Bladder Cancer Clinical Trial
Official title:
Enhanced Recovery After Radical Cystectomy Study
Verified date | February 2018 |
Source | Hospital Universitario Fundación Alcorcón |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Prospective non randomized study of two cohorts: usual protocol and the application of accelerated recovery protocol. F/up after discharge, 90 days and thereafter according to protocol of each center. Compliance to be assessed.
Status | Completed |
Enrollment | 241 |
Est. completion date | December 2017 |
Est. primary completion date | February 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Consecutive patients scheduled for radical cystectomy in the participating hospitals - Signed informed consent Exclusion Criteria: - Refusal to sign informed consent |
Country | Name | City | State |
---|---|---|---|
Spain | 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 | Fundación Jiménez Díaz | Madrid | |
Spain | Hospital Doce de Octubre | Madrid | |
Spain | Hospital Infanta Leonor | Madrid | |
Spain | Hospital Universitario Gregorio Marañon | 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 |
Lead Sponsor | Collaborator |
---|---|
Carlos Llorente |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In-hospital length-of-stay (LOS), defined as the number of days since the admission of the patient to the hospital until the day of discharge, Morbidity of surgery. Categorized by the Clavien complications scale at 30-, 60- and 90-postoperative days | Day 1: Admission to the hospital Last day of accountant: Discharge from the hospital or death in the hospital. | 5-40 days | |
Secondary | Mortality at 30-, 60- and 90- postoperative days | 90 days | ||
Secondary | 30-day readmission rate | 30 days | ||
Secondary | Transfusion rate | 90 days | ||
Secondary | Patient satisfaction measured with the enclosed questionnaire | Do you know the names of your attending physician and nurse? The quality of the preoperative care and information has been: The quality of the postoperative care and information has been: Do you think that the information on the care of your urostomy has been enough? Yes/No If NO, on which of the following points would you have liked receiving more information? Types of collecting bags and accessories Stomal hygiene and change of bags Complications of the stoma and the surrounding skin Counseling on food habits, dress apparel, and physical and sexual activity Comunity counselling: Stoma therapist, patients associations If you had a neobladder performed, were you trained in self-catheterization ? How would you rate your motivation in learning the above mentioned issues? In all, the quality of the health care that you have received is: |
90 days |
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