Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy

San Donato Group (GSD)

Status: Enrolling

Conditions: Neobladder; Bladder Cancer Stage IIb; Urinary Diversion; Progression, Disease; Bladder Cancer Stage IV; Muscle Invasive Bladder Urothelial Carcinoma; Bladder Urothelial Carcinoma; Bladder Cancer Stage IIa; Bladder Cancer Stage IIIc; Bladder Cancer Stage IIIa; Bladder Cancer Stage IIIb; Bladder Cancer; Bladder Cancer TNM Staging; Bladder Cancer Stage II; Muscle-Invasive Bladder Carcinoma; Radical Cystectomy; Bladder Leiomyosarcoma

Treatments: Procedure: Radical Cystectomy

Study type: Observational

Funder types: Other

Identifiers

NCT06170177

2012/Vescica

Details and patient eligibility

About

Observational study on the quality of life and pathological state of patients underwent radical cystectomy.

Full description

Each patient will be followed for approximately 10 years starting from the date of surgery. The patient may be contacted for yearly follow-up through one of the preferred methods indicated (phone call, email or home address) which will be carried out by the staff of the Urology Department. The data for each patient will then be transferred to the database itself. The data collected will be handled following the most strict GCPs and privacy norms.

The data entered will concern:

• period before hospitalization (symptoms, clinical data) and completion of a pre-surgery questionnaire
• hospitalization period with all its related data
• questionnaires relating to quality of life which will be administered to the patient once a year according to the preferred method expressed by the patient in the informed consent.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• subjects underwent radical cystectomy
• > 18 years old
• Ability to read and sign the informed consent

Exclusion criteria

• Age <18 years
• Inability to read and sign the informed consent

Trial design

4,000 participants in 1 patient group

Patients underwent radical cystectomy

Treatment:

Procedure: Radical Cystectomy