NCT06188858

Brief Summary

Our aim was to identify optimal incision sites for LVA in extremity lymphedema that would result in the most effective drainage effect for reducing limb edema and enhancing patients' quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 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

January 1, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 3, 2024

Completed
Last Updated

January 3, 2024

Status Verified

December 1, 2023

Enrollment Period

3.9 years

First QC Date

December 10, 2023

Last Update Submit

December 18, 2023

Conditions

Lymphedema

Outcome Measures

Primary Outcomes (4)

  • Number of Participants with lymphedema stage

    stage 0-3

    through study completion, an average of 4 year

  • Number of Optimal Incision Site Design

    Optimal Incision Site Design for Lymphaticovenular Anastomosis

    through study completion, an average of 4 year

  • Rate of lymphatic vessel Functional Parameters

    intraoperative functional lymphatic vessel assessment

    through study completion, an average of 4 year

  • Circumferential Reduction rate

    postoperative limb reduction and patient satisfaction

    through study completion, an average of 4 year

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lymphedema patients

You may not qualify if:

  • lipedema；myoedema

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chong Liu

Zhejiang, 318000, China

Location

MeSH Terms

Conditions

Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic DiseasesHemic and Lymphatic Diseases

Study Officials

  • yomao zheng

    employee

    STUDY DIRECTOR

  • chong liu

    employee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

December 10, 2023

First Posted

January 3, 2024

Study Start

January 1, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

January 3, 2024

Record last verified: 2023-12

Locations

CN(1)