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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06132321
Enrollment
93
Registered
2023-11-15
Start date
2020-06-23
Completion date
2026-06-30
Last updated
2023-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vulvar Neoplasms

Keywords

Vulvar Neoplasms, Vulvar cancer, Vulvar Reconstruction, Vulvoperineal Reconstruction, Gynecological Cancer, Quality of Life

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.

Interventions

BEHAVIORALQuality 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

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
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

Design outcomes

Primary

MeasureTime frameDescription
Rand 36June 2020 - June 2025Changes in RAND-36 score before and after surgery

Secondary

MeasureTime frameDescription
ICIQ-SFJune 2020 - June 2025Changes in ICIQ-SF score before and after surgery
FSFIJune 2020 - June 2025Changes in FSFI score before and after surgery
ECOGJune 2020 - June 2025Changes in ECOG score before and after surgery
LYM-LEG-QoLJune 2020 - June 2025Changes in LYM-LEG-QoL score before and after surgery

Countries

Italy

Contacts

Primary ContactStefano Gentileschi, Prof.
stefano.gentileschi@policlinicogemelli.it+390630151
Backup ContactAnna Amelia Caretto, MD
carettoaa@gmail.com+390630151

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026