Lymphovenous bypass procedure to prevent lymphedema after lymphadenectomy
Prophylactic Lymphovenous Bypass Procedure Following Inguinal Lymphadenectomy: A Prospective Observational Study
This study is testing if a special surgery called lymphovenous bypass can help prevent swelling in the legs after patients have lymph nodes removed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05992909 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate whether performing a lymphovenous bypass (LVB) procedure during inguinal lymphadenectomy (ILND) can prevent the development of lymphedema. It will compare outcomes of patients who receive the LVB procedure at the time of surgery with those who undergo standard surgery without the intervention. The study will involve patients aged 18 and older who are undergoing ILND and are willing to participate. The goal is to gather data on the protective benefits of LVB surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for inguinal lymphadenectomy.
Not a fit: Patients taking anticoagulants, pregnant individuals, those with a BMI over 50, or those unable to commit to follow-up may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of lymphedema in patients undergoing lymphadenectomy.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating that this may be a novel investigation.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ashleigh Francis, MD — M.D. Anderson Cancer Center
- Study coordinator: Ashleigh Francis, MD
- Email: amfrancis@mdanderson.org
- Phone: 713-563-4598
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.