Observational Study on the Occurrence of Possible Relapses and on the Quality of Life in Patients Who Underwent Endoscopic Resection Surgery for Bladder Cancer (TURBK).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- IRCCS San Raffaele
- Enrollment
- 20,000
- Locations
- 1
- Primary Endpoint
- improve the patient's scientific knowledge and develop new procedures for the diagnosis and treatment of the patient
Study Overview
Brief Summary
A database has been created and will be used in which data will be collected in electronic format relating to adult patients who underwent one of the following endoscopic resection surgeries: TURBK, MAPPING, TURBK SECOND LOOK, BLADDER BIOPSIES.
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 follwing 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years or older
- •Patients with non-muscle invasive bladder cancer
- •Indication to cancer removal through endoscopic resection surgery
- •Ability to read and sign the informed consent
Exclusion Criteria
- •Age <18 years
- •Inability to read and sign the informed consent
Outcomes
Primary Outcomes
improve the patient's scientific knowledge and develop new procedures for the diagnosis and treatment of the patient
Time Frame: 1 Annual follow-up from the date of surgery untile the date in which 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.
obtain health benefit for the patients themselves and for future patients suffering from bladder cancer
Time Frame: 1 Annual follow-up from the date of surgery until the date in which patient decides to stop providing follow-up responses or until the date of death from any cause.
All patients, before underwent endoscopic resection surgery, 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Francesco Montorsi
Professor
IRCCS San Raffaele