies have evaluated the feasibility and applicability of this concept in resource constrained settings. The aim of this study protocol is to establish the feasibility of rural trauma team development and training in a cohort of medical trainees and traffic law enforcement professionals in Uganda. Muticenter interrupted time series of prospective interventional trainings, using the rural trauma team development course (RTTDC) model of the American College of Surgeons. A team of surgeon consultants will execute the training. A prospective cohort of participants will complete a before and after training validated trauma related multiple choice questionnaire during September 2019-November 2023. The difference in mean prepost training percentage multiple choice questionnaire scores will be compared using ANOVA-test at 95% CI. Time series regression models will be used to test for autocorrelations in performance. Acceptability and relevance of the training will be assessed using 3 and 5-point-Likert scales. All analyses will be performed using Stata 15.0. Ethical approval was obtained from Research and Ethics Committee of Mbarara University of Science and Technology (Ref: MUREC 1/7, 05/05-19) and Uganda National Council for Science and Technology (Ref: SS 5082). Retrospective registration was accomplished with Research Registry (UIN: researchregistry9490).
{"title":"Rural trauma team development training amongst medical trainees and traffic law enforcement professionals in a low-income country: a protocol for a prospective multicenter interrupted time series","authors":"Herman Lule, M. Mugerwa, R. Ssebuufu, P. Kyamanywa, J. P. Posti, M. L. Wilson","doi":"10.1097/sp9.0000000000000013","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000013","url":null,"abstract":"\u0000 \u0000 Road traffic injuries and their resulting mortality disproportionately affect rural communities in low-middle-income countries (LMICs) due to limited human and infrastructural resources for postcrash care. Evidence from high-income countries show that trauma team development training could improve the efficiency, care, and outcome of injuries. A paucity of studies have evaluated the feasibility and applicability of this concept in resource constrained settings. The aim of this study protocol is to establish the feasibility of rural trauma team development and training in a cohort of medical trainees and traffic law enforcement professionals in Uganda.\u0000 \u0000 \u0000 \u0000 Muticenter interrupted time series of prospective interventional trainings, using the rural trauma team development course (RTTDC) model of the American College of Surgeons. A team of surgeon consultants will execute the training. A prospective cohort of participants will complete a before and after training validated trauma related multiple choice questionnaire during September 2019-November 2023. The difference in mean prepost training percentage multiple choice questionnaire scores will be compared using ANOVA-test at 95% CI. Time series regression models will be used to test for autocorrelations in performance. Acceptability and relevance of the training will be assessed using 3 and 5-point-Likert scales. All analyses will be performed using Stata 15.0. Ethical approval was obtained from Research and Ethics Committee of Mbarara University of Science and Technology (Ref: MUREC 1/7, 05/05-19) and Uganda National Council for Science and Technology (Ref: SS 5082). Retrospective registration was accomplished with Research Registry (UIN: researchregistry9490).\u0000","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139793429","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 : 2024-02-08DOI: 10.1097/sp9.0000000000000013
Herman Lule, M. Mugerwa, R. Ssebuufu, P. Kyamanywa, J. P. Posti, M. L. Wilson
Road traffic injuries and their resulting mortality disproportionately affect rural communities in low-middle-income countries (LMICs) due to limited human and infrastructural resources for postcrash care. Evidence from high-income countries show that trauma team development training could improve the efficiency, care, and outcome of injuries. A paucity of studies have evaluated the feasibility and applicability of this concept in resource constrained settings. The aim of this study protocol is to establish the feasibility of rural trauma team development and training in a cohort of medical trainees and traffic law enforcement professionals in Uganda. Muticenter interrupted time series of prospective interventional trainings, using the rural trauma team development course (RTTDC) model of the American College of Surgeons. A team of surgeon consultants will execute the training. A prospective cohort of participants will complete a before and after training validated trauma related multiple choice questionnaire during September 2019-November 2023. The difference in mean prepost training percentage multiple choice questionnaire scores will be compared using ANOVA-test at 95% CI. Time series regression models will be used to test for autocorrelations in performance. Acceptability and relevance of the training will be assessed using 3 and 5-point-Likert scales. All analyses will be performed using Stata 15.0. Ethical approval was obtained from Research and Ethics Committee of Mbarara University of Science and Technology (Ref: MUREC 1/7, 05/05-19) and Uganda National Council for Science and Technology (Ref: SS 5082). Retrospective registration was accomplished with Research Registry (UIN: researchregistry9490).
{"title":"Rural trauma team development training amongst medical trainees and traffic law enforcement professionals in a low-income country: a protocol for a prospective multicenter interrupted time series","authors":"Herman Lule, M. Mugerwa, R. Ssebuufu, P. Kyamanywa, J. P. Posti, M. L. Wilson","doi":"10.1097/sp9.0000000000000013","DOIUrl":"https://doi.org/10.1097/sp9.0000000000000013","url":null,"abstract":"\u0000 \u0000 Road traffic injuries and their resulting mortality disproportionately affect rural communities in low-middle-income countries (LMICs) due to limited human and infrastructural resources for postcrash care. Evidence from high-income countries show that trauma team development training could improve the efficiency, care, and outcome of injuries. A paucity of studies have evaluated the feasibility and applicability of this concept in resource constrained settings. The aim of this study protocol is to establish the feasibility of rural trauma team development and training in a cohort of medical trainees and traffic law enforcement professionals in Uganda.\u0000 \u0000 \u0000 \u0000 Muticenter interrupted time series of prospective interventional trainings, using the rural trauma team development course (RTTDC) model of the American College of Surgeons. A team of surgeon consultants will execute the training. A prospective cohort of participants will complete a before and after training validated trauma related multiple choice questionnaire during September 2019-November 2023. The difference in mean prepost training percentage multiple choice questionnaire scores will be compared using ANOVA-test at 95% CI. Time series regression models will be used to test for autocorrelations in performance. Acceptability and relevance of the training will be assessed using 3 and 5-point-Likert scales. All analyses will be performed using Stata 15.0. Ethical approval was obtained from Research and Ethics Committee of Mbarara University of Science and Technology (Ref: MUREC 1/7, 05/05-19) and Uganda National Council for Science and Technology (Ref: SS 5082). Retrospective registration was accomplished with Research Registry (UIN: researchregistry9490).\u0000","PeriodicalId":42077,"journal":{"name":"International Journal of Surgery Protocols","volume":null,"pages":null},"PeriodicalIF":0.9,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139852894","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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