Mammary Gland Hyperplasia Clinical Trial
Official title:
Indications for Breast Reduction in the Public Health Care System
| NCT number | NCT04889469 |
| Other study ID # | 2021-01508 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 1, 2021 |
| Est. completion date | August 1, 2031 |
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.
| Status | Recruiting |
| Enrollment | 2000 |
| Est. completion date | August 1, 2031 |
| Est. primary completion date | August 1, 2026 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 75 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Sahlgrenska university hospital | Gothenburg |
| Lead Sponsor | Collaborator |
|---|---|
| Vastra Gotaland Region |
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: p — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | Complications | Complications after surgery classified according to Clavien-Dindo | 1 year | |
| Primary | 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 | |
| Primary | Range of motion | Measured with goniometer in degrees | 1 year | |
| Primary | 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 | |
| Primary | Cost-effectiveness | Analysis of costs related to quality-adjusted life years, comparing operation with no operation. | 1 year | |
| Secondary | 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 | |
| Secondary | Patient reported health | EQ VAS measures health on a scale from 0-100, where 100 equals perfect health and 0 worst possible health. | 5 years | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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