NCT06067880

Brief Summary

Supermicrosurgical LVA has been proven effective in treating moderate to severe lymphedema, including cases with diffuse dermal backflow (DB) and even severe lymphatic fluid leakage. Therefore, the use of LVA should not be limited to mild lymphedema, and its indications should be expanded to become a primary surgical approach for more severe lymphedema cases. Among all surgical procedures for lymphedema, LVA is the least invasive, allowing for rapid recovery, minimizing the complications, and reducing medical costs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

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 23, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
Last Updated

October 5, 2023

Status Verified

September 1, 2023

Enrollment Period

6 months

First QC Date

September 28, 2023

Last Update Submit

September 28, 2023

Conditions

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

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

Other: Cancer-related UnilateralOther: Normal + Ectasis LVs

Interventions

This group included patients who have used only contraction type LVs.

Lower Limb Lymphedema

This group included patients who had only non- contraction type LVs.

Lower Limb Lymphedema

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • This study including patients diagnosed with lymphatic-related diseases at Kaohsiung Chang Gung Memorial Hospital from September 1, 2015, to August 31, 2022.

You may not qualify if:

  • Patients under the age of 20.
  • Patients with incomplete medical records.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

Related Publications (1)

  • Knoz M, Wang YM, Luo SD, Wu SC, Lin WC, Tsai PY, Chien PC, Hsieh CH, Yang JC. Comparison of contraction-type and noncontraction-type lymphatic vessels in lymphaticovenous anastomosis for cancer-related unilateral lower limb lymphedema: a retrospective cohort propensity-score-matched outcome analysis. Int J Surg. 2024 Apr 1;110(4):1913-1918. doi: 10.1097/JS9.0000000000001106.

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

September 28, 2023

First Posted

October 5, 2023

Study Start

September 23, 2022

Primary Completion

March 10, 2023

Study Completion

September 1, 2023

Last Updated

October 5, 2023

Record last verified: 2023-09

Locations