20 Chapter 2 METHODS Study design This study was designed as a prospective single center study, including all patients who underwent OPS (volume replacement or volume displacement) for breast cancer between January 2017 and December 2020 at the Alrijne Hospital in the Netherlands. Ethical considerations The study protocol was approved by the local institutional ethical review board (N21.053) and informed consent was obtained from all participants. The study was conducted in accordance with the Declaration of Helsinki and reported according to the strengthening the reporting of observational studies in epidemiology (STROBE) statement.12, 13 Surgical technique All patients were operated by four plastic surgeons. For volume displacement, the Wise or Grisotti technique was used.11, 14 For volume replacement, the TDAP flap or bilobed swing flap was used.10 15 Complications and definitions All complications were collected in a prospective manner. Postoperative complications (seroma, hematoma, surgical site infection (SSI), wound dehiscence and necrosis) were graded according to Clavien-Dindo classification (CD).16 In this study, for grade 1 complications, the normal postoperative course was not deviated and no interventions were necessary. Grade 2 complications required pharmacological treatment with antibiotics. Grade 3 complications required surgical drainage. Clinically relevant postoperative complications were defined as complications with a CD score of 2 or more. BREAST-Q Patient reported quality of life and satisfaction was measured with the BREAST-Q breast conserving therapy (BCT) module, which was sent online to all participating patients (Castor EDC). The BREAST-Q is a validated, disease-specific patient reported outcome measure and patient reported experience measure to assess patient satisfaction and health-related quality of life.17 Responses from each scale were summed and transformed into Q-scores ranging from 0 to 100, with higher numbers representing greater satisfaction or quality of life. Patient reported cosmetic outcomes Patients received an online questionnaire for self-assessment of cosmetic outcomes. Participants were asked to provide a score, from 1-4 (1: poor, 2: fair, 3:
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