Reconstructions With Back Donor Site Flaps and Validation of Quality of Life Scales
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 550
- 试验地点
- 2
- 主要终点
- Patient satisfaction and breast-related quality of life after breast reconstruction
研究概览
简要总结
The latissimus dorsi flap is the oldest and most used technique for breast reconstruction. Nonetheless, there are few studies evaluation the long-term effect of harvesting one of the muscles of the back. This project has four parts.
- Validation of scales/instrument for Swedish.
- Long-term results after reconstruction with latissimus dorsi- a ten year retrospective follow-up.
- Thoracodorsal artery perforator flap (TDAP) vs latissimus dorsi flap- a randomized controlled trial - breast reconstruction.
- TDAP vs Limber flap - a randomized controlled trial- reconstruction of axillary hidradenitis suppurativa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients eligible for breast reconstruction following mastectomy and radiation
- •Non-smokers or ex-smokers (>6 weeks)
- •BMI < 30
排除标准
- •Inability to leave informed consent
- •Inability to understand Swedish
- •Previous surgery with scaring on back
结局指标
主要结局
Patient satisfaction and breast-related quality of life after breast reconstruction
时间窗: 10 years
Breast Q reconstruction.The BREAST-Q has multiple domains, each scored from 0 to 100 (higher scores indicate greater satisfaction or quality of life), there is no overall BREAST-Q score.
Abdominal satisfaction after breast reconstruction
时间窗: 10 years
Breast Q abdominal satisfaction and abdominal well-being.The scale is scored from 0 (worst) to 100
Back and shoulder function after breast reconstruction
时间窗: 10 years
Breast Q the back and shoulder function scale. The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Back appearance after breast reconstruction
时间窗: 10 years
Breast-Q the back appearance scale.The scale is scored from 0 (worst) to 100 (best). Higher scores reflect a better outcome.
Shoulder function after breast reconstruction
时间窗: 10 years
Western Ontario Osteoarthritis of the shoulder index (WOOS) provides scores on four domains: (1) physical symptoms; (2) sport, recreation, and work; (3) lifestyle; and (4) emotions.Each question has a possible score from 0-100 giving a total score up to 1900. The highest or most symptomatic score is 1900 and the best or asymptomatic score is 0.
次要结局
- Complications after breast reconstruction(2 years)