Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04889469

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast reduction

Procedure

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

Primary outcomes

  1. Patient reported quality of life

    Time frame: 5 years

    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.

  2. Complications

    Time frame: 1 year

    Complications after surgery classified according to Clavien-Dindo

  3. Preferences (utility)

    Time frame: 5 years

    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.

  4. Range of motion

    Time frame: 1 year

    Measured with goniometer in degrees

  5. Muscle strength

    Time frame: 1 year

    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

  6. Cost-effectiveness

    Time frame: 1 year

    Analysis of costs related to quality-adjusted life years, comparing operation with no operation.

Secondary outcomes

  1. Patient reported health

    Time frame: 5 years

    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.

  2. Patient reported health

    Time frame: 5 years

    EQ VAS measures health on a scale from 0-100, where 100 equals perfect health and 0 worst possible health.

  3. Body image

    Time frame: 5 years

    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.

  4. Body investment

    Time frame: 5 years

    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. Pain intensity and quality

    Time frame: 5 years

    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.

  6. Pain intensity and effect on every-day life

    Time frame: 5 years

    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.

  7. Most important reason for operation

    Time frame: Pre-operative

    In-house designed questionnaire where patients preoperatively rank the most important reasons why they want to be operated on.

  8. Most important effects of an operation

    Time frame: 1 year

    In-house designed questionnaire where patients postoperatively rank what the most important effects of the operation are.

  9. The experience of breast hypertrophy and a breast reduction

    Time frame: 1 year

    The issues will be examined mainly with the help of semi-structured qualitative in-depth interviews.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Hansson, PhD

CONTACT

[email protected]

+46313421000

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Important dates

Study start
2021
Primary completion
2028
Study completion
2031
First posted
May 17, 2021
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.