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 reconstruction was initiated in 1994. The methods were: the lateral thoracodorsal flap, the latissimus dorsi flap, and the pedicled transverse rectus abdominis muscle flap. In the present paper we describe the study design, primary endpoints, and inclusion and exclusion criteria. Results from preoperative questionnaires about problems after mastectomy and expectations of the reconstruction are presented. The preoperative questionnaires, completed before randomisation, included a health related quality of life questionnaire, the SF-36, and a questionnaire concerning the impact of breast loss and expectations of the reconstruction. A total of 87 patients have been randomised in SVEA and 30 patients have been followed up outside the randomised study, comprising a reference group. The results from preoperative questionnaires, completed by 106 of the total 117 women, showed that they encountered many problems after mastectomy, primarily about feeling mutilated and being bothered socially. They held high expectations on the breast reconstruction in these areas. The women in the present study did not differ from Swedish women in general regarding health related quality of life, with two exceptions: the study sample scored lower on physical functioning and mental health.

RCT Entities:   Population Interventions Outcomes