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Completed
NCT05687006
Accuracy of Deep Inferior Epigastric Artery Perforator Mapping - Color Doppler Ultrasound Versus CT Angiography
Conditions: Mammaplasty
Sex: Female
Ages: 18 Years – 65 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 60
Sponsor: St. Anne's University Hospital Brno, Czech Republic
Location: Czechia
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].
Eligibility Criteria
Inclusion Criteria:female;aged 18 to 65 years;undergoing uni- or bilateral breast free flap reconstruction harvested from the lower abdomen;signed informed consent to participate in the study.Exclusion Criteria:history of allergy to iodinated contrast material;history of abdominoplasty;Body Mass index > 35;active oncological disease ;Karnofsky Performance Status < 50;change of the reconstructive method as a result of the preoperative mapping;non-standard performed CTA examination.
Source: ClinicalTrials.gov (NCT05687006). StuddyBuddy aggregates publicly available trial information.