Indications for Breast Reduction in the Public Health Care System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Complications
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Inability to provide informed consent
- •Inability to understand the Swedish language
- •Age under 18 years
结局指标
主要结局
Complications
时间窗: 1 year
Complications after surgery classified according to Clavien-Dindo
Range of motion
时间窗: 1 year
Measured with goniometer in degrees
Cost-effectiveness
时间窗: 1 year
Analysis of costs related to quality-adjusted life years, comparing operation with no operation.
Patient reported quality of life
时间窗: 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.
Preferences (utility)
时间窗: 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.
Muscle strength
时间窗: 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
次要结局
- Most important effects of an operation(1 year)
- Pain intensity and quality(5 years)
- Pain intensity and effect on every-day life(5 years)
- Patient reported health(5 years)
- Body image(5 years)
- Most important reason for operation(Pre-operative)
- Body investment(5 years)
- The experience of breast hypertrophy and a breast reduction(1 year)