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Enhanced Recovery After Radical Cystectomy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02328417
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : February 22, 2018
Sponsor:
Information provided by (Responsible Party):
Carlos Llorente, Hospital Universitario Fundación Alcorcón

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.

Condition or disease Intervention/treatment
Bladder Cancer Other: Consecutive radical cystectomies

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.

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Study Type : Observational
Actual Enrollment : 241 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhanced Recovery After Radical Cystectomy Study
Study Start Date : December 2014
Actual Primary Completion Date : February 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mortality at 30-, 60- and 90- postoperative days [ Time Frame: 90 days ]
  2. 30-day readmission rate [ Time Frame: 30 days ]
  3. Transfusion rate [ Time Frame: 90 days ]
  4. 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:




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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to sign informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02328417


Locations
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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
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
Sponsors and Collaborators
Carlos Llorente
Investigators
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Principal Investigator: Carlos Llorente, MD Hospital Fundación de Alcorcón
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Responsible Party: Carlos Llorente, Doctor in Medicine, Hospital Universitario Fundación Alcorcón
ClinicalTrials.gov Identifier: NCT02328417    
Other Study ID Numbers: PRO-RAC
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: February 22, 2018
Last Verified: February 2018
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases