Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: A Prospective Observational Study
NCT ID: NCT05992909
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
20 participants
OBSERVATIONAL
2023-08-02
2027-08-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lymphovenous bypass procedure (LBP)
A surgical procedure for treating lymphedema called lymphovenous bypass procedure (LBP), but it is usually only done after a patient develops lymphedema
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
Interventions
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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
Eligibility Criteria
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Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ashleigh Francis, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2023-06282
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0203
Identifier Type: -
Identifier Source: org_study_id