BREAST trial study protocol: evaluation of a non-invasive technique for breast reconstruction in a multicentre, randomised controlled trial.

INTRODUCTION: Pioneers have shown that it is possible to reconstruct a full breast using just autologous fat harvested by liposuction or autologous fat transfer (AFT). This study describes the first multicentre randomised study protocol to thoroughly investigate the effectiveness of AFT to reconstruct full breasts following mastectomy procedures (primarily and delayed). METHODS AND ANALYSIS: This study is designed as a multicentre, randomised controlled clinical superiority trial with a 1:1 allocation ratio. A total of 196 patients (98 patients per treatment arm) are aimed to be included. Patients who wish to undergo breast reconstruction with either one of the two techniques are randomly allocated into the AFT group (intervention) or the tissue-expander/prosthesis group (control). The primary outcome measure for the quality of life is measured by the validated BREAST-Q questionnaire. ETHICS AND DISSEMINATION: Approval for this study was obtained from the medical ethics committee of Maastricht University Medical Centre/Maastricht University; the trial has been registered at ClinicalTrials.gov. The results of this randomised controlled trial will be presented at scientific meetings as abstracts for poster or oral presentations and published in peer-reviewed journals. TRIAL STATUS: Enrolment into the trial has started in October 2015. Data collection and data analysis are expected to be completed in December 2021. TRIAL REGISTRATION NUMBER: NCT02339779.

"Scarless" umbilicoplasty: a new umbilicoplasty technique and a review of the English language literature.

Many techniques have been described for umbilicoplasty after abdominoplasty, but none of these techniques seems ideal. In this report, we wish to report a new "scarless" umbilicoplasty technique, which bears many of the characteristics of an ideal technique: it is easy to perform and results in the complete absence of visible scars and with a preferred vertical orientation. The aesthetic results of this technique are subjectively and objectively evaluated as compared with the classic umbilicoplasty and these results are discussed among the English language literature. In the period of 2004 to 2005, a series of 138 female patients have had an abdominoplasty with either the classic umbilicoplasty (n = 31) or with our scarless umbilicoplasty (n = 107). After a follow-up period of at least 3 (of 6) months, a questionnaire was send to all of these patients to evaluate patient satisfaction. Twenty-five patients from the classic umbilicoplasty group responded, 53 patients from the scarless umbilicoplasty group. Age (mean 45 with range, 22-66 years) and body mass index (29 with range, 22-35) did not differ among both groups. Also a random selection of fifteen photos from both groups was analyzed and rated according to the system of Strasser by an independent panel. There were no major complications in both groups, but in the classic group, there were some cases with hypertrophic scarring. Patients who underwent the scarless umbilicoplasty technique graded the appearance of their umbilicus significantly better on shape, depth, hygiene, and scar. No significant differences were found in grading size and wound healing. Objective evaluation of the photos demonstrated significant better results for the scarless umbilicoplasty technique. Based on our subjective and objective analysis we conclude that our new technique of the scarless umbilicoplasty features many of the characteristics of the ideal umbilicoplasty: a rather simple and reliable method for creating a natural looking umbilicus when performing an abdominoplasty.