Indications for Breast Reduction in the Public Health Care System

Обзор

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.

Вмешательства

• Процедура Breast reduction
  Procedure to remove excess fat, tissue and skin from the breasts.

Первичные конечные точки

• Patient reported quality of life [Срок оценки: 5 years]
• Complications [Срок оценки: 1 year]
• Preferences (utility) [Срок оценки: 5 years]
• Range of motion [Срок оценки: 1 year]
• Muscle strength [Срок оценки: 1 year]
• Cost-effectiveness [Срок оценки: 1 year]

Вторичные конечные точки (9)

• Patient reported health [Срок оценки: 5 years]
• Patient reported health [Срок оценки: 5 years]
• Body image [Срок оценки: 5 years]
• Body investment [Срок оценки: 5 years]
• Pain intensity and quality [Срок оценки: 5 years]
• Pain intensity and effect on every-day life [Срок оценки: 5 years]
• Most important reason for operation [Срок оценки: Pre-operative]
• Most important effects of an operation [Срок оценки: 1 year]
• The experience of breast hypertrophy and a breast reduction [Срок оценки: 1 year]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Inability to provide informed consent
• Inability to understand the Swedish language
• Age under 18 years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Швеция · 1 центр

• Sahlgrenska university hospital — Gothenburg

Публикации

• 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. PMID 34511096

Идентификаторы

NCT: NCT04889469 · 2021-01508

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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