Condition category
Surgery
Date applied
22/11/2010
Date assigned
10/01/2011
Last edited
06/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Struthers

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

v6.3

Study information

Scientific title

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

Acronym

PicoPEX

Study hypothesis

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

The South West Research Ethics Committee (REC) approved on the 22nd February 2010 (ref: 09/H0206/63)

Study design

Pilot prospective single centre blinded randomised controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Picolax®

Primary outcome measures

Exercise capacity, assessed by CPET

Secondary outcome measures

No secondary outcome measures

Overall trial start date

21/11/2010

Overall trial end date

31/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

9

Participant 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

Recruitment start date

21/11/2010

Recruitment end date

31/01/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Anaesthesia
Plymouth
PL6 8DH
United Kingdom

Sponsor information

Organisation

Plymouth Hospitals NHS Trust (UK)

Sponsor details

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

Sponsor type

Not defined

Website

Funders

Funder type

Charity

Funder name

Gastrointestinal Research Study Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes