Plain English Summary
Background and study aims
Bladder cancer happens when a tumour develops in the lining of the bladder. Treatment for the condition depends on how advanced the cancer is and how much it has spread. If the cancer has spread to the muscle lining the bladder (i.e. it has become muscle-invasive) treatment may involve removing the entire bladder in an operation called a radical cystectomy. In some cases, it is now possible to have keyhole, or laparoscopic, surgery to remove the bladder. It is less invasive than the other two types of radical cystectomy surgery available (conventional and open abdomen surgery) as smaller cuts are made. To date, these three types of surgery have not been compared to see which one may be the most successful in curing the cancer or has the fastest recovery time. This study involves asking patients if they would agree to be randomly allocated to having one of the three types of surgery and following their progress while they are in hospital and after they have been discharged.
Who can participate?
Adults that are aged 18-80, have muscle-invasive bladder cancer and need a radical cystectomy.
What does the study involve?
Participants that agree to take part in the study are randomly allocated into one of three groups. Those in group 1 undergo conventional surgery. Those in group 2 undergo open abdomen surgery. Those in group 3 undergo laparoscopic surgery. They all receive the usual pre and post-surgery care. The progress of each participant is then followed while in hospital and they are asked to fill in questionnaires when they go to their local clinic for check-ups after discharge. The information gathered about their general health, test results and questionnaire answers is used to help decide which of the three types of surgery should be routinely offered to patients.
What are the possible benefits and risks of participating?
There are no particular risks or benefits associated with taking part in the trial, as this is an information gathering exercise. There are no new medicines or surgical tools to test as part of this study.
Where is the study run from?
Guys and St Thomas NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
November 2008 to October 2013
Who is funding the study?
Guys and St Thomas NHS Foundation Trust (UK)
Who is the main contact?
Mr M. Shamim Khan
Shamim.khan@gstt.nhs.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1: August 2008
Study information
Scientific title
A pilot randomized controlled trial of open, laparoscopic and robotic radical cystectomy for bladder cancer
Acronym
CORAL
Study hypothesis
Will patients permit random allocation to open or minimally invasive surgery to take out the bladder where there is no clear advantage offered by one surgical method over another in terms of operation success and shortened recovery time back to usual activity?
Ethics approval
Guys and St Thomas Research Ethics Committee, 23/02/2009, ref: 08/H0804/135
Study design
Pilot randomised feasibility study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Bladder cancer
Intervention
Patients consenting to participate were randomly assigned using the sealed envelope method to one of three surgical procedures (conventional, open abdominal surgery or laparoscopic or robot assisted minimal access surgery) to remove their bladder to cure cancer. All patients underwent a standardised Enhanced Recovery Pathway for radical cystectomy. Clavien methodology was utilised to record any adverse clinical issues for up to 30 days post-surgery. Outpatient care followed our standard procedures for post procedure imaging surveillance and all necessary nursing care of stomas etc.
Intervention type
Procedure/Surgery
Phase
Drug names
Primary outcome measure
1. To determine the best methods of recruitment for the study, and the likely uptake of patients to facilitate future sample size estimates.
2. To determine patients and families likelihood of agreeing to participate in repeated interviews, the best time period for re-interview and the likely attrition from the study.
After discharge, all patients received routine clinical review at 2 weeks, 3, 6, and 12 months , and then yearly thereafter. Patient reported outcomes were sought using the validated questionnaire Functional Assessment of Cancer therapy - Bladder ( FACT - BL) at each visit to clinic in their first year and yearly after that.
Secondary outcome measures
1. To determine the most appropriate methods of capturing data on symptoms, quality of life, preferences and experience among patients with the different methods of surgery to remove the urinary bladder
2. To determine the most appropriate methods of analysis of the study, in particular how to handle missing data due to attrition
3. To determine primary clinical outcome- composite complication rates such as transfusion, urine leakage, ileus, bowel leak/obstruction, cardiovascular and respiratory complications
4. To determine primary economic outcome: length of post-operative hospital stay (LOS)
5. To determine estimated blood loss, operative time
6. To determine economic evaluation: cost implications of clinical outcomes i.e., complications, LOS (based on unit daily cost of a NHS bed along with surgical, nursing and pharmaceutical support calculated at £500/day), blood loss, return to normal activity as studied by the physical and mental domains of the SF-8 questionnaire.
7. Economic modelling: Markov model and Monte Carlo simulation of the long term follow-up: 90-day readmission; 1-year potency in those previously potent; 1-year quality of life (SF-8); 2 year metastasis rate; 5-year RFS
8. Sample size calculation 141 patients with 47 in each arm
As per local protocol, loopogram studies were performed at 3 months to assess for uretero-enteric anastomotic strictures. Computed tomography (CT) scans of the chest, abdomen and pelvis were performed at 6 and 12 months to assess for recurrence
Overall trial start date
01/11/2008
Overall trial end date
30/10/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 18−80
2. Sex−Male or female
3. Able to give informed consent
4. Proven muscle invasive bladder cancer or uncontrolled superficial bladder cancer requiring cystectomy .
5. Fit for major surgery
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
141 recommended after statistical advice
Participant exclusion criteria
1. Previous extensive abdominal or pelvic surgery
2. Previous treatment with external beam therapy or history of pelvic irradiation
3. Uncontrolled bleeding disorder
4. Unfit for major surgery
5. Unable to give informed consent
6. Pregnancy
Recruitment start date
01/11/2008
Recruitment end date
30/10/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Urology Centre
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
Guy's and St Thomas NHS Foundation Trust (UK)
Sponsor details
Trust Research and Development Department
Floor 16: Tower Wing
Guys Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
+44 (0)20 7188 7188
karen.ignatian@gstt.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Guy's and St Thomas' NHS Foundation Trust
Alternative name(s)
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26272237