Supermicrosurgical LVA for Lymphedema Treatment

Supermicrosurgical Lymphatic Venous Anastomosis for Lymphedema Treatment

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.

Study Overview

• Status: Completed
• Conditions: Lymphedema
• Intervention / Treatment: Other: LVEEA; Other: LVESA; Other: LVSEA

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 83301
    • Kaohsiung Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This retrospective observational study was approved by the institutional review board in our hospital. From March 2016 to October 2018, 100 patients with 103 lymphedematous lower limbs (International Society of Lymphology stage I-III) were included. All the patients underwent supermicrosurgical LVA performed by a single surgeon using a high-power microscope.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients underwent supermicrosurgical LVA; Patients underwent supermicrosurgical LVA by a single surgeon from March 2016 to October 2018.	Other: LVEEA; lymphaticovenous end-to-end; Other: LVESA; lymphaticovenous end-to-side; Other: LVSEA; lymphaticovenous side-to-end

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
survival or failure	The primary free flap outcome was determined as its survival or failure.	up to 3 months

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): July 30, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 24, 2020
• First Submitted That Met QC Criteria: February 24, 2020
• First Posted (Actual): February 26, 2020

Study Record Updates

• Last Update Posted (Actual): February 26, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lymphatic Diseases; Lymphedema
• Other Study ID Numbers: 201801774B0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No