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临床试验/NCT03031457
NCT03031457已完成不适用

Microsurgical Breast Reconstruction - Identifying Procedure-Specific Risk Factors for Venous Thromboembolism

Stanford University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Flow velocity (in cm/sec)

研究概览

简要总结

Venous thromboembolism (VTE) encompasses pulmonary embolism (PE) and deep venous thrombosis (DVT) and continues to be a major patient safety issue after reconstructive plastic surgery. Significant morbidity and mortality is associated with VTE events. This disease entity represents the most common cause of preventable in-hospital death as evidenced by over 100,000 annual VTE-related deaths in the U.S. The associated economic burden is substantial, with annual costs to the U.S. healthcare system in excess of $7 billion.

Cancer patients have been identified as a particularly vulnerable patient population. Of these, breast cancer patients represent the largest group treated by plastic surgeons. An increasing number of breast reconstructions are performed in the U.S. with a documented 35% increase in the annual number of breast reconstructions since 2000. Over 106,000 breast reconstructions were performed in 2015 alone.

Of all reconstructive modalities, autologous breast reconstruction using abdominal flaps is associated with the highest risk for VTE. We believe that a key element rendering these patients susceptible to postoperative VTE is inadequate duration of chemoprophylaxis. This is supported by the observation that VTE risk remains elevated for up to 12 weeks postoperatively. We hypothesize that lower extremity deep venous system stasis is a procedure-specific key contributing factor to postoperative VTE risk.

This study examines the duration of postoperative lower extremity venous stasis to identify patients who might benefit from extended chemoprophylaxis. We will use Duplex imaging technology to examine the lower extremity deep venous system preoperatively, on postoperative day 1, and on the day of discharge to determine if patients display radiographic evidence of lower extremity venous stasis at the time of hospital discharge.

A better understanding of pathophysiologic mechanisms that contribute to the development of VTE as well as surgical means that reduce VTE risk factors have the potential to optimize VTE prophylaxis, thus, favorably impacting clinical outcome in a large patient population.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • see study population description

排除标准

  • Superficial inferior epigastric artery flaps
  • Donor-sites other than the abdomen
  • Chronic obstructive pulmonary disease (COPD)
  • Liver disease.

结局指标

主要结局

Flow velocity (in cm/sec)

时间窗: 1 Day of discharge

Cross-sectional area (in cm^2)

时间窗: 1 Day of discharge

Vessel diameter (in cm)

时间窗: 1 Day of discharge

次要结局

  • Abdominal hernia/bulge rate at 1 year postop(1 year)
  • 90-day VTE event(90-day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arash Momeni

Assistant Professor of Surgery

Stanford University

研究点 (1)

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