NCT06249360

Brief Summary

This study aimed to determine the impact on outcomes when recipient veins with reflux were used for LVA for the treatment of unilateral lower limb lymphedema.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

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

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 8, 2024

Completed
Last Updated

February 8, 2024

Status Verified

August 1, 2023

Enrollment Period

3 months

First QC Date

January 31, 2024

Last Update Submit

January 31, 2024

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (1)

  • Volume change after LVA.

    The primary endpoint was the volume change at 6/12 months after LVA.

    6/12 months

Study Arms (1)

Lower Limb Lymphedema

Patients with cancer-related unilateral lower limb lymphedema were enrolled.

Other: Veins with refluxOther: Reflux-free recipient veins

Interventions

Veins with refluxOTHER

This group included patients who used only recipient veins with reflux

Lower Limb Lymphedema
Reflux-free recipient veinsOTHER

This group included patients who utilized only reflux-free recipient veins

Lower Limb Lymphedema

Eligibility Criteria

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

All adult patients (age \>20 years) receiving LVA for lower limb lymphedema at a tertiary medical center were retrospectively reviewed from October 2015 to December 2022.

You may qualify if:

  • This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from October 1, 2015, to December 31, 2022.
  • Patients who underwent LVA for unilateral lower-limb lymphedema.

You may not qualify if:

  • Patients under the age of 20.
  • Patients lost to follow-up or with incomplete data.

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 31, 2024

First Posted

February 8, 2024

Study Start

September 1, 2023

Primary Completion

November 15, 2023

Study Completion

December 30, 2023

Last Updated

February 8, 2024

Record last verified: 2023-08

Locations

TW(1)