Skip to main content
OpenTrials
Completed

NCT Number: NCT02328417

Enhanced Recovery After Radical Cystectomy Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bladder Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Site Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Principe de Asturias, Alcalá de Henares, Madrid, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Refusal to sign informed consent

Treatment and study plan

Consecutive radical cystectomies

Other

Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process

Primary outcomes

  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 outcomes

  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:

Sponsors and collaborators

Lead sponsor

Carlos Llorente

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Dec 31, 2014
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.