Lymphedema of LegNCT05270629
Supermicrosurgical Lymphvenous Bypass Intervention for Treatment
An observational study of Lymphedema of Leg, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Background: In addition to antegrade anastomosis, retrograde anastomosis has been thought to offer further improvements after lymphaticovenous anastomosis (LVA) by bypassing the retrograde lymphatic flow. However, this concept has yet to be validated. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lymphedema of Leg
- What is being tested?
- Antegrade and retrograde anastomoses and Antegrade-only anastomoses
- How many people
- 87 participants
- Where
- 1 siteTaiwan
- Study dates
- 6 Sep 2021to 5 Sep 2022
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (age > 18 years) with lower limb lymphedema patients were enrolled from March 2016 to December 2020.
Who may be able to join
- 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.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Hsiao-Yun Hsieh, MSc, +886-7-7317123 ext. 2947, sylvia19870714@hotmail.com
About this study
Official title: Supermicrosurgical Lymphvenous Bypass Intervention for Lymphedema Treatment
Background: In addition to antegrade anastomosis, retrograde anastomosis has been thought to offer further improvements after lymphaticovenous anastomosis (LVA) by bypassing the retrograde lymphatic flow. However, this concept has yet to be validated. The aim of this study was to determine the impacts on outcomes of performing both retrograde and antegrade anastomosis, as compared to antegrade-only anastomosis for treating lower limb lymphedema.
- Conditions
- Lymphedema of Leg
- Being tested
- Antegrade and retrograde anastomoses, Antegrade-only anastomoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antegrade and retrograde anastomosesOther
Patients who had received both antegrade and retrograde anastomoses.
Antegrade-only anastomosesOther
Patients who had received antegrade-only anastomoses.
| Study group | Role | What they receive |
|---|---|---|
| Lower limb lymphedema patients | This was a retrospective cohort propensity score-matched study. Patients with lower limb lymphedema were enrolled. Receives: Other: Antegrade and retrograde anastomoses; Other: Antegrade-only anastomoses |
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 outcome assessments. The primary endpoint was the volume change at 6 months 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 posted8 Mar 2022
- Study start6 Sep 2021
- Primary completion31 Aug 2022 (estimated)
- Study completion5 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphedema of LegStudies 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
- 87 participants (estimated)
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
- NCT05270629
- Sponsor's protocol ID
- 202101384B0
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2022
- Last updated
- 8 Mar 2022
- 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 8 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supermicrosurgical Lymphvenous Bypass Intervention for Lymphedema Treatment
- ClinicalTrials.gov ID
- NCT05270629
- Acronym / sponsor ID
- 202101384B0
- Conditions
- Lymphedema of Leg
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 6 Sep 2021 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 5 Sep 2022 (estimated)
- First posted
- 8 Mar 2022 (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.
Background: In addition to antegrade anastomosis, retrograde anastomosis has been thought to offer further improvements after lymphaticovenous anastomosis (LVA) by bypassing the retrograde lymphatic flow. However, this concept has yet to be validated. The aim of this study was to determine the impacts on outcomes of performing both retrograde and antegrade anastomosis, as compared to antegrade-only anastomosis for treating lower limb lymphedema.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lower limb lymphedema patients | – | Other: Antegrade and retrograde anastomoses, Other: Antegrade-only anastomosesThis was a retrospective cohort propensity score-matched study. Patients with lower limb lymphedema were enrolled. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (age > 18 years) with lower limb lymphedema patients were enrolled from March 2016 to December 2020.
Key inclusion criteria (1 listed)
- 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 |
|---|---|---|
| Antegrade and retrograde anastomosesPatients who had received both antegrade and retrograde anastomoses. | Other | Lower limb lymphedema patients |
| Antegrade-only anastomosesPatients who had received antegrade-only anastomoses. | Other | Lower limb lymphedema patients |
Primary outcome
Magnetic resonance volumetry
Time frame: 6 months after LVA
Magnetic resonance volumetry was used for outcome assessments. The primary endpoint was the volume change at 6 months after LVA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2022.
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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.
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 of Leg, 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: status not confirmed, as of the sponsor's last update on 8 Mar 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ching-Hua Hsieh, PhD (+886-7-7317123 ext. 2947, m93chinghua@gmail.com), or a site near the patient. 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 8 Mar 2022.