LymphedemaNCT04285762
Supermicrosurgical LVA for Lymphedema Treatment
An observational study of Lymphedema, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
LVA orientations such as lymphaticovenous end-to-end (LVEEA), end-to-side (LVESA), and side-to-end (LVSEA) are commonly performed. Each orientation has its own advantages and disadvantages. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Lymphedema
- What is being tested?
- LVEEA, LVESA and LVSEA
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Nov 2018to 31 Dec 2019
- 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: This retrospective observational study was approved by the institutional review board in our hospital. From March 2016 to October 2018, 100 patients with 103 lymphedematous lower limbs (International Society of Lymphology stage I-III) were included. All the patients underwent supermicrosurgical LVA performed by a single surgeon using a high-power microscope.
Who may be able to join
- lymphedematous lower limbs (International Society of Lymphology stage I-III) between March 2016 to October 2018 were included
Who cannot join
- Patients whose data were missing will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supermicrosurgical Lymphatic Venous Anastomosis for Lymphedema Treatment
LVA orientations such as lymphaticovenous end-to-end (LVEEA), end-to-side (LVESA), and side-to-end (LVSEA) are commonly performed. Each orientation has its own advantages and disadvantages. The key factors affecting the type of anastomotic orientation are the sizes of the LVs and the RVs, and the relative distance between them. Most published literatures have focused on LVSEA2-9, which is considered to be the most efficient. With one anastomosis in LVSEA, the RV is able to drain both the antegrade and retrograde lymphatic flow. Nevertheless, how to determine the anastomotic orientation has remained ambiguous. In this study, we aimed to establish the basis of selecting the proper anastomotic orientation, based on the size and comparative size discrepancy between LV and RV. To the best of our knowledge, this is the first report to focus on this subject.
- Conditions
- Lymphedema
- Being tested
- LVEEA, LVESA, LVSEA
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LVEEAOther
lymphaticovenous end-to-end
LVESAOther
lymphaticovenous end-to-side
LVSEAOther
lymphaticovenous side-to-end
| Study group | Role | What they receive |
|---|---|---|
| Patients underwent supermicrosurgical LVA | Patients underwent supermicrosurgical LVA by a single surgeon from March 2016 to October 2018. Receives: Other: LVEEA; Other: LVESA; Other: LVSEA |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival or failure
The primary free flap outcome was determined as its survival or failure.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start1 Nov 2018
- Primary completion30 Jul 2019
- Study completion31 Dec 2019
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
- 100 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
- NCT04285762
- Sponsor's protocol ID
- 201801774B0
- Status last verified
- Feb 2020
- First submitted
- 24 Feb 2020
- Last updated
- 26 Feb 2020
- 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 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supermicrosurgical Lymphatic Venous Anastomosis for Lymphedema Treatment
- ClinicalTrials.gov ID
- NCT04285762
- Acronym / sponsor ID
- 201801774B0
- Conditions
- Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 26 Feb 2020 (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.
LVA orientations such as lymphaticovenous end-to-end (LVEEA), end-to-side (LVESA), and side-to-end (LVSEA) are commonly performed. Each orientation has its own advantages and disadvantages. The key factors affecting the type of anastomotic orientation are the sizes of the LVs and the RVs, and the relative distance between them. Most published literatures have focused on LVSEA2-9, which is considered to be the most efficient. With one anastomosis in LVSEA, the RV is able to drain both the antegrade and retrograde lymphatic flow. Nevertheless, how to determine the anastomotic orientation has remained ambiguous. In this study, we aimed to establish the basis of selecting the proper anastomotic orientation, based on the size and comparative size discrepancy between LV and RV. To the best of our knowledge, this is the first report to focus on this subject.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients underwent supermicrosurgical LVA | – | Other: LVEEA, Other: LVESA, Other: LVSEAPatients underwent supermicrosurgical LVA by a single surgeon from March 2016 to October 2018. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective observational study was approved by the institutional review board in our hospital. From March 2016 to October 2018, 100 patients with 103 lymphedematous lower limbs (International Society of Lymphology stage I-III) were included. All the patients underwent supermicrosurgical LVA performed by a single surgeon using a high-power microscope.
Key inclusion criteria (1 listed)
- lymphedematous lower limbs (International Society of Lymphology stage I-III) between March 2016 to October 2018 were included
Key exclusion criteria (1 listed)
- Patients whose data were missing will be 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 |
|---|---|---|
| LVEEAlymphaticovenous end-to-end | Other | Patients underwent supermicrosurgical LVA |
| LVESAlymphaticovenous end-to-side | Other | Patients underwent supermicrosurgical LVA |
| LVSEAlymphaticovenous side-to-end | Other | Patients underwent supermicrosurgical LVA |
Primary outcome
survival or failure
Time frame: up to 3 months
The primary free flap outcome was determined as its survival or failure.
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 26 Feb 2020.
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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 1 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 26 Feb 2020. 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?
survival or failure (time frame: up to 3 months). 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 26 Feb 2020.