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文章:

一项前瞻性观察性队列研究:比较高复杂性与传统盆腔廓清术

A Prospective Observational Cohort Study Comparing High-Complexity Against Conventional Pelvic Exenteration Surgery

原文发布日期:1 January 2025

DOI: 10.3390/cancers17010111

类型: Article

开放获取: 是

 

英文摘要:

Background:Conventional pelvic exenteration (PE) comprises the removal of all or most central pelvic organs and is established in clinical practise. Previously, tumours involving bone or lateral sidewall structures were deemed inoperable due to associated morbidity, mortality, and poor oncological outcomes. Recently however high-complexity PE is increasingly described and is defined as encompassing conventional PE with the additional resection of bone or pelvic sidewall structures. This observational cohort study aimed to assess surgical outcomes, health-related quality of life (HrQoL), decision regret, and costs of high-complexity PE for more advanced tumours not treatable with conventional PE.Methods:High-complexity PE data were retrieved from a prospectively maintained quaternary database. The primary outcome was overall survival. Secondary outcomes were perioperative mortality, disease control, major morbidity, HrQoL, and health resource use. For cost–utility analysis, a no-PE group was extrapolated from the literature.Results:In total, 319 cases were included, with 64 conventional and 255 high-complexity PE, and the overall survival was equivalent, with medians of 10.5 and 9.8 years (p= 0.52), respectively. Local control (p= 0.30); 90-day mortality (0.0% vs. 1.2%,p= 1.00); R0-resection rate (87% vs. 83%,p= 0.08); 12-month HrQoL (p= 0.51); and decision regret (p= 0.90) were comparable. High-complexity PE significantly increased overall major morbidity (16% vs. 31%,p= 0.02); and perioperative costs (GBP 37,271 vs. GBP 45,733,p< 0.001). When modelled against no surgery, both groups appeared cost-effective with incremental cost-effectiveness ratios of GBP 2446 and GBP 5061.Conclusions:High-complexity PE is safe and feasible, offering comparable survival outcomes and HrQoL to conventional PE, but with greater morbidity and resource use. Despite this, it appears cost-effective when compared to no surgery and palliation.

 

摘要翻译: 

背景:传统盆腔廓清术(PE)涉及切除全部或大部分盆腔中央器官,已在临床实践中确立。既往认为累及骨骼或侧壁结构的肿瘤因相关并发症、死亡率及不良肿瘤学预后而被视为不可手术。然而近年来,高复杂性PE(定义为在传统PE基础上额外切除骨骼或盆腔侧壁结构)的报道日益增多。本研究旨在评估针对无法通过传统PE治疗的晚期肿瘤实施高复杂性PE的手术结局、健康相关生活质量(HrQoL)、决策后悔度及医疗成本。 方法:从前瞻性维护的四级诊疗数据库中提取高复杂性PE病例数据。主要结局指标为总生存期,次要结局包括围手术期死亡率、疾病控制率、主要并发症发生率、HrQoL及医疗资源使用情况。通过文献数据推演构建非手术对照组进行成本-效用分析。 结果:共纳入319例病例,其中传统PE 64例,高复杂性PE 255例。两组总生存期相当(中位生存期分别为10.5年与9.8年,p=0.52)。局部控制率(p=0.30)、90天死亡率(0.0% vs. 1.2%,p=1.00)、R0切除率(87% vs. 83%,p=0.08)、12个月HrQoL(p=0.51)及决策后悔度(p=0.90)均无显著差异。高复杂性PE显著增加总体主要并发症发生率(16% vs. 31%,p=0.02)及围手术期费用(37,271英镑 vs. 45,733英镑,p<0.001)。与不手术模型相比,两组均显示成本效益优势,增量成本效益比分别为2,446英镑和5,061英镑。 结论:高复杂性PE安全可行,其生存结局与HrQoL与传统PE相当,但并发症发生率与医疗资源消耗更高。尽管如此,相较于不手术及姑息治疗,该术式仍具有成本效益优势。

 

原文链接:

A Prospective Observational Cohort Study Comparing High-Complexity Against Conventional Pelvic Exenteration Surgery

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