NCT00625924已完成不适用
Sensory Morbidity Following Breast Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- To evaluate the prevalence, severity and level of distress of subjective breast sensations following mastectomy and postmastectomy reconstruction.
研究概览
简要总结
The goal of the study is measure breast sensations after breast surgery. The results of this study will help surgeons better understand breast sensations and may improve the way surgery is done.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The Samples used will be derived from three cohorts below and will only include patients who have completed mastectomy or reconstruction within 1-5 years of enrollment.
- •Patients who have undergone immediate, two-stage expander/implant postmastectomy reconstruction
- •Patients who have undergone immediate, autogenous tissue flap reconstruction following mastectomy
- •Patients who have undergone mastectomy alone
- •Patients at least 21 years of age
- •Patients who completed mastectomy ± immediate post-mastectomy reconstruction at least one year but no longer than five years prior to study entry
排除标准
- •Patients who have had any of the following:
- •delayed reconstruction (no reconstruction at time of surgery) combined autogenous tissue/implant breast reconstruction, and/or
- •Patients who have a pre-surgical history of complex regional pain syndrome
- •Patients who have had radiation therapy
- •Patients who have had a local recurrence
- •Patients who do not speak the English language (validated translations of key questionnaires are not available).
结局指标
主要结局
To evaluate the prevalence, severity and level of distress of subjective breast sensations following mastectomy and postmastectomy reconstruction.
时间窗: conclusion of the study
次要结局
- To compare sensory morbidity following three types of breast surgery: tissue expander/implant breast reconstruction, autogenous tissue reconstruction, and no reconstruction.(conclusion of the study)
研究者
研究点 (1)
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