Assessment Of Bladder Tumors Stage And Grade By Outpatient Flexible Cystoscopy Performed By Urology Resident
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.
研究概览
研究类型
注册 (预期的)
联系人和位置
学习地点
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Aldakahlia
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Mansoura、Aldakahlia、埃及、35516
- 招聘中
- Urology and nephrology center
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接触：
- Abdelwahab R. Hashem, Msc
- 电话号码：00201069678979
- 邮箱：abdelwahab_hashem@yahoo.com
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接触：
- Mohammed H. Zahran, MD
- 电话号码：00201063338690
- 邮箱：zahranmha@yahoo.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Men and women 18 years or older
- Denovo or recurrent NMIBC
- Bladder mass discovered in hematuria investigation
- Willing to share in study
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents
大体时间：1 year
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Outcome measures by histopathological results of bladder biopsy
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1 year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Evaluation of pain perception in patient undergoing flexible or rigid diagnostic cystoscopy
大体时间：1 year
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Outcome measures by visual analog scale (VAS) pain score
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1 year
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Assessment of the patient reported outcomes after both flexible and rigid cystoscopy
大体时间：1 year
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Outcome measures by Freiburg Index of Patient Satisfaction (FIPS) questionnaire
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1 year
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Assessment of the prognostic value of gross morphology with recurrence, progression
大体时间：2 year
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Outcome measures by Number of patients surviving for two year without tumor recurrence will be counted and compared
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2 year
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合作者和调查者
调查人员
- 研究主任：Ahmed Mosbah, MD、Urology and nephrology center
- 学习椅：Hassan Abol-Enein, MD、Urology and nephrology center
- 首席研究员：Mohamed Abdelbaset, Msc、Urology and nephrology center
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- F-Cystoscopy NMIBC
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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