Lymphadenectomy
Conditions
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.
Interventions
PROCEDURELymphovenous bypass procedure
Participants will return to the clinic 14 days, 6 months, 12 months, 18 months, and 24 months after your surgery for measurements of your legs to see if there are changes over time
Sponsors
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03 | through study completion; an average of 1 year |
Countries
United States
Contacts
CONTACTAshleigh Francis, MD
PRINCIPAL_INVESTIGATORAshleigh Francis, MD
M.D. Anderson Cancer Center
Outcome results
None listed