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Sponsor study identifier
observational
2,000
1 country
1
Study Start
August 1, 2021
Actual (reported)Primary Completion
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
August 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 24, 2021
Actual (reported)May 17, 2021
Actual (reported)August 1, 2021
Actual (reported)August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
August 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Patient reported health
5 years
Patient reported health
5 years
Body image
5 years
Body investment
5 years
Pain intensity and quality
5 years
Women who have had a breast reduction in the public health care system
Women with symptoms of breast hypertrophy, who do not fulfill the requirements to have a breast reduction in the public health care system
Patients who have breast hypertrophy due to cosmetic breast augmentation
Random sample of the general public
Procedure to remove excess fat, tissue and skin from the breasts.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Sahlgrenska university hospital
Gothenburg, 413 45, Sweden
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.
Emma Hansson, PhD
Göteborg University
First Submitted
April 24, 2021
First Posted
May 17, 2021
Study Start
August 1, 2021
Actual (reported)Primary Completion
August 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
1 year
Cost-effectiveness
Analysis of costs related to quality-adjusted life years, comparing operation with no operation.
1 year
Contact the study team to confirm eligibility.
Study Completion
August 1, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 3, 2025
Record last verified: 2025-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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