Enhanced Recovery After Radical Cystectomy Study
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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
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Condition or disease | Intervention/treatment |
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Bladder Cancer | Other: Consecutive radical cystectomies |
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 |
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 |

Group/Cohort | Intervention/treatment |
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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
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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 |
- 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.
- Mortality at 30-, 60- and 90- postoperative days [ Time Frame: 90 days ]
- 30-day readmission rate [ Time Frame: 30 days ]
- Transfusion rate [ Time Frame: 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:

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
Inclusion Criteria:
- Consecutive patients scheduled for radical cystectomy in the participating hospitals
- Signed informed consent
Exclusion Criteria:
- Refusal to sign informed consent

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
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 |
Principal Investigator: | Carlos Llorente, MD | Hospital Fundación de Alcorcón |
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 |
Urinary Bladder Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Neoplasms Urinary Bladder Diseases Urologic Diseases |