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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema of Leg

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