Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema

Withdrawn

• Conditions: Lymph Leakage
• Interventions: Procedure: Lymphovenous bypass

• Registration Number: NCT03683095
• Lead Sponsor: Ottawa Hospital Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-16
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-20
• Last Update Posted: 2022-09-22
• Study Start: 2023-04-01
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lymphovenous bypass	Lymphovenous bypass	Patients with extremity lymphedema treated with lymphovenous bypass.

Primary Outcome Measures

Name	Time	Method
Extremity volume (v)	Assessed preoperatively and 12-months postoperatively.	Extremity volume will be calculated using the truncated cone formula based on limb circumference measurements.

Secondary Outcome Measures

Name	Time	Method
Quality of life assessment tool for lymphedema of the limbs (LYMQOL).	Assessed preoperatively and 12-months postoperatively.	Quality of life assessment tool for lymphedema of the limbs.