Evaluating criteria for breast reduction in public healthcare
Indications for Breast Reduction in the Public Health Care System
This study is trying to figure out the best ways to decide who can get breast reduction surgery in public healthcare by looking at factors like weight, breast size, and symptoms to see how they affect recovery and satisfaction.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Vastra Gotaland Region Government |
| Locations | 1 site (Gothenburg) |
| Trial ID | NCT04889469 on ClinicalTrials.gov |
What this trial studies
This project aims to establish a scientific basis for determining which patients should be eligible for breast reduction surgery within the public health care system. It will examine current national guidelines and investigate how factors such as BMI, breast volume, and preoperative symptoms influence surgical outcomes, including complication risks and patient satisfaction. Additionally, the study will assess the economic implications of breast reduction, focusing on maximizing health benefits while minimizing costs. The research will include both operated and non-operated controls to provide a comprehensive analysis of the benefits of breast reduction.
Who should consider this trial
Good fit: Ideal candidates include women with breast volume greater than 800 ml, specific BMI criteria based on age, and symptoms of breast hypertrophy.
Not a fit: Patients who do not meet the eligibility criteria, such as those with lower breast volume or higher BMI, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved guidelines for breast reduction surgery, enhancing patient outcomes and satisfaction.
How similar studies have performed: While there have been studies on breast reduction, this specific approach focusing on economic perspectives and detailed patient criteria is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Gothenburg
- Sahlgrenska university hospital — Gothenburg, Sweden (Recruiting)
Study contacts
- Principal investigator: Emma Hansson, PhD — Göteborg University
- Study coordinator: Emma Hansson, PhD
- Email: emma.hansson.2@gu.se
- Phone: +46313421000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.