Supermicrosurgical LVA for Lymphedema Treatment

Lymphedema Clinical Trial

Official title:

Supermicrosurgical Lymphatic Venous Anastomosis for Lymphedema Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04285762
• Other study ID #: 201801774B0
• Status: Completed
• Start date: November 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

LVA orientations such as lymphaticovenous end-to-end (LVEEA), end-to-side (LVESA), and side-to-end (LVSEA) are commonly performed. Each orientation has its own advantages and disadvantages. The key factors affecting the type of anastomotic orientation are the sizes of the LVs and the RVs, and the relative distance between them. Most published literatures have focused on LVSEA2-9, which is considered to be the most efficient. With one anastomosis in LVSEA, the RV is able to drain both the antegrade and retrograde lymphatic flow. Nevertheless, how to determine the anastomotic orientation has remained ambiguous. In this study, we aimed to establish the basis of selecting the proper anastomotic orientation, based on the size and comparative size discrepancy between LV and RV. To the best of our knowledge, this is the first report to focus on this subject.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

Inclusion Criteria:

• lymphedematous lower limbs (International Society of Lymphology stage I-III) between March 2016 to October 2018 were included

Exclusion Criteria:

• Patients whose data were missing will be excluded.

Related Conditions & MeSH terms

• Lymphedema

Intervention

Other:
• LVEEA
lymphaticovenous end-to-end
• LVESA
lymphaticovenous end-to-side
• LVSEA
lymphaticovenous side-to-end

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	survival or failure	The primary free flap outcome was determined as its survival or failure.	up to 3 months