Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04889469
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2021-04-24
Brief Title:
Indications for Breast Reduction in the Public Health Care System
Sponsor:
Vastra Gotaland Region
Organization:
Vastra Gotaland Region
Study Overview
Official Title:
Indications for Breast Reduction in the Public Health Care System
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 womens 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
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 womens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None