Colorectal CancerNCT00737828
Cardiopulmonary Exercise Testing and Preoperative Risk Stratification
A study testing Perioperative care pathway guided by CPX results in people with Colorectal Cancer and Anaesthesia, run by University College London Hospitals at 3 sites in United Kingdom.
Trial summary
The investigators would like to evaluate the use of cardiopulmonary exercise tests (CPX) in guiding the care pathway of patients undergoing colorectal operations. In the intervention group care will be guided by CPX results and in the control group care will be guided by the doctors assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Anaesthesia, Critical Illness
- What is being tested?
- Perioperative care pathway guided by CPX results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- Aug 2008to May 2014
- Phase
- Interventional
- 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
Who may be able to join
- Adults ≥ 18 years age
- Males
- Females
- Listed for elective(non-emergency) colorectal surgery
Who cannot join
- Age < 18 years age
- Patient unwilling/unable to consent
- Adults with learning disabilities or dementia
- Prisoners
- Any contraindication to cardiopulmonary exercise testing (as outlined by *American Association of Anaesthesia:
- Acute MI (3-5 days)
Show all 24Show fewer
- Unstable angina
- Uncontrolled arrhythmias
- Syncope
- Acute endocarditis
- Acute myocarditis
- Acute pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled heart failure
- Acute pulmonary embolism or infarction
- Thrombosis of lower extremities
- Dissecting aneurysm
- Uncontrolled asthma
- Pulmonary oedema
- Room air desaturation at rest <85%
- Respiratory failure
- Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise Mental impairment leading to inability to co-operate
- Patients already enrolled in an interventional study
- Previous CPX test result recorded in the medical notes
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Whittington Hospital NHS Trust
London, N19 5NF
University College London Hospitals NHS Foundation Trust
London, NW1 2BU
Southampton University Hospitals NHS Trust
Southampton
About this study
Official title: A Randomised Controlled Trial of the Utility of Cardiopulmonary Exercise (CPX) Testing for Preoperative Risk Stratification to Guide Perioperative Care and Thereby Reduce Postoperative Morbidity
The investigators would like to evaluate the use of cardiopulmonary exercise tests (CPX) in guiding the care pathway of patients undergoing colorectal operations. In the intervention group care will be guided by CPX results and in the control group care will be guided by the doctors assessment. The investigators would like to assess the impact of this on patient outcome, patient satisfaction and resource usage.
Read the detailed description
Each year 20000 UK patients die within 30 days of surgery. It seems that in the UK a patient's chances of becoming seriously unwell or dying following surgery is higher than in comparable countries. Fewer beds in the UK are given over to Intensive Care than in these other countries. Closer attention to the care given after operations, which can be achieved on intensive care units (ICU), almost certainly reduces the chances of serious illness following major surgery. An increase in the number of intensive care unit beds in the UK is extremely unlikely. Better use of the available intensive care beds could be achieved by allocating them where they are believed to improve outcome (following surgery) and by allocating them to patients most likely to benefit.
Tests used to assess risk of surgery to patients are largely ineffective. Cardiopulmonary exercise tests (CPX) seem to be effective at identifying patients at risk of death or serious illness post surgery. This information has been used in studies to select patients for ICU beds and reduce deaths. The studies so far have limitations in their design and scope which means we can't be certain this approach works in the UK.
We suggest a study to answer this question more conclusively and more specifically in UK patients. We will randomly divide patients between two groups. In the 1st group choice of postoperative care environment is based on best current practice and in the other group we will make these decisions (critical care or ward) based on the results of the CPX.
We hope that the benefits will include less patients becoming seriously ill or dying and shorter stays in hospital after surgery following major operations. We also hope the information will help patients understand the risks of their operation better and therefore make better informed decisions. This may also reduce the overall cost of surgery for hospitals.
- Conditions
- Colorectal Cancer, Anaesthesia, Critical Illness
- Being tested
- Perioperative care pathway guided by CPX results
- Keywords
- Cardiopulmonary exercise test, CPX, CPEX, surgical outcome, colorectal surgery, risk stratification
- Medical subject headings
- Colorectal Neoplasms, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative care pathway guided by CPX resultsOther
- AT > 11ml/min/kg no myocardial ischaemia or Ve/VO2 <35 - Level 1 Ward Care
- AT > 11ml/min/kg with myocardial ischaemia or Ve/VO2 >35 - Level 2/3 (ITU) Critical Care Unit
- AT <11mls/min/kg - Level 2/3 Critical Care Unit
- AT <8mls/min/kg - Level 2/3 Critical Care Unit/ consider cancellation or alternative procedure
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Control - Standard Perioperative Pathway, clinician decides post-operative care environment (usual care) Receives: Other: Perioperative care pathway guided by CPX results |
| B | Experimental | Intervention - Perioperative care pathway guided by CPX Results i.e.anaerobic threshold \& ventilatory equivalents Receives: Other: Perioperative care pathway guided by CPX results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morbidity (presence or absence of POMS defined morbidity)
Measured: Day 5
Secondary outcomes (6)
Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary
Measured: Day 5
Total postoperative ITU bed utilisation
Measured: End of hospital stay i.e. day of hospital discharge
Total postoperative bed utilisation
Measured: End of hospital stay i.e. day of hospital discharge
ITU re-admission
Measured: End of hospital stay i.e. day of hospital discharge
Death
Measured: Should death occur
SF36 (compared with SF36 at baseline)
Measured: 12 months post day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionJun 2013
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College London Hospitals
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Responsible party
- Principal investigator, Mike Grocott, University College London Hospitals
- Investigators
- Michael PW Grocott, Study director, University College, LondonPaula Meale, Principal investigator, University College, LondonMichael Mythen, Principal investigator, University College, LondonAyo Oshowo, Principal investigator, Whittington Hospital NHS TrustMervyn Singer, Principal investigator, University College, LondonGeoff Bellingan, Principal investigator, University College London HospitalsKay Mitchell, Principal investigator, University College, LondonHasan Muktar, Principal investigator, The Whittington Hospital Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737828
- Sponsor's protocol ID
- 07/0114
- Other IDs
- 07/H0716/55, PB-PG-0906-11426
- Status last verified
- May 2014
- First submitted
- 18 Aug 2008
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of the Utility of Cardiopulmonary Exercise (CPX) Testing for Preoperative Risk Stratification to Guide Perioperative Care and Thereby Reduce Postoperative Morbidity
- ClinicalTrials.gov ID
- NCT00737828
- Acronym / sponsor ID
- 07/0114
- Conditions
- Colorectal Cancer, Anaesthesia, Critical Illness
- Keywords
- Cardiopulmonary exercise test, CPX, CPEX, surgical outcome, colorectal surgery, risk stratification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- University College London HospitalsUniversity, hospital or other
- Collaborators
- University Hospital Southampton NHS Foundation Trust
- Study start
- Aug 2008
- Primary completion
- Jun 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 20 Aug 2008 (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.
