Varicose VeinsNCT00702897
Ambulatory Surgery of Lower Extremity Varicose Vein
An observational study of Varicose Veins, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
OBJECTIVE: To retrospectively analyze the results of ambulatory treatment on Taiwanese patients with primary varicosities of the lower extremities including the use of endovenous laser, phlebectomy, and sclerotherapy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Varicose Veins
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2008to not given
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients with varicose veins who underwent endovenous laser treatment for GSV reflux in our hospital were reviewed.
Who may be able to join
- All patients with varicose veins who underwent endovenous laser treatment for GSV reflux in our hospital were reviewed
Who cannot join
- poor general health, inability to walk, active inflammation of varicose veins, deep venous occlusion disease, hypercoagulability, pregnancy and breast-feeding.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
Taipei
Chih-Yang Chan, MD, PhD, 886-8966-7000, chanchihyang@mail.femh.org.tw
About this study
OBJECTIVE: To retrospectively analyze the results of ambulatory treatment on Taiwanese patients with primary varicosities of the lower extremities including the use of endovenous laser, phlebectomy, and sclerotherapy.
METHODS: We routinely used tumescent anesthesia and ultrasound-guided approaches for the application of endovenous laser. Vein access was achieved by either a percutaneous or stab wound. The laser power was usually 10 - 20 watts; laser treatment usually was begun from 4-10 cm below the saphenofemoral junction, and stopped around the knee, not over 10 cm below the knee. In the same operation, we used Mueller's phlebectomy and/or sclerotherapy if there were prominent branch varicosities. We instructed each patient to walk around immediately after the operation, to go home, and to come back 1-3 days later for follow-up. Ultrasound scan and venous function follow-up was scheduled at 1 month, 6 months, 12 months, and then annually.
- Conditions
- Varicose Veins
- Medical subject headings
- Varicose Veins
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2008 (estimated)
- Study startJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose VeinsStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00702897
- Sponsor's protocol ID
- FEMH-96041
- Status last verified
- Jun 2008
- First submitted
- 18 Jun 2008
- Last updated
- 20 Jun 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Surgery of Lower Extremity Varicose Vein
- ClinicalTrials.gov ID
- NCT00702897
- Acronym / sponsor ID
- FEMH-96041
- Conditions
- Varicose Veins
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2008
- First posted
- 20 Jun 2008 (estimated)
- 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.
OBJECTIVE: To retrospectively analyze the results of ambulatory treatment on Taiwanese patients with primary varicosities of the lower extremities including the use of endovenous laser, phlebectomy, and sclerotherapy.
METHODS: We routinely used tumescent anesthesia and ultrasound-guided approaches for the application of endovenous laser. Vein access was achieved by either a percutaneous or stab wound. The laser power was usually 10 - 20 watts; laser treatment usually was begun from 4-10 cm below the saphenofemoral junction, and stopped around the knee, not over 10 cm below the knee. In the same operation, we used Mueller's phlebectomy and/or sclerotherapy if there were prominent branch varicosities. We instructed each patient to walk around immediately after the operation, to go home, and to come back 1-3 days later for follow-up. Ultrasound scan and venous function follow-up was scheduled at 1 month, 6 months, 12 months, and then annually.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients with varicose veins who underwent endovenous laser treatment for GSV reflux in our hospital were reviewed.
Key inclusion criteria (1 listed)
- All patients with varicose veins who underwent endovenous laser treatment for GSV reflux in our hospital were reviewed
Key exclusion criteria (1 listed)
- poor general health, inability to walk, active inflammation of varicose veins, deep venous occlusion disease, hypercoagulability, pregnancy and breast-feeding.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2008.
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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 Varicose Veins, run by Far Eastern 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 20 Jun 2008. 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 Chih-Yang Chan, ME, PhD (886-8966-7000, chanchihyang@mail.femh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 20 Jun 2008.