Microsurgical Breast Reconstruction & VTE
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|ClinicalTrials.gov Identifier: NCT03031457|
Recruitment Status : Completed
First Posted : January 25, 2017
Last Update Posted : May 1, 2018
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.
|Condition or disease||Intervention/treatment|
|Breast Reconstruction Venous Thromboembolism||Diagnostic Test: Duplex ultrasound|
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Microsurgical Breast Reconstruction - Identifying Procedure-Specific Risk Factors for Venous Thromboembolism|
|Actual Study Start Date :||January 30, 2017|
|Actual Primary Completion Date :||December 15, 2017|
|Actual Study Completion Date :||December 15, 2017|
Patients undergo primary fascial closure of abdominal donor-site
Diagnostic Test: Duplex ultrasound
Duplex ultrasound of lower extremity venous system
- Vessel diameter (in cm) [ Time Frame: 1 Day of discharge ]
- Cross-sectional area (in cm^2) [ Time Frame: 1 Day of discharge ]
- Flow velocity (in cm/sec) [ Time Frame: 1 Day of discharge ]
- 90-day VTE event [ Time Frame: 90-day ]
- Abdominal hernia/bulge rate at 1 year postop [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031457
|United States, California|
|Stanford University Medical Center|
|Stanford, California, United States, 94305|
|Principal Investigator:||Arash Momeni, MD||Stanford University|