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

Recruiting

• Conditions: Bladder Cancer Stage IIIb; Urinary Diversion; Muscle Invasive Bladder Urothelial Carcinoma; Bladder Cancer Stage IV; Bladder Cancer Stage II; Bladder Cancer Stage IIIc; Progression, Disease; Bladder Cancer Stage IIb; Bladder Leiomyosarcoma; Bladder Cancer Stage IIIa
• Interventions: Procedure: Radical Cystectomy

• Registration Number: NCT06170177
• Lead Sponsor: IRCCS San Raffaele

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2013-02-04
• Study First Submitted: 2023-10-16
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-06
• Last Update Submitted: 2023-12-06
• Study First Posted: 2023-12-14
• Last Update Posted: 2023-12-14
• Primary Completion: 2063-02
• Study Completion: 2063-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients underwent radical cystectomy	Radical Cystectomy	-

Primary Outcome Measures

Name	Time	Method
obtain health benefit for the patients themselves and for future patients underwent radical cystectomy	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.	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.
improve the patient's scientific knowledge and develop new procedures for the diagnosis and treatment of the patient	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.	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.

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milan, MI, Italy