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Trial Title:
Quality of Life in Patients Undergone Vulvar Reconstruction After Vulvar Cancer Resection (3233)
NCT ID:
NCT06132321
Condition:
Vulvar Neoplasms
Conditions: Official terms:
Vulvar Neoplasms
Conditions: Keywords:
Vulvar Neoplasms
Vulvar cancer
Vulvar Reconstruction
Vulvoperineal Reconstruction
Gynecological Cancer
Quality of Life
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Quality of life questionnaires
Description:
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
Arm group label:
Patients operated for vulvar cancer with reconstruction
Arm group label:
Patients operated for vulvar cancer without reconstruction
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.
Criteria for eligibility:
Study pop:
Patients undergoing ablative surgery for vulvar cancer associated or not to vulvoperineal
reconstruction
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Address:
City:
Rome
Zip:
00168
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Stefano Gentileschi, Prof.
Phone:
+390630151
Email:
stefano.gentileschi@policlinicogemelli.it
Contact backup:
Last name:
Anna Amelia Caretto, MD
Phone:
+390630151
Email:
carettoaa@gmail.com
Start date:
June 23, 2020
Completion date:
June 30, 2026
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06132321
