Intraoperative Ultrasound Guidance in Breast-Conserving  Surgery Improves Cosmetic Outcomes and Patient Satisfaction:  Results of a Multicenter Randomized Controlled Trial (COBALT).
BACKGROUND
Ultrasound-guided breast-conserving surgery (USS) 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 USS also leads to improvements in cosmetic outcome and patient satisfaction when compared with standard palpation-guided surgery (PGS).


METHODS
A total of 134 patients with T1–T2 invasive breast cancer were included in the COBALT trial (NTR2579) and randomized to either USS (65 patients) or PGS (69 patients). Cosmetic outcomes were assessed by a three-member panel using computerized software Breast Cancer Conservative Treatment cosmetic results (BCCT.- core) and by patient self-evaluation, including patient satisfaction. Time points for follow-up were 3, 6, and 12 months after surgery. Overall cosmetic outcome and patient 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
Ultrasound-guided breast-conserving surgery achieved better cosmetic outcomes, with 20 % excellence overall and only 6 % rated as poor, whereas 14 % of PGS outcomes were rated excellent and 13 % as poor. USS also had consistently lower odds for worse cosmetic outcomes (odds ratio 0.55, p = 0.067) than PGS. The chance of having a worse outcome was significantly increased by a larger lumpectomy volume (ptrend = 0.002); a volume [40 cc showed odds 2.78-fold higher for a worse outcome than a volume B40 cc. USS resulted in higher patient satisfaction compared with PGS.


CONCLUSIONS
Ultrasound-guided breast-conserving surgery achieved better overall cosmetic outcomes and patient satisfaction than PGS. Lumpectomy volumes[40 cc resulted in significantly worse cosmetic outcomes.
Max H
MH
Haloua
José H
JH
Volders
Nicole M A
NM
Krekel
Alexander M F
AM
Lopes Cardozo
Wifred K
WK
de Roos
Louise M
LM
de Widt-Levert
Henk
H
van der Veen
Herman
H
Rijna
Elisabeth
E
Bergers
Katarzyna
K
Jóźwiak
Sybren
S
Meijer
Petrousjka
P
van den Tol
D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology / Q000601:surgery*; D003357:Cosmetic Techniques / Q000295:instrumentation*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007430:Intraoperative Care; D015412:Mastectomy, Segmental; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D009367:Neoplasm Staging; D017060:Patient Satisfaction; D011379:Prognosis; D011788:Quality of Life; D025321:Surgery, Computer-Assisted; D016217:Ultrasonography, Mammary