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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06170177
Enrollment
4000
Registered
2023-12-14
Start date
2013-02-04
Completion date
2063-02-28
Last updated
2023-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Radical Cystectomy

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.

Interventions

PROCEDURERadical Cystectomy

A radical cystectomy is an operation to remove the whole bladder

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
obtain health benefit for the patients themselves and for future patients underwent radical cystectomyBaseline 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 patientBaseline 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.

Countries

Italy

Contacts

Primary ContactFrancesco Montorsi, MD
montorsi.francesco@hsr.it+390226437286
Backup ContactGiusy Burgio, MSc
burgio.giusy@hsr.it+390226436764

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026