LymphedemaNCT06685926
The Impact of Supermicrosurgery Intervention on Patients with Lower Extremity Lymphedema Using Groin-Only Approach Lymphaticovenous Anastomosis
An observational study of Lymphedema and Lymphedema of Leg, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
This study employs a propensity score-matched analysis to compare the treatment outcomes, focusing on percentage volume reduction between the conventional multi-incision lymphaticovenous anastomosis (LVA) technique and the novel single groin incision LVA technique in patients with unilateral lower extremity… Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- Lymphedema, Lymphedema of Leg
- What is being tested?
- Supermicrosurgical LVA, Groin Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis) and Supermicrosurgical LVA, Conventional Multiple Access Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis)
- Type of treatment
- Surgery or procedure
- How many people
- 189 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2015to Sep 2024
- 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
Who may be able to join
- Patients diagnosed with lymphatic-related diseases to the lower extremity
- Patients who is undergoing LVA for unilateral lower-limb lymphedema.
Who cannot join
- Primary lymphedema
- Bilateral lower limb lymphedema
- History of previous treatment for lymphedema (LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure) - Those that were lost to follow-up.
- Patients who recieved both LVA to the groin site and non-groin site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Groin-Only Lymphaticovenous Anastomosis for Lower Extremity Lymphoedema: a Retrospective Cohort Propensity-Score Matched Analysis of a Novel Supermicrosurgical Concept
This study employs a propensity score-matched analysis to compare the treatment outcomes, focusing on percentage volume reduction between the conventional multi-incision lymphaticovenous anastomosis (LVA) technique and the novel single groin incision LVA technique in patients with unilateral lower extremity lymphoedema.
Read the detailed description
Lymphaticovenous anastomosis (LVA), a surgical technique that connects lymphatic vessels (LVs) to adjacent veins, has demonstrated efficacy in alleviating lymphedema by enabling the drainage of stagnant lymphatic fluid.
Conventional LVA treatment for lower extremity lymphoedema (LEL) has favored distal, multiple incisions in the lower leg due to the denser and more superficial distribution of LVs and recipient veins in the distal regions.
Based on the recent advancement in the understaning of lymphosomes and the role of antegrade lymph flow, a shift to more proximal LVA around the groin region for LEL could be theoretically advantagous, but its clinical efficacy compared to conventional distal LVA remains underexplored.
- Conditions
- Lymphedema, Lymphedema of Leg
- Being tested
- Supermicrosurgical LVA, Groin Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis), Supermicrosurgical LVA, Conventional Multiple Access Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis)
- Keywords
- propensity score matching, LVA, supermicrosurgery, lymphaticovenous anastomosis, lymphovenous bypass
- Medical subject headings
- Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supermicrosurgical LVA, Groin Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis)Procedure or surgery
Supermicrosurgical LVA, Conventional Multiple Access Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Groin-Only Approach LVA | This is a group of patients who had a single incision based LVA procedure. Receives: Procedure: Supermicrosurgical LVA, Groin Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis) | |
| Conventional Approach LVA | This is a group of patients who had the conventional LVA approach with multiple incisions for access. Receives: Procedure: Supermicrosurgical LVA, Conventional Multiple Access Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volume change after LVA
The primary endpoint is limb volume change at 6 and 12 months after intervention, measured using magnetic resonance volumetry.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study startSep 2015
- Primary completionSep 2024
- Study completionSep 2024
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
- Enrolment
- 189 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
- NCT06685926
- Sponsor's protocol ID
- 202401630B0
- Status last verified
- Oct 2024
- First submitted
- 7 Nov 2024
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Groin-Only Lymphaticovenous Anastomosis for Lower Extremity Lymphoedema: a Retrospective Cohort Propensity-Score Matched Analysis of a Novel Supermicrosurgical Concept
- ClinicalTrials.gov ID
- NCT06685926
- Acronym / sponsor ID
- 202401630B0
- Conditions
- Lymphedema, Lymphedema of Leg
- Keywords
- propensity score matching, LVA, supermicrosurgery, lymphaticovenous anastomosis, lymphovenous bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Sep 2024 (actual)
- Study completion
- Sep 2024 (actual)
- First posted
- 13 Nov 2024 (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.
This study employs a propensity score-matched analysis to compare the treatment outcomes, focusing on percentage volume reduction between the conventional multi-incision lymphaticovenous anastomosis (LVA) technique and the novel single groin incision LVA technique in patients with unilateral lower extremity lymphoedema.
Detailed description
Lymphaticovenous anastomosis (LVA), a surgical technique that connects lymphatic vessels (LVs) to adjacent veins, has demonstrated efficacy in alleviating lymphedema by enabling the drainage of stagnant lymphatic fluid.
Conventional LVA treatment for lower extremity lymphoedema (LEL) has favored distal, multiple incisions in the lower leg due to the denser and more superficial distribution of LVs and recipient veins in the distal regions.
Based on the recent advancement in the understaning of lymphosomes and the role of antegrade lymph flow, a shift to more proximal LVA around the groin region for LEL could be theoretically advantagous, but its clinical efficacy compared to conventional distal LVA remains underexplored.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Groin-Only Approach LVA | – | Procedure: Supermicrosurgical LVA, Groin Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis)This is a group of patients who had a single incision based LVA procedure. |
| Conventional Approach LVA | – | Procedure: Supermicrosurgical LVA, Conventional Multiple Access Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis)This is a group of patients who had the conventional LVA approach with multiple incisions for access. |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients diagnosed with lymphatic-related diseases to the lower extremity
- Patients who is undergoing LVA for unilateral lower-limb lymphedema.
Key exclusion criteria (4 listed)
- Primary lymphedema
- Bilateral lower limb lymphedema
- History of previous treatment for lymphedema (LVA, vascularized lymph node transfer (VLNT), liposuction, or excisional therapy such as the Charles procedure) - Those that were lost to follow-up.
- Patients who recieved both LVA to the groin site and non-groin site.
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 |
|---|---|---|
| Supermicrosurgical LVA, Groin Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis) | Procedure or surgery | Groin-Only Approach LVA |
| Supermicrosurgical LVA, Conventional Multiple Access Approach Only (lymphatic vessel to recipient vien lumen-to-lumen anastomosis) | Procedure or surgery | Conventional Approach LVA |
Primary outcome
Volume change after LVA
Time frame: 6 and 12 months
The primary endpoint is limb volume change at 6 and 12 months after intervention, measured using magnetic resonance volumetry.
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 13 Nov 2024.
- Individual participant dataSharing planned: No
Related trials for Lymphedema
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
Enrolling by invitation
Comparison of the Effects of Kinesio Taping and Compression Bandaging on Edema, Range of Motion, Upper Extremity Function, and Grip Strength in Patients With Breast Cancer-Related Lymphedema
Lymphedema, Lymphedema Arm
RecruitingObservational study
A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons
Open Surgery, Lymphedema
Not yet recruiting
Agentic AI App and Home Bioimpedance Monitoring for Endocrine Therapy Adherence and Lymphedema in Breast Cancer Survivors
Breast Neoplasm Malignant Primary, Lymphedema Arm
Active, not recruiting
The Effectiveness of Lymphatic Bypass Supermicrosurgery
Breast Cancer Related Lymphedema, Lymphedema Arm
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 and 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 2 inclusion and 4 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 13 Nov 2024. 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?
Volume change after LVA (time frame: 6 and 12 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 13 Nov 2024.