LymphedemaNCT06188858
Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity Lymphedema
An observational study of Lymphedema, run by Taizhou Hospital at 1 site in China.
Trial summary
Our aim was to identify optimal incision sites for LVA in extremity lymphedema that would result in the most effective drainage effect for reducing limb edema and enhancing patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lymphedema
- How many people
- 267 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Dec 2023
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Lymphedema patients
Who may be able to join
None listed.
Who cannot join
- lipedema；myoedema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity
Our aim was to identify optimal incision sites for LVA in extremity lymphedema that would result in the most effective drainage effect for reducing limb edema and enhancing patients' quality of life.
Read the detailed description
designing the optimal incision sites and identifying functional lymphatic vessels imaging is crucial for success, primarily due to its efficacy in draining edematous lymphatic fluid and reducing swelling in patients with lymphedema. In this study, we conducted patients with LVA lymphedema to investigate the correlation between LVA incision design, intraoperative functional lymphatic vessel assessment, postoperative limb reduction, and patient satisfaction.
question 1：Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity lymphedema
- Conditions
- Lymphedema
- Medical subject headings
- Lymphedema
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with lymphedema stage
stage 0-3
Measured: through study completion, an average of 4 year
Number of Optimal Incision Site Design
Optimal Incision Site Design for Lymphaticovenular Anastomosis
Measured: through study completion, an average of 4 year
Rate of lymphatic vessel Functional Parameters
intraoperative functional lymphatic vessel assessment
Measured: through study completion, an average of 4 year
Circumferential Reduction rate
postoperative limb reduction and patient satisfaction
Measured: through study completion, an average of 4 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start1 Jan 2020
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
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.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taizhou Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haihua Yang, Taizhou Hospital
- Investigators
- yomao zheng, Study director, employeechong liu, Principal investigator, employee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188858
- Sponsor's protocol ID
- Taizhou Hospital OISD
- Status last verified
- Dec 2023
- First submitted
- 10 Dec 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity
- ClinicalTrials.gov ID
- NCT06188858
- Acronym / sponsor ID
- Taizhou Hospital OISD
- Conditions
- Lymphedema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Taizhou HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 3 Jan 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.
Our aim was to identify optimal incision sites for LVA in extremity lymphedema that would result in the most effective drainage effect for reducing limb edema and enhancing patients' quality of life.
Detailed description
designing the optimal incision sites and identifying functional lymphatic vessels imaging is crucial for success, primarily due to its efficacy in draining edematous lymphatic fluid and reducing swelling in patients with lymphedema. In this study, we conducted patients with LVA lymphedema to investigate the correlation between LVA incision design, intraoperative functional lymphatic vessel assessment, postoperative limb reduction, and patient satisfaction.
question 1：Optimal Incision Site Design for Lymphaticovenular Anastomosis in Extremity lymphedema
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Lymphedema patients
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- lipedema；myoedema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with lymphedema stage
Time frame: through study completion, an average of 4 year
stage 0-3
Number of Optimal Incision Site Design
Time frame: through study completion, an average of 4 year
Optimal Incision Site Design for Lymphaticovenular Anastomosis
Rate of lymphatic vessel Functional Parameters
Time frame: through study completion, an average of 4 year
intraoperative functional lymphatic vessel assessment
Circumferential Reduction rate
Time frame: through study completion, an average of 4 year
postoperative limb reduction and patient satisfaction
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 3 Jan 2024.
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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.
yomao zheng study director
employee
chong liu principal investigator
employee
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 Taizhou Hospital at 1 site in China.
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 0 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 3 Jan 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 China. 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?
Number of Participants with lymphedema stage (time frame: through study completion, an average of 4 year). The study lists 4 primary outcomes in all. 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 3 Jan 2024.