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

Recruiting
Conditions
Vulvar Neoplasms
Interventions
Behavioral: Quality of life questionnaires
Registration Number
NCT06132321
Lead Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
93
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients operated for vulvar cancer with reconstructionQuality of life questionnaires-
Patients operated for vulvar cancer without reconstructionQuality of life questionnaires-
Primary Outcome Measures
NameTimeMethod
Rand 36June 2020 - June 2025

Changes in RAND-36 score before and after surgery

Secondary Outcome Measures
NameTimeMethod
ICIQ-SFJune 2020 - June 2025

Changes in ICIQ-SF score before and after surgery

ECOGJune 2020 - June 2025

Changes in ECOG score before and after surgery

LYM-LEG-QoLJune 2020 - June 2025

Changes in LYM-LEG-QoL score before and after surgery

FSFIJune 2020 - June 2025

Changes in FSFI score before and after surgery

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

🇮🇹

Rome, Italy

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