Enhanced Recovery After Radical Cystectomy Study

• ClinicalTrials.gov Identifier: NCT02328417
• Recruitment Status: Completed
• First Posted: December 31, 2014
• Last Update Posted: February 22, 2018
• Sponsor: Carlos Llorente
• Information provided by (Responsible Party): Carlos Llorente, Hospital Universitario Fundación Alcorcón

Study Description

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.

Condition or disease	Intervention/treatment
Bladder Cancer	Other: Consecutive radical cystectomies

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 Design

• 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

Groups and Cohorts

Group/Cohort	Intervention/treatment
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)	Other: Consecutive radical cystectomies; Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Mortality at 30-, 60- and 90- postoperative days [ Time Frame: 90 days ]
2. 30-day readmission rate [ Time Frame: 30 days ]
3. Transfusion rate [ Time Frame: 90 days ]
4. 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:

Eligibility Criteria

• 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

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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Refusal to sign informed consent

Contacts and Locations

Locations

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

Sponsors and Collaborators

Carlos Llorente

Investigators

• Principal Investigator: Carlos Llorente, MD; Hospital Fundación de Alcorcón

More Information

• 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
• Last Update Posted: February 22, 2018
• Last Verified: February 2018

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases