Lymphedema in the Lower Extremities After Urologic Surgery With Lymph Node Dissection
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Number of patients with self-reported lymphedema at 12 months
Study Overview
Brief Summary
Lymphedema of the extremities is common after lymph node surgery in treating several forms of cancer, e.g., breast cancer. However, very little is known of the occurrence of lymphedema of the lower extremities after urologic surgery with lymph node dissection. This project aims to describe the frequency and grade of lymphedema arising after urologic surgery, using the Lymphedema Quality of Life Questionnaire (LymQOL), Delfin MoistureMeter D, and lower limb volume measurements.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients undergoing urologic surgery with lymph node dissection
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of patients with self-reported lymphedema at 12 months
Time Frame: 12 months after surgery
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
Number of patients with self-reported lymphedema at 24 months
Time Frame: 24 months after surgery
Frequency and grade of self-reported swelling of the lower extremities as graded by LymQOL questionnaire
Change in tissue water content measured by MoistureMeterD Compact at 12 months
Time Frame: 12 months after surgery
Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact
Change in tissue water content measured by MoistureMeterD Compact at 24 months
Time Frame: 24 months after surgery
Percent tissue water content calculated from the dielectric constant as measured by MoistureMeterD Compact
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 12 months
Time Frame: 12 months after surgery
Change in lower limb volume calculated by measuring the circumference of the lower extremities at 24 months
Time Frame: 24 months after surgery
Secondary Outcomes
- Number of patients with self-reported lymphedema at 3 months(3 months after surgery)
- Number of patients with self-reported lymphedema at 1 month(1 month after surgery)
- Change in tissue water content measured by MoistureMeterD Compact at 3 months(3 months after surgery)
- Change in lower limb volume calculated by measuring the circumference of the lower extremities at 1 month(1 month after surgery)
- Number of patients with self-reported lymphedema at 6 months(6 months after surgery)
- Change in tissue water content measured by MoistureMeterD Compact at 1 month(1 month after surgery)
- Change in tissue water content measured by MoistureMeterD Compact at 6 months(6 months after surgery)
- Change in lower limb volume calculated by measuring the circumference of the lower extremities at 3 month(3 month after surgery)
- Change in lower limb volume calculated by measuring the circumference of the lower extremities at 6 month(6 month after surgery)