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A study into the effect of mechanical bowel preparation on aerobic exercise capacity as measured by cardiopulmonary exercise testing

Randomised controlled crossover trial of Picolax® and pre-operative cardio-pulmonary exercise testing

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78243308
Enrollment
9
Registered
2011-01-10
Start date
2010-11-21
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal surgery Surgery Colorectal surgery

Interventions

Cardiopulmonary Exercise Test (CPET) CPET will be performed by all participants in the afternoon of the day of testing. The test will be done in accordance with the consensus protocol from UK centre w

Sponsors

Plymouth Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Healthy American Society of Anesthesiologists (ASA) 1 Males 2. Willingness to participate

Exclusion criteria

Exclusion criteria: 1. ASA II or more Absolute (definitive and independent) criteria: 2. Acute myocardial infarction (3?5 days) 3. Unstable angina 4. Uncontrolled arrhythmias causing symptoms or haemodynamic compromise 5. Syncope 6. Active endocarditis 7. Acute myocarditis or pericarditis 8. Symptomatic severe aortic stenosis 9. Uncontrolled heart failure 10. Acute pulmonary embolus or pulmonary infarction 11. Thrombosis of lower extremities 12. Suspected dissecting aneurysm 13. Uncontrolled asthma 14. Pulmonary oedema 15. Room air desaturation at rest < 85%* 16. Respiratory failure 17. Acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis) 18. Previous reaction to mechanical bowel preparation Relative (dependent or related to other factors) criteria: 19. Left main coronary stenosis or its equivalent 20. Moderate stenotic valvular heart disease 21. Severe untreated arterial hypertension (200 mm Hg systolic, 120 mm Hg diastolic) 22. Tachyarrhythmias or bradyarrhythmias 23. High-degree atrioventricular block 24. Hypertrophic cardiomyopathy 25. Significant pulmonary hypertension 26. Advanced or complicated pregnancy 27. Electrolyte abnormalities 28. Orthopaedic impairment that compromises exercise performance

Design outcomes

Primary

MeasureTime frame
Exercise capacity, assessed by CPET

Secondary

MeasureTime frame
No secondary outcome measures

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026