Quality of Life in Patients Undergone Vulvar Reconstruction After Vulvar Cancer Resection (3233)
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT06132321
Collaborator
(none)
93
1
72.2
1.3
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Study Type:
Observational
Anticipated Enrollment
:
93 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Monocentric Prospective Observational Multiparametric Study on the Quality of Life in Patients Undergone Surgery for Vulvar Cancer and Reconstruction (3233)
Actual Study Start Date
:
Jun 23, 2020
Anticipated Primary Completion Date
:
Jun 30, 2026
Anticipated Study Completion Date
:
Jun 30, 2026
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Rand 36 [June 2020 - June 2025]
Changes in RAND-36 score before and after surgery
Secondary Outcome Measures
- ICIQ-SF [June 2020 - June 2025]
Changes in ICIQ-SF score before and after surgery
- FSFI [June 2020 - June 2025]
Changes in FSFI score before and after surgery
- ECOG [June 2020 - June 2025]
Changes in ECOG score before and after surgery
- LYM-LEG-QoL [June 2020 - June 2025]
Changes in LYM-LEG-QoL score before and after surgery
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | 00168 |
Sponsors and Collaborators
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Investigators
- Principal Investigator: Stefano Gentileschi, Prof., Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Gentileschi Stefano,
Associate Professor,
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ClinicalTrials.gov Identifier:
NCT06132321
Other Study ID Numbers:
- 3233
First Posted:
Nov 15, 2023
Last Update Posted:
Nov 15, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Gentileschi Stefano,
Associate Professor,
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Additional relevant MeSH terms: