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Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema

NCT03683095 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-09-22

No results posted yet for this study

Summary

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.

Conditions

  • Lymph Leakage

Interventions

PROCEDURE

Lymphovenous bypass

Lymphovenous bypass will be performed under general anesthetic. Indocyanine green lymphangiography will be performed by injecting indocyanine green into each finger / toe web of the lymphedematous limb and mapping the lymphatic system with the NOVADAQ SPY Fluorescence Imaging (Mississauga, Canada). Subdermal dissection of lymphatics and venules will be carried out under a surgical microscope. Lymphatic vessels will be anastomosed to adjacent recipient venules to create the bypass between the lymphatic and the venous systems. In total, 1-5 anastomoses will be performed. This will require 1-5 incisions, each with a length of 2-3 cm. Postoperatively, the limb will be wrapped loosely with compression bandages. No special postoperative monitoring is required. The surgery will be performed on an outpatient basis with no planned hospital stay.

Sponsors & Collaborators

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Moein Momtazi, MD · Division of Plastic & Reconstructive Surgery, Department of Surgery, University of Ottawa

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-10-01
Completion
2024-10-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03683095 on ClinicalTrials.gov