Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy or Pelvic Lymphadenectomy: A Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
Study Overview
Brief Summary
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.
Detailed Description
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.
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
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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
Intervention: Lymphovenous bypass procedure (Procedure)
Outcomes
Primary Outcomes
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
Time Frame: through study completion; an average of 1 year
Secondary Outcomes
No secondary outcomes reported