肿瘤外科预防性抗生素方案（PARITY）：一项多中心随机对照研究，比较接受肿瘤切除和内置假体置换术患者的替代抗生素方案——统计分析计划。

Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY): a multi-center randomized controlled study comparing alternative antibiotic regimens in patients undergoing tumor resections with endoprosthetic replacements-a statistical analysis plan.

机构信息

Department of Surgery, McMaster University, Hamilton, ON, L8V 1C3, Canada.

Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, L8S 4L8, ON, Canada.

出版信息

Trials. 2021 Mar 22;22(1):223. doi: 10.1186/s13063-021-05147-2.

DOI:10.1186/s13063-021-05147-2

PMID:33752752

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7983267/

Abstract

BACKGROUND

Limb salvage with endoprosthetic reconstruction is the current standard practice for the surgical management of lower extremity bone tumors in skeletally mature patients and typically includes tumor resection followed by the functional limb reconstruction with modular metallic and polyethylene endoprosthetic implants. However, owing to the complexity and length of these procedures, as well as the immunocompromised nature of patients treated with chemotherapy, the risk of surgical site infection (SSI) is high. The primary research objective of the Prophylactic Antibiotic Regimens In Tumor Surgery (PARITY) trial is to assess whether a 5-day regimen of post-operative antibiotics decreases the risk of SSI at 1 year post-operatively compared to a 1-day regimen. This article describes the statistical analysis plan for the PARITY trial.

METHODS/DESIGN: The PARITY trial is an ongoing multi-center, blinded parallel two-arm randomized controlled trial (RCT) of 600 participants who have been diagnosed with a primary bone tumor, a soft tissue sarcoma that has invaded the bone or oligometastatic bone disease of the femur or tibia that requires surgical resection and endoprosthetic reconstruction. This article describes the overall analysis principles, including how participants will be included in each analysis, the presentation of results, adjustments for covariates, the primary and secondary outcomes, and their respective analyses. Additionally, we will present the planned sensitivity and sub-group analyses.

DISCUSSION

Our prior work has demonstrated (1) high rates of SSI after the treatment of lower extremity tumors by surgical excision and endoprosthetic reconstruction, (2) highly varied opinion and practice among orthopedic oncologists with respect to prophylactic antibiotic regimens, (3) an absence of applicable RCT evidence, (4) extensive support from international investigators to participate in a RCT, and (5) the feasibility of conducting a definitive RCT to evaluate a 5-day regimen of post-operative antibiotics in comparison with a 1-day regimen.

TRIAL REGISTRATION

ClinicalTrials.gov NCT01479283 . Registered on 24 November 2011.

摘要

背景

在骨骼成熟的患者中，保肢治疗下肢骨肿瘤的当前标准方法是进行内置物重建，通常包括肿瘤切除，然后用模块化金属和聚乙烯内置物进行功能性肢体重建。然而，由于这些手术的复杂性和长度，以及接受化疗的患者的免疫功能低下，手术部位感染（SSI）的风险很高。肿瘤手术预防性抗生素方案（PARITY）试验的主要研究目的是评估与 1 天疗程相比，术后 5 天疗程的抗生素是否能降低术后 1 年 SSI 的风险。本文描述了 PARITY 试验的统计分析计划。

方法/设计：PARITY 试验是一项正在进行的多中心、盲法平行双臂随机对照试验（RCT），纳入了 600 名患者，这些患者被诊断患有原发性骨肿瘤、侵犯骨骼的软组织肉瘤或股骨或胫骨的寡转移骨病，需要手术切除和内置物重建。本文描述了总体分析原则，包括如何将参与者纳入每项分析、结果的呈现、协变量的调整、主要和次要结果及其各自的分析。此外，我们将介绍计划的敏感性和亚组分析。

讨论

我们之前的工作表明：（1）下肢肿瘤通过手术切除和内置物重建治疗后 SSI 的发生率很高；（2）骨科肿瘤学家在预防性抗生素方案方面的意见和做法存在很大差异；（3）缺乏适用的 RCT 证据；（4）国际研究者对参与 RCT 的大力支持；（5）进行一项比较 5 天疗程和 1 天疗程的术后抗生素的确定性 RCT 的可行性。