Indications for Breast Reduction in the Public Health Care System
Recruiting now
Conditions studied: Mammary Gland Hyperplasia
In brief
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.
Key facts
- Study ID
- NCT04889469
- Run by
- Vastra Gotaland Region
- People needed
- 2000
- Starts
- 2021-08-01
- Expected to finish
- 2031-08-01
- Last updated by the study team
- 2025-07-03
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Inability to provide informed consent
- Inability to understand the Swedish language
- Age under 18 years
Where it is running
- Sahlgrenska university hospital — Gothenburg, Sweden (enrolling)
Full record on ClinicalTrials.gov
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