NCT02328417

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

2.2 years

First QC Date

November 18, 2014

Last Update Submit

February 21, 2018

Conditions

Bladder Cancer

Outcome Measures

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

    Day 1: Admission to the hospital Last day of accountant: Discharge from the hospital or death in the hospital.

    5-40 days

Secondary Outcomes (4)

  • 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

    90 days

Study Arms (2)

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

Interventions

Consecutive radical cystectomiesOTHER

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

Active Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Refusal to sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hospital Universitario Principe de Asturias

Alcalá de Henares, Madrid, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Location

Hospital Universitario de Getafe

Getafe, Madrid, Spain

Location

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, Spain

Location

Hospital Universitario Rey Juan Carlos

Móstoles, Madrid, Spain

Location

Hospital Universitario de Torrejón

Torrejón de Ardoz, Madrid, Spain

Location

Hospital Universitario Infanta Elena

Valdemoro, Madrid, Spain

Location

Fundación Jiménez Díaz

Madrid, Spain

Location

Hospital Doce de Octubre

Madrid, Spain

Location

Hospital Infanta Leonor

Madrid, Spain

Location

Hospital Universitario Gregorio Marañon

Madrid, Spain

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Officials

  • Carlos Llorente, MD

    Hospital Fundación de Alcorcón

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor in Medicine

Study Record Dates

First Submitted

November 18, 2014

First Posted

December 31, 2014

Study Start

December 1, 2014

Primary Completion

February 1, 2017

Study Completion

December 1, 2017

Last Updated

February 22, 2018

Record last verified: 2018-02

Locations

ES(12)