Enhanced Recovery After Radical Cystectomy Study

NCT ID: NCT02328417

Last Updated: 2018-02-22

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

241 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Bladder Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Refusal to sign informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Carlos Llorente

OTHER

Sponsor Role lead

Responsible Party

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Carlos Llorente

Doctor in Medicine

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Site Status

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Site Status

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Site Status

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Site Status

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, Spain

Site Status

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, Spain

Site Status

Hospital Universitario Infanta Elena

Valdemoro, Madrid, Spain

Site Status

Fundación Jiménez Díaz

Madrid, , Spain

Site Status

Hospital Doce de Octubre

Madrid, , Spain

Site Status

Hospital Infanta Leonor

Madrid, , Spain

Site Status

Hospital Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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PRO-RAC

Identifier Type: -

Identifier Source: org_study_id

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