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Randomized Controlled Trial Comparing Health-Related Quality of Life in Patients Undergoing Vertical Scar versus Inferior Pedicle Technique for Reduction Mammoplasty
Achilleas Thoma, MD, MSc, Teegan A. Ignacy, BSc, Eric K. Duku, MSc, Robert S. Patterson, MD, Arianna Dal Cin, MD, Carolyn M. Levis, MD, Charles H. Goldsmith, PhD.
McMaster University, Hamilton, ON, Canada.

PURPOSE:
To compare health-related quality of life in women undergoing vertical scar (VS) and inferior pedicle (IP) reduction mammoplasty in government insured patients at 1 year post-op.
METHODS:
Two hundred and forty-nine patients were randomized using a centralized computer randomization system to either the VS or IP techniques immediately before surgery. Patients completed four validated instruments: a utility index, Health Utilities Index (HUI); a generic scale, the SF-36; and two specific scales, the Breast-Related Symptoms Questionnaire (BRSQ) and the Multidimensional Body-Self Relations Questionnaire (MBSRQ), at pre-op (1 week before surgery) and 1 year post-operatively. The utility and generic scales assess all aspects of the patients’ health-related quality of life while the BRSQ focuses on physical breast symptoms and the MBRSQ assesses body image. An intention-to-treat analysis was performed. This trial was registered on clinicaltrials.gov as NCT00149344.
RESULTS:
Patient characteristics at baseline are outlined in Table 1. No differences were observed between groups at baseline. Results of quality of life measurements are presented in Table 2. Patients undergoing both the VS and IP techniques gained a statistically significant and clinically important improvement from baseline to 1 year post-op in the HUI and the BRSQ.
There was improvement in patients undergoing both techniques in the SF-36 physical summary score, although this improvement did not meet the minimum clinically important difference of 10 points. No significant improvement was seen in the SF-36 mental summary score between baseline and 1 year post-op.
A statistically significant improvement was detected in both groups in the MBSRQ appearance evaluation domain, while no change was observed in the appearance orientation domain. Although a definite improvement was found in both techniques from baseline to 1 year post-op, which were statistically significant and clinically important, no statistical nor clinical differences were detected between the two techniques.
CONCLUSION:
There was a clinically important improvement between baseline and 1 year post-op in the VS and IP groups in the HUI. No differences were observed between the change from baseline to 1 year post-op between the VS and IP groups, therefore we conclude that the techniques are similar when quality of life is the outcome of interest.
Table 1. Patient characteristics
Vertical Scar
Mean (standard deviation)
Inferior Pedicle
Mean (standard deviation)
Age (years)41.9 (13.3)42.3 (16.8)
Body Mass Index (kg/m2)29.9 (5.7)28.4 (6.1)
Weight resected from left breast (g)450.0 (183.2)470.0 (184.2)
Weight resected from right breast (g)421.9 (163.0)459.9 (183.6)

Table 2. Quality of life measurements
Vertical ScarVertical ScarVertical ScarInferior PedicleInferior PedicleInferior Pedicle
Preop
Mean (standard deviation)
1 Year Postop
Mean (standard deviation)
p-valuePreop
Mean (standard deviation)
1 Year Postop
Mean (standard deviation)
p-value
Health Utilities Index0.81 (0.16)0.87 (0.19)< 0.0010.79 (0.20)0.89 (0.14)< 0.001
SF-36 Physical Summary Score46.3 (7.9)51.2 (8.0)< 0.00147.7 (7.9)51.2 (8.7)< 0.001
SF-36 Mental Summary Score51.2 (8.8)53.1 (9.2)0.07151.5 (8.6)53.8 (8.4)0.018
Breast-Related Symptoms Questionnaire52.3 (24.5)92.4 (9.4)< 0.00153.7 (24.4)94.2 (9.8)< 0.001
MBSRQ - Appearance Evaluation2.57 (0.70)3.02 (0.77)< 0.0012.62 (0.72)3.10 (0.85)< 0.001
MBSRQ - Appearance Orientation3.12 (0.53)3.05 (0.48)0.3043.12 (0.53)3.07 (0.48)0.103


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