Intraoperative ultrasound guidance in breast-conserving surgery shows superiority in oncological outcome, long-term cosmetic and patient-reported outcomes: Final outcomes of a randomized controlled trial (COBALT).

BACKGROUND: The multicenter randomized controlled COBALT trial demonstrated that ultrasound-guided breast-conserving surgery (USS) results in a significant reduction of margin involvement (3.1% vs. 13%) and excision volumes compared to palpation-guided surgery (PGS). The aim of the present study was to determine long term oncological and patient-reported outcomes including quality of life (QoL), together with their progress over time. METHODS: 134 patients with T1-T2 breast cancer were randomized to USS (N = 65) or PGS (N = 69). Cosmetic outcomes were assessed with the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software, panel-evaluation and patient self-evaluation on a 4-point Likert-scale. QoL was measured using the EORTC QLQ-C30/-BR23 questionnaire. RESULTS: No locoregional recurrences were reported after mean follow-up of 41 months. Seven patients (5%) developed distant metastatic disease (USS 6.3%, PGS 4.4%, p = 0.466), of whom six died of disease (95.5% overall survival). USS achieved better cosmetic outcomes compared to PGS, with poor outcomes of 11% and 21% respectively, a result mainly attributable to mastectomies due to involved margins following PGS. There was no difference after 1 and 3 years in cosmetic outcome. Dissatisfied patients included those with larger excision volumes, additional local therapies and worse QoL. Patients with poor/fair cosmetic outcomes scored significantly lower on aspects of QoL, including breast-symptoms, body image and sexual enjoyment. CONCLUSION: By significantly reducing positive margin status and lowering resection volumes, USS improves the rate of good cosmetic outcomes and increases patient-satisfaction. Considering the large impact of cosmetic outcome on QoL, USS has great potential to improve QoL following breast-conserving therapy.

Adherence to Enhanced Recovery After Surgery and length of stay after colonic resection.

AIM: The Enhanced Recovery After Surgery (ERAS) programme is a multimodal approach to improve peri-operative care in colon surgery. The aim of this study was to report on the adherence to and outcomes of ERAS in the first years after implementation. METHOD: Data of patients undergoing elective colon resections for malignancy in 2006 until 2010 were compared with patients receiving conventional care in 2005. Retrospective analysis was performed including length of stay (LOS), protocol adherence and complications. The predictive values of ERAS items and baseline characteristics on LOS and complications were analysed using univariate and multivariate analysis. RESULTS: Length of stay (LOS) was significantly shorter in 2006 and 2007 (P ≤ 0.009 and P ≤ 0.004) but not in 2008 and 2009. The mean adherence rate to the ERAS items was 84.1% in 2006 and 2007 and 72.4% in 2008 and 2009 (P < 0.001). In 2005, 2008 and 2009 LOS was significantly shorter for laparoscopically operated patients than for patients with open resections (P < 0.002, P < 0.001 and P < 0.004 respectively). Multivariate analysis showed that age, laparoscopic surgery, removal of nasogastric tube before extubation, mobilization within 24 h after surgery, starting nonsteroidal anti-inflammatory drugs at day 1 and removal of thoracic epidural analgesia at day 2 were independent predictors of LOS. CONCLUSION: Strict adherence to the ERAS protocol was associated with reduced LOS and improved outcome in elective colon surgery for malignancy. These benefits were lost when protocol adherence was lower. Embedding the ERAS protocol into an organization and repetitive education are vital to sustain its beneficial effects on LOS and outcome.

Ultrasound-guided surgery for palpable breast cancer is cost-saving: results of a cost-benefit analysis.

Ultrasound-guided surgery (USS) has recently been proven to result in a significant reduction of tumour-involved surgical margins, for patients with palpable invasive breast cancer. The objective of this economic evaluation alongside a randomised trial was to evaluate the costs and benefits of USS compared to palpation-guided surgery (PGS). The hospital perspective was used. On the cost side of the analysis, resource use related to baseline treatment was taken into account and on the benefit side, resource use related to additional treatments was included. On the cost side, the difference in costs per patient was €193 (95% CI €153-€233) with higher costs in the USS group. On the benefit side, the difference in costs per patient was -€349 (95% CI -€591 to -€103) with higher costs in the PGS group. This resulted in a cost decrease of -€154 (95% CI -€388 to €81) in the USS group compared to the PGS group. Intra-operative use of a US system during BCS reduces the rate of tumour-involved margins and thereby the costs of additional treatments.

Optimising surgical accuracy in palpable breast cancer with intra-operative breast ultrasound--feasibility and surgeons' learning curve.

AIMS: To evaluate if intra-operative guidance with ultrasonography (US) could improve surgical accuracy of palpable breast cancer excision, and to evaluate the performance of surgeons during training for US-guided excision. MATERIALS AND METHODS: Thirty female patients undergoing breast-conserving surgery for palpable T1-T2 invasive breast cancer were recruited. Three individual breast surgeons, assisted by US, targeted and excised the tumours. The main objective was to obtain adequate resection margins with optimal resection volumes. The specimen volume, tumour diameter and histological margin status were recorded. The specimen volume was divided by the optimal resection volume, defined as the spherical tumour volume plus a 1.0-cm margin. The resulting calculated resection ratio (CRR) indicated the amount of excess tissue resected. RESULTS: All tumours were correctly identified during surgery, 29 of 30 tumours (96.7%) were removed with adequately negative margins, and one tumour was removed with focally positive margins. The median CRR was 1.0 (range, 0.4-2.8), implying optimal excision volume. For all breast surgeons, CRR improved during the training period. By the 8th procedure, all surgeons showed proficiency in performing intra-operative breast US. CONCLUSION: Surgeons can easily learn the skills needed to perform intra-operative US for palpable breast tumour excision. The technique is non-invasive, simple, safe and effective for obtaining adequate resection margins. Within the first two cases, resections reached optimal volumes, thereby, presumably resulting in improved cosmetic outcomes. In a multicentre, randomised, clinical trial, intra-operative US guidance for palpable breast tumours will be evaluated for oncological and cosmetic outcomes.