- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04698707
Role of Supermicrosurgical LVA for Lower Limb Lymphedema
January 5, 2021 updated by: Chang Gung Memorial Hospital
The Role of Supermicrosurgical Lymphaticovenous Anastomosis for Lower Limb Lymphedema - A Retrospective Cohort Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
131
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kaohsiung, Taiwan, 83301
- Kaohsiung Chang Gung Memorial Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 100 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
From November 2014 to January 2019, a total of 131 lower limb lymphedema patients were enrolled.
Description
Inclusion Criteria:
- From November 2014 to January 2019
- Lower limb lymphedema patients
Exclusion Criteria:
- Patients who have had previous LVA, liposuction, or excisional therapy such as the Charles procedure were excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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).
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Patients who have received VLNT as their primary treatment but with minimal improvement
Patients without prior lymphedema surgery
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Magnetic resonance volumetry
Time Frame: 6 months after LVA
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Magnetic resonance volumetry was used for measuring preoperative and postoperative volume changes at least 6-month after LVA.
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6 months after LVA
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 28, 2020
Primary Completion (ACTUAL)
October 5, 2020
Study Completion (ACTUAL)
November 19, 2020
Study Registration Dates
First Submitted
January 5, 2021
First Submitted That Met QC Criteria
January 5, 2021
First Posted (ACTUAL)
January 7, 2021
Study Record Updates
Last Update Posted (ACTUAL)
January 7, 2021
Last Update Submitted That Met QC Criteria
January 5, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202001420B0
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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