Trial ID or NCT#

NCT03031457

Status

RECRUITING

Purpose

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. First, 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. Next, we will determine if the use of bridging mesh repair of abdominal fascia will decrease the degree and duration of postoperative lower extremity venous stasis. Finally, we will examine the association between bridging mesh repair of abdominal fascia and abdominal bulge and hernia rate at 1 year. 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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Investigator(s)

Arash Momeni, MD
Plastic and reconstructive surgeon, Breast reconstructive surgeon
Assistant Professor of Surgery (Plastic and Reconstructive Surgery) at the Stanford University Medical Center
Dung Nguyen
Plastic and reconstructive surgeon, Breast reconstructive surgeon, Breast surgeon, Cosmetic plastic surgeon, Plastic surgeon
Clinical Associate Professor, Surgery - Plastic & Reconstructive Surgery

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CONTACT

Arash Momeni, MD
(650) 723-6189