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

ISRCTN	ISRCTN78243308
DOI	https://doi.org/10.1186/ISRCTN78243308
Secondary identifying numbers	v6.3

Submission date: 22/11/2010
Registration date: 10/01/2011
Last edited: 06/02/2014

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 Richard Struthers
Scientific

Department of Anaesthesia
Derriford Hospital
Derriford
Crownhill
Plymouth
PL6 8DH
United Kingdom

Study information

Study design	Pilot prospective single centre blinded randomised controlled crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	Randomised controlled crossover trial of Picolax® and pre-operative cardio-pulmonary exercise testing
Study acronym	PicoPEX
Study objectives	1. Does mechanical bowel preparation and fasting influence aerobic exercise capacity as characterised by performance in a cardiopulmonary exercise test? 2. Does a carbohydrate-loading drink influence aerobic exercise capacity as characterised by performance in a cardiopulmonary exercise test? We hypothesise that mechanical bowel preparation may have a profound impact on aerobic exercise capacity as measured by CPET in patients undergoing elective colorectal surgery. Any impact would be limited by avoidance of bowel preparation and administering oral carbohydrate. We will initially test this hypothesis on healthy volunteers.
Ethics approval(s)	The South West Research Ethics Committee (REC) approved on the 22nd February 2010 (ref: 09/H0206/63)
Health condition(s) or problem(s) studied	Colorectal surgery
Intervention	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 with reference to ATS / ACCP recommendations. Anaerobic threshold will be determined by the V slope method and correlation with ventilatory equivalents. All participants will be encouraged to exercise until their maximum effort has been achieved irrespective of the intervention group. Bias may be introduced with less-than-maximal performance, which would be reflected by a reduced Peak V02. The Anaerobic Threshold is effort-independent and hence participant effort will not affect its value. Participants will be randomised to receive either 1. Picolax® On the day prior to CPET, participants will have clear fluids only and take one sachet of Picolax® at 8am and 4pm. Each individual will receive two litres of Hartmanns Solution (Macopharma, Twickenham, UK) infused over six hours in the morning prior to CPET. This will reflect usual practice for individuals taking MBP in our Trust. 2. Carbohydrate-Loading Drinks Each individual will drink two cartons of Ensure/Enlive® nutritional supplements the night before and then 400 mls of carbohydrate-loading drinks (Pre-Op, Nutricia, UK) two hours prior to CPET as per ERAS protocol. They can have breakfast (by 8am) on the day of testing and then only clear fluids until the carbohydrate-loading drinks. Frequency of testing is three times per participant with at least one week duration between the different interventions.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Picolax®
Primary outcome measure	Exercise capacity, assessed by CPET
Secondary outcome measures	No secondary outcome measures
Overall study start date	21/11/2010
Completion date	31/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target number of participants	9
Key inclusion criteria	1. Healthy American Society of Anesthesiologists (ASA) 1 Males 2. Willingness to participate
Key exclusion criteria	1. ASA II or more Absolute (definitive and independent) criteria: 2. Acute myocardial infarction (35 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
Date of first enrolment	21/11/2010
Date of final enrolment	31/01/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Department of Anaesthesia

Plymouth
PL6 8DH
United Kingdom

Sponsor information

Plymouth Hospitals NHS Trust (UK)
Not defined

c/o Lisa Vickers
(Plymouth Research and Development Manager)
Room N17
ITTC Building
Tamar Science Park
Derriford
Plymouth
PL6 8BX
United Kingdom

"ROR"	https://ror.org/05x3jck08

Funders

Funder type

Charity

Gastrointestinal Research Study Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No