Indications for Breast Reduction in the Public Health Care System

The overall purpose of the project is to create a scientific basis for which patients should be offered breast reduction in the public sector. More specifically , the project aims to:

• To examine the evidence for current national guidelines for breast reduction. The hypothesis is that BMI, breast volume, resection weight, and mental and physical symptoms affect the outcome of breast reconstruction, both in terms of complication risks, patient satisfaction and quality of life .
• To investigate which patients benefit the most from a breast reduction, in a health economic perspective. The starting point is that resources are limited and the purpose is to maximize the health effects for the patient at as low cost as possible. The hypothesis is that the health benefits, for the individual and society, are different depending on how big the breasts are and how much symptoms a patient has preoperatively.
• To examine back function and objective problems in women, with both natural and augmented breasts, with different body constitutions and volumes. The hypothesis is that a certain breast volume give rise to different physical symptoms in different women, depending on their other physical factors.
• To develop preferences for benign breast conditions that are treated in plastic surgery and for complications that the treatment can cause. Preferences are used to calculate QALY (quality-adjusted life years). Knowledge of preferences is essential for an analysis of healthcare needs.
• To examine women's experiences of how their breast hypertrophy affects them and their expectations of a breast reduction. The hypothesis is that the experience breast hypertrophy affects patients differently, and that expectations on a breast reduction can vary between different individuals.

Study Overview

• Status: Recruiting
• Conditions: Mammary Gland Hyperplasia
• Intervention / Treatment: Procedure: Breast reduction

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Emma Hansson, PhD; Phone Number: +46313421000; Email: emma.hansson.2@gu.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Emma Hansson, PhD; Phone Number: +46 31 342 10 00; Email: emma.hansson.2@gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Normal weight women with breast volumes over >800 ml (augmented or natural) with or without symptoms of breast hypertrophy. Normal weight women with a breast volume under 800 ml with symptoms of breast hypertrophy.

Description

Inclusion Criteria:

• Breast volume > 800 ml
• BMI< 25 if under 50 years of age and BMI<2 if over the age of 50
• Symptoms of breast hypertrophy
• Non-smokers

Un-operad controls:

-Symptoms of breast hypertrophy, but do not comply with the criteria above.

Augmented controls:

• Augmented breast volume > 800 ml
• BMI< 25 if under 50 years of age and BMI<2 if over the age of 50

Exclusion Criteria:

• Inability to provide informed consent
• Inability to understand the Swedish language
• Age under 18 years

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast hypertrophy operated; Women who have had a breast reduction in the public health care system	Procedure: Breast reduction; Procedure to remove excess fat, tissue and skin from the breasts.
Breast hypertrophy controls; Women with symptoms of breast hypertrophy, who do not fulfill the requirements to have a breast reduction in the public health care system
Augmented controls; Patients who have breast hypertrophy due to cosmetic breast augmentation
The general public; Random sample of the general public

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported quality of life	Breast -Q breast reduction preoperatively and postoperatively measures quality of life and patient satisfaction in 6 domains: physical well-being, psychosocial well-being, sexual well-being, satisfaction with the breasts, satisfaction with the result and satisfaction with care. Each domain is scored 0-100, where a higher score indicate a better outcome.	5 years
Complications	Complications after surgery classified according to Clavien-Dindo	1 year
Preferences (utility)	utility scores for various benign breast conditions that may require plastic surgery , including complications after cosmetic surgery, will be measured. Complications will be compared with situations without these , but also with congenital conditions that give a similar appearance. Measured with a visual analogue scale from 1-100.	5 years
Range of motion	Measured with goniometer in degrees	1 year
Muscle strength	Biering-Sörensen test measuring how many seconds the subject is able to keep the unsupported upper body horizontal, while placed prone with the buttocks and legs fixed to the couch by three wide canvas straps and the arms folded across the chest	1 year
Cost-effectiveness	Analysis of costs related to quality-adjusted life years, comparing operation with no operation.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported health	EuroQol-5 dimensions - 3 levels -5D is a generic instrument developed for health economic and clinical evaluation of healthcare.A total score between 0 and 1 is calculated. = equals death and 1 perfect health.	5 years
Patient reported health	EQ VAS measures health on a scale from 0-100, where 100 equals perfect health and 0 worst possible health.	5 years
Body image	Multidimensional body-self relation questionnaire - appearance scales ( MBSRQ -AS).It is a 34-item self-report questionnaire designed to measure appearance related components of body-image. In consists of five subscales: appearance evaluation, appearance orientation, body areas satisfaction, overweight preoccupation, and self-classified weight. It is a 5-point Likert-scale ranging from 1 to 5.	5 years
Body investment	Appearance schemes inventory-revised ( ASI -R)is a 20-item self-report questionnaire designed to measure body-image investment. It consists of two subscales, self-evaluative salience (SES) and motivational salience (MS). It is a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). Twelve items relate to SES and eight items relate to MS. The total score is the mean of the 20 items, and the score of the subscales is the mean of the items relating to each subscale. A high score indicates greater body-image investment.	5 years
Pain intensity and quality	Short Form McGill Pain Questionnaire (SF- MPQ ).Measures pain on three subscales : a sensory subscale with 11 words, an affective subscale with 4 words that measures the quality of pain and a visual analogue scale (VAS) where the patient rates pain intensity from 1 to 10.	5 years
Pain intensity and effect on every-day life	Brief Pain Inventory -Short Form ( BPI -SF).Measures both pain intensity (sensory scale) and how pain affects the patient's life ( activity scale). The instrument also contains questions about pain relief, pain quality and the patient's experience of the cause of pain.The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.	5 years
Most important reason for operation	In-house designed questionnaire where patients preoperatively rank the most important reasons why they want to be operated on.	Pre-operative
Most important effects of an operation	In-house designed questionnaire where patients postoperatively rank what the most important effects of the operation are.	1 year
The experience of breast hypertrophy and a breast reduction	The issues will be examined mainly with the help of semi-structured qualitative in-depth interviews.	1 year

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Emma Hansson, PhD, Göteborg University

Publications and helpful links

General Publications

• Widmark-Jensen E, Bernhardsson S, Eriksson M, Hallberg H, Jepsen C, Jivegard L, Liljegren A, Petzold M, Svensson M, Warnberg F, Hansson E. A systematic review and meta-analysis of risks and benefits with breast reduction in the public healthcare system: priorities for further research. BMC Surg. 2021 Sep 11;21(1):343. doi: 10.1186/s12893-021-01336-7.

Helpful Links

• Health Technology Assessment (HTA) report 2021:121

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2031

Study Registration Dates

• First Submitted: April 24, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: breast reduction; breast hypertrophy; reduction mammaplasty
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperplasia
• Other Study ID Numbers: 2021-01508

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No