Bladder Archive: Observational Study on the Quality of Life and Pathological State in Patients Who Underwent Radical Cystectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- obtain health benefit for the patients themselves and for future patients underwent radical cystectomy
研究概览
简要总结
Observational study on the quality of life and pathological state of patients underwent radical cystectomy.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects underwent radical cystectomy
- •> 18 years old
- •Ability to read and sign the informed consent
排除标准
- •Age <18 years
- •Inability to read and sign the informed consent
结局指标
主要结局
obtain health benefit for the patients themselves and for future patients underwent radical cystectomy
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Francesco Montorsi
Professor
IRCCS San Raffaele