Microsurgical Breast Reconstruction & VTE

NCT03031457 | Completed

• 1 other identifier: 39855
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Reconstruction; Venous Thromboembolism

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (2)

• 90-day VTE event

  90-day

• Abdominal hernia/bulge rate at 1 year postop

  1 year

Study Arms (1)

1

Patients undergo primary fascial closure of abdominal donor-site

Diagnostic Test: Duplex ultrasound

Interventions

Duplex ultrasound DIAGNOSTIC_TEST

Duplex ultrasound of lower extremity venous system

1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• see study population description

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• University of Utah: collaborator

Study Sites (1)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 30907811 DERIVED

MeSH Terms

Conditions

Venous Thromboembolism

Interventions

Ultrasonography, Doppler, Duplex

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography, Doppler; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Arash Momeni, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Study Record Dates

• First Submitted: January 23, 2017
• First Posted: January 25, 2017
• Study Start: January 30, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: May 1, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)