CT-Angiography Prior to DIEP Flap Breast Reconstruction

NCT ID: NCT02883387

Last Updated: 2022-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-03-01

Brief Summary

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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).

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preoperative CT Angiography

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

Group Type EXPERIMENTAL

Preoperative CT angiography

Intervention Type OTHER

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

No Imaging Preoperatively

No preoperative vessel mapping will be done

Group Type ACTIVE_COMPARATOR

No Preoperative Imaging

Intervention Type OTHER

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

Interventions

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Preoperative CT angiography

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

Intervention Type OTHER

No Preoperative Imaging

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David W Mathes, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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15-2448

Identifier Type: -

Identifier Source: org_study_id

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