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Microsurgical Breast Reconstruction & VTE

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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
Change History
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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