Immediate Lymphatic Reconstruction After Lymphadenectomy in Melanoma Patients: a Parallel Cohort Pilot 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
- Safety and adverse events
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
To examine if performing lymphovenous bypass (LVB) at the time of axillary lymph node dissection (ALND) or inguinal lymph node dissection (ILND) in the melanoma participant population impacts the period prevalence of lymphedema occurrence one year from surgery. To assess wound complications rates occurring in first 30-days post operatively from the time of surgery. To estimate time to drain removal. To estimate the point prevalence of LE following surgery at 3 months, 6 months, and 1 year following surgery. To estimate the cumulative incidence associated with the first appearance of LE. To assess quality of life and survivorship, using Lymphedema Quality of Life (LYMQOL) questionnaire over the study follow-up domain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Participants greater than or equal to 18 years of age.
- •Participants willing to participate.
- •Participants able to complete informed consent.
- •Participants with a diagnosis of Melanoma undergoing ALND or ILND.
排除标准
- •Participant staking anticoagulants within 7 days prior to surgery.
- •Participants that are known to be pregnant at the time of surgery.
- •Participants with BMI greater than 50.0
研究组 & 干预措施
Upper extremity group recieving ALND
Participants will be recruited pre-operatively by their treating physicians.
干预措施: Lymphovenous bypass (LVB) (Procedure)
Lower extremity group getting ILND
Participants will be recruited pre-operatively by their treating physicians.
干预措施: Lymphovenous bypass (LVB) (Procedure)
结局指标
主要结局
Safety and adverse events
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
次要结局
未报告次要终点