NCT06742242

Brief Summary

The aim of the present study was to investigate the impact of non-ICG(+) LVs on the outcomes after LVA compared to ICG(+) LVs with propensity-score-match analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

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, 2015

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 19, 2024

Completed
Last Updated

December 19, 2024

Status Verified

April 1, 2024

Enrollment Period

7.5 years

First QC Date

October 4, 2024

Last Update Submit

December 17, 2024

Conditions

Lymphedema

Keywords

propensity score matchingLVASupermicrosurgerylymphaticovenous anastomosislymphovenous bypass

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)

The Use of Non-ICG-Enhanced Lymphatic Vessels for LVA

EXPERIMENTAL

The use of non-ICG-enhanced lymphatic vessels for LVA

Procedure: lymphaticovenous anastomosis

Interventions

lymphaticovenous anastomosisPROCEDURE

supermicrosurgical lymphatic vessel to recipient ven lumen-to-lumen coaptation

The Use of Non-ICG-Enhanced Lymphatic Vessels for LVA

Eligibility Criteria

Age20 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from September 2015 to March 2023.
  • Patients who underwent LVA for unilateral lower-limb lymphedema.

You may not qualify if:

  • Primary lymphedema
  • Bilateral lower limb lymphedema
  • History of previous treatment for lymphedema (LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure) - Those that were lost to follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 833, Taiwan

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2024

First Posted

December 19, 2024

Study Start

September 1, 2015

Primary Completion

March 1, 2023

Study Completion

March 1, 2023

Last Updated

December 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)