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临床试验/NCT02769559
NCT02769559已完成不适用

Reduction Mammaplasty Safely Increases the Quality of Life in Patients With Mammary Hypetrophy.

University Hospital Bratislava1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2000年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Quality of life

研究概览

简要总结

The data gathered here will be used to evaluate the efficacy and safety of the mammary reduction in patients with macromastia.

详细描述

The data was gathered using retrospective and follow-up prospective study of a group of patients, consisting of adult women that underwent a breast reduction surgery at the Clinic of Plastic, Reconstructive and Aesthetic Surgery Faculty of Comenius University and at the University Hospital in Bratislava, Ružinov, during the time period between 2000 until May 2014. The data concerning the quality of life of these patients was gathered by using the globally standardized questionnaire "Breast Q questionnaire©" with the separate software system evaluation tool "QScore©". The statistical analysis was conducted using GraphpadPrism program v. 6.01. The total number of respondents consisted of 52 people who were followed-up for up to 12 years.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 63 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • above 18 years
  • macromastia on clinical examination
  • fulfilled Breast Q Questionnaire prior to surgery and after surgery
  • signed informed consent

排除标准

  • failed to sign informed consent
  • failed to fill the Breast Q Questionnaire
  • patients with altered mental status and behaviour
  • patients with concomitant breast disease, or with previous breast interventions as are radiotherapy, surgery, or breast cancer

结局指标

主要结局

Quality of life

时间窗: 2000-2014

Questionnaires about quality of life before and up to 12 years after surgery

次要结局

  • Rate of adverse outcomes(2000-2014)

研究者

发起方
University Hospital Bratislava
申办方类型
Other
责任方
Principal Investigator
主要研究者

Julius Hodosy

Reduction mammaplasty safely increases the quality of life in patients with mammary hypetrophy.

University Hospital Bratislava

研究点 (1)

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