Clinical trial NCT04889469: Indications for Breast Reduction in the Public Health Care System
Official title: Indications for Breast Reduction in the Public Health Care System
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mammary Gland Hyperplasia
Keywords: breast reduction
reduction mammaplasty
breast hypertrophy
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2021-05-17
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normal weight women with breast volumes over \>800 ml (augmented or natural) with or without symptoms of breast hypertrophy. Normal weight women with a breast volume under 800 ml with symptoms of breast hypertrophy.

Brief summary: 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.


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

Primary outcomes:
measure: Patient reported quality of life
timeFrame: 5 years
measure: Complications
timeFrame: 1 year
measure: Preferences (utility)
timeFrame: 5 years
measure: Range of motion
timeFrame: 1 year
measure: Muscle strength
timeFrame: 1 year
measure: Cost-effectiveness
timeFrame: 1 year
Secondary outcomes:
measure: Patient reported health
timeFrame: 5 years
measure: Patient reported health
timeFrame: 5 years
measure: Body image
timeFrame: 5 years
measure: Body investment
timeFrame: 5 years
measure: Pain intensity and quality
timeFrame: 5 years
measure: Pain intensity and effect on every-day life
timeFrame: 5 years
measure: Most important reason for operation
timeFrame: Pre-operative
measure: Most important effects of an operation
timeFrame: 1 year
measure: The experience of breast hypertrophy and a breast reduction
timeFrame: 1 year
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska university hospital
Study officials:
affiliation: Göteborg University
name: Emma Hansson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.