Clinical application of indocyanine green angiography in patients with early stage breast cancer undergoing mastectomy and reconstruction with autologous tissue

Abstract

Background Breast cancer is a major health concern worldwide. Patients diagnosed with early breast cancer undergo breast surgery as part of their treatment strategy. Mastectomy surgeries can result in a reduced quality of life and, for this reason, are often followed by immediate breast reconstruction. Many plastic surgeons consider the use of autologous tissue to be the gold standard. However, breast reconstruction with autologous tissue can result in significant complications such as tissue necrosis, which consequently requires revision surgeries and can worsen patient satisfaction and quality of life. Objectives To compare the difference in the rate of necrosis after breast reconstruction

with autologous tissue between a group of patients studied with indocyanine green an- giography in the peri-operative period versus a control group undergoing conventional

surgery. To evaluate the quality of life and patient satisfaction between the two groups. Design and methods This study is a multicentre randomized single-blind clinical trial between two groups of patients. The experimental group will be studied intra-operatively with indocyanine green angiography, thus flap delineation will be guided by the images provided by this method. The control group will undergo surgery without prior imaging, and flap design will be based on theoretical vascular knowledge. Surgeons will complete a

data collection form detailing the breast reconstruction and complications during follow- up and patients will be administered three quality of life questionnaires.

Study participants Both groups will be integrated by 225 patients between 25 and 65 years of age, suffering from early stage breast cancer and tributary to mastectomy and breast reconstruction with autologous tissue.

Statistical analysis We will perform a univariate, bivariate and multivariate analysis, tak- ing a 95% confidence interval and a p-value ≤0.05 for clinical significance