Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema

Lymph Leakage Clinical Trial

Official title:

Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03683095
• Other study ID #: 20180289-01H
• Status: Withdrawn
• Start date: April 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: September 2022
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymph Leakage
• Lymphedema

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of episodes of cellulitis (n / year)	Number of episodes of cellulitis requiring antimicrobial therapy (n / year).	Patient estimate from the 12-months preoperatively compared with 12-months postoperatively.
Other	Need for ongoing compression therapy (yes / no)	Need for ongoing compression therapy as defined by the use of acute bandaging, compression garments, or manual compression therapy (yes / no).	Assessed preoperatively and 12-months postoperatively.
Primary	Extremity volume (v)	Extremity volume will be calculated using the truncated cone formula based on limb circumference measurements.	Assessed preoperatively and 12-months postoperatively.
Secondary	Quality of life assessment tool for lymphedema of the limbs (LYMQOL).	Quality of life assessment tool for lymphedema of the limbs.	Assessed preoperatively and 12-months postoperatively.