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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

Tracking Information
First Submitted Date November 18, 2014
First Posted Date December 31, 2014
Last Update Posted Date February 22, 2018
Study Start Date December 2014
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 2, 2015)
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.
Original Primary Outcome Measures
 (submitted: December 30, 2014)
  • 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 [ Time Frame: 5-40 days ]
    Day 1: Admission to the hospital Last day of accountant: Discharge from the hospital or death in the hospital.
  • Morbidity of surgery. Categorized by the Clavien complications scale at 30-, 60- and 90-postoperative days [ Time Frame: 90 days ]
Change History
Current Secondary Outcome Measures
 (submitted: December 30, 2014)
  • 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:
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Enhanced Recovery After Radical Cystectomy Study
Official Title Enhanced Recovery After Radical Cystectomy Study
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Bladder Cancer
Intervention Other: Consecutive radical cystectomies
Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process
Study Groups/Cohorts
  • 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)

    Intervention: Other: Consecutive radical cystectomies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 10, 2017)
241
Original Estimated Enrollment
 (submitted: December 30, 2014)
188
Actual Study Completion Date December 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal to sign informed consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT02328417
Other Study ID Numbers PRO-RAC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Carlos Llorente, Hospital Universitario Fundación Alcorcón
Study Sponsor Carlos Llorente
Collaborators Not Provided
Investigators
Principal Investigator: Carlos Llorente, MD Hospital Fundación de Alcorcón
PRS Account Hospital Universitario Fundación Alcorcón
Verification Date February 2018