Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
241 participants
OBSERVATIONAL
2014-12-31
2017-12-31
Brief Summary
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Detailed Description
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The degree of compliance with the protocol will be assessed through a checklist indicating compliance with each of the steps of the protocol in both groups. All patients will sign an informed consent for the study authorizing the use of their clinical data for statistical analysis.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Control
Consecutive radical cystectomies up to 94 patients in 13 participating hospitals in Madrid, Spain. These patients will be taken care of as it is done regularly in each of participating hospitals. All study variables will be prospectively collected in this group
No interventions assigned to this group
Active Treatment
After recruiting cotrol group, another consecutive radical cystectomies up to 94 patients in 13 participating hospitals will be recruited and the following measures will be followed with them:
I.-PREOPERATIVE MEASURES: (eight measures according to Protocol) II.- INTRAOPERATIVE MEASURES: (six measures according to Protocol) III.- POSTOPERATIVE MEASURES: (eight measures according to Protocol)
Consecutive radical cystectomies
Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process
Interventions
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Consecutive radical cystectomies
Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process
Eligibility Criteria
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Inclusion Criteria
* Signed informed consent
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Carlos Llorente
OTHER
Responsible Party
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Carlos Llorente
Doctor in Medicine
Principal Investigators
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Carlos Llorente, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Fundación de Alcorcón
Locations
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Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Universitario de Getafe
Getafe, Madrid, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, Spain
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, Spain
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid, Spain
Hospital Universitario Infanta Elena
Valdemoro, Madrid, Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital Doce de Octubre
Madrid, , Spain
Hospital Infanta Leonor
Madrid, , Spain
Hospital Universitario Gregorio Marañon
Madrid, , Spain
Countries
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Other Identifiers
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PRO-RAC
Identifier Type: -
Identifier Source: org_study_id
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