Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03683095|
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : September 5, 2019
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.
|Condition or disease||Intervention/treatment|
|Lymph Leakage||Procedure: Lymphovenous bypass|
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|Official Title:||Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema|
|Estimated Study Start Date :||December 1, 2019|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||October 1, 2022|
Patients with extremity lymphedema treated with lymphovenous bypass.
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.
- Extremity volume (v) [ Time Frame: Assessed preoperatively and 12-months postoperatively. ]Extremity volume will be calculated using the truncated cone formula based on limb circumference measurements.
- Quality of life assessment tool for lymphedema of the limbs (LYMQOL). [ Time Frame: Assessed preoperatively and 12-months postoperatively. ]Quality of life assessment tool for lymphedema of the limbs.
- Number of episodes of cellulitis (n / year) [ Time Frame: Patient estimate from the 12-months preoperatively compared with 12-months postoperatively. ]Number of episodes of cellulitis requiring antimicrobial therapy (n / year).
- Need for ongoing compression therapy (yes / no) [ Time Frame: Assessed preoperatively and 12-months postoperatively. ]Need for ongoing compression therapy as defined by the use of acute bandaging, compression garments, or manual compression therapy (yes / no).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683095
|Contact: Moein Momtazi, MD||613-737-8899 ext email@example.com|
|Contact: Linden K Head, MDfirstname.lastname@example.org|
|Principal Investigator:||Moein Momtazi, MD||Division of Plastic & Reconstructive Surgery, Department of Surgery, University of Ottawa|