Ultrasound-guided breast-sparing surgery to improve cosmetic outcomes and quality of life. A prospective multicentre randomised controlled clinical trial comparing ultrasound-guided surgery to traditional palpation-guided surgery (COBALT trial)

Table 1 Outcome Parameters

Patient	Age
	Race
	Breast size
	Medical history
Pre-operative	Experience of the surgeon
	Complications
	Duration of the procedure
	Cost of the procedure
	Type of surgery in the axilla (SN or ALND)
	Adequate margins based on US ex vivo
	Specimen volume (fluid displacement
Histological	Surgical specimen volume
	Tumour volume (diameter) within the specimen
	Margin status
	Shortest distance to the nearest resection margin
Adjuvant therapy	Radiotherapy (dose, boost)
	Chemotherapy
	Hormonal therapy
Two weeks post-operatively	(Wound) complications
Three and six months post-operatively	Cosmetic outcome measurements
	Quality of life (questionnaires)

ISSN: 1471-2482