NCT02883387

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

3.5 years

First QC Date

August 25, 2016

Last Update Submit

February 22, 2022

Conditions

Breast Cancer

Keywords

DIEP flapDeep inferior epigastric artery perforator flap

Outcome Measures

Primary Outcomes (1)

  • Total Operative Time

    Time required to perform breast reconstruction with DIEP flap

    Time of incision to incision closure

Study Arms (2)

Preoperative CT Angiography

EXPERIMENTAL

Patients will receive preoperative CT angiography to map the blood vessels potentially used for reconstruction

Other: Preoperative CT angiography

No Imaging Preoperatively

ACTIVE COMPARATOR

No preoperative vessel mapping will be done

Other: No Preoperative Imaging

Interventions

Preoperative CT angiographyOTHER

Patients will receive a CT scan to map the blood vessels to be used during surgery for breast reconstruction

Preoperative CT Angiography
No Preoperative ImagingOTHER

No imaging will be done to map blood vessels prior to surgery

No Imaging Preoperatively

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • David W Mathes, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2016

First Posted

August 30, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2020

Study Completion

March 1, 2020

Last Updated

February 24, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)