A prospective randomised study (named SVEA) of three methods of delayed breast reconstruction. Study design, patients' preoperative problems and expectations

A randomised study named SVEA to compare three methods for delayed breast r econstruction was initiated in 1994. The methods were: the lateral thoracod orsal flap, the latissimus dorsi flap, and the pedicled transverse rectus a bdominis muscle flap. In the present paper we describe the study design, pr imary endpoints, and inclusion and exclusion criteria. Results from preoper ative questionnaires about problems after mastectomy and expectations of th e reconstruction are presented. The preoperative questionnaires, completed before randomisation, included a health related quality of life questionnai re, the SF-36, and a questionnaire concerning the impact of breast loss and expectations of the reconstruction. A total of 87 patients have been rando mised in SVEA and 30 patients have been followed up outside the randomised study, comprising a reference group. The results from preoperative question naires, completed by 106 of the total 117 women, showed that they encounter ed many problems after mastectomy, primarily about feeling mutilated and be ing bothered socially. They held high expectations on the breast reconstruc tion in these areas. The women in the present study did not differ from Swe dish women in general regarding health related quality of life, with two ex ceptions: the study sample scored lower on physical functioning and mental health.