NCT05889000

Brief Summary

There are currently no specific validated patient-centric tools for the clinical evaluation of patients with chronic pelvic venous disorders (CPVD). The study involves the development and validation of a questionnaire for the quality of life and a scale of disease severity for a patient with pelvic venous disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 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 10, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 24, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 5, 2023

Completed
Last Updated

June 5, 2023

Status Verified

May 1, 2023

Enrollment Period

3 years

First QC Date

May 24, 2023

Last Update Submit

May 24, 2023

Conditions

Pelvic Congestion Syndrome

Keywords

quality of life questionnairechronic pelvic venous disordersPelvic Varicose Veins Questionnairepelvic congestion syndromevalidationPelvi Venous Clinical Severity Score

Outcome Measures

Primary Outcomes (5)

  • internal consistency assessment

    To assess the degree of internal consistency, the Cronbach's alpha coefficient will be used, which is calculated by the formula: α = N \* r / (1 + r \* (N - 1)), where N is the number of components under study, r is the average correlation coefficient between the components. The study will assess the reliability of the questionnaire and the scale as a whole, as well as the impact on the overall reliability of each individual domain. Domain correlation will be assessed using Spearman's rank correlation method (r).

    At baseline

  • discriminant validity evaluation internal consistency score

    To assess discriminant validity, the level of quality of life and disease severity of patients with CPVD will be compared with similar levels of healthy participants.

    At baseline

  • internal consistency score

    Assessment of internal consistency will be performed by retesting stable patients without treatment after 14 days, followed by calculation of Cronbach's alpha.

    At baseline and after 14 days

  • determination of criterion validity

    To assess the validity, the reliability of the construct will be studied by determining the criterion validity, i.e. identifying the correlation coefficient or relationships between the scales of both questionnaires with some external criterion. The scales of the SF-36 questionnaire will be used as external criteria for assessing the quality of life, and elements of visual analogue scales will be used to assess the severity of the disease.

    At baseline

  • Sensitivity assessment.

    To assess the sensitivity, a comparison of the indicators of the questionnaire questionnaires at the points before treatment and 2 months after the treatment will be carried out.

    At baseline and after 2 months

Study Arms (2)

main group

304 patients with verified CPVD

Other: questionnaire responses

comparison group

93 participants without signs of CPVD.

Other: questionnaire responses

Interventions

questionnaire responsesOTHER

questionnaire responses - Pelvic Varicose Veins Questionnaire (PVVQ) and Pelvic Venous Clinical Severity Score (PVCSS)

comparison groupmain group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients attending primary care

You may qualify if:

  • presence of PVV;
  • completed Patient Informed Consent Form;
  • age from 18 to 70 years;
  • ability to understand and answer the questions of the proposed questionnaire.

You may not qualify if:

  • absence of confirmed PVV;
  • lack of Patient Informed Consent Form;
  • under the age of 18 or over 70 years old;
  • pregnancy at any stage and 12-month postpartum period;
  • presence of a gynecological or other concomitant (urological, neurological, procto-logical, etc.) significant pathology that has similar clinical symptoms with CPVD and re-quires specific treatment;
  • presence of severe concomitant gastrointestinal or hematopoietic system pathology, terminal stages of cardiovascular, respiratory, renal and hepatic failure, stage IV malignant tumor, obliterating diseases of lower limbs arteries;
  • dementia and other mental disorders that limit the ability to understand the essence of the research, fill out Patient Informed Consent Form and answer the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Medical University

Kazan', Tatarstan Republic, Russia

Location

MeSH Terms

Interventions

Coping Responses Inventory

Study Officials

  • Aigul A Mutygullina, PhD

    Kazan State Medical University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of the Department of Cardiovascular and Endovascular Surgery

Study Record Dates

First Submitted

May 24, 2023

First Posted

June 5, 2023

Study Start

January 10, 2018

Primary Completion

December 31, 2020

Study Completion

January 10, 2022

Last Updated

June 5, 2023

Record last verified: 2023-05

Locations

RU(1)