Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast hypertrophy operated | Women 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast reduction | Procedure | Procedure to remove excess fat, tissue and skin from the breasts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Patient reported health |
Not provided
Inclusion Criteria:
Un-operad controls:
-Symptoms of breast hypertrophy, but do not comply with the criteria above.
Augmented controls:
Exclusion Criteria:
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emma Hansson, PhD | Contact | +46313421000 | emma.hansson.2@gu.se |
| Name | Affiliation | Role |
|---|---|---|
| Emma Hansson, PhD | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska university hospital | Recruiting | Gothenburg | 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34511096 | Result | 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. |
| Label | URL |
|---|---|
| Health Technology Assessment (HTA) report 2021:121 | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C536821 | Gigantomastia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
EQ VAS measures health on a scale from 0-100, where 100 equals perfect health and 0 worst possible health. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 1 year |