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Microsurgical Breast Reconstruction & VTE

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


Condition or disease Intervention/treatment
Breast Reconstruction Venous Thromboembolism Diagnostic Test: Duplex ultrasound

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Microsurgical Breast Reconstruction - Identifying Procedure-Specific Risk Factors for Venous Thromboembolism
Actual Study Start Date : January 30, 2017
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : December 15, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1
Patients undergo primary fascial closure of abdominal donor-site
Diagnostic Test: Duplex ultrasound
Duplex ultrasound of lower extremity venous system




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

Secondary Outcome Measures :
  1. 90-day VTE event [ Time Frame: 90-day ]
  2. Abdominal hernia/bulge rate at 1 year postop [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03031457


Locations
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
University of Utah
Investigators
Principal Investigator: Arash Momeni, MD Stanford University

Responsible Party: Arash Momeni, Assistant Professor of Surgery, Stanford University
ClinicalTrials.gov Identifier: NCT03031457     History of Changes
Other Study ID Numbers: 39855
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases