Stopped: Insufficient resources
BACKGROUND: Lymphedema is a pathologic soft tissue swelling that arises secondary to disruption of the lymphatic system. Lymphedema affects approximately 250 million people worldwide and causes significant physical and psychological morbidity. There is no definitive treatment for lymphedema. Lymphovenous bypass - microsurgically anastomosing lymphatic channels and venules - has demonstrated promising results in the treatment of lymphedema. PURPOSE: The purpose of this study is to determine the efficacy of lymphovenous bypass in treating extremity lymphedema. METHODS: This is a prospective, single-arm, cohort study. Eligible patients between 18-70 years of age with extremity lymphedema will undergo lymphovenous bypass. The primary outcome measure will be extremity volume and the secondary outcome measure will be quality of life assessed by a validated assessment tool for lymphedema of the limbs (LYMQOL). Patients will be assessed preoperatively and at 3, 6, 9, and 12-months postoperatively. Each participant will serve as their own control. Primary and secondary outcome measures will be assessed with paired t-tests. With a sample size of 9 patients we will have at least 80% power to reject the null hypothesis assuming an alpha level of 0.01. To further increase the power and to account for patients lost to follow-up the investigators will target a patient recruitment of 20. The findings of this study will help further elucidate the role of lymphovenous bypass in the treatment of extremity lymphedema.
Age range
18 Years – 70 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Extremity volume (v)
Timeframe: Assessed preoperatively and 12-months postoperatively.