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Biological behabiour of low grade bladder cancer tumors is well known. They have a very high rate of recurrences during their follow up but very low (less than 1%) risk of progression.
Until now, the gold standard of any bladder recurrence for this patients is performing an immediate transurethral ressection of the tumor.
This surgery has risk of complications and, due to the low risk of these subgroup of tumors, sometimes it becomes an overtreatment for the patients.
This is the reason why new conservative or less invasive surgeries are proposed to follow up and treat these patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active surveillance | No Intervention | After a recurrence in patient with previous low grade bladder cancer tumor, strict follow up with cystoscopy and cytology, avoiding immediate surgery | |
| endoscopic fulguration | Active Comparator | After a recurrence in patient with previous low grade bladder cancer tumor, fulguration under local anesthesia and sedation will be performed using a flexible cystoscope and a monopolar electrode |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic fulguration | Procedure | already included. WE will use Storz monopolar device for fulguration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression rate | Number of patients that progress during the follow up | two years |
| Complications rate | Number and grade of complications in both arms. Clavien Dindo Scale will be used | two years |
| Measure | Description | Time Frame |
|---|---|---|
| recurrence rate | number of recurrences | two years |
| quality of life measured with CAVICAVENMI questionnaire | quality of life of the patients in both subgroups. CAVICAVENMI questionnaire will be used |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fernando Lozano Palacio | Barcelona | 08035 | Spain |
codified information (anonymous information)
after completing the recruitment (two years), data will be available, for 5 years
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| two years |
| 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 |