Mammaplasty Clinical Trial
— CDUxCTAOfficial title:
Accuracy of Deep Inferior Epigastric Artery Perforator Mapping - Color Doppler Ultrasound Versus CT Angiography: A Randomized Controlled Trial
Verified date | January 2023 |
Source | St. Anne's University Hospital Brno, Czech Republic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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].
Status | Completed |
Enrollment | 60 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Czechia | St. Anne´s University Hospital Brno | Brno |
Lead Sponsor | Collaborator |
---|---|
St. Anne's University Hospital Brno, Czech Republic | Masaryk University |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The average deviations (?) in localization of perforators in each of the groups [cm] | In CDU group ?CDU calculated for each dissected perforator as the Euclidean distance between (before the surgery, using CDU) mapped XY coordinates and the reference XY coordinates measured during the surgery. XY[0;0]=umbilicus
In CTA+CDU group ?CTU (because XY coordinates in this group are deducted only based on CTA, CDU in this group is used only as an additional modality to help predict the dissection category A, B, C not to deduct XY coordinates) calculated for each dissected perforator as the Euclidean distance between (before the surgery, using CTA) mapped XY coordinates and the reference XY coordinates measured during the surgery. XY[0;0]=umbilicus |
Through study completion, an average of 1 year | |
Primary | The success rate in estimating proper dissecting strategy [%] | In what percentage of cases the finally dissected flap category (A, B, C) is the same as the category estimated before the surgery based on CDU or CTA+CDU mapping. | Through study completion, an average of 1 year | |
Secondary | The time duration of the CDU examination. | The time duration of the CDU examination was measured. | 3 months post-operative | |
Secondary | Fat Necrosis of the flap | Detected using clinical examination. Assessment for fat necrosis took place 3 months postoperatively by another plastic surgeon who was therefore blinded to the mapping method. | 3 months post-operative | |
Secondary | Flap Loss | Partial flap loss defined as tissue loss greater than 5 percent of the flap or clinically manifested fat necrosis. Total flap loss was also assessed. These assessments were done during regular follow-up appointments with the care team. | 1 week post-op, 2 weeks post-op, 6-8 weeks post-op and 3 months post-op |
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