Health TrialsbyHealthPanel

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

ConditionVulvar Neoplasms
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing surgery for vulvar cancer

Patients providing consent to be enrolled in the study

Disqualifiers

Cognitive impairment

psychiatric disorder

neurodegenerative disorder

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Quality of life questionnaires

    Behavioral

    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

Treatment groups

93 Participants
are divided into 2 treatment groups
Group A: Patients operated for vulvar cancer without reconstruction1 intervention
Group B: Patients operated for vulvar cancer with reconstruction1 intervention

Trial outcomes

Primary outcomes

1

Rand 36

Changes in RAND-36 score before and after surgery

Time frame
June 2020 - June 2025

Secondary outcomes

1

ICIQ-SF

Changes in ICIQ-SF score before and after surgery

Time frame
June 2020 - June 2025
2

FSFI

Changes in FSFI score before and after surgery

Time frame
June 2020 - June 2025
3

ECOG

Changes in ECOG score before and after surgery

Time frame
June 2020 - June 2025
4

LYM-LEG-QoL

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

Time frame
June 2020 - June 2025

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Lead sponsor

Source ClinicalTrials.gov
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