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Updated: Jul 10, 2026
Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
Reduction mammaplasty is effective treatment according to two quality of life instruments. A prospective randomised
Kai M M Saariniemi1, Ulla H Keranen, Paivi K Salminen-Peltola
1Department of Plastic Surgery, Helsinki University Central Hospital, HUS, Finland. kai.saariniemi@helsinki.fi
Purpose:
Debate around reduction mammaplasty has continued due to lack of prospective randomised clinical trials (RCTs). Therefore, a prospective randomised clinical trial was designed to assess the effectiveness of reduction mammaplasty performed for symptomatic breast hypertrophy.
Patients And Methods:
82 patients were randomised, 40 patients to the operative group, and 42 patients to the nonoperative group. Groups were examined at 0 and 6 months. Instruments used were the Short Form-36 quality of life questionnaire (SF-36), the 15D quality of life questionnaire, the Finnish Breast-Associated Symptoms questionnaire (FBAS), and the Finnish Pain Questionnaire (FPQ). Analysis of covariance (ANCOVA) was applied for instrumental data comparison.
Results:
29 patients in the operative group and 35 patients in the nonoperative group completed the study. Mean age was 46 years. At second examination, the utility index score (SF-6D) and the physical summary score of SF-36, the index score of 15D, the breast-associated symptoms score of FBAS, and the pain score of FPQ demonstrated high significant statistical (P<0.0001) and clinical difference between groups. For the mental summary score of SF-36 findings were less significant statistically and clinically.
Conclusions:
Reduction mammaplasty results in significant improvement of quality of life and decrease in pain and breast-associated symptoms. Future studies should be focused on patient selection and justification of the treatment by comparing with other approved treatments.