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Accuracy of Deep Inferior Epigastric Artery Perforator Mapping - Color Doppler Ultrasound Versus CT Angiography

NCT05687006 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-01-17

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the accuracy and contribution of Color Doppler Ultrasound (CDU) guided Deep Inferior Epigastric Artery (DIEA) perforator mapping with or without mapping using Computer Tomography angiography (CTA) in women over 18 years undergoing 2021 unilateral or bilateral breast reconstruction with an abdominal free flap.

Participants underwent scheduled reconstruction of one or both breasts with a free flap transferred from the lower abdomen. If there is a comparison group: Researchers compared interventional groups - examined using preoperative CTA of the abdominal wall supplemented with an examination of the perforators using CDU (active comparator group), and examined exclusively by using the CDU (experimental group), to see the comparison of the accuracy and contribution of CDU-guided DIEA perforator mapping with CTA mapping.

The hypothesis is that CDU examination alone is not inferior to CTA examination supplemented with parameters that CTA does not show (flow velocity, vessel diameters), by measuring these parameters with CDU.

The main questions it aims to answer are:

* To evaluate the comparison of the accuracy of surgeon-conducted CDU perforator mapping in defining the significant/dominant perforators and their exact location \[XY coordinates\] with the accuracy of CTA mapping.
* To compare the time duration of the CDU examination was measured.
* To measure the Fat Necrosis of the flap \[3 months postoperative \]
* To measure the Flap Loss \[1-week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op\].

Conditions

  • Mammaplasty

Interventions

PROCEDURE

Colour Doppler Ultrasound

The main perforators were examined using a LOGIQ S8/V1 CDU device (GE Healthcare, Chalfont St Giles, Great Britain) with a linear transducer of frequency 4-11 MHz. Measured parameters were: 1) calibre of artery and vein; 2) Peak systolic velocity (PSV) of blood in the artery \[cm/s\]; 3) blood velocity in the perforator vein \[cm/s\]; 2) the thickness of the subcutaneous tissue of the lower abdomen measured 4 cm caudal and lateral to the umbilicus. Any additional perforators were marked nor have CTA deducted XY coordinates of marked perforators changed based on the CDU examination. The same sonography surgeon performed all CDU examinations. The time duration of the CDU examination was measured.

Sponsors & Collaborators

  • Masaryk University

    collaborator OTHER

  • St. Anne's University Hospital Brno, Czech Republic

    lead OTHER

Principal Investigators

  • Libor Streit, MD, PhD. · St. Anne´s University Hospital Brno

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05687006 on ClinicalTrials.gov