Enhanced Recovery After Radical Cystectomy Study

Completed

• Conditions: Bladder Cancer
• Interventions: Other: Consecutive radical cystectomies

• Registration Number: NCT02328417
• Lead Sponsor: Carlos Llorente

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 Timeline

• Study First Submitted: 2014-11-18
• Study Start: 2014-12
• Study First Submitted QC: 2014-12-30
• Study First Posted: 2014-12-31
• Primary Completion: 2017-02
• Study Completion: 2017-12
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-21
• Last Update Posted: 2018-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

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

Exclusion Criteria

• Refusal to sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active Treatment	Consecutive radical cystectomies	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)

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Transfusion rate	90 days
30-day readmission rate	30 days
Mortality at 30-, 60- and 90- postoperative days	90 days
Patient satisfaction measured with the enclosed questionnaire	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:

Trial Locations

Locations (12)

Hospital Doce de Octubre; 🇪🇸 Madrid, Spain

Hospital Universitario Fundación Alcorcón; 🇪🇸 Alcorcón, Madrid, Spain

Hospital Universitario Principe de Asturias; 🇪🇸 Alcalá de Henares, Madrid, Spain

Hospital Universitario de Getafe; 🇪🇸 Getafe, Madrid, Spain

Hospital Puerta de Hierro; 🇪🇸 Majadahonda, Madrid, Spain

Hospital Universitario Severo Ochoa; 🇪🇸 Leganés, 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 Universitario Gregorio Marañon; 🇪🇸 Madrid, Spain

Hospital Infanta Leonor; 🇪🇸 Madrid, Spain