Enhanced Recovery After Radical Cystectomy Study

Bladder Cancer Clinical Trial

Official title:

Enhanced Recovery After Radical Cystectomy Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328417
• Other study ID #: PRO-RAC
• Status: Completed
• Phase: N/A
• First received: November 18, 2014
• Last updated: February 21, 2018
• Start date: December 2014
• Est. completion date: December 2017

Study information

• Verified date: February 2018
• Source: Hospital Universitario Fundación Alcorcón
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: December 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Consecutive patients scheduled for radical cystectomy in the participating hospitals

• Signed informed consent

Exclusion Criteria:

• Refusal to sign informed consent

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Other:
• Consecutive radical cystectomies
Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process

Locations

Country	Name	City	State
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	Fundación Jiménez Díaz	Madrid
Spain	Hospital Doce de Octubre	Madrid
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital Universitario Gregorio Marañon	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

Sponsors (1)

Lead Sponsor	Collaborator
Carlos Llorente

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality at 30-, 60- and 90- postoperative days		90 days
Secondary	30-day readmission rate		30 days
Secondary	Transfusion rate		90 days
Secondary	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