NCT04698707

Brief Summary

Vascularized lymph node flap transfer (VLNT) was believed to be the treatment of choice for moderate-to-severe lymphedema. Recent publications have supported the use of supermicrosurgical lymphaticovenous anastomosis (LVA) for treating severe lymphedema. This study hypothesizes whether LVA can be performed on post-VLNT patients seeking further improvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

August 28, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2021

Completed
Last Updated

January 7, 2021

Status Verified

January 1, 2021

Enrollment Period

1 month

First QC Date

January 5, 2021

Last Update Submit

January 5, 2021

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

  • Magnetic resonance volumetry

    Magnetic resonance volumetry was used for measuring preoperative and postoperative volume changes at least 6-month after LVA.

    6 months after LVA

Study Arms (1)

lower limb lymphedema patients

This retrospective cohort study enrolled 131 lower limb lymphedema patients including 10 patients who have received VLNT as their primary lymphedema surgery showing minimal post-VLNT improvement (Group I) and 121 patients without previous lymphatic surgery (Group II).

Other: Vascularized lymph node flap transferOther: Patients without prior lymphedema surgery

Interventions

Vascularized lymph node flap transferOTHER

Patients who have received VLNT as their primary treatment but with minimal improvement

lower limb lymphedema patients
Patients without prior lymphedema surgeryOTHER

Patients without prior lymphedema surgery

lower limb lymphedema patients

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

From November 2014 to January 2019, a total of 131 lower limb lymphedema patients were enrolled.

You may qualify if:

  • From November 2014 to January 2019
  • 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

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic 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

January 5, 2021

First Posted

January 7, 2021

Study Start

August 28, 2020

Primary Completion

October 5, 2020

Study Completion

November 19, 2020

Last Updated

January 7, 2021

Record last verified: 2021-01

Locations

TW(1)