NCT05992909Recruiting
Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy or Pelvic Lymphadenectomy: A Prospective Observational Study
M.D. Anderson Cancer Center
Start Date
8/2/2023
Completion Date
8/1/2027
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Eligibility Criteria:
1. Patients greater than or equal to 18 years of age.
2. Patients willing to participate.
3. Patients able to complete informed consent.
4. Patients undergoing ILND and/or PLND.
Exclusion Criteria:
1. Patients taking anticoagulants within 7 days prior to surgery.
2. Patients that are known to be pregnant at the time of surgery.
3. Patients are available for follow-up less than 18 months or do not undergo measurements within the scheduled period.
4. Patients with BMI greater than 50.0.
Interventions
PROCEDURE
Lymphovenous bypass procedure
Conditions
Lymphadenectomy
Locations
MD Anderson Cancer Center
Houston, Texas 77030
United States