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

Lymphadenectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992909
• Other study ID #: 2023-0203
• Secondary ID: NCI-2023-06282
• Status: Recruiting
• Start date: August 2, 2023
• Est. completion date: August 1, 2027

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: Ashleigh Francis, MD
• Phone: 713-563-4598
• Email: amfrancis[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 1, 2027
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphadenectomy

Intervention

Procedure:
• Lymphovenous 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

Locations

Country	Name	City	State
United States	MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   M D Anderson Cancer Center