Abstract

This paper presents the results of a randomized controlled trial (RCT) that focus on health-related quality-of-life (QoL) and patient-reported satisfaction following breast reconstruction with pedicled flaps from the back. We included women for unilateral delayed breast reconstruction. Patients were randomized to reconstruction by either a latissimus dorsi (LD) flap or a thoracodorsal artery perforator (TAP) flap. Assessment of QoL and patient satisfaction was made using two different patient-reported outcome measures (PROMs): The EORTC QLQ-30 and the Breast-Q questionnaire for post-mastectomy breast reconstruction. A total of 50 women were enrolled over a two-year period and allocated to reconstruction. Forty patients completed both surgery and follow-up and were included in the analysis - 18 in the LD group and 22 in the TAP group. The EORTC QLQ-30 was administered at the baseline and at one-year follow-up. There was no significant effect of introducing the TAP flap on either the summary score, the global QoL-score or the financial impact-score when compared to the LD flap. The Breast-Q questionnaire was administered only at one-year follow-up. There was no significant difference between the two groups for the scores for satisfaction with the reconstructed breast, the overall outcome and QoL related to psycho-social, sexual and physical well-being. Women from both groups report high satisfaction and QoL following the reconstruction. The quality of the dataset and the study design are, however, insufficient to rule out any existing difference. A larger cohort, longer follow-up and different design are warranted to assess the true clinical significance these reconstructions might have on satisfaction and QoL.

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