LymphedemaNCT04698707
Role of Supermicrosurgical LVA for Lower Limb Lymphedema
An observational study of Lymphedema, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- Vascularized lymph node flap transfer and Patients without prior lymphedema surgery
- How many people
- 131 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Aug 2020to 19 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: From November 2014 to January 2019, a total of 131 lower limb lymphedema patients were enrolled.
Who may be able to join
- From November 2014 to January 2019
- Lower limb lymphedema patients
Who cannot join
- Patients who have had previous LVA, liposuction, or excisional therapy such as the Charles procedure were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Lymphedema
- Being tested
- Vascularized lymph node flap transfer, Patients without prior lymphedema surgery
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascularized lymph node flap transferOther
Patients who have received VLNT as their primary treatment but with minimal improvement
Patients without prior lymphedema surgeryOther
Patients without prior lymphedema surgery
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Vascularized lymph node flap transfer; Other: Patients without prior lymphedema surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic resonance volumetry
Magnetic resonance volumetry was used for measuring preoperative and postoperative volume changes at least 6-month after LVA.
Measured: 6 months after LVA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2021
- Study start28 Aug 2020
- Primary completion5 Oct 2020
- Study completion19 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04698707
- Sponsor's protocol ID
- 202001420B0
- Status last verified
- Jan 2021
- First submitted
- 5 Jan 2021
- Last updated
- 7 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Supermicrosurgical Lymphaticovenous Anastomosis for Lower Limb Lymphedema - A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT04698707
- Acronym / sponsor ID
- 202001420B0
- Conditions
- Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 5 Oct 2020 (actual)
- Study completion
- 19 Nov 2020 (actual)
- First posted
- 7 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lower limb lymphedema patients | – | Other: Vascularized lymph node flap transfer, Other: Patients without prior lymphedema surgeryThis 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). |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- From November 2014 to January 2019, a total of 131 lower limb lymphedema patients were enrolled.
Key inclusion criteria (2 listed)
- From November 2014 to January 2019
- Lower limb lymphedema patients
Key exclusion criteria (1 listed)
- Patients who have had previous LVA, liposuction, or excisional therapy such as the Charles procedure were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascularized lymph node flap transferPatients who have received VLNT as their primary treatment but with minimal improvement | Other | lower limb lymphedema patients |
| Patients without prior lymphedema surgeryPatients without prior lymphedema surgery | Other | lower limb lymphedema patients |
Primary outcome
Magnetic resonance volumetry
Time frame: 6 months after LVA
Magnetic resonance volumetry was used for measuring preoperative and postoperative volume changes at least 6-month after LVA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphedema, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic resonance volumetry (time frame: 6 months after LVA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021.