Clinical trial NCT02328417: Enhanced Recovery After Radical Cystectomy Study
Official title: Enhanced Recovery After Radical Cystectomy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Lead sponsor: Hospital Universitario Fundación Alcorcón
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All consecutive male and female patients older than 18 years submitted to radical cystectomy due to bladder cancer in the 13 participating hospitals.

Brief summary: 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.

Detailed description: This is a prospective non randomized study of two cohorts, one defined by the usual protocol and the other one by the application of accelerated recovery protocol. It's discarded a priori a prospective randomized trial, since it does not seem feasible to avoid byass of control group when synchronizing the active intervention and control. Subjects surgery will be followed after discharge for a minimum of 90 days, and thereafter according to protocol of each center. Patients will be provided with a satisfaction survey 90 days after surgery.

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.

Eligibility criteria: Inclusion Criteria:

* Consecutive patients scheduled for radical cystectomy in the participating hospitals
* Signed informed consent

Exclusion Criteria:

* Refusal to sign informed consent

Primary outcomes:
measure: 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
timeFrame: 5-40 days
Secondary outcomes:
measure: Mortality at 30-, 60- and 90- postoperative days
timeFrame: 90 days
measure: 30-day readmission rate
timeFrame: 30 days
measure: Transfusion rate
timeFrame: 90 days
measure: Patient satisfaction measured with the enclosed questionnaire
timeFrame: 90 days
Other outcomes:
Locations:
city: Alcalá de Henares
country: Spain
facility: Hospital Universitario Principe de Asturias
state: Madrid
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Getafe
country: Spain
facility: Hospital Universitario de Getafe
state: Madrid
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa
state: Madrid
city: Majadahonda
country: Spain
facility: Hospital Puerta de Hierro
state: Madrid
city: Móstoles
country: Spain
facility: Hospital Universitario Rey Juan Carlos
state: Madrid
city: Torrejón de Ardoz
country: Spain
facility: Hospital Universitario de Torrejón
state: Madrid
city: Valdemoro
country: Spain
facility: Hospital Universitario Infanta Elena
state: Madrid
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Doce de Octubre
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañon
Study officials:
affiliation: Hospital Fundación de Alcorcón
name: Carlos Llorente, MD
role: PRINCIPAL_INVESTIGATOR
References: