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NCT05270629 Clinical Trial

Supermicrosurgical Lymphvenous Bypass Intervention for Treatment

Lymphedema of Leg Clinical Trial

Official title:
Supermicrosurgical Lymphvenous Bypass Intervention for Lymphedema Treatment

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05270629
Other study ID # 202101384B0
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 6, 2021
Est. completion date September 5, 2022

Study information
Verified date February 2022
Source Chang Gung Memorial Hospital
Contact Ching-Hua Hsieh, PhD
Phone +886-7-7317123
Email m93chinghua@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background: In addition to antegrade anastomosis, retrograde anastomosis has been thought to offer further improvements after lymphaticovenous anastomosis (LVA) by bypassing the retrograde lymphatic flow. However, this concept has yet to be validated. The aim of this study was to determine the impacts on outcomes of performing both retrograde and antegrade anastomosis, as compared to antegrade-only anastomosis for treating lower limb lymphedema.

Recruitment information / eligibility
Status Recruiting
Enrollment 87
Est. completion date September 5, 2022
Est. primary completion date August 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Lower limb lymphedema patients. Exclusion Criteria: - Patients who have had previous LVA, liposuction, or excisional therapy such as the Charles procedure were excluded.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Antegrade and retrograde anastomoses
Patients who had received both antegrade and retrograde anastomoses.
• Antegrade-only anastomoses
Patients who had received antegrade-only anastomoses.

Locations
Country Name City State
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)
Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Magnetic resonance volumetry Magnetic resonance volumetry was used for outcome assessments. The primary endpoint was the volume change at 6 months after LVA. 6 months after LVA
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