Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy or Pelvic Lymphadenectomy: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
研究概览
简要总结
To learn if LBP can help to prevent lymphedema when it is performed at the time of surgery rather than after a patient has already developed the disease.
详细描述
Primary Objectives:
The objective of this study is to evaluate the protective benefit to performing LVB surgery at the time of ILND and/or PLND. In the secondary objective, we will compare the medical outcomes for patients that received the LVB surgery with those receiving standard surgery in whom the intervention could not 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
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria:
- •Patients greater than or equal to 18 years of age.
- •Patients willing to participate.
- •Patients able to complete informed consent.
- •Patients undergoing ILND and/or PLND.
排除标准
- •Patients taking anticoagulants within 7 days prior to surgery.
- •Patients that are known to be pregnant at the time of surgery.
- •Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.
- •Patients with BMI greater than 50.0.
研究组 & 干预措施
Lymphovenous bypass procedure (LBP)
A surgical procedure for treating lymphedema called lymphovenous bypass procedure (LBP), but it is usually only done after a patient develops lymphedema
干预措施: Lymphovenous bypass procedure (Procedure)
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
时间窗: through study completion; an average of 1 year
次要结局
未报告次要终点