Efficacy of Lymphovenous Bypass in the Treatment of Extremity Lymphedema

O

Ottawa Hospital Research Institute

Status

Withdrawn

Conditions

Lymph Leakage

Treatments

Procedure: Lymphovenous bypass

Study type

Observational

Funder types

Other

Identifiers

NCT03683095
20180289-01H

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 18-70 years.
  • Lymphedema of the upper or lower extremity.
  • International Society of Lymphology Stage I-II.

Exclusion criteria

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

Trial design

0 participants in 1 patient group

Lymphovenous bypass
Description:
Patients with extremity lymphedema treated with lymphovenous bypass.
Treatment:
Procedure: Lymphovenous bypass

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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