Clinical trial NCT03031457: Microsurgical Breast Reconstruction & VTE
Official title: Microsurgical Breast Reconstruction - Identifying Procedure-Specific Risk Factors for Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Reconstruction
Venous Thromboembolism
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of Utah
First posted: 2017-01-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Vessel diameter (in cm)
timeFrame: 1 Day of discharge
measure: Cross-sectional area (in cm^2)
timeFrame: 1 Day of discharge
measure: Flow velocity (in cm/sec)
timeFrame: 1 Day of discharge
Secondary outcomes:
measure: 90-day VTE event
timeFrame: 90-day
measure: Abdominal hernia/bulge rate at 1 year postop
timeFrame: 1 year
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
affiliation: Stanford University
name: Arash Momeni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.