Occult Uterine Cancer and Power Morcellation in Hysterectomy and Myomectomy

子宫切除术和子宫肌瘤切除术中的隐匿性子宫癌和动力分碎术

• 批准号: 9303269
• 负责人: XIAO XU
• 金额: $ 30.94万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-07-01 至 2019-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9303269
• 关键词: Occult; Uterine; Cancer; Power; Morcellation

Patient safety in hysterectomy and myomectomy is important given the large number of women undergoing these procedures (over 600,000 hysterectomies/myomectomies each year). Increasing use of laparoscopic hysterectomy/myomectomy has improved patient outcomes because of lower complication rates and more rapid recovery compared to traditional abdominal surgery. Uterine power morcellation is a technique of tissue removal that enables completion of these procedures with small incisions. However, recent concern about possible spread of occult (i.e., preoperatively undetected) uterine cancer into the peritoneal cavity caused the Food and Drug Administration (FDA) issuing a safety warning in 2014 against the use of power morcellation in hysterectomy/myomectomy. This act has been controversial due to inconclusive data on the risk of occult uterine cancer (expected to be quite low) and the impact of power morcellation on cancer prognosis. Despite sparse data, the highly publicized FDA warning has prompted major changes in clinical practice leading to alterations in surgical routes and techniques. While these changes can reduce the risk of disseminating cancer cells, they may expose patients to higher risk of complications associated with more invasive surgical routes or unknown risks from novice, understudied techniques, posing an urgent patient safety issue. As conventional ways of gathering safety data (e.g., establishment of patient registries) cannot meet the need for timely evidence, the objective of this study is to demonstrate how we can capitalize on existing, large health care databases to provide opportune evidence to inform policy and clinical decisions regarding uterine power morcellation. We have three specific aims: 1) to determine the prevalence and characteristics of occult uterine cancer (uterine sarcoma and endometrial carcinoma) in women undergoing hysterectomy or myomectomy for presumed benign indications; 2) to examine the impact of uncontained power morcellation on cancer prognosis among women with occult uterine malignancy; and 3) to assess practice changes in hysterectomy and myomectomy following the FDA warning, factors that influence practice response, and the associated impact on patient safety and health care costs. Using linked cancer registry and hospital discharge record data from the State of New York and two national databases, this study will provide population-based estimates on the prevalence and prognosis of occult uterine cancer, assess safety and financial impact of the FDA action, and identify patient- and hospital-level factors that may influence practice response. The project is innovative as we use unique existing databases to provide timely evidence to inform policy discussion; we thoroughly evaluate two types of uterine cancer and analyze both inpatient and outpatient hysterectomy/myomectomy to ensure a comprehensive assessment; and we use actual practices observed before and after the FDA warning to simulate real world impact of practice changes. The findings will enhance our ability to deliver evidence-based medicine, and appropriately counsel patients about the risks and benefits of uterine power morcellation.

考虑到大量妇女接受子宫切除术和子宫肌瘤切除术， 这些手术（每年60多万例子宫切除术/肌瘤切除术）。腹腔镜的使用越来越多 由于并发症发生率较低等，子宫切除术/子宫肌瘤切除术改善了患者的预后 与传统腹部手术相比，恢复速度更快。子宫粉碎术是一种组织 移除，使得能够以小切口完成这些手术。然而，最近对 神秘学的可能传播（即，术前未被发现）子宫癌进入腹膜腔导致 美国食品和药物管理局（FDA）在2014年发布了一项安全警告，禁止在 子宫切除术/子宫肌瘤切除术。这项法案一直有争议，由于不确定的数据的风险隐匿 子宫癌（预期非常低）和粉碎术对癌症预后的影响。尽管 由于数据稀少，FDA的警告引起了临床实践的重大变化， 手术路线和技术的改变。虽然这些变化可以降低癌症传播的风险， 细胞，它们可能使患者暴露于与更具侵入性的手术途径相关的更高并发症风险， 来自新手、未充分研究的技术的未知风险，造成了紧急的患者安全问题。与常规 收集安全数据的方式（例如，建立病人登记册）不能满足及时 证据，这项研究的目的是证明我们如何利用现有的，大型医疗保健 提供适当证据的数据库，为有关子宫动力的政策和临床决策提供信息 粉碎我们有三个具体目标：1）确定隐匿性子宫内膜异位症的患病率和特点 接受子宫切除术或子宫肌瘤切除术的女性中的癌症（子宫肉瘤和子宫内膜癌）， 假定良性指征; 2）检查不含粉末粉碎对癌症预后的影响 隐匿性子宫恶性肿瘤的妇女;和3）评估子宫切除术的实践变化， FDA警告后的子宫肌瘤切除术，影响实践反应的因素，以及相关影响 病人的安全和医疗费用。使用链接的癌症登记和医院出院记录数据， 纽约州和两个国家数据库，这项研究将提供基于人口的估计， 隐匿性子宫癌的患病率和预后，评估FDA行动的安全性和财务影响，以及 确定可能影响实践反应的患者和医院层面的因素。该项目是创新的，因为我们 使用独特的现有数据库提供及时的证据，为政策讨论提供信息;我们彻底评估 两种类型的子宫癌，并分析住院和门诊子宫切除术/肌瘤切除术，以确保 全面评估;我们使用FDA警告之前和之后观察到的实际做法， 模拟实践变化对真实的世界的影响。这些发现将提高我们提供基于证据的 医学，并适当地向患者提供有关子宫力量分碎术的风险和益处的咨询。