NCT06290973

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2023

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 23, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

November 23, 2023

Last Update Submit

February 26, 2024

Conditions

Quality of LifeVaricose Veins

Outcome Measures

Primary Outcomes (2)

  • changes in qol questionarie SF-12 after surgery of varicose veins

    measured in SF-12 score

    before and 90 days after surgery

  • changes in qol questionarie Veines QoL/Sym after surgery of

    measured in Veines Qol/Sym score

    before and 90 days after surgery

Secondary Outcomes (1)

  • changes in VCSS after surgery of varicose veins

    before and 90 days after surgery

Interventions

surgery of varicose veinsPROCEDURE

including ablation with radiofrequency, phlebectomy and saphenectomy.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with varicose veins undergoing surgery between january and february of 2023 in Valladolid Clinical Hospital

You may qualify if:

  • patients with reflux in saphenous vein

You may not qualify if:

  • no reflux in saphenous vein

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital CLínico Universitario de Valladolid

Valladolid, Spain

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 23, 2023

First Posted

March 4, 2024

Study Start

January 2, 2023

Primary Completion

February 28, 2023

Study Completion

November 14, 2023

Last Updated

March 4, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)