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Spots Global Cancer Trial Database for Cardiopulmonary Exercise Testing and Preoperative Risk Stratification

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Trial Identification

Brief Title: Cardiopulmonary Exercise Testing and Preoperative Risk Stratification

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

Study ID: NCT00737828

Study Description

Brief 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. 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Whittington Hospital NHS Trust, London, , United Kingdom

University College London Hospitals NHS Foundation Trust, London, , United Kingdom

Southampton University Hospitals NHS Trust, Southampton, , United Kingdom

Contact Details

Name: Michael PW Grocott

Affiliation: University College, London

Role: STUDY_DIRECTOR

Name: Paula Meale

Affiliation: University College, London

Role: PRINCIPAL_INVESTIGATOR

Name: Michael Mythen

Affiliation: University College, London

Role: PRINCIPAL_INVESTIGATOR

Name: Ayo Oshowo

Affiliation: Whittington Hospital NHS Trust

Role: PRINCIPAL_INVESTIGATOR

Name: Mervyn Singer

Affiliation: University College, London

Role: PRINCIPAL_INVESTIGATOR

Name: Geoff Bellingan

Affiliation: University College London Hospitals

Role: PRINCIPAL_INVESTIGATOR

Name: Kay Mitchell

Affiliation: University College, London

Role: PRINCIPAL_INVESTIGATOR

Name: Hasan Muktar

Affiliation: The Whittington Hospital Hospital NHS Trust

Role: PRINCIPAL_INVESTIGATOR

Name: Alistair Windsor

Affiliation: University College London Hospitals

Role: PRINCIPAL_INVESTIGATOR

Name: Jim Down

Affiliation: University College London Hospitals

Role: PRINCIPAL_INVESTIGATOR

Name: Martin B Kuper

Affiliation: Whittington Hospital NHS Trust

Role: PRINCIPAL_INVESTIGATOR

Name: Denny ZH Levett

Affiliation: University College, London

Role: PRINCIPAL_INVESTIGATOR

Name: Phil Hennis, PhD

Affiliation: UCL

Role: PRINCIPAL_INVESTIGATOR

Name: Alasdair O'Doherty, MSc

Affiliation: UCL

Role: PRINCIPAL_INVESTIGATOR

Name: Alec Engledow

Affiliation: UCLH

Role: PRINCIPAL_INVESTIGATOR

Name: Aundrea Mulreany

Affiliation: Whittington Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Carolyn Dr Way

Affiliation: University Hospital Southampton NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Name: Karen Linford

Affiliation: University Hospital Southampton NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Name: Clare Bolger

Affiliation: University Hospital Southampton NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Name: Paul Nichols

Affiliation: University Hospital Southampton NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Name: Kim Golder

Affiliation: University Hospital Southampton NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Name: John S Knight

Affiliation: University Hospital Southampton NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Name: Michael Celinski

Affiliation: University Hospital Southampton NHS Foundation Trust

Role: PRINCIPAL_INVESTIGATOR

Name: Grace Adesina

Affiliation: University College London Hospitals

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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