Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema

NCT ID: NCT03683095

Last Updated: 2022-09-22

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-10-01

Brief 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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Lymphovenous bypass

Patients with extremity lymphedema treated with lymphovenous bypass.

Lymphovenous bypass

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. 18-70 years.

2. Lymphedema of the upper or lower extremity.

3. International Society of Lymphology Stage I-II.

Exclusion Criteria

1. Significant comorbidities that would preclude a patient from receiving a general anesthetic.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moein Momtazi, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Plastic & Reconstructive Surgery, Department of Surgery, University of Ottawa

Other Identifiers

20180289-01H

Identifier Type: -

Identifier Source: org_study_id