Enhanced Recovery After Radical Cystectomy Study

Study Overview
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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.

Official Title
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Enhanced Recovery After Radical Cystectomy Study

Conditions
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Bladder Cancer

Intervention / Treatment
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* Other: Consecutive radical cystectomies


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>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<br>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<br>* Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process<br>|

What is the study measuring?
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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 | 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 |  | 90 days | 
| 30-day readmission rate |  | 30 days | 
| Transfusion rate |  | 90 days | 
| Patient satisfaction measured with the enclosed questionnaire | 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 |