Indications for Breast Reduction in the Public Health Care System
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breast reduction.
- Who it may be relevant to
- Registry conditions: Mammary Gland Hyperplasia. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Breast reduction
Procedure to remove excess fat, tissue and skin from the breasts.
Primary outcome measures
- Patient reported quality of life [Time frame: 5 years]
- Complications [Time frame: 1 year]
- Preferences (utility) [Time frame: 5 years]
- Range of motion [Time frame: 1 year]
- Muscle strength [Time frame: 1 year]
- Cost-effectiveness [Time frame: 1 year]
Secondary outcome measures (9)
- Patient reported health [Time frame: 5 years]
- Patient reported health [Time frame: 5 years]
- Body image [Time frame: 5 years]
- Body investment [Time frame: 5 years]
- Pain intensity and quality [Time frame: 5 years]
- Pain intensity and effect on every-day life [Time frame: 5 years]
- Most important reason for operation [Time frame: Pre-operative]
- Most important effects of an operation [Time frame: 1 year]
- The experience of breast hypertrophy and a breast reduction [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Sweden · 1 center
- Sahlgrenska university hospital — Gothenburg
Publications
- Widmark-Jensen E, Bernhardsson S, Eriksson M, Hallberg H, Jepsen C, Jivegard L, Liljegren A, Petzold M, Svensson M, Warnberg F, Hansson E. A systematic review and meta-analysis of risks and benefits with breast reduction in the public healthcare system: priorities for further research. BMC Surg. 2021 Sep 11;21(1):343. doi: 10.1186/s12893-021-01336-7. PMID 34511096
Identifiers
NCT: NCT04889469 · 2021-01508