NCT03031457

Microsurgical Breast Reconstruction & VTE

Completed Last updated 1 May 2018

What this trial tests

trial testing Duplex ultrasound in Breast Reconstruction in 30 participants. Completed in 15 December 2017.

Timeline

30 January 2017

Primary endpoint
15 December 2017

15 December 2017

Quick facts

Lead sponsor	Stanford University
Status	Completed
Study type	OBSERVATIONAL
Enrollment	30
Start date	30 January 2017
Primary completion	15 December 2017
Estimated completion	15 December 2017
Sites	1 location across United States

Drugs / interventions tested

• Duplex ultrasound

Conditions studied

• Breast Reconstruction — all drugs for Breast Reconstruction →
• Venous Thromboembolism — all drugs for Venous Thromboembolism →

Sponsor

Stanford University

Who can join

Adults 18 to 90, female only, with Breast Reconstruction or Venous Thromboembolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.