Indications for Breast Reduction in the Public Health Care System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2031-08-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Mammary Gland Hyperplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast hypertrophy operated

Women who have had a breast reduction in the public health care system

Breast reduction

Intervention Type PROCEDURE

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

No interventions assigned to this group

Augmented controls

Patients who have breast hypertrophy due to cosmetic breast augmentation

No interventions assigned to this group

The general public

Random sample of the general public

No interventions assigned to this group

Interventions

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Breast reduction

Procedure to remove excess fat, tissue and skin from the breasts.

Intervention Type PROCEDURE

Eligibility Criteria

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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