NCT03963427进行中（未招募）不适用
GoBreast - a Prospective Randomized Trial on Breast Reconstruction Methods
Vastra Gotaland Region0 个研究点目标入组 220 人开始时间: 2008年3月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 220
- 主要终点
- Aesthetic outcome
研究概览
简要总结
A randomized clinical trial with two arms: irradiated women and non-irradiated women. Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Irradiated patients:
- •Inclusion Criteria:
- •Age 18-60
- •DIEP is technically possible
- •Unilateral mastectomy
排除标准
- •Scars on abdomen or back
- •Bilateral mastectomy
- •Previous liposuction abdomen
- •61 years of age or older
- •Non-irradiated patients
- •Inclusion Criteria:
- •>18 years of age
- •Unilateral mastectomy
- •Exclusion Criteria:
- •Bilateral mastectomy
- •extensive scars on thorax
结局指标
主要结局
Aesthetic outcome
时间窗: 1 year post-operatively
Photo evaluations
次要结局
- Breast related quality of life and satisfaction(Pre-operatively and 3 years post-operatively)
- Depression(Pre-operatively and 3 years post-operatively)
- General quality of life(Pre-operatively and 3 years post-operatively)
- General quality of life measurement used for health economics(Pre-operatively and 3 years post-operatively)
- Early complication frequency(2 weeks post-operatively)
- Long-term complications(Five years post-operatively)
- Health economics(Five years post-operatively)
- Implant survival (Ancillary study)(19 years)
研究者
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