Bladder CancerNCT02328417
Enhanced Recovery After Radical Cystectomy Study
An observational study of Bladder Cancer, run by Carlos Llorente at 12 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Consecutive radical cystectomies
- How many people
- 241 participants
- Where
- 12 sitesSpain
- Study dates
- Dec 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Consecutive patients scheduled for radical cystectomy in the participating hospitals
- Signed informed consent
Who cannot join
- Refusal to sign informed consent
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Universitario Principe de Asturias
Alcalá de Henares, Madrid
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid
Hospital Universitario de Getafe
Getafe, Madrid
Hospital Universitario Severo Ochoa
Leganés, Madrid
Fundación Jiménez Díaz
Madrid
Hospital Doce de Octubre
Madrid
Hospital Infanta Leonor
Madrid
Hospital Universitario Gregorio Marañon
Madrid
Hospital Puerta de Hierro
Majadahonda, Madrid
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid
Hospital Universitario de Torrejón
Torrejón de Ardoz, Madrid
Hospital Universitario Infanta Elena
Valdemoro, Madrid
About this 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.
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Consecutive radical cystectomies
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consecutive radical cystectomiesOther
Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Consecutive radical cystectomies |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-40 days
Secondary outcomes (4)
Mortality at 30-, 60- and 90- postoperative days
Measured: 90 days
30-day readmission rate
Measured: 30 days
Transfusion rate
Measured: 90 days
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:
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionFeb 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carlos Llorente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carlos Llorente, Hospital Universitario Fundación Alcorcón
- Investigators
- Carlos Llorente, MD, Principal investigator, Hospital Fundación de Alcorcón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328417
- Sponsor's protocol ID
- PRO-RAC
- Status last verified
- Feb 2018
- First submitted
- 18 Nov 2014
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Recovery After Radical Cystectomy Study
- ClinicalTrials.gov ID
- NCT02328417
- Acronym / sponsor ID
- PRO-RAC
- Conditions
- Bladder Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Carlos LlorenteUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Feb 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Consecutive radical cystectomiesAfter 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Consecutive patients scheduled for radical cystectomy in the participating hospitals
- Signed informed consent
Key exclusion criteria (1 listed)
- Refusal to sign informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Consecutive radical cystectomiesPre-, intra- and post-operative clinical measures during radical cystectomy clinical process | Other | Active Treatment |
Primary outcome
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.
4 secondary outcomes
Mortality at 30-, 60- and 90- postoperative days
Time frame: 90 days
30-day readmission rate
Time frame: 30 days
Transfusion rate
Time frame: 90 days
Patient satisfaction measured with the enclosed questionnaire
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Llorente, MD principal investigator
Hospital Fundación de Alcorcón
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer, run by Carlos Llorente at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.