NCT04209010已完成不适用
Comparison of One-stage Direct-to-implant With Acellular Dermal Matrix and Two-stage Implant-based Breast Reconstruction: A Cohort Study
Aarhus University Hospital0 个研究点目标入组 44 人开始时间: 2012年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 主要终点
- Postoperative complications
研究概览
简要总结
The aim of this study is to contribute to the knowledge regarding immediate implant-based BR by investigating whether the one-stage technique with ADM is superior to the two-stage expander to implant technique. Primary endpoint in first publication is postoperative complications, secondary endpoint is patient and investigator assessed aesthetic outcome. Primary endpoint in second publication is cost, secondary endpoint is patient reported outcome measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Skin sparing mastectomy due to breast cancer, ductal carcinoma in situ or high genetic risk of developing breast cancer
- •Mastectomy weight ≤ 600 g
- •Patient older than 18 years
- •Ability to complete the study questionnaire
- •Only for the two-stage group no later than 2 years and 4 months from breast reconstruction
排除标准
- 未提供
结局指标
主要结局
Postoperative complications
时间窗: 3 months
Minor (not requiring surgery - seroma, cellulitis). Obtained by review of patient chart.
次要结局
- Patient assessed satisfaction with aesthetic result(2 years)
- Investigator assessed satisfaction with aesthetic result(2 years)
- Patient reported outcome measures(2 years)
- Cost(2 years)
研究者
Mette Eline Brunbjerg, MD
MD, PhD student, Principal Investigator
Aarhus University Hospital
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