Actively Recruiting
Bladder Archive: Observational Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy
Led by IRCCS San Raffaele · Updated on 2023-12-14
4000
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This observational study focuses on patients who have undergone radical cystectomy, an operation to remove the entire bladder, to assess their quality of life and pathological state over time. The study aims to gain health insights that may benefit current and future patients and to improve scientific knowledge and diagnostic and treatment procedures related to this surgery. Participants will be followed for approximately 10 years starting from their surgery date. Data collection includes pre-hospitalization clinical information and symptoms, hospitalization details, and annual quality of life questionnaires administered through the participant's preferred communication method, such as phone, email, or home visits. The study is managed by the Urology Department staff who will securely record and transfer data into a dedicated database. Throughout the study, participants may be contacted yearly for follow-up assessments that gather clinical data and quality of life information. The primary outcomes measured include health benefits for participants and advancements in medical understanding related to radical cystectomy. The study continues annually until participants choose to stop responding or until death. Data privacy and good clinical practices are strictly followed during the entire observation period.
CONDITIONS
Brief Title
Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects underwent radical cystectomy
- Older than 18 years
- Ability to read and sign the informed consent
You will not qualify if you...
- Younger than 18 years
- Inability to read and sign the informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Hospitalization period
Participants undergo a radical cystectomy, which is an operation to remove the whole bladder.
1 hospitalization period
Duration - Approximately 10 years
Participants are followed for approximately 10 years after surgery with yearly quality of life questionnaires administered via phone call, email, or home address according to participant preference.
Annual follow-up contacts
Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele
Milan, MI, Italy, 20132
Actively Recruiting
Research Team
F
Francesco Montorsi, MD
G
Giusy Burgio, MSc
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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