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Indications for Breast Reduction in the Public Health Care System

V

Vastra Gotaland Region

Status

Enrolling

Conditions

Mammary Gland Hyperplasia

Treatments

Procedure: Breast reduction

Study type

Observational

Funder types

Other

Identifiers

NCT04889469
2021-01508

Details and patient eligibility

About

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.

Enrollment

2,000 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

2,000 participants in 4 patient groups

Breast hypertrophy operated
Description:
Women who have had a breast reduction in the public health care system
Treatment:
Procedure: Breast reduction
Breast hypertrophy controls
Description:
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
Description:
Patients who have breast hypertrophy due to cosmetic breast augmentation
The general public
Description:
Random sample of the general public

Trial contacts and locations

1

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Central trial contact

Emma Hansson, PhD

Data sourced from clinicaltrials.gov

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