Indications for Breast Reduction in the Public Health Care System

Last updated: June 30, 2025
Sponsor: Vastra Gotaland Region
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Breast reduction

Clinical Study ID

NCT04889469
2021-01508
  • Ages 18-75
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Inability to provide informed consent

  • Inability to understand the Swedish language

  • Age under 18 years

Study Design

Total Participants: 2000
Treatment Group(s): 1
Primary Treatment: Breast reduction
Phase:
Study Start date:
August 01, 2021
Estimated Completion Date:
August 01, 2031

Connect with a study center

  • Sahlgrenska university hospital

    Gothenburg, 413 45
    Sweden

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.