Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and XXXX Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT).

@entity1 @entity1104 @entity0
BACKGROUND: @entity0 ( @entity0 ) results in a significant reduction in both margin involvement and excision volumes (COBALT trial). OBJECTIVE: The aim of the present study was to determine whether @entity0 also leads to improvements in cosmetic outcome and @entity1 satisfaction when compared with standard @entity1104 ( @entity1104 ). METHODS: A total of 134 @entity1 with T1-T2 @entity0 were included in the COBALT trial (NTR2579) and randomized to either @entity0 (65 @entity1 ) or @entity1104 (69 @entity1 ). Cosmetic outcomes were assessed by a three-member panel using computerized software Breast Cancer Conservative Treatment cosmetic results (BCCT.core) and by @entity1 self-evaluation, including @entity1 satisfaction. Time points for follow-up were 3, 6, and 12  months after surgery. Overall cosmetic outcome and @entity1 satisfaction were scored on a 4-point Likert scale (excellent, good, fair, or poor), and outcomes were analyzed using a multilevel, mixed effect, proportional odds model for ordinal responses. RESULTS: @entity0 achieved better cosmetic outcomes, with 20  % excellence overall and only 6  % rated as poor, whereas 14  % of @entity1104 outcomes were rated excellent and 13  % as poor. @entity0 also had consistently lower odds for worse cosmetic outcomes (odds ratio 0.55, p  =  0.067) than @entity1104 . The chance of having a worse outcome was significantly increased by a larger lumpectomy volume (p trend  =  0.002); a volume >40  cc showed odds 2.78-fold higher for a worse outcome than a volume  <=40  cc. @entity0 resulted in higher @entity1 satisfaction compared with @entity1104 . CONCLUSION: @entity0 achieved better overall cosmetic outcomes and @entity1 satisfaction than @entity1104 . Lumpectomy volumes  >40  cc resulted in significantly worse cosmetic outcomes.
