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Sponsor study identifier
observational
30
1 country
1
Study Start
January 30, 2017
Actual (reported)Primary Completion
December 15, 2017
Actual (reported)Study Completion
December 15, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 23, 2017
Actual (reported)January 25, 2017
Actual (reported)January 30, 2017
Actual (reported)December 15, 2017
Actual (reported)December 15, 2017
Actual (reported)Vessel diameter (in cm)
1 Day of discharge
Cross-sectional area (in cm^2)
1 Day of discharge
Flow velocity (in cm/sec)
1 Day of discharge
90-day VTE event
90-day
Abdominal hernia/bulge rate at 1 year postop
1 year
Patients undergo primary fascial closure of abdominal donor-site
Duplex ultrasound of lower extremity venous system
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Adult (age ≥18 years) female patients who are scheduled to undergo autologous breast reconstruction following mastectomy. Only patients who undergo breast reconstruction with free abdominal flaps that require violation of the anterior rectus sheath, i.e. MS-TRAM and DIEP flaps, will be included in the study.
Stanford University Medical Center
Stanford, California, 94305, United States
Momeni A, Sorice SC, Li AY, Nguyen DH, Pannucci C. Breast Reconstruction with Free Abdominal Flaps Is Associated with Persistent Lower Extremity Venous Stasis. Plast Reconstr Surg. 2019 Jun;143(6):1144e-1150e. doi: 10.1097/PRS.0000000000005613.
Arash Momeni, MD
Stanford University
30 participants (actual enrollment reported by the registry).
First Submitted
January 23, 2017
First Posted
January 25, 2017
Study Start
January 30, 2017
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 15, 2017
Actual (reported)Study Completion
December 15, 2017
Actual (reported)Last Updated
May 1, 2018
Record last verified: 2018-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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