Supermicrosurgical LVA for Lymphedema Treatment

NCT04285762 | Completed

• 1 other identifier: 201801774B0
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

• survival or failure

  The primary free flap outcome was determined as its survival or failure.

  up to 3 months

Study Arms (1)

Patients underwent supermicrosurgical LVA

Patients underwent supermicrosurgical LVA by a single surgeon from March 2016 to October 2018.

Other: LVEEA; Other: LVESA; Other: LVSEA

Interventions

LVEEA OTHER

lymphaticovenous end-to-end

Patients underwent supermicrosurgical LVA

LVESA OTHER

lymphaticovenous end-to-side

Patients underwent supermicrosurgical LVA

LVSEA OTHER

lymphaticovenous side-to-end

Patients underwent supermicrosurgical LVA

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Patients whose data were missing will be excluded.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2020
• First Posted: February 26, 2020
• Study Start: November 1, 2018
• Primary Completion: July 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Locations

TW (1)