Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616001300460
Ethics application status
Approved
Date submitted
19/08/2016
Date registered
16/09/2016
Date last updated
16/09/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of oral fluid intake on volume depletion in patients having a colonoscopy.
Scientific title
The effect of oral fluid intake during the immediate pre-colonscopy time period on volume depletion in patients who receive sodium picosulfate.
Secondary ID [1] 289945 0
Nil known.
Universal Trial Number (UTN)
U1111-1186-5323
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peri-operative hydration during colonscopy 299930 0
Condition category
Condition code
Cardiovascular 299827 299827 0 0
Diseases of the vasculature and circulation including the lymphatic system
Anaesthesiology 299828 299828 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Encourage oral hydration up to 2.5 hours before commencement of afternoon colonoscopy list. This is done by offering two 600 ml bottles of Gatorade at the pre-anaesthesia consultation along with written instructions for their use on the day of the procedure. Each 600 ml bottle contains 36g sugars, 13.7 mmol sodium and 3.6 mmol potassium. The written instructions explained that the drink was to be consumed between 0700 and arrival at hospital on the day of the procedure around 1100. Participants were asked what actual volume they had consumed in the recovery room after the procedure.
Intervention code [1] 295630 0
Treatment: Other
Comparator / control treatment
Fasting from 0600 before afternoon colonoscopy list
Control group
Active

Outcomes
Primary outcome [1] 299304 0
postural blood pressure change using noninvasive blood pressure measurement.standing and lying.
Timepoint [1] 299304 0
On arrival during preparation for the procedure.
Primary outcome [2] 299485 0
Postural heart rate change on standing and lying. The measurements are made using a Welch Allen noninvasive monitor, first lying and then within five minutes of standing.
Timepoint [2] 299485 0
On arrival during preparation for the procedure.
Secondary outcome [1] 326789 0
Urinary specific gravity
Timepoint [1] 326789 0
On arrival during preparation for the procedure.
Secondary outcome [2] 326790 0
Presence of thirst on arrival during preparation for the procedure. This was asked by the admission nurse.
Timepoint [2] 326790 0
On arrival during preparation for the procedure.
Secondary outcome [3] 326791 0
Proceduralist perception of quality of bowel prep. The proceduralist rates the quality using a four point scale at the end of the colonoscopy.
Timepoint [3] 326791 0
On completion of colonoscopy.
Secondary outcome [4] 326792 0
Vasopressor use as recorded on the anaesthesia chart.
Timepoint [4] 326792 0
During procedure.
Secondary outcome [5] 327300 0
Presence of dry mouth on arrival during preparation for the procedure. This was asked by the admission nurse.
Timepoint [5] 327300 0
On arrival during preparation for the procedure.
Secondary outcome [6] 327302 0
Presence of dizziness on arrival during preparation for the procedure. This was asked by the admission nurse.
Timepoint [6] 327302 0
On arrival during preparation for the procedure.
Secondary outcome [7] 327303 0
Presence of headache on arrival during preparation for the procedure. This was asked by the admission nurse.
Timepoint [7] 327303 0
On arrival during preparation for the procedure.
Secondary outcome [8] 327304 0
Intravenous fluid volume administered as recorded on anaesthesia chart.
Timepoint [8] 327304 0
During procedure.

Eligibility
Key inclusion criteria
Patients attending pre-admission clinic that are scheduled for afternoon colonoscopy. They will all receive a sodium picosulphate bowel prep on the day prior to the procedure.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
uncontrolled congestive cardiac failure, haemodynamic instability, bowel obstruction, renal failure on fluid restriction, hospitalised patients, emergency cases, non-English speaking and those with intellectual disabilities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concelaed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
List generated using random number generator in Excel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Blinding is broken at end of procedure by asking patient how much oral hydration consumed.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Contingency tables are analysed with Fisher's Exact test and Chi squared tests.
Continuous variables arecompared using Mann-Whitney U tests.
Sample size estimation:
The primary outcome of this study was to achieve a 50% reduction in the incidence of significant orthostatic changes in haemodynamic variables (blood pressure reduction and pulse increase). The reported incidence of this being 20% after receiving sodium phosphate and picosulfate for bowel cleansing. To achieve a reduction of 50% (20% to 10%) in orthostatic changes, 199 patients were required in each group, allowing for p 8 0.05 and power of 80%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2012
Date of last participant enrolment
Anticipated
Actual
1/05/2015
Date of last data collection
Anticipated
Actual
31/05/2015
Sample size
Target
398
Accrual to date
Final
392
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14053 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 294320 0
Hospital
Name [1] 294320 0
Department of Anaesthesia, St,. George Hospital
Country [1] 294320 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, St. George Hospital
Address
Gray St. Kogarah NSW 2217
Country
Australia
Secondary sponsor category [1] 293160 0
None
Name [1] 293160 0
None
Address [1] 293160 0
None
Country [1] 293160 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295746 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 295746 0
James Laws House
St. George Hospital
Gray St. Kogarah NSW 2217
Ethics committee country [1] 295746 0
Australia
Date submitted for ethics approval [1] 295746 0
22/08/2011
Approval date [1] 295746 0
22/12/2011
Ethics approval number [1] 295746 0
HREC/11/STG/176

Summary
Brief summary
This project aims to test whether enhanced fluid intake on the morning of a colonoscopy can avoid some of the deleterious effects associated with bowel preparation and prolonged fasting.
It will examine whether increased fluid intake of up to 1,200 mls of Gatorade during the morning, up to 2.5 hours before the start of the afternoon list will alter the incidence of fluid depletion and dehydration, and the associated symptoms and clinical signs such as headache, dry moth, thirst, dizziness, postural hypotension and concentrated urine. This will be compared to a control group fasting from 0600 on the day of the procedure.
Trial website
None
Trial related presentations / publications
None
Public notes
Data colection and analysis are complete. Findings await publication.

Contacts
Principal investigator
Name 68298 0
A/Prof Richard Morris
Address 68298 0
Department of Anaesthesia
St. George Hospital
Gray St. Kogarah, NSW, 2217
Country 68298 0
Australia
Phone 68298 0
+61 2 9113 2100
Fax 68298 0
Email 68298 0
[email protected]
Contact person for public queries
Name 68299 0
A/Prof Richard Morris
Address 68299 0
Department of Anaesthesia
St. George Hospital
Gray St. Kogarah, NSW, 2217
Country 68299 0
Australia
Phone 68299 0
+61 2 9113 2100
Fax 68299 0
Email 68299 0
[email protected]
Contact person for scientific queries
Name 68300 0
A/Prof Richard Morris
Address 68300 0
Department of Anaesthesia
St. George Hospital
Gray St. Kogarah, NSW, 2217
Country 68300 0
Australia
Phone 68300 0
+61 2 9113 2100
Fax 68300 0
Email 68300 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Effect of Oral Intake during the Immediate Pre-Colonoscopy Time Period on Volume Depletion in Patients who Receive Sodium Picosulfate.2017https://dx.doi.org/10.1177/0310057X1704500412
N.B. These documents automatically identified may not have been verified by the study sponsor.