Mammary Gland HyperplasiaNCT04889469
Indications for Breast Reduction in the Public Health Care System
An observational study of Mammary Gland Hyperplasia, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Mammary Gland Hyperplasia
- What is being tested?
- Breast reduction
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteSweden
- Study dates
- 1 Aug 2021to 1 Aug 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 9Show fewer
- Augmented controls:
- Augmented breast volume > 800 ml
- BMI< 25 if under 50 years of age and BMI<2 if over the age of 50
Who cannot join
- Inability to provide informed consent
- Inability to understand the Swedish language
- Age under 18 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska university hospital
Gothenburg, 413 45
Emma Hansson, PhD, +46 31 342 10 00, emma.hansson.2@gu.se
About this study
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
- Being tested
- Breast reduction
- Keywords
- breast reduction, reduction mammaplasty, breast hypertrophy
- Medical subject headings
- Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast reductionProcedure or surgery
Procedure to remove excess fat, tissue and skin from the breasts.
| Study group | Role | What they receive |
|---|---|---|
| Breast hypertrophy operated | Women who have had a breast reduction in the public health care system Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Complications
Complications after surgery classified according to Clavien-Dindo
Measured: 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.
Measured: 5 years
Range of motion
Measured with goniometer in degrees
Measured: 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
Measured: 1 year
Cost-effectiveness
Analysis of costs related to quality-adjusted life years, comparing operation with no operation.
Measured: 1 year
Secondary outcomes (9)
Patient reported health
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.
Measured: 5 years
Patient reported health
EQ VAS measures health on a scale from 0-100, where 100 equals perfect health and 0 worst possible health.
Measured: 5 years
Body image
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.
Measured: 5 years
Body investment
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.
Measured: 5 years
Pain intensity and quality
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.
Measured: 5 years
Pain intensity and effect on every-day life
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.
Measured: 5 years
Most important reason for operation
In-house designed questionnaire where patients preoperatively rank the most important reasons why they want to be operated on.
Measured: Pre-operative
Most important effects of an operation
In-house designed questionnaire where patients postoperatively rank what the most important effects of the operation are.
Measured: 1 year
The experience of breast hypertrophy and a breast reduction
The issues will be examined mainly with the help of semi-structured qualitative in-depth interviews.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start1 Aug 2021
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mammary Gland HyperplasiaStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Emma Hansson, PhD, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04889469
- Sponsor's protocol ID
- 2021-01508
- Status last verified
- Jun 2025
- First submitted
- 24 Apr 2021
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34511096
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Indications for Breast Reduction in the Public Health Care System
- ClinicalTrials.gov ID
- NCT04889469
- Acronym / sponsor ID
- 2021-01508
- Conditions
- Mammary Gland Hyperplasia
- Keywords
- breast reduction, reduction mammaplasty, breast hypertrophy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Aug 2031 (estimated)
- First posted
- 17 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Breast hypertrophy operated | – | Procedure: Breast reductionWomen who have had a breast reduction in the public health care system |
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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
- -Symptoms of breast hypertrophy, but do not comply with the criteria above.
Key exclusion criteria (3 listed)
- Inability to provide informed consent
- Inability to understand the Swedish language
- Age under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast reductionProcedure to remove excess fat, tissue and skin from the breasts. | Procedure or surgery | Breast hypertrophy operated |
Primary outcome
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.
Complications
Time frame: 1 year
Complications after surgery classified according to Clavien-Dindo
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.
Range of motion
Time frame: 1 year
Measured with goniometer in degrees
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
Cost-effectiveness
Time frame: 1 year
Analysis of costs related to quality-adjusted life years, comparing operation with no operation.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Results publication: PubMed 34511096Widmark-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.
- Health Technology Assessment (HTA) report 2021:121Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emma Hansson, PhD principal investigator
Göteborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mammary Gland Hyperplasia, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Hansson, PhD (+46313421000, emma.hansson.2@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient reported quality of life (time frame: 5 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04889469, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.