Quality of LifeNCT06290973
Quality of Life and Health Perception After Surgery of Varicose Veins
An observational study of Quality of Life and Varicose Veins, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
Trial summary
The aim of this study is to analyze changes in health perception and quality of life in patients after surgery for varicose veins using clinical score VCSS and QoL scores SF12 as general health questionary and Veines QoL/Sym as disease specific questionary. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Quality of Life, Varicose Veins
- What is being tested?
- surgery of varicose veins
- Type of treatment
- Surgery or procedure
- How many people
- 58 participants
- Where
- 1 siteSpain
- Study dates
- 2 Jan 2023to 14 Nov 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with varicose veins undergoing surgery between january and february of 2023 in Valladolid Clinical Hospital
Who may be able to join
- patients with reflux in saphenous vein
Who cannot join
- no reflux in saphenous vein
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to analyze changes in health perception and quality of life in patients after surgery for varicose veins using clinical score VCSS and QoL scores SF12 as general health questionary and Veines QoL/Sym as disease specific questionary.
- Conditions
- Quality of Life, Varicose Veins
- Being tested
- surgery of varicose veins
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery of varicose veinsProcedure or surgery
including ablation with radiofrequency, phlebectomy and saphenectomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in qol questionarie SF-12 after surgery of varicose veins
measured in SF-12 score
Measured: before and 90 days after surgery
changes in qol questionarie Veines QoL/Sym after surgery of
measured in Veines Qol/Sym score
Measured: before and 90 days after surgery
Secondary outcomes (1)
changes in VCSS after surgery of varicose veins
measured in VCSS score
Measured: before and 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start2 Jan 2023
- Primary completion28 Feb 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies 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
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clínico Universitario de Valladolid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana Gutierrez Castillo, Hospital Clínico Universitario de Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290973
- Sponsor's protocol ID
- PI-23-3017
- Status last verified
- Feb 2024
- First submitted
- 23 Nov 2023
- Last updated
- 4 Mar 2024
- Results posted
- 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 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life and Health Perception After Surgery of Varicose Veins
- ClinicalTrials.gov ID
- NCT06290973
- Acronym / sponsor ID
- PI-23-3017
- Conditions
- Quality of Life, Varicose Veins
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Hospital Clínico Universitario de ValladolidUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 4 Mar 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.
The aim of this study is to analyze changes in health perception and quality of life in patients after surgery for varicose veins using clinical score VCSS and QoL scores SF12 as general health questionary and Veines QoL/Sym as disease specific questionary.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with varicose veins undergoing surgery between january and february of 2023 in Valladolid Clinical Hospital
Key inclusion criteria (1 listed)
- patients with reflux in saphenous vein
Key exclusion criteria (1 listed)
- no reflux in saphenous vein
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 |
|---|---|---|
| surgery of varicose veinsincluding ablation with radiofrequency, phlebectomy and saphenectomy. | Procedure or surgery | – |
Primary outcome
changes in qol questionarie SF-12 after surgery of varicose veins
Time frame: before and 90 days after surgery
measured in SF-12 score
changes in qol questionarie Veines QoL/Sym after surgery of
Time frame: before and 90 days after surgery
measured in Veines Qol/Sym score
1 secondary outcome
changes in VCSS after surgery of varicose veins
Time frame: before and 90 days after surgery
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 4 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Quality of Life
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Study of a Support Program for Quality of Life in Chinese Cancer Patients and Survivors
Cancer, Survivorship
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
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 Quality of Life and Varicose Veins, run by Hospital Clínico Universitario de Valladolid at 1 site in Spain.
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 4 Mar 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 Spain. 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?
changes in qol questionarie SF-12 after surgery of varicose veins (time frame: before and 90 days after surgery). The study lists 2 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 4 Mar 2024.