Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents
研究概览
简要总结
This will be a prospective trial comparing the perspective gross morphological of bladder tumor assessment done by outpatient flexible cystoscopy performed by resident, inpatient rigid cystoscopy done by senior staff and their prediction of the degree of invasion of bladder tumor plus the prediction of the grade compared with the standard pathological result.
Also, assessment of the patient reported outcomes after both flexible and rigid cystoscopy will be done.
In the long run of the study, the prognostic gross morphology with recurrence, progression and cancer specific survival will be assessed.
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
- •Men and women 18 years or older
- •Denovo or recurrent NMIBC
- •Bladder mass discovered in hematuria investigation
- •Willing to share in study
排除标准
- •inability to cooperate with flexible cystoscopic evaluations
- •cystoscopies for other kind of intervention (e.g., removal of a ureteral stent)
- •Untreated infections
- •Other causes of storage or voiding symptoms as untreated benign prostatic hyperplasia (BPH) or interstitial cystitis
- •Unpassable urethral stricture
结局指标
主要结局
Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents
时间窗: 1 year
Outcome measures by histopathological results of bladder biopsy
次要结局
- Evaluation of pain perception in patient undergoing flexible or rigid diagnostic cystoscopy(1 year)
- Assessment of the patient reported outcomes after both flexible and rigid cystoscopy(1 year)
- Assessment of the prognostic value of gross morphology with recurrence, progression(2 year)
研究者
Abdelwahab Hashem
Urology Msc, Oncology fellow at Urology and Nephrology Center, Principal Investigator
Mansoura University