Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: A Prospective Observational Study

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Lymphadenectomy

Treatments: Procedure: Lymphovenous bypass procedure

Study type: Observational

Funder types: Other

Identifiers

NCT05992909

2023-0203

NCI-2023-06282 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

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.

Trial design

20 participants in 1 patient group

Lymphovenous bypass procedure (LBP)

Description:

A surgical procedure for treating lymphedema called lymphovenous bypass procedure (LBP), but it is usually only done after a patient develops lymphedema

Treatment:

Procedure: Lymphovenous bypass procedure