Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: a Prospective Observational Study
Recruiting
- Conditions
- Lymphadenectomy
- Interventions
- Procedure: Lymphovenous bypass procedure
- Registration Number
- NCT05992909
- Lead Sponsor
- M.D. Anderson Cancer Center
- 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. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Lymphovenous bypass procedure (LBP) Lymphovenous bypass procedure A surgical procedure for treating lymphedema called lymphovenous bypass procedure (LBP), but it is usually only done after a patient develops lymphedema
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States