Microsurgical Breast Reconstruction & VTE

Completed

• Conditions: Breast Reconstruction; Venous Thromboembolism
• Interventions: Diagnostic Test: Duplex ultrasound

• Registration Number: NCT03031457
• Lead Sponsor: Stanford University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-23
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-25
• Study Start: 2017-01-30
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-29
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• see study population description

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Duplex ultrasound	Patients undergo primary fascial closure of abdominal donor-site

Primary Outcome Measures

Name	Time	Method
Flow velocity (in cm/sec)	1 Day of discharge
Cross-sectional area (in cm^2)	1 Day of discharge
Vessel diameter (in cm)	1 Day of discharge

Secondary Outcome Measures

Name	Time	Method
Abdominal hernia/bulge rate at 1 year postop	1 year
90-day VTE event	90-day

Trial Locations

Locations (1)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States