Quality of Life and Health Perception After Surgery of Va... | NCT06290973

Studies
Quality of Life and Health Perception After Surgery of Varicose Veins

NCT06290973

Sponsor

Hospital Clínico Universitario de Valladolid

Status

Completed

Last Update Posted

Mar 4, 2024Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Quality of Life
Varicose Veins

Interventions

surgery of varicose veins

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2023Actual

Primary Completion Date

Feb 28, 2023Actual

Completion Date

Nov 14, 2023Actual

First Submitted Date

Nov 23, 2023

First Submission Date that Met QC Criteria

Feb 26, 2024

First Posted Date

Mar 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2024

Last Update Posted Date

Mar 4, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Diana Gutierrez Castillo, PhD, Hospital Clínico Universitario de ValladolidPrincipal Investigator

Lead Sponsor

Hospital Clínico Universitario de ValladolidOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery of varicose veins	Procedure	including ablation with radiofrequency, phlebectomy and saphenectomy.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
changes in VCSS after surgery of varicose veins	measured in VCSS score	before and 90 days after surgery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with reflux in saphenous vein

Exclusion Criteria:

no reflux in saphenous vein

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital CLínico Universitario de Valladolid		Valladolid			Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014648	Varicose Veins

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided