120 Chapter 8 Another recently published study protocol is the PROFAS study, a double blinded, prospective, randomized controlled pilot study, including patients who are opting for bilateral prophylactic mastectomies in the Academic Breast Cancer Centre Rotterdam, with a within-subject design.16 The PF will be preserved in one breast, and in the other breast, the PF will be removed. The focus of the study is to assess the impact of PF removal versus preservation on seroma formation and drain policy, and it is hypothesized that PF preservation will decrease seroma, drain volume and postoperative complications. The study started in 2021 but due to the COVID-19 pandemic, prophylactic mastectomies were postponed, and inclusion is still in progress. The influence of PF preservation on seroma formation has already been studied in two RCT’s included in the previous mentioned systematic review in chapter 3. The incidence of seroma was reduced (31% vs 39.8%) in the PF preservation group in the study of Dalberg et al., but these differences were not statistically significant.9 In the study of Abdelhamid et al., the PF preservation group showed a significantly lower rate of seroma formation—5.6% vs. 24.3%.8 Unfortunately, this study did not define seroma, so the outcomes of the PROFAS study will hopefully provide more evidence for this specific outcome. An advantage of the PROFAS study is the small sample size (21 patients) because of the within-subject design, which eliminates all confounders (apart from the performing surgeon and left/right dominance). Unfortunately, the results will be unable to address the oncological safety of PF preservation, because the population only consist of women opting for bilateral prophylactic mastectomies. Except for the studies included in the systematic review, in which no significant differences in oncological outcomes (local recurrence, regional recurrence, or distant metastasis) were found and the study of Mohamed et al,13 no other recent, large studies have been published on the oncological safety of PF preservation. Because of this, our study group developed the ‘PRESERVED’ study protocol, a multicentre RCT of patients undergoing a mastectomy with either PF removal or PF preservation, followed by a direct two-stage reconstruction. A total of 354 patients were required, with 177 patients in each group. Unfortunately, after multiple attempts, we were not able to receive sufficient funding to perform this trial. The nation-wide survey included in this thesis shows that oncological safety is the primary reason for surgeons and plastic surgeons in the Netherlands to remove the PF, even though there is no evidence for this statement in the present literature.17 One in five breast surgeons reported that the PF was only preserved in cases when the tumor was placed at a safe distance from the fascia, which varied between 1 mm and 2 cm. This suggests that there is no agreement on what constitutes a “safe distance” in this situation. Previous studies showed that
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