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The aim of this pilot study is to assess the efficacy and toxicity of immediate pre-operative instillation of mitomycin C compared to the standard early post-operative .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IPOI | Experimental | One arm with pre-operative instillation of mitomycine 1h before TURB (IPOI : Instillation pré-opératoire immédiate), |
|
| IPOP | Active Comparator | One arm with early post-operative instillation of mitomycine within 24 hours (IPOP : Instillation Post Opératoire Précoce). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IPOI (pre-operative) | Procedure |
| ||
| IPOP (post-operative) |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jacques IRANI, MD, PhD | Contact | : +33 (0)5.49.44.44.77 | jacques.irani@chu-poitiers.fr |
| Name | Affiliation | Role |
|---|---|---|
| Jacques IRANI, MD, PhD | Poitiers University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bicêtre Hospital | Recruiting | Le Kremlin-Bicêtre | 94270 | France |
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|
| Poitiers University Hospital | Recruiting | Poitiers | 86100 | France |
|
| Rouen University Hospital | Active, not recruiting | Rouen | 76000 | France |
| ID | Term |
|---|---|
| D000093284 | Non-Muscle Invasive Bladder Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| 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 |
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| ID | Term |
|---|---|
| D011184 | Postoperative Period |
| ID | Term |
|---|---|
| D059035 | Perioperative Period |
| D013514 | Surgical Procedures, Operative |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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