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

NCT ID: NCT06170177

Last Updated: 2023-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-04

Study Completion Date

2063-02-28

Brief Summary

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

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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.

Conditions

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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 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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients underwent radical cystectomy

Radical Cystectomy

Intervention Type PROCEDURE

A radical cystectomy is an operation to remove the whole bladder

Interventions

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Radical Cystectomy

A radical cystectomy is an operation to remove the whole bladder

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Francesco Montorsi

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Francesco Montorsi, MD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale San Raffaele

Locations

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IRCCS Ospedale San Raffaele

Milan, MI, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Montorsi, MD

Role: CONTACT

[email protected]
+390226437286

Giusy Burgio, MSc

Role: CONTACT

[email protected]
+390226436764

Facility Contacts

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Francesco Montorsi, MD

Role: primary

[email protected]
+390226437286

Giusy Burgio, MSc

Role: backup

[email protected]
+390226436764

Other Identifiers

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2012/Vescica

Identifier Type: -

Identifier Source: org_study_id

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