CT-Angiography Prior to DIEP Flap Breast Reconstruction

CT-Angiography Prior to DIEP Flap Breast Reconstruction a Randomized Controlled Trial

This study will Investigate whether or not preoperative computed tomography (CT) angiography will lower operative times and post operative complications for breast reconstruction performed with a deep inferior epigastric artery perforator flap (DIEP).

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Preoperative CT angiography; Other: No Preoperative Imaging

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Anschutz Medical Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Planning breast reconstruction with DIEP flap
• Age 18 to 75 years

Exclusion Criteria:

• Mild to moderate loss of kidney function (Estimated Glomerular Filtration Rate (eGFR) < 60)
• Decisionally challenged
• Pregnant
• Hepatic failure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preoperative CT Angiography; Patients will receive preoperative CT angiography to map the blood vessels potentially used for reconstruction	Other: Preoperative CT angiography; Patients will receive a CT scan to map the blood vessels to be used during surgery for breast reconstruction
Active Comparator: No Imaging Preoperatively; No preoperative vessel mapping will be done	Other: No Preoperative Imaging; No imaging will be done to map blood vessels prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Operative Time	Time required to perform breast reconstruction with DIEP flap	Time of incision to incision closure

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: David W Mathes, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): March 1, 2020

Study Registration Dates

• First Submitted: August 25, 2016
• First Submitted That Met QC Criteria: August 25, 2016
• First Posted (Estimate): August 30, 2016

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: DIEP flap; Deep inferior epigastric artery perforator flap
• Other Study ID Numbers: 15-2448

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No