Indications for Breast Reduction in the Public Health Care System

NCT04889469 | Recruiting

• 1 other identifier: 2021-01508
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Mammary Gland Hyperplasia

Keywords

breast reduction; reduction mammaplasty; breast hypertrophy

Outcome Measures

Primary Outcomes (6)

• Patient reported quality of life

  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.

  5 years

• Complications

  Complications after surgery classified according to Clavien-Dindo

  1 year

• Preferences (utility)

  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.

  5 years

• Range of motion

  Measured with goniometer in degrees

  1 year

• Muscle strength

  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

  1 year

• Cost-effectiveness

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

  1 year

Secondary Outcomes (9)

• Patient reported health

  5 years

• Patient reported health

  5 years

• Body image

  5 years

• Body investment

  5 years

• Pain intensity and quality

  5 years

Study Arms (4)

Breast hypertrophy operated

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

Procedure: Breast reduction

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

Augmented controls

Patients who have breast hypertrophy due to cosmetic breast augmentation

The general public

Random sample of the general public

Interventions

Breast reduction PROCEDURE

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

Breast hypertrophy operated

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska university hospital

Gothenburg, 413 45, Sweden

RECRUITING

Related Publications (1)

• 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 RESULT

Related Links

• Health Technology Assessment (HTA) report 2021:121

MeSH Terms

Conditions

Gigantomastia

Study Officials

• Emma Hansson, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Hansson, PhD

CONTACT

+46313421000; emma.hansson.2@gu.se

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2021
• First Posted: May 17, 2021
• Study Start: August 1, 2021
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2031
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)