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

Study Overview
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Brief Summary
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Observational study on the quality of life and pathological state of patients underwent radical cystectomy.

Detailed Description
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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.

Official Title
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Bladder Archive: Observational Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy

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

Intervention / Treatment
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* Procedure: Radical Cystectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients underwent radical cystectomy<br> | Procedure: Radical Cystectomy<br>* A radical cystectomy is an operation to remove the whole bladder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| obtain health benefit for the patients themselves and for future patients underwent radical cystectomy | All patients, before underwent radical cystectomy, receive a diary in which we ask a detailed clinical history of the patient with their symptoms, diagnosis and previous urological e non urological treatments performed before the operation. A detailed intraoperative, postoperative and follow-up clinical history. | Baseline and Follow-up. 1 Annual follow-up until the patient decides to stop providing follow-up responses or until the date of death from any cause. | 
| improve the patient's scientific knowledge and develop new procedures for the diagnosis and treatment of the patient | Through the collection of a detailed clinical history of the patient in which themselves report symptoms, diagnosis and previous urological and non-urological treatments and also through the medical record. | Baseline and Follow-up. 1 Annual follow-up until the patient decides to stop providing follow-up responses or until the date of death from any cause. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radical Cystectomy