Post-Operative Morbidity-Exercise: pre-operative exercise biology and post-operative outcomes
| ISRCTN | ISRCTN90019424 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90019424 |
| Protocol serial number | N/A |
| Sponsor | University College London Hospitals NHS Foundation Trust (UK) |
| Funders | Academy of Medical Sciences/The Health Foundation (UK) - Clinician Scientist Award to Dr GL Ackland, University College London Hospitals NHS Foundation Trust (UK) - Comprehensive Biomedical Research Centre, University College London (UK) - Centre for Anaesthesia, Critical Care and Pain Medicine |
- Submission date
- 08/03/2010
- Registration date
- 27/04/2010
- Last edited
- 12/04/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Gareth Ackland
Scientific
Scientific
Wolfson Institute for Biomedical Research
University College London
Gower Street
London
WC1E 6BT
United Kingdom
| g.ackland@ucl.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Observational cohort study of the immune, bioenergetic and microcirculatory response to cardiopulmonary exercise testing in healthy volunteers and non-cardiac surgical patients |
| Study acronym | POM-E |
| Study objectives | Exercise-induced changes in immune, autonomic and cardiovascular physiology are predictive of post-operative morbidity independent of exercise capacity. |
| Ethics approval(s) | Outer South East London REC - South London REC Office (4), 29/12/2009, ref: 09/H0805/59 |
| Health condition(s) or problem(s) studied | Post-operative morbidity |
| Intervention | Visit 0 (baseline): screening for inclusion/exclusion criteria; informed consent; demographic data collection Visit 1 (within 3 weeks): cardiopulmonary exercise test; blood samples, microvascular and cardiopulmonary data collected pre- and 60 minutes post-exercise Visit 2 (post-operative day 2): blood samples, microvascular and cardiopulmonary data collected pre- and 60 minutes post-exercise Visit 3 (post-operative day 3): morbidity documented Visit 4 (post-operative day 5): morbidity documented Visit 5 (post-operative day 8): morbidity documented Visit 6 (post-operative day 15): morbidity documented Visit 7 (day of discharge): length of stay recorded |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Morbidity on post-operative day 3 |
| Key secondary outcome measure(s) |
Immune, bioenergetic, microcirculatory and cellular correlates associated with development of post-operative morbidity and length of hospital stay |
| Completion date | 01/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 106 |
| Key inclusion criteria | Patients undergoing major elective major surgical procedures that are associated with a high incidence of post-operative morbidity (abdominal/oesophageal/hepatic resection/gynaecology/urological reconstructive surgery) and who meet the following criteria: 1. American Society of Anaesthesiologists (ASA) risk grade 3 - 4 2. Aged greater than 50 years, either sex |
| Key exclusion criteria | 1. Acute myocardial ischaemia (contraindication for inotropic support) 2. Acute arrhythmias (contraindication for inotropic support) 3. Pregnancy (lithium-based cardiac output monitoring device) 4. Patients receiving palliative treatment only |
| Date of first enrolment | 29/03/2010 |
| Date of final enrolment | 01/09/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Wolfson Institute for Biomedical Research
London
WC1E 6BT
United Kingdom
WC1E 6BT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/04/2017: No publications found in PubMed, verifying study status with principal investigator.
