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

ConditionLymphadenectomy

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorM.D. Anderson Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

M D Anderson Cancer Center

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Lymphovenous bypass procedure
Procedure/Surgery
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

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Lymphovenous bypass procedure (LBP)1 intervention

Trial 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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Source ClinicalTrials.gov

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