Cargando…

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 satisfactio...

Descripción completa

Detalles Bibliográficos
Autores principales: Haloua, Max H., Volders, José H., Krekel, Nicole M. A., Lopes Cardozo, Alexander M. F., de Roos, Wifred K., de Widt-Levert, Louise M., van der Veen, Henk, Rijna, Herman, Bergers, Elisabeth, Jóźwiak, Katarzyna, Meijer, Sybren, van den Tol, M. Petrousjka
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer US 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4695494/
https://www.ncbi.nlm.nih.gov/pubmed/26486999
http://dx.doi.org/10.1245/s10434-015-4906-4
_version_ 1782407648581255168
author Haloua, Max H.
Volders, José H.
Krekel, Nicole M. A.
Lopes Cardozo, Alexander M. F.
de Roos, Wifred K.
de Widt-Levert, Louise M.
van der Veen, Henk
Rijna, Herman
Bergers, Elisabeth
Jóźwiak, Katarzyna
Meijer, Sybren
van den Tol, M. Petrousjka
author_facet Haloua, Max H.
Volders, José H.
Krekel, Nicole M. A.
Lopes Cardozo, Alexander M. F.
de Roos, Wifred K.
de Widt-Levert, Louise M.
van der Veen, Henk
Rijna, Herman
Bergers, Elisabeth
Jóźwiak, Katarzyna
Meijer, Sybren
van den Tol, M. Petrousjka
author_sort Haloua, Max H.
collection PubMed
description 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 (p(trend) = 0.002); a volume >40 cc showed odds 2.78-fold higher for a worse outcome than a volume ≤40 cc. USS resulted in higher patient satisfaction compared with PGS. CONCLUSION: 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.
format Online
Article
Text
id pubmed-4695494
institution National Center for Biotechnology Information
language English
publishDate 2015
publisher Springer US
record_format MEDLINE/PubMed
spelling pubmed-46954942016-01-07 Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT) Haloua, Max H. Volders, José H. Krekel, Nicole M. A. Lopes Cardozo, Alexander M. F. de Roos, Wifred K. de Widt-Levert, Louise M. van der Veen, Henk Rijna, Herman Bergers, Elisabeth Jóźwiak, Katarzyna Meijer, Sybren van den Tol, M. Petrousjka Ann Surg Oncol Breast Oncology 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 (p(trend) = 0.002); a volume >40 cc showed odds 2.78-fold higher for a worse outcome than a volume ≤40 cc. USS resulted in higher patient satisfaction compared with PGS. CONCLUSION: 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. Springer US 2015-10-20 2016 /pmc/articles/PMC4695494/ /pubmed/26486999 http://dx.doi.org/10.1245/s10434-015-4906-4 Text en © The Author(s) 2015 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
spellingShingle Breast Oncology
Haloua, Max H.
Volders, José H.
Krekel, Nicole M. A.
Lopes Cardozo, Alexander M. F.
de Roos, Wifred K.
de Widt-Levert, Louise M.
van der Veen, Henk
Rijna, Herman
Bergers, Elisabeth
Jóźwiak, Katarzyna
Meijer, Sybren
van den Tol, M. Petrousjka
Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT)
title Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT)
title_full Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT)
title_fullStr Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT)
title_full_unstemmed Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT)
title_short Intraoperative Ultrasound Guidance in Breast-Conserving Surgery Improves Cosmetic Outcomes and Patient Satisfaction: Results of a Multicenter Randomized Controlled Trial (COBALT)
title_sort intraoperative ultrasound guidance in breast-conserving surgery improves cosmetic outcomes and patient satisfaction: results of a multicenter randomized controlled trial (cobalt)
topic Breast Oncology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4695494/
https://www.ncbi.nlm.nih.gov/pubmed/26486999
http://dx.doi.org/10.1245/s10434-015-4906-4
work_keys_str_mv AT halouamaxh intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt
AT voldersjoseh intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt
AT krekelnicolema intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt
AT lopescardozoalexandermf intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt
AT derooswifredk intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt
AT dewidtlevertlouisem intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt
AT vanderveenhenk intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt
AT rijnaherman intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt
AT bergerselisabeth intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt
AT jozwiakkatarzyna intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt
AT meijersybren intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt
AT vandentolmpetrousjka intraoperativeultrasoundguidanceinbreastconservingsurgeryimprovescosmeticoutcomesandpatientsatisfactionresultsofamulticenterrandomizedcontrolledtrialcobalt