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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cystoscopy | Device | Outpatient flexible cystoscopy and inpatient rigid cystoscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of clinical grade and stage of bladder lesions diagnosed by flexible cystoscopy done by urology residents | Outcome measures by histopathological results of bladder biopsy | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of pain perception in patient undergoing flexible or rigid diagnostic cystoscopy | Outcome measures by visual analog scale (VAS) pain score | 1 year |
| Assessment of the patient reported outcomes after both flexible and rigid cystoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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All patients diagnosed with suspected denovo, recurrent bladder mass or hematuria needing assessment by flexible cystoscopy will be asked to participate in this study at Urology and Nephrology Center Outpatient Clinics and will be provided with an informed consent form in line with Good Clinical Practise and the Declaration of Helsinki.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Abdelwahab R. Hashem, Msc | Contact | 01069678979 | 002 | abdelwahab_hashem@yahoo.com |
| Mohammed H. Zahran, MD | Contact | 01063338690 | 002 | zahranmha@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Hassan Abol-Enein, MD | Urology and Nephrology center | Study Chair |
| Ahmed Mosbah, MD | Urology and Nephrology center | Study Director |
| Mohamed Abdelbaset, Msc |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Urology and Nephrology Center | Recruiting | Al Mansurah | Aldakahlia | 35516 | Egypt |
meta-analyses by contact the Prof. Hassan Abol-Enein, MD, Phd (Study Chair)
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| D010149 | Pain, Postoperative |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D003558 | Cystoscopy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Bladder biopsy and urine cytology
Outcome measures by Freiburg Index of Patient Satisfaction (FIPS) questionnaire
| 1 year |
| Assessment of the prognostic value of gross morphology with recurrence, progression | Outcome measures by Number of patients surviving for two year without tumor recurrence will be counted and compared | 2 year |
| Urology and Nephrology Center |
| Principal Investigator |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003950 | Diagnostic Techniques, Urological |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |