NCT05270629

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
87

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 6, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2022

Completed
Last Updated

March 8, 2022

Status Verified

February 1, 2022

Enrollment Period

12 months

First QC Date

February 28, 2022

Last Update Submit

February 28, 2022

Conditions

Lymphedema of Leg

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Lower limb lymphedema patients

This was a retrospective cohort propensity score-matched study. Patients with lower limb lymphedema were enrolled.

Other: Antegrade and retrograde anastomosesOther: Antegrade-only anastomoses

Interventions

Antegrade and retrograde anastomosesOTHER

Patients who had received both antegrade and retrograde anastomoses.

Lower limb lymphedema patients
Antegrade-only anastomosesOTHER

Patients who had received antegrade-only anastomoses.

Lower limb lymphedema patients

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (age \> 18 years) with lower limb lymphedema patients were enrolled from March 2016 to December 2020.

You may qualify if:

  • Lower limb lymphedema patients.

You may not qualify if:

  • Patients who have had previous LVA, liposuction, or excisional therapy such as the Charles procedure were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

RECRUITING

Central Study Contacts

Ching-Hua Hsieh, PhD

CONTACT

+886-7-7317123m93chinghua@gmail.com

Study Design

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

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 8, 2022

Study Start

September 6, 2021

Primary Completion

August 31, 2022

Study Completion

September 5, 2022

Last Updated

March 8, 2022

Record last verified: 2022-02

Locations

TW(1)