RELEVANT Prevalence of Patient-Reported Lymphedema Following Surgical Management of Cervical or Vulvar Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- prevalence of patient-reported lower extremity lymphedema
研究概览
简要总结
The purpose of this study is to collect information that may identify people who are at risk of developing lower extremity lymphedema (LEL) after sentinel lymph node biopsy (SLN) during surgery for early-stage vulvar or cervical cancer, and to improve the quality and accuracy of the information that is given to people who have this procedure.
Please note that, during this study, the researchers will collect information from a questionnaire completed by people who had SLN and LND+/- SLN during surgery for early-stage cervical or vulvar cancer. No form of treatment will be provided as part of the study, and no investigational tests or procedures will be performed.
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
- •Presented to MSK with newly diagnosed early-stage cervical cancer of any histologic profile or early stage vulvar cancer of any histologic profile.
- •°Early stage: Stage 1-2
- •Underwent primary surgery at our institution between January 2006 and January
- •Alive at the time of study activation
- •English comprehension
- •Capable of providing informed consent
排除标准
- •Had documented macroscopic evidence of metastatic disease at the time of initial diagnosis
结局指标
主要结局
prevalence of patient-reported lower extremity lymphedema
时间窗: 1 year
Prevalence will be measured using the 13-item questionnaire as reported by the patient.
次要结局
未报告次要终点