The investigators would like to evaluate the use of cardiopulmonary exercise tests (CPX) in guiding the care pathway of patients undergoing colorectal operations. In the intervention group care will be guided by CPX results and in the control group care will be guided by the doctors assessment. The investigators would like to assess the impact of this on patient outcome, patient satisfaction and resource usage.
Detailed description
Each year 20000 UK patients die within 30 days of surgery. It seems that in the UK a patient's chances of becoming seriously unwell or dying following surgery is higher than in comparable countries. Fewer beds in the UK are given over to Intensive Care than in these other countries. Closer attention to the care given after operations, which can be achieved on intensive care units (ICU), almost certainly reduces the chances of serious illness following major surgery. An increase in the number of intensive care unit beds in the UK is extremely unlikely. Better use of the available intensive care beds could be achieved by allocating them where they are believed to improve outcome (following surgery) and by allocating them to patients most likely to benefit.
Tests used to assess risk of surgery to patients are largely ineffective. Cardiopulmonary exercise tests (CPX) seem to be effective at identifying patients at risk of death or serious illness post surgery. This information has been used in studies to select patients for ICU beds and reduce deaths. The studies so far have limitations in their design and scope which means we can't be certain this approach works in the UK.
We suggest a study to answer this question more conclusively and more specifically in UK patients. We will randomly divide patients between two groups. In the 1st group choice of postoperative care environment is based on best current practice and in the other group we will make these decisions (critical care or ward) based on the results of the CPX.
We hope that the benefits will include less patients becoming seriously ill or dying and shorter stays in hospital after surgery following major operations. We also hope the information will help patients understand the risks of their operation better and therefore make better informed decisions. This may also reduce the overall cost of surgery for hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Other: Perioperative care pathway guided by CPX resultsControl - Standard Perioperative Pathway, clinician decides post-operative care environment (usual care) |
| B | Experimental | Other: Perioperative care pathway guided by CPX resultsIntervention - Perioperative care pathway guided by CPX Results i.e.anaerobic threshold \& ventilatory equivalents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥ 18 years age
- Males
- Females
- Listed for elective(non-emergency) colorectal surgery
Key exclusion criteria (24 listed)
- Age < 18 years age
- Patient unwilling/unable to consent
- Adults with learning disabilities or dementia
- Prisoners
- Any contraindication to cardiopulmonary exercise testing (as outlined by *American Association of Anaesthesia:
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 |
|---|---|---|
| Perioperative care pathway guided by CPX results* AT > 11ml/min/kg no myocardial ischaemia or Ve/VO2 <35 - Level 1 Ward Care * AT > 11ml/min/kg with myocardial ischaemia or Ve/VO2 >35 - Level 2/3 (ITU) Critical Care Unit * AT <11mls/min/kg - Level 2/3 Critical Care Unit * AT <8mls/min/kg - Level 2/3 Critical Care Unit/ consider cancellation or alternative procedure | Other | A, B |
Primary outcome
Postoperative morbidity (presence or absence of POMS defined morbidity)
Time frame: Day 5
6 secondary outcomes
Post operative morbidity domains e.g. gastrointestinal, renal, pulmonary
Time frame: Day 5
Total postoperative ITU bed utilisation
Time frame: End of hospital stay i.e. day of hospital discharge
Total postoperative bed utilisation
Time frame: End of hospital stay i.e. day of hospital discharge
ITU re-admission
Time frame: End of hospital stay i.e. day of hospital discharge
Death
Time frame: Should death occur
SF36 (compared with SF36 at baseline)
Time frame: 12 months post day of surgery
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 21 May 2014.
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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.
Michael PW Grocott study director
University College, London
Paula Meale principal investigator
University College, London
Michael Mythen principal investigator
University College, London
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perioperative care pathway guided by CPX results in people with Colorectal Cancer and Anaesthesia, run by University College London Hospitals at 3 sites in United Kingdom.
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 4 inclusion and 24 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 21 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. 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?
Postoperative morbidity (presence or absence of POMS defined morbidity) (time frame: Day 5). 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 21 May 2014.