Microsurgical Breast Reconstruction & VTE

• ClinicalTrials.gov Identifier: NCT03031457
• Recruitment Status: Completed
• First Posted: January 25, 2017
• Last Update Posted: May 1, 2018
• Sponsor: Stanford University
• Collaborator: University of Utah
• Information provided by (Responsible Party): Arash Momeni, Stanford University

Tracking Information

• First Submitted Date: January 23, 2017
• First Posted Date: January 25, 2017
• Last Update Posted Date: May 1, 2018
• Actual Study Start Date: January 30, 2017
• Actual Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 24, 2017)

• Vessel diameter (in cm) [ Time Frame: 1 Day of discharge ]
• Cross-sectional area (in cm^2) [ Time Frame: 1 Day of discharge ]
• Flow velocity (in cm/sec) [ Time Frame: 1 Day of discharge ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 24, 2017)

• 90-day VTE event [ Time Frame: 90-day ]
• Abdominal hernia/bulge rate at 1 year postop [ Time Frame: 1 year ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Microsurgical Breast Reconstruction & VTE
• Official Title: Microsurgical Breast Reconstruction - Identifying Procedure-Specific Risk Factors for Venous Thromboembolism

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Breast Reconstruction
• Venous Thromboembolism

Intervention

Diagnostic Test: Duplex ultrasound

Duplex ultrasound of lower extremity venous system

Study Groups/Cohorts

1

Patients undergo primary fascial closure of abdominal donor-site

Intervention: Diagnostic Test: Duplex ultrasound

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 29, 2018): 30
• Original Estimated Enrollment (submitted: January 24, 2017): 74
• Actual Study Completion Date: December 15, 2017
• Actual Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Female

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03031457
• Other Study ID Numbers: 39855
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Arash Momeni, Stanford University
• Study Sponsor: Stanford University
• Collaborators: University of Utah

Investigators

• Principal Investigator: Arash Momeni, MD; Stanford University

• PRS Account: Stanford University
• Verification Date: April 2018