Quality of Life in Patients Undergone Vulvar Reconstruction After Vulvar Cancer Resection (3233)

November 13, 2023 updated by: Gentileschi Stefano, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Monocentric Prospective Observational Multiparametric Study on the Quality of Life in Patients Undergone Surgery for Vulvar Cancer and Reconstruction (3233)

This study aims to evaluate the patients'quality of life before and after surgery for vulvar cancer and reconstruction, employing different questionnaires and investigating different items.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

93

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing ablative surgery for vulvar cancer associated or not to vulvoperineal reconstruction

Description

Inclusion Criteria:

  • Patients undergoing surgery for vulvar cancer
  • Patients providing consent to be enrolled in the study

Exclusion Criteria:

  • Cognitive impairment
  • psychiatric disorder
  • neurodegenerative disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients operated for vulvar cancer without reconstruction
Behavioral: Quality of life questionnaires
Detecting by mean of questionnaires quality of life, urinary function, pain, sexual function and lymphedema status before and after surgery for vulvar cancer, associated or not to vulvar reconstruction
Patients operated for vulvar cancer with reconstruction
Behavioral: Quality of life questionnaires
Detecting by mean of questionnaires quality of life, urinary function, pain, sexual function and lymphedema status before and after surgery for vulvar cancer, associated or not to vulvar reconstruction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rand 36
Time Frame: June 2020 - June 2025
Changes in RAND-36 score before and after surgery
June 2020 - June 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICIQ-SF
Time Frame: June 2020 - June 2025
Changes in ICIQ-SF score before and after surgery
June 2020 - June 2025
FSFI
Time Frame: June 2020 - June 2025
Changes in FSFI score before and after surgery
June 2020 - June 2025
ECOG
Time Frame: June 2020 - June 2025
Changes in ECOG score before and after surgery
June 2020 - June 2025
LYM-LEG-QoL
Time Frame: June 2020 - June 2025
Changes in LYM-LEG-QoL score before and after surgery
June 2020 - June 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Stefano Gentileschi, Prof., Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2020

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

March 11, 2023

First Submitted That Met QC Criteria

November 13, 2023

First Posted (Actual)

November 15, 2023

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3233

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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