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脊柱原发性肿瘤的手术不良事件及其对预后的影响:来自原发性肿瘤研究与预后网络的一项观察性研究

Surgical Adverse Events for Primary Tumors of the Spine and Their Impact on Outcomes: An Observational Study From the Primary Tumors Research and Outcomes Network.

作者信息

Laflamme Mathieu, Gasbarrini Alessandro, Rhines Laurence D, Lazary Aron, Gokaslan Ziya L, Reynolds Jeremy J, Luzzati Alessandro, Disch Alexander C, Chou Dean, Clarke Michelle J, Wei Feng, Bettegowda Chetan, Rampersaud Y Raja, Boriani Stefano, Shin John H, Lord Elizabeth, Sciubba Daniel M, Laufer Ilya, Sahgal Arjun, Fisher Charles G, Dea Nicolas

机构信息

Division of Neurosurgery, Department of Surgery, CHU de Québec - Université Laval, Québec City , Québec , Canada.

Department of Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Bologna , Italy.

出版信息

Neurosurgery. 2025 Feb 5;97(1):264-276. doi: 10.1227/neu.0000000000003369.

Abstract

BACKGROUND AND OBJECTIVES

Aggressive resection for primary tumors of the spine are associated with a high rate of adverse events (AEs), but the impact of AEs on patient-reported outcomes (PROs) remains unknown and is critical to the shared decision-making. Our primary objective was to assess the impact of surgical AEs on PROs using an international registry. Assessing the impact on clinical outcomes and identifying risk factors for AEs were our secondary objectives.

METHODS

Patients who underwent surgery for a primary spinal tumor were selected through the Primary Tumor Research and Outcomes Network. Our primary outcome was the impact of AEs on PROs at 3 and 12 months after surgery (measured with Spinal Oncology Study Group Outcomes Questionnaire, Short-Form 36, and EuroQol 5 Dimension). We also assessed the impact on clinical outcomes (local control, surgical margins, readmission, reoperation, and mortality). We stratified our results according to severity of AEs, histology, and type of resection.

RESULTS

374 patients met inclusion criteria (219 males/155 females). The mean age of the cohort was 48.7 years. The most frequent histology was chordoma (37.3%) followed by chondrosarcoma (8.8%). Sixty-seven patients (17.9%) experienced at least 1 intraoperative AE and 117 patients (31.3%) had at least 1 postoperative AE within 3 months. Overall, 159 patients (42.5%) experienced AEs. The readmission rate was significantly higher in patients who experienced AEs (Any AE: 10.1% vs no AE: 1.9% within 3 months; P = <0.001). PROs were not significantly affected by AEs in most questionnaires. Local control, risk of reoperation, mortality, and achieving preplanned margins were similar between AE groups.

CONCLUSION

The rate of surgical AEs is considerable in this population. Surgical AEs seem to be associated with a higher number of readmissions, but do not seem to result in significant differences in PROs or in a higher risk of reoperation, mortality, and failure to achieve preplanned margins.

摘要

背景与目的

脊柱原发性肿瘤的积极手术切除与高不良事件(AE)发生率相关,但AE对患者报告结局(PRO)的影响仍不明确,而这对共同决策至关重要。我们的主要目的是使用国际登记处评估手术AE对PRO的影响。评估对临床结局的影响并确定AE的危险因素是我们的次要目的。

方法

通过原发性肿瘤研究与结局网络选择接受原发性脊柱肿瘤手术的患者。我们的主要结局是AE在术后3个月和12个月时对PRO的影响(采用脊柱肿瘤学研究组结局问卷、简短健康调查36项量表和欧洲五维度健康量表进行测量)。我们还评估了对临床结局的影响(局部控制、手术切缘、再入院、再次手术和死亡率)。我们根据AE的严重程度、组织学类型和切除类型对结果进行分层。

结果

374例患者符合纳入标准(男性219例/女性155例)。该队列的平均年龄为48.7岁。最常见的组织学类型是脊索瘤(37.3%),其次是软骨肉瘤(8.8%)。67例患者(17.9%)经历了至少1次术中AE,117例患者(31.3%)在3个月内至少有1次术后AE。总体而言,159例患者(42.5%)经历了AE。经历AE的患者再入院率显著更高(任何AE:3个月内为10.1%,无AE:为1.9%;P = <0.001)。在大多数问卷中,PRO未受到AE的显著影响。AE组之间的局部控制、再次手术风险、死亡率以及达到预定切缘情况相似。

结论

该人群中手术AE的发生率相当高。手术AE似乎与更多的再入院相关,但似乎不会导致PRO出现显著差异,也不会导致再次手术风险、死亡率升高以及无法达到预定切缘的风险增加。

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Eliciting adverse effects data from participants in clinical trials.从临床试验参与者中获取不良反应数据。
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