Enhanced Recovery After Radical Cystectomy Study

February 21, 2018 updated by: Carlos Llorente
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

241

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Madrid, Spain
        • Hospital Doce de Octubre
      • Madrid, Spain
        • Hospital Infanta Leonor
      • Madrid, Spain
        • Hospital Universitario Gregorio Marañón
    • Madrid
      • Alcalá de Henares, Madrid, Spain
        • Hospital Universitario Príncipe de Asturias
      • Alcorcón, Madrid, Spain
        • Hospital Universitario Fundacion Alcorcon
      • Getafe, Madrid, Spain
        • Hospital Universitario de Getafe
      • Leganés, Madrid, Spain
        • Hospital Universitario Severo Ochoa
      • Majadahonda, Madrid, Spain
        • Hospital Puerta de Hierro
      • Móstoles, Madrid, Spain
        • Hospital Universitario Rey Juan carlos
      • Torrejón de Ardoz, Madrid, Spain
        • Hospital Universitario de Torrejon
      • Valdemoro, Madrid, Spain
        • Hospital Universitario Infanta Elena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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)
Other: Consecutive radical cystectomies
Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 5-40 days
Day 1: Admission to the hospital Last day of accountant: Discharge from the hospital or death in the hospital.
5-40 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at 30-, 60- and 90- postoperative days
Time Frame: 90 days
90 days
30-day readmission rate
Time Frame: 30 days
30 days
Transfusion rate
Time Frame: 90 days
90 days
Patient satisfaction measured with the enclosed questionnaire
Time Frame: 90 days

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carlos Llorente

Investigators

  • Principal Investigator: Carlos Llorente, MD, Hospital Fundación de Alcorcón

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

November 18, 2014

First Submitted That Met QC Criteria

December 30, 2014

First Posted (Estimate)

December 31, 2014

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO-RAC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